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나도 꽃 / 김용택

Mon, 23 Nov 2009 16:54:30 +0900

나도 꽃 - 김용택

수천 수만 송이
아름다운 꽃들이 피어납니다.
생각에 생각을 보태며
나도 한송이 들국으로
그대 곁에
가만가만 핍니다.

Photo by S.W. Kang,blog-Aries21usa.11.22.2009
music/ Je N′ai Que Mon Ame (나에겐 마음 밖에 없어)

Je N′ai Que Mon Ame (나에겐 마음 밖에 없어) / Natasha St Pier

Tue, 24 Nov 2009 03:57:59 +0900

Puisqu'il faut dire, puisqu'il faut parler de soi
Puisque ton cœur ne brule plus comme autrefois
Meme si l'amour, je crois, ne se dit pas
Mais puisqu'il faut parler alors ecoute-moi
Mais je n'ai que mon ame

Pour te parler de moi
Oh juste mon ame Mon ame et ma voix
Si fragiles flammes
Au bout de mes doigts
Derisoires armes Pour parler de moi

Meme si tu dis que je fais partie de toi
Que notre histoire nous suivra pas a pas
Je sais tellement que l'amour a ses lois
S'il faut le sauver alors ecoute-moi
Mais je n'ai que mon ame

Pour te parler de moi
Oh juste mon ame Mon ame et ma voix
Et mon corps qui s'enflamme
Au son de ta voix
Je ne suis qu'une femme
Qui t'aime tout bas
Mais que Dieu me damne

Si j'oublie ma voie Que la vie me condamne
Si tu n'es plus ma loi
Et s'eteint cette flamme Qui brule pour toi

Je n'ai que mon ame
Pour parler de moi
Je n'ai que mon ame
Pour parler de moi

Photo by S.W. Kang,blog-Aries21usa.11.22.2009

PROSCAR® (finasteride) Tablets

Mon, 23 Nov 2009 17:15:14 +0900

DRUG DESCRIPTION

PROSCAR* (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT).

Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The empirical formula of finasteride is C₂₃H₃₆N₂O₂ and its molecular weight is 372.55. Its structural formula is:

Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water.

PROSCAR (finasteride) tablets for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: hydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, hydroxypropyl cellulose LF, hydroxypropyl methylcellulose, titanium dioxide, magnesium stearate, talc, docusate sodium, FD&C Blue 2 aluminum lake and yellow iron oxide.

INDICATIONS

PROSCAR is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

-Improve symptoms
-Reduce the risk of acute urinary retention
-Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥ 4 point increase in AUA symptom score).

DOSAGE AND ADMINISTRATION

The recommended dose is 5 mg orally once a day.

PROSCAR can be administered alone or in combination with the alpha-blocker doxazosin (see CLINICAL PHARMACOLOGY, Clinical Studies).

PROSCAR may be administered with or without meals.

No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

HOW SUPPLIED

No. 3094 - PROSCAR tablets 5 mg are blue, modified apple-shaped, film-coated tablets, with the code MSD 72 on one side and PROSCAR on the other. They are supplied as follows:

NDC 0006-0072-31 unit of use bottles of 30
NDC 0006-0072-58 unit of use bottles of 100
NDC 0006-0072-28 unit dose packages of 100
NDC 0006-0072-82 bottles of 1000.

Storage and Handling

Store at room temperatures below 30°C (86°F). Protect from light and keep container tightly closed.

Women should not handle crushed or broken PROSCAR tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus (see WARNINGS, EXPOSURE OF WOMEN - RISK TO MALE FETUS, and PRECAUTIONS, Information for Patients and Pregnancy).

SIDE EFFECTS

PROSCAR is generally well tolerated; adverse reactions usually have been mild and transient.

4-Year Placebo-Controlled Study

In PLESS, 1524 patients treated with PROSCAR and 1516 patients treated with placebo were evaluated for safety over a period of 4 years. The most frequently reported adverse reactions were related to sexual function. 3.7% (57 patients) treated with PROSCAR and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported adverse reactions.

Table 4 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on PROSCAR was ≥ 1% and greater than placebo over the 4 years of the study. In years 2-4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.

TABLE 4
Drug-Related Adverse Experiences

	Year 1 (%)		Years 2, 3 and 4* (%)
	Finasteride	Placebo	Finasteride	Placebo
Impotence	8.1	3.7	5.1	5.1
Decreased Libido	6.4	3.4	2.6	2.6
Decreased Volume of Ejaculate	3.7	0.8	1.5	0.5
Ejaculation Disorder	0.8	0.1	0.2	0.1
Breast Enlargement	0.5	0.1	1.8	1.1
Breast Tenderness	0.4	0.1	0.7	0.3
Rash	0.5	0.2	0.5	0.1
*Combined Years 2-4 N = 1524 and 1516, finasteride vs placebo, respectively

Phase III Studies and 5-Year Open Extensions

The adverse experience profile in the 1-year, placebo-controlled, Phase III studies, the 5-year open extensions, and PLESS were similar.

Medical Therapy of Prostatic Symptoms (MTOPS) Study

The incidence rates of drug-related adverse experiences reported by ≥ 2% of patients in any treatment group in the MTOPS Study are listed in Table 5.

The individual adverse effects which occurred more frequently in the combination group compared to either drug alone were: asthenia, postural hypotension, peripheral edema, dizziness, decreased libido, rhinitis, abnormal ejaculation, impotence and abnormal sexual function (see Table 5). Of these, the incidence of abnormal ejaculation in patients receiving combination therapy was comparable to the sum of the incidences of this adverse experience reported for the two monotherapies.

Combination therapy with finasteride and doxazosin was associated with no new clinical adverse experience.

Four patients in MTOPS reported the adverse experience breast cancer. Three of these patients were on finasteride only and one was on combination therapy. (See ADVERSE REACTIONS, Long-Term Data.)

The MTOPS Study was not specifically designed to make statistical comparisons between groups for reported adverse experiences. In addition, direct comparisons of safety data between the MTOPS study and previous studies of the single agents may not be appropriate based upon differences in patient population, dosage or dose regimen, and other procedural and study design elements.

Table 5
Incidence ≥ 2% in One or More Treatment Groups Drug-Related Clinical Adverse Experiences in MTOPS

Adverse Experience	Placebo (N=737) (%)	Doxazosin 4 mg or 8 mg* (N=756) (%)	Finasteride (N=768) (%)	Combination (N=786) (%)
Body as a whole
Asthenia	7.1	15.7	5.3	16.8
Headache	2.3	4.1	2.0	2.3
Cardiovascular
Hypotension	0.7	3.4	1.2	1.5
Postural Hypotension	8.0	16.7	9.1	17.8
Metabolic and Nutritional
Peripheral Edema	0.9	2.6	1.3	3.3
Nervous
Dizziness	8.1	17.7	7.4	23.2
Libido Decreased	5.7	7.0	10.0	11.6
Somnolence	1.5	3.7	1.7	3.1
Respiratory
Dyspnea	0.7	2.1	0.7	1.9
Rhinitis	0.5	1.3	1.0	2.4
Urogenital
Abnormal Ejaculation	2.3	4.5	7.2	14.1
Gynecomastia	0.7	1.1	2.2	1.5
Impotence	12.2	14.4	18.5	22.6
Sexual Function Abnormal	0.9	2.0	2.5	3.1
*Doxazosin dose was achieved by weekly titration (1 to 2 to 4 to 8 mg). The final tolerated dose (4 mg or 8 mg) was administered at end-Week 4. Only those patients tolerating at least 4 mg were kept on doxazosin. The majority of patients received the 8-mg dose over the duration of the study.

Long-Term Data

There is no evidence of increased adverse experiences with increased duration of treatment with PROSCAR. New reports of drug-related sexual adverse experiences decreased with duration of therapy.

During the 4- to 6-year placebo- and comparator-controlled MTOPS study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with finasteride but no cases in men not treated with finasteride. During the 4-year, placebo-controlled PLESS study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men, but no cases were reported in men treated with finasteride. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.

In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, 9060 had prostate needle biopsy data available for analysis. In the PROSCAR group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) men in the placebo group. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (stage T1 or T2). The clinical significance of these findings is unknown. This information from the literature (Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med 2003;349:213-22) is provided for consideration by physicians when PROSCAR is used as indicated (see INDICATIONS). PROSCAR is not approved to reduce the risk of developing prostate cancer.

Post-Marketing Experience

The following additional adverse effects have been reported in post-marketing experience:

- hypersensitivity reactions, including pruritus, urticaria, and swelling of the lips and face
- testicular pain.

DRUG INTERACTIONS

No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug metabolizing enzyme system. Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found.

Other Concomitant Therapy: Although specific interaction studies were not performed, PROSCAR was concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, angiotensin-converting enzyme (ACE) inhibitors, analgesics, anti-convulsants, beta-adrenergic blocking agents, diuretics, calcium channel blockers, cardiac nitrates, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), benzodiazepines, H₂ antagonists and quinolone anti-infectives without evidence of clinically significant adverse interactions.

WARNINGS

PROSCAR is not indicated for use in pediatric patients (see PRECAUTIONS, Pediatric Use) or women (see also WARNINGS, EXPOSURE OF WOMEN - RISK TO MALE FETUS; PRECAUTIONS, Information for Patients and Pregnancy; and HOW SUPPLIED).

Exposure Of Women - Risk To Male Fetus

Women should not handle crushed or broken PROSCAR tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. PROSCAR tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. (See CONTRAINDICATIONS; PRECAUTIONS, Information for Patients and Pregnancy; and HOW SUPPLIED.)

PRECAUTIONS

General

Prior to initiating therapy with PROSCAR, appropriate evaluation should be performed to identify other conditions such as infection, prostate cancer, stricture disease, hypotonic bladder or other neurogenic disorders that might mimic BPH.

Patients with large residual urinary volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. These patients may not be candidates for finasteride therapy.

Caution should be used in the administration of PROSCAR in those patients with liver function abnormalities, as finasteride is metabolized extensively in the liver.

Effects on PSA and Prostate Cancer Detection

No clinical benefit has been demonstrated in patients with prostate cancer treated with PROSCAR. Patients with BPH and elevated PSA were monitored in controlled clinical studies with serial PSAs and prostate biopsies. In these BPH studies, PROSCAR did not appear to alter the rate of prostate cancer detection, and the overall incidence of prostate cancer was not significantly different in patients treated with PROSCAR or placebo.

PROSCAR causes a decrease in serum PSA levels by approximately 50% in patients with BPH, even in the presence of prostate cancer. This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. Analysis of PSA data from over 3000 patients in PLESS confirmed that in typical patients treated with PROSCAR for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men. This adjustment preserves the sensitivity and specificity of the PSA assay and maintains its ability to detect prostate cancer.

Any sustained increases in PSA levels while on PROSCAR should be carefully evaluated, including consideration of non-compliance to therapy with PROSCAR.

Percent free PSA (free to total PSA ratio) is not significantly decreased by PROSCAR. The ratio of free to total PSA remains constant even under the influence of PROSCAR. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing finasteride therapy, no adjustment to its value appears necessary.

Drug/Laboratory Test Interactions

In patients with BPH, PROSCAR has no effect on circulating levels of cortisol, estradiol, prolactin, thyroid-stimulating hormone, or thyroxine. No clinically meaningful effect was observed on the plasma lipid profile (i.e., total cholesterol, low density lipoproteins, high density lipoproteins and triglycerides) or bone mineral density. Increases of about 10% were observed in luteinizing hormone (LH) and follicle- stimulating hormone (FSH) in patients receiving PROSCAR, but levels remained within the normal range. In healthy volunteers, treatment with PROSCAR did not alter the response of LH and FSH to gonadotropin-releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not affected.

Treatment with PROSCAR for 24 weeks to evaluate semen parameters in healthy male volunteers revealed no clinically meaningful effects on sperm concentration, mobility, morphology, or pH. A 0.6 mL (22.1%) median decrease in ejaculate volume with a concomitant reduction in total sperm per ejaculate was observed. These parameters remained within the normal range and were reversible upon discontinuation of therapy with an average time to return to baseline of 84 weeks.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of a tumorigenic effect was observed in a 24-month study in Sprague-Dawley rats receiving doses of finasteride up to 160 mg/kg/day in males and 320 mg/kg/day in females. These doses produced respective systemic exposure in rats of 111 and 274 times those observed in man receiving the recommended human dose of 5 mg/day. All exposure calculations were based on calculated AUC_{(0-24 hr)} for animals and mean AUC_{(0-24 hr)} for man (0.4 μg?hr/mL).

In a 19-month carcinogenicity study in CD-1 mice, a statistically significant (p < 0.05) increase in the incidence of testicular Leydig cell adenomas was observed at a dose of 250 mg/kg/day (228 times the human exposure). In mice at a dose of 25 mg/kg/day (23 times the human exposure, estimated) and in rats at a dose of ≥ 40 mg/kg/day (39 times the human exposure) an increase in the incidence of Leydig cell hyperplasia was observed. A positive correlation between the proliferative changes in the Leydig cells and an increase in serum LH levels (2- to 3-fold above control) has been demonstrated in both rodent species treated with high doses of finasteride. No drug-related Leydig cell changes were seen in either rats or dogs treated with finasteride for 1 year at doses of 20 mg/kg/day and 45 mg/kg/day (30 and 350 times, respectively, the human exposure) or in mice treated for 19 months at a dose of 2.5 mg/kg/day (2.3 times the human exposure, estimated).

No evidence of mutagenicity was observed in an in vitrobacterial mutagenesis assay, a mammalian cell mutagenesis assay, or in an in vitro alkaline elution assay. In an in vitro chromosome aberration assay, using Chinese hamster ovary cells, there was a slight increase in chromosome aberrations. These concentrations correspond to 4000-5000 times the peak plasma levels in man given a total dose of 5 mg. In an in vivo chromosome aberration assay in mice, no treatment-related increase in chromosome aberration was observed with finasteride at the maximum tolerated dose of 250 mg/kg/day (228 times the human exposure) as determined in the carcinogenicity studies.

In sexually mature male rabbits treated with finasteride at 80 mg/kg/day (543 times the human exposure) for up to 12 weeks, no effect on fertility, sperm count, or ejaculate volume was seen. In sexually mature male rats treated with 80 mg/kg/day of finasteride (61 times the human exposure), there were no significant effects on fertility after 6 or 12 weeks of treatment; however, when treatment was continued for up to 24 or 30 weeks, there was an apparent decrease in fertility, fecundity and an associated significant decrease in the weights of the seminal vesicles and prostate. All these effects were reversible within 6 weeks of discontinuation of treatment. No drug-related effect on testes or on mating performance has been seen in rats or rabbits. This decrease in fertility in finasteride-treated rats is secondary to its effect on accessory sex organs (prostate and seminal vesicles) resulting in failure to form a seminal plug. The seminal plug is essential for normal fertility in rats and is not relevant in man.

Pregnancy

Pregnancy Category X

See CONTRAINDICATIONS.

PROSCAR is not indicated for use in women.

Administration of finasteride to pregnant rats at doses ranging from 100 μg/kg/day to 100 mg/kg/day (1-1000 times the recommended human dose of 5 mg/day) resulted in dose-dependent development of hypospadias in 3.6 to 100% of male offspring. Pregnant rats produced male offspring with decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development when given finasteride at ≥ 30 μg/kg/day ( ≥ 3/10 of the recommended human dose of 5 mg/day) and decreased anogenital distance when given finasteride at ≥ 3 μg/kg/day ( ≥ 3/100 of the recommended human dose of 5 mg/day). The critical period during which these effects can be induced in male rats has been defined to be days 16-17 of gestation. The changes described above are expected pharmacological effects of drugs belonging to the class of Type II 5α-reductase inhibitors and are similar to those reported in male infants with a genetic deficiency of Type II 5a-reductase. No abnormalities were observed in female offspring exposed to any dose of finasteride in utero.

No developmental abnormalities have been observed in first filial generation (F₁) male or female offspring resulting from mating finasteride-treated male rats (80 mg/kg/day; 61 times the human exposure) with untreated females. Administration of finasteride at 3 mg/kg/day (30 times the recommended human dose of 5 mg/day) during the late gestation and lactation period resulted in slightly decreased fertility in F₁ male offspring. No effects were seen in female offspring. No evidence of malformations has been observed in rabbit fetuses exposed to finasteride in utero from days 6-18 of gestation at doses up to 100 mg/kg/day (1000 times the recommended human dose of 5 mg/day). However, effects on male genitalia would not be expected since the rabbits were not exposed during the critical period of genital system development.

The in utero effects of finasteride exposure during the period of embryonic and fetal development were evaluated in the rhesus monkey (gestation days 20-100), a species more predictive of human development than rats or rabbits. Intravenous administration of finasteride to pregnant monkeys at doses as high as 800 ng/day (at least 60 to 120 times the highest estimated exposure of pregnant women to finasteride from semen of men taking 5 mg/day) resulted in no abnormalities in male fetuses. In confirmation of the relevance of the rhesus model for human fetal development, oral administration of a dose of finasteride (2 mg/kg/day; 20 times the recommended human dose of 5 mg/day or approximately 1-2 million times the highest estimated exposure to finasteride from semen of men taking 5 mg/day) to pregnant monkeys resulted in external genital abnormalities in male fetuses. No other abnormalities were observed in male fetuses and no finasteride-related abnormalities were observed in female fetuses at any dose.

Nursing Mothers

PROSCAR is not indicated for use in women.

It is not known whether finasteride is excreted in human milk.

Pediatric Use

PROSCAR is not indicated for use in pediatric patients.

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Of the total number of subjects included in PLESS, 1480 and 105 subjects were 65 and over and 75 and over, respectively. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. No dosage adjustment is necessary in the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Clinical Studies).

OVERDOSE

Patients have received single doses of PROSCAR up to 400 mg and multiple doses of PROSCAR up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with PROSCAR can be recommended.

Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m² (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m² (400 mg/kg) and 5900 mg/m² (1000 mg/kg), respectively.

CONTRAINDICATIONS

PROSCAR is contraindicated in the following:

Hypersensitivity to any component of this medication.

Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to DHT, finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. (See also WARNINGS, EXPOSURE OF WOMEN - RISK TO MALE FETUS and PRECAUTIONS, Information for Patients and Pregnancy.) In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.

CLINICAL PHARMACOLOGY

The development and enlargement of the prostate gland is dependent on the potent androgen, 5a-dihydrotestosterone (DHT). Type II 5α-reductase metabolizes testosterone to DHT in the prostate gland, liver and skin. DHT induces androgenic effects by binding to androgen receptors in the cell nuclei of these organs.

Finasteride is a competitive and specific inhibitor of Type II 5α-reductase with which it slowly forms a stable enzyme complex. Turnover from this complex is extremely slow (t_½~ 30 days). This has been demonstrated both in vivo and in vitro. Finasteride has no affinity for the androgen receptor. In man, the 5α-reduced steroid metabolites in blood and urine are decreased after administration of finasteride.

In man, a single 5-mg oral dose of PROSCAR produces a rapid reduction in serum DHT concentration, with the maximum effect observed 8 hours after the first dose. The suppression of DHT is maintained throughout the 24-hour dosing interval and with continued treatment. Daily dosing of PROSCAR at 5 mg/day for up to 4 years has been shown to reduce the serum DHT concentration by approximately 70%. The median circulating level of testosterone increased by approximately 10-20% but remained within the physiologic range.

Adult males with genetically inherited Type II5α-reductase deficiency also have decreased levels of DHT. Except for the associated urogenital defects present at birth, no other clinical abnormalities related to Type II 5α-reductase deficiency have been observed in these individuals. These individuals have a small prostate gland throughout life and do not develop BPH.

In patients with BPH treated with finasteride (1-100 mg/day) for 7-10 days prior to prostatectomy, an approximate 80% lower DHT content was measured in prostatic tissue removed at surgery, compared to placebo; testosterone tissue concentration was increased up to 10 times over pretreatment levels, relative to placebo. Intraprostatic content of prostate-specific antigen (PSA) was also decreased.

In healthy male volunteers treated with PROSCAR for 14 days, discontinuation of therapy resulted in a return of DHT levels to pretreatment levels in approximately 2 weeks. In patients treated for three months, prostate volume, which declined by approximately 20%, returned to close to baseline value after approximately three months of discontinuation of therapy.

Pharmacokinetics

Absorption

In a study of 15 healthy young subjects, the mean bioavailability of finasteride 5-mg tablets was 63% (range 34-108%), based on the ratio of area under the curve (AUC) relative to an intravenous (IV) reference dose. Maximum finasteride plasma concentration averaged 37 ng/mL (range, 27-49 ng/mL) and was reached 1-2 hours postdose. Bioavailability of finasteride was not affected by food.

Distribution

Mean steady-state volume of distribution was 76 liters (range, 44-96 liters). Approximately 90% of circulating finasteride is bound to plasma proteins. There is a slow accumulation phase for finasteride after multiple dosing. After dosing with 5 mg/day of finasteride for 17 days, plasma concentrations of finasteride were 47 and 54% higher than after the first dose in men 45-60 years old (n=12) and ≥ 70 years old (n=12), respectively. Mean trough concentrations after 17 days of dosing were 6.2 ng/mL (range, 2.4- 9.8 ng/mL) and 8.1 ng/mL (range, 1.8-19.7 ng/mL), respectively, in the two age groups. Although steady state was not reached in this study, mean trough plasma concentration in another study in patients with BPH (mean age, 65 years) receiving 5 mg/day was 9.4 ng/mL (range, 7.1-13.3 ng/mL; n=22) after over a year of dosing.

Finasteride has been shown to cross the blood brain barrier but does not appear to distribute preferentially to the CSF.

In 2 studies of healthy subjects (n=69) receiving PROSCAR 5 mg/day for 6-24 weeks, finasteride concentrations in semen ranged from undetectable ( < 0.1 ng/mL) to 10.54 ng/mL. In an earlier study using a less sensitive assay, finasteride concentrations in the semen of 16 subjects receiving PROSCAR 5 mg/day ranged from undetectable ( < 1.0 ng/mL) to 21 ng/mL. Thus, based on a 5-mL ejaculate volume, the amount of finasteride in semen was estimated to be 50- to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating DHT levels in men (see also PRECAUTIONS, Pregnancy).

Metabolism

Finasteride is extensively metabolized in the liver, primarily via the cytochrome P450 3A4 enzyme subfamily. Two metabolites, the t-butyl side chain monohydroxylated and monocarboxylic acid metabolites, have been identified that possess no more than 20% of the 5a-reductase inhibitory activity of finasteride.

Excretion

In healthy young subjects (n=15), mean plasma clearance of finasteride was 165 mL/min (range, 70- 279 mL/min) and mean elimination half-life in plasma was 6 hours (range, 3-16 hours). Following an oral dose of ¹⁴C-finasteride in man (n=6), a mean of 39% (range, 32-46%) of the dose was excreted in the urine in the form of metabolites; 57% (range, 51-64%) was excreted in the feces.

The mean terminal half-life of finasteride in subjects ≥ 70 years of age was approximately 8 hours (range, 6-15 hours; n=12), compared with 6 hours (range, 4-12 hours; n=12) in subjects 45-60 years of age. As a result, mean AUC_{(0-24 hr)} after 17 days of dosing was 15% higher in subjects ≥ 70 years of age than in subjects 45-60 years of age (p=0.02).

Special Populations

Pediatric: Finasteride pharmacokinetics have not been investigated in patients < 18 years of age.

Gender: Finasteride pharmacokinetics in women are not available.

Geriatric: No dosage adjustment is necessary in the elderly. Although the elimination rate of finasteride is decreased in the elderly, these findings are of no clinical significance. See also Pharmacokinetics, Excretion, PRECAUTIONS, Geriatric Use and DOSAGE AND ADMINISTRATION.

Race: The effect of race on finasteride pharmacokinetics has not been studied.

Renal Insufficiency: No dosage adjustment is necessary in patients with renal insufficiency. In patients with chronic renal impairment, with creatinine clearances ranging from 9.0 to 55 mL/min, AUC, maximum plasma concentration, half-life, and protein binding after a single dose of ¹⁴C-finasteride were similar to values obtained in healthy volunteers. Urinary excretion of metabolites was decreased in patients with renal impairment. This decrease was associated with an increase in fecal excretion of metabolites. Plasma concentrations of metabolites were significantly higher in patients with renal impairment (based on a 60% increase in total radioactivity AUC). However, finasteride has been well tolerated in BPH patients with normal renal function receiving up to 80 mg/day for 12 weeks, where exposure of these patients to metabolites would presumably be much greater.

Hepatic Insufficiency: The effect of hepatic insufficiency on finasteride pharmacokinetics has not been studied. Caution should be used in the administration of PROSCAR in those patients with liver function abnormalities, as finasteride is metabolized extensively in the liver.

Drug Interactions

(also see PRECAUTIONS: DRUG INTERACTIONS)

No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug metabolism enzyme system. Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin, and no clinically meaningful interactions were found.

Mean (SD) Pharmacokinetic Parameters in Healthy Young Subjects (n=15)

	Mean (± SD)
Bioavailability	63% (34-108%)*
Clearance (mL/min)	165 (55)
Volume of Distribution (L)	76 (14)
Half-Life (hours)	6.2 (2.1)
*Range

Mean (SD) Noncompartmental Pharmacokinetic Parameters After Multiple Doses of 5 mg/day in Older Men

	Mean (± SD)
	45-60 years old (n=12)	≥ 70 years old (n=12)
AUC (ng?hr/mL)	389 (98)	463 (186)
Peak Concentration (ng/mL)	46.2 (8.7)	48.4 (14.7)
Time to Peak (hours)	1.8 (0.7)	1.8 (0.6)
Half-Life (hours)*	6.0 (1.5)	8.2 (2.5)
*First-dose values; all other parameters are last-dose values

Clinical Studies

PROSCAR 5 mg/day was initially evaluated in patients with symptoms of BPH and enlarged prostates by digital rectal examination in two 1-year, placebo-controlled, randomized, double-blind studies and their 5-year open extensions.

PROSCAR was further evaluated in the PROSCAR Long-Term Efficacy and Safety Study (PLESS), a double-blind, randomized, placebo-controlled, 4-year, multicenter study. 3040 patients between the ages of 45 and 78, with moderate to severe symptoms of BPH and an enlarged prostate upon digital rectal examination, were randomized into the study (1524 to finasteride, 1516 to placebo) and 3016 patients were evaluable for efficacy. 1883 patients completed the 4-year study (1000 in the finasteride group, 883 in the placebo group).

Effect on Symptom Score

Symptoms were quantified using a score similar to the American Urological Association Symptom Score, which evaluated both obstructive symptoms (impairment of size and force of stream, sensation of incomplete bladder emptying, delayed or interrupted urination) and irritative symptoms (nocturia, daytime frequency, need to strain or push the flow of urine) by rating on a 0 to 5 scale for six symptoms and a 0 to 4 scale for one symptom, for a total possible score of 34.

Patients in PLESS had moderate to severe symptoms at baseline (mean of approximately 15 points on a 0-34 point scale). Patients randomized to PROSCAR who remained on therapy for 4 years had a mean (± 1 SD) decrease in symptom score of 3.3 (± 5.8) points compared with 1.3 (± 5.6) points in the placebo group. (See Figure 1.) A statistically significant improvement in symptom score was evident at 1 year in patients treated with PROSCAR vs placebo (-2.3 vs -1.6), and this improvement continued through Year 4.

Figure 1
Symptom Score in PLESS

Results seen in earlier studies were comparable to those seen in PLESS. Although an early improvement in urinary symptoms was seen in some patients, a therapeutic trial of at least 6 months was generally necessary to assess whether a beneficial response in symptom relief had been achieved. The improvement in BPH symptoms was seen during the first year and maintained throughout an additional 5 years of open extension studies.

Effect on Acute Urinary Retention and the Need for Surgery

In PLESS, efficacy was also assessed by evaluating treatment failures. Treatment failure was prospectively defined as BPH-related urological events or clinical deterioration, lack of improvement and/or the need for alternative therapy. BPH-related urological events were defined as urological surgical intervention and acute urinary retention requiring catheterization. Complete event information was available for 92% of the patients. The following table (Table 1) summarizes the results.

Table 1
All Treatment Failures in PLESS

	Patients (%) *
Event	Placebo N=1503	Finasteride N=1513	Relative Risk**	95% CI	P Value**
All Treatment Failures	37.1	26.2	0.68	(0.57 to 0.79)	< 0.001
Surgical Interventions for BPH	10.1	4.6	0.45	(0.32 to 0.63)	< 0.001
Acute Urinary Retention Requiring Catheterization	6.6	2.8	0.43	(0.28 to 0.66)	< 0.001
Two consecutive symptom scores ≥ 20	9.2	6.7
Bladder Stone	0.4	0.5
Incontinence	2.1	1.7
Renal Failure	0.5	0.6
UTI	5.7	4.9
Discontinuation due to worsening of BPH, lack of improvement, or to receive other medical treatment	21.8	13.3
patients with multiple events may be counted more than once for each type of event *Hazard ratio based on log rank test

Compared with placebo, PROSCAR was associated with a significantly lower risk for acute urinary retention or the need for BPH-related surgery [13.2% for placebo vs 6.6% for PROSCAR; 51% reduction in risk, 95% CI: (34 to 63%)]. Compared with placebo, PROSCAR was associated with a significantly lower risk for surgery [10.1% for placebo vs 4.6% for PROSCAR; 55% reduction in risk, 95% CI: (37 to 68%)] and with a significantly lower risk of acute urinary retention [6.6% for placebo vs 2.8% for PROSCAR; 57% reduction in risk, 95% CI: (34 to 72%)]; see Figures 2 and 3.

Figure 2
Percent of Patients Having Surgery for BPH, Including TURP

Placebo Group
No. of events, cumulative No. at risk, per year	37 1503	89 1454	121 1374	152 1314
Finasteride Group
No. of events, cumulative No. at risk, per year	18 1513	40 1483	49 1438	69 1410

Figure 3
Percent of Patients Developing Acute Urinary Retention (Spontaneous and Precipitated)

Placebo Group
No. of events, cumulative No. at risk, per year	36 1503	61 1454	81 1398	99 1347
Finasteride Group
No. of events, cumulative No. at risk, per year	14 1513	25 1487	32 1449	42 1421

Effect on Maximum Urinary Flow Rate

In the patients in PLESS who remained on therapy for the duration of the study and had evaluable urinary flow data, PROSCAR increased maximum urinary flow rate by 1.9 mL/sec compared with 0.2 mL/sec in the placebo group.

There was a clear difference between treatment groups in maximum urinary flow rate in favor of PROSCAR by month 4 (1.0 vs 0.3 mL/sec) which was maintained throughout the study. In the earlier 1- year studies, increase in maximum urinary flow rate was comparable to PLESS and was maintained through the first year and throughout an additional 5 years of open extension studies.

Effect on Prostate Volume

In PLESS, prostate volume was assessed yearly by magnetic resonance imaging (MRI) in a subset of patients. In patients treated with PROSCAR who remained on therapy, prostate volume was reduced compared with both baseline and placebo throughout the 4-year study. PROSCAR decreased prostate volume by 17.9% (from 55.9 cc at baseline to 45.8 cc at 4 years) compared with an increase of 14.1% (from 51.3 cc to 58.5 cc) in the placebo group (p < 0.001). (See Figure 4.)

Results seen in earlier studies were comparable to those seen in PLESS. Mean prostate volume at baseline ranged between 40-50 cc. The reduction in prostate volume was seen during the first year and maintained throughout an additional five years of open extension studies.

Figure 4
Prostate Volume in PLESS

Placebo (?) n =	155	136	11 9	98	85
Finasteride ( ) n =	157	144	130	11 6	102

Prostate Volume as a Predictor of Therapeutic Response

A meta-analysis combining 1-year data from seven double-blind, placebo-controlled studies of similar design, including 4491 patients with symptomatic BPH, demonstrated that, in patients treated with PROSCAR, the magnitude of symptom response and degree of improvement in maximum urinary flow rate were greater in patients with an enlarged prostate at baseline.

Medical Therapy of Prostatic Symptoms

The Medical Therapy of Prostatic Symptoms (MTOPS) Trial was a double-blind, randomized, placebo-controlled, multicenter, 4- to 6-year study (average 5 years) in 3047 men with symptomatic BPH, who were randomized to receive PROSCAR 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the combination of PROSCAR 5 mg/day and doxazosin 4 or 8 mg/day (n=786), or placebo (n=737). All participants underwent weekly titration of doxazosin (or its placebo) from 1 to 2 to 4 to 8 mg/day. Only those who tolerated the 4 or 8 mg dose level were kept on doxazosin (or its placebo) in the study. The participant's final tolerated dose (either 4 mg or 8 mg) was administered beginning at end-Week 4. The final doxazosin dose was administered once per day, at bedtime.

The mean patient age at randomization was 62.6 years (±7.3 years). Patients were Caucasian (82%), African American (9%), Hispanic (7%), Asian (1%) or Native American ( < 1%). The mean duration of BPH symptoms was 4.7 years (±4.6 years). Patients had moderate to severe BPH symptoms at baseline with a mean AUA symptom score of approximately 17 out of 35 points. Mean maximum urinary flow rate was 10.5 mL/sec (±2.6 mL/sec). The mean prostate volume as measured by transrectal ultrasound was 36.3 mL (+20.1 mL). Prostate volume was ≤ 20 mL in 16% of patients, ≥ 50 mL in 18% of patients and between 21 and 49 mL in 66% of patients.

The primary endpoint was a composite measure of the first occurrence of any of the following five outcomes: a ≥ 4 point confirmed increase from baseline in symptom score, acute urinary retention, BPH- related renal insufficiency (creatinine rise), recurrent urinary tract infections or urosepsis, or incontinence. Compared to placebo, treatment with PROSCAR, doxazosin, or combination therapy resulted in a reduction in the risk of experiencing one of these five outcome events by 34% (p=0.002), 39% (p < 0.001), and 67% (p < 0.001), respectively. Combination therapy resulted in a significant reduction in the risk of the primary endpoint compared to treatment with PROSCAR alone (49%; p ≤ 0.001) or doxazosin alone (46%; p ≤ 0.001). (See Table 2.)

Table 2
Count and Percent Incidence of Primary Outcome Events by Treatment Group in MTOPS

Event	Treatment Group
Event	Placebo N=737 N (%)	Doxazosin N=756 N (%)	Finasteride N=768 N (%)	Combination N=786 N (%)	Total N=3047 N (%)
AUA 4-point rise	100 (13.6)	59 (7.8)	74 (9.6)	41 (5.2)	274 (9.0)
Acute urinary retention	18 (2.4)	13 (1.7)	6 (0.8)	4 (0.5)	41 (1.3)
Incontinence	8 (1.1)	11 (1.5)	9 (1.2)	3 (0.4)	31 (1.0)
Recurrent UTI/urosepsis	2 (0.3)	2 (0.3)	0 (0.0)	1 (0.1)	5 (0.2)
Creatinine rise	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Total Events	128 (17.4)	85 (11.2)	89 (11.6)	49 (6.2)	351 (11.5)

The majority of the events (274 out of 351; 78%) was a confirmed ≥ 4 point increase in symptom score, referred to as symptom score progression. The risk of symptom score progression was reduced by 30% (p=0.016), 46% (p < 0.001), and 64% (p < 0.001) in patients treated with PROSCAR, doxazosin, or the combination, respectively, compared to patients treated with placebo (see Figure 5). Combination therapy significantly reduced the risk of symptom score progression compared to the effect of PROSCAR alone (p < 0.001) and compared to doxazosin alone (p=0.037).

Figure 5
Cumulative Incidence of a 4-Point Rise in AUA Symptom Score by Treatment Group

Treatment with PROSCAR, doxazosin or the combination of PROSCAR with doxazosin, reduced the mean symptom score from baseline at year 4. Table 3 provides the mean change from baseline for AUA symptom score by treatment group for patients who remained on therapy for four years.

Table 3
Change From Baseline in AUA Symptom Score by Treatment Group at Year 4 in MTOPS

The results of MTOPS are consistent with the findings of the 4-year, placebo-controlled study PLESS (see CLINICAL PHARMACOLOGY, Clinical Studies) in that treatment with PROSCAR reduces the risk of acute urinary retention and the need for BPH-related surgery. In MTOPS, the risk of developing acute urinary retention was reduced by 67% in patients treated with PROSCAR compared to patients treated with placebo (0.8% for PROSCAR and 2.4% for placebo). Also, the risk of requiring BPH-related invasive therapy was reduced by 64% in patients treated with PROSCAR compared to patients treated with placebo (2.0% for PROSCAR and 5.4% for placebo).

Summary of Clinical Studies

The data from these studies, showing improvement in BPH-related symptoms, reduction in treatment failure (BPH-related urological events), increased maximum urinary flow rates, and decreasing prostate volume, suggest that PROSCAR arrests the disease process of BPH in men with an enlarged prostate.

PATIENT INFORMATION

Women should not handle crushed or broken PROSCAR tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to the male fetus (see CONTRAINDICATIONS; WARNINGS, EXPOSURE OF WOMEN - RISK TO MALE FETUS; PRECAUTIONS, Pregnancy and HOW SUPPLIED).

Physicians should inform patients that the volume of ejaculate may be decreased in some patients during treatment with PROSCAR. This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with PROSCAR (see ADVERSE REACTIONS).

Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge. Breast changes including breast enlargement, tenderness and neoplasm have been reported (see ADVERSE REACTIONS).

Physicians should instruct their patients to read the patient package insert before starting therapy with PROSCAR and to reread it each time the prescription is renewed so that they are aware of current information for patients regarding PROSCAR.

Consumer

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

FINASTERIDE - ORAL

(fin-AST-er-ide)

COMMON BRAND NAME(S): Proscar

USES: Finasteride is used to shrink an enlarged prostate (benign prostatic hyperplasia or BPH) in adult men. It may be used alone or taken in combination with other medications to reduce symptoms of BPH and may also reduce the need for surgery.

Finasteride may improve symptoms of BPH and provide benefits such as decreased urge to urinate, better urine flow with less straining, less of a feeling that the bladder is not completely emptied, and decreased nighttime urination.

This medication works by decreasing the amount of a natural body hormone (DHT) that causes growth of the prostate.

Women and children should not use this medication.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start taking finasteride and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take this medication by mouth, with or without food, usually once a day, or as directed by your doctor.

If the tablet is crushed or broken, it should not be handled by a woman who is pregnant or by a woman who may become pregnant (see also Precautions section).

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Do not stop taking this medication without consulting your doctor.

It may take 6-12 months to notice a benefit.

Inform your doctor if your condition persists or worsens.

Consumer (continued)

SIDE EFFECTS: Decreased sexual ability/desire may occur. In some men, this medication can decrease the amount of semen released during sex. This is harmless. Finasteride may also increase hair growth. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: lump in the breast, nipple discharge, breast enlargement/tenderness/pain, pain in the testicles, inability to urinate.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking finasteride, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, prostate cancer, infections, urinary problems.

Finasteride should not be used in children.

The drug can be absorbed through the skin. If the film coating of the tablet has been broken or the tablet crushed, it should not be handled by a woman who is pregnant or planning to become pregnant. Exposing a developing male infant to finasteride can result in abnormalities of the genitals.

Finasteride is not recommended for use in women and must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately.

Because this drug is not intended for use in women, it is not known if finasteride passes into breast milk. Consult your doctor before breast-feeding.

Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

This medication can affect the results of the blood test used to detect prostate cancer (prostatic-specific antigen or PSA levels). Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., prostate exams, PSA levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all appointments with your doctor and the laboratory. You should have a complete physical examination. Follow your doctor's instructions for examining your breasts and testicles, and report any lumps immediately.

Although early improvement is often seen, at least 6 to 12 months of therapy may be necessary in some patients to assess whether or not a benefit has occurred. Therefore, it is important to keep regular doctor appointments and get blood tests as scheduled to make sure this medication is working.

Many men are born with the condition this drug mimics (prostate glands that are smaller than usual) and lead normal lives with normal sex drives.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store US product at room temperature below 86 degrees F (30 degrees C) away from light and moisture in a tightly closed container.

Store Canadian product at room temperature between 59 to 86 degrees F (15 to 30 degrees C) away from light and moisture in a tightly closed container.

Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Scrap;RX List

다양한 종류의 아이스크림

Sun, 22 Nov 2009 10:29:59 +0900

다양한 종류의 아이스크림.

꿈에 아이스크림 먹으면서 단맛이 강하게 느껴졌다면
정신이 맑아지고 일상의 번뇌가 싹 가신다는 의미라는데
서먹했던 인간관계 역시 좋아진다고 합니다.
무엇보다도 중요한 것은
꿈의 해몽은 마음가짐이라고 하더군요.

일반적을 쉽게 주변에서 볼 수 없는 아이스크림을 담아 보았습니다.

▲ 철갑 상어알(캐비어)을 얻은 아이스크림 입니다.

▲ 유기농 옥수수로 만든 아이스크림.

▲ 숮으로 만든 아이스크림- 점점 종류가 다양해지죠.

▲ 베이컨 아이스크림.

▲ 당근과 카레로 만든 아이스크림.

▲ 낙지 아이스크림- 별별 아이스크림이 다 있군요.

▲ 낙지로 만든 아이스크림이 있으니 당연히 생선으로 만든 아이스크림도
있겠지요.

▲ 그런데... 잠자리 들기 전에 먹는 아이스크림 인가봅니다.
비아그라 아이스크림.

아이스크림 중 낮에 먹어서는 곤란한 아이스크림이 다 있으니
세상은 참 넓고 다양해 지는것 같습니다.
자연 성분이라고 하는데...
개발해서 한국에서 판매를 하면 어떨까요?
혹시 이것도 처방을 받아야 하는지...

불현듯 다녀오고 싶다.

Sat, 21 Nov 2009 16:20:52 +0900

며칠전 밤새우다시피 하며 모처럼 한국 드라마<아이리스>를 보았다.

영화나 드라마가 그렇듯
허구인걸 알면서도 왠지 현실에서 벌어지는 일인것처럼 생각되어 흥미진진
역시 잘 만든 작품들은 뻔히 조작 된거라는걸 알면서도 자기도 모르게 빠져드는 재미랄까...

아름다운 장면도 많이 나온다. 사탕 주고 받는 키스신도 물론 재밌었고...
눈이 많이 내리는 일본 ...
오래전에 읽으면서 가보고 싶다고 생각했던
'가와바다 야스나리'의 노벨문학상 받은 작품 '설국'에 대하여도 언뜻 운운.
아 그곳이 그곳인가?

눈내리는 풍경은 가히 환상. 나도 조만간 그곳에서 그저 푹 파묻혀 연락두절되고 싶단 생각을
해보며 실실...감촉같이 4박 5일이면? 하다가...
거기까지 갔다가 한국 안들려 가족 친지들 안보고 온다는건 역시 말도 안되겠지.
현실에선 또 어림도 없을 상상. 이미 복잡하게 몇단계를 하고 있음을 발견,,,
이게 뭐하는 짓인가 피식 웃고 만다.

배경속의 음식점의 풍경이 이곳과는 너무 대조적...
일식을 좋아해서인지 -사실 일본에서의 맛은 우리가 늘 먹던 그것과는 조금 달랐던듯...
보고 있는 내내 식욕이 동했다.
잘 마시지도 못하는 도꾸리가 환상으로 보이고...

'나 혼자 좀 다녀오면 안될까? 조용히 살짝? '

하고 물어보려니

'당신 미쳤어?...아주 가서 오지도마... 그럴것 같다.'
물론 버럭 소리지르며...ㅠ

자기는 언제나 자기하고 싶은거 가고 싶은곳 마음대로 다 하고 다녔으면서...

심통은 나지만서도 뭐... 코딱지나 후빌까보다...' 그래 당신잘났어' 하며...ㅋㅋ

-사실 생각해 보면 혼자선 그런곳에 떠나 돌아다닐 자신도 없다, 아무 연고도 없고
볼 일도 없는곳...여행은 혼자라야 멋(?)이 더 한다던데...-

PROPECIA®(finasteride) Tablets,1mg

Sat, 21 Nov 2009 20:15:22 +0900

Women who are or may potentially be pregnant must not use PROPECIA and should not handle crushed or broken PROPECIA tablets because the active ingredient may cause abnormalities of a male baby’s sex organs. If a woman who is pregnant comes into contact with the active ingredient in PROPECIA, a doctor should be consulted. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

설명된 바와 같이
머리카락손상이나 그 외에 합당한 이유의 남성만이 먹을수 있는약이다.
가임기 여성. 남성,어린이는 복용 금지.
그 밖의 지침에 따라 매우 조심스럽게 다뤄져야 하며
반드시 전문의의 지시하에 복용하여야 한다.
절대로
깨지거나 파손된 정제 혹은 깨물거나 녹여(?) 먹으면 안되는 약...

DRUG DESCRIPTION

PROPECIA^* (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5a-reductase, an intracellular enzyme that converts the androgen testosterone into 5a-dihydrotestosterone (DHT).

Finasteride is 4-azaandrost-1-ene-17-carboxamide,N-(1,1-dimethylethyl)-3-oxo-,(5a,17b)-. The empirical formula of finasteride is C₂₃H₃₆N₂O₂ and its molecular weight is 372.55. Its structural formula is:

Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water.

PROPECIA tablets for oral administration are film-coated tablets that contain 1 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, hydroxypropyl methylcellulose, hydroxypropyl cellulose LF, titanium dioxide, magnesium stearate, talc, docusate sodium, yellow ferric oxide, and red ferric oxide.

INDICATIONS

PROPECIA is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Safety and efficacy were demonstrated in men between 18 to 41 years of age with mild to moderate hair loss of the vertex and anterior mid-scalp area (see CLINICAL PHARMACOLOGY, Clinical Studies).

Efficacy in bitemporal recession has not been established.

PROPECIA is not indicated in women (see CLINICAL PHARMACOLOGY, Clinical Studies and CONTRAINDICATIONS).

PROPECIA is not indicated in children (see PRECAUTIONS, Pediatric Use).

DOSAGE AND ADMINISTRATION

The recommended dosage is 1 mg orally once a day.

PROPECIA may be administered with or without meals.

In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.

HOW SUPPLIED

No. 6642 ? PROPECIA tablets, 1 mg, are tan, octagonal, film-coated convex tablets with "stylized P" logo on one side and PROPECIA on the other. They are supplied as follows:

NDC 0006-0071-31 unit of use bottles of 30 (with desiccant)
NDC 0006-0071-61 PROPAK^®*** - carton of 3 unit of use bottles of 30 (with desiccant)
NDC 0006-0071-54 PROPAK - carton of 1 unit of use bottle of 90 (with desiccant).

Storage and Handling

Store at room temperature, 15-30°C (59-86°F). Keep container closed and protect from moisture.

Women should not handle crushed or broken PROPECIA tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed. (See WARNINGS, EXPOSURE OF WOMEN - RISK TO MALE FETUS; and PRECAUTIONS, Information for Patients and Pregnancy.)

*** Registered trademark of MERCK & CO., Inc.
Whitehouse Station, NJ 08889, USA

Issued October 2004 Printed in USA

SIDE EFFECTS

Clinical Studies for PROPECIA (finasteride 1 mg) in the Treatment of Male Pattern Hair Loss

In three controlled clinical trials for PROPECIA of 12-month duration, 1.4% of patients taking PROPECIA (n=945) were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo; n=934).

Clinical adverse experiences that were reported as possibly, probably or definitely drug-related in ³1% of patients treated with PROPECIA or placebo are presented in Table 1.

TABLE 1 Drug-Related Adverse Experiences for PROPECIA (finasteride 1 mg) in Year 1 (%) MALE PATTERN HAIR LOSS
	PROPECIA N=945	Placebo N=934
Decreased Libido	1.8	1.3
Erectile Dysfunction	1.3	0.7
Ejaculation Disorder	1.2	0.7
(Decreased Volume of Ejaculate)	(0.8)	(0.4)
Discontinuation due to drug-related sexual adverse experiences	1.2	0.9

Integrated analysis of clinical adverse experiences showed that during treatment with PROPECIA, 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04). Resolution occurred in men who discontinued therapy with PROPECIA due to these side effects and in most of those who continued therapy. The incidence of each of the above adverse experiences decreased to ￡0.3% by the fifth year of treatment with PROPECIA.

In a study of finasteride 1 mg daily in healthy men, a median decrease in ejaculate volume of 0.3 mL (-11%) compared with 0.2 mL (-8%) for placebo was observed after 48 weeks of treatment. Two other studies showed that finasteride at 5 times the dosage of PROPECIA (5 mg daily) produced significant median decreases of approximately 0.5 mL (-25%) compared to placebo in ejaculate volume, but this was reversible after discontinuation of treatment.

In the clinical studies with PROPECIA, the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicular pain in finasteride-treated patients were not different from those in patients treated with placebo.

Postmarketing Experience for PROPECIA (finasteride 1 mg)

Breast tenderness and enlargement; hypersensitivity reactions including rash, pruritus, urticaria, and swelling of the lips and face; and testicular pain. See Controlled Clinical Trials and Long-Term Open Extension Studies for PROSCAR* (finasteride 5 mg) in the Treatment of Benign Prostatic Hyperplasia.

Controlled Clinical Trials and Long-Term Open Extension Studies for PROSCAR* (finasteride 5 mg) in the Treatment of Benign Prostatic Hyperplasia

In the PROSCAR Long-Term Efficacy and Safety Study (PLESS), a 4-year controlled clinical study, 3040 patients between the ages of 45 and 78 with symptomatic BPH and an enlarged prostate were evaluated for safety over a period of 4 years (1524 on PROSCAR 5 mg/day and 1516 on placebo). 3.7% (57 patients) treated with PROSCAR 5 mg and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported adverse reactions.

Table 2 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on PROSCAR was ³1% and greater than placebo over the 4 years of the study. In years 2-4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.

TABLE 2 : Drug-Related Adverse Experiences for PROSCAR (finasteride 5 mg) BENIGN PROSTATIC HYPERPLASIA
	Year 1 (%)		Years 2, 3 and 4* (%)
	Finasteride, 5 mg	Placebo	Finasteride, 5 mg	Placebo
Impotence	8.1	3.7	5.1	5.1
Decreased Libido	6.4	3.4	2.6	2.6
Decreased Volume of Ejaculate	3.7	0.8	1.5	0.5
Ejaculation Disorder	0.8	0.1	0.2	0.1
Breast Enlargement	0.5	0.1	1.8	1.1
Breast Tenderness	0.4	0.1	0.7	0.3
Rash	0.5	0.2	0.5	0.1
*Combined Years 2-4
N = 1524 and 1516, finasteride vs placebo, respectively

The adverse experience profiles in the 1-year, placebo-controlled, Phase III BPH studies and the 5-year open extensions with PROSCAR 5 mg and PLESS were similar.

There is no evidence of increased adverse experiences with increased duration of treatment with PROSCAR 5 mg. New reports of drug-related sexual adverse experiences decreased with duration of therapy.

The relationship between long-term use of finasteride and male breast neoplasia is currently unknown. During a 4- to 6-year placebo- and comparator-controlled study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with PROSCAR but no cases in men not treated with PROSCAR. In another 4-year, placebo-controlled study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men, but no cases were reported in men treated with PROSCAR.

In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, 9060 had prostate needle biopsy data available for analysis. In the PROSCAR group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) men in the placebo group. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (stage T1 or T2). The clinical significance of these findings is unknown. This information from the literature (Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med 2003;349:213-22) is provided for consideration by physicians when PROSCAR is used as indicated. PROSCAR is not approved to reduce the risk of developing prostate cancer.

DRUG INTERACTIONS

No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug-metabolizing enzyme system. Compounds that have been tested in man include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found.

Other concomitant therapy

Although specific interaction studies were not performed, finasteride doses of 1 mg or more were concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, a-blockers, analgesics, angiotensin-converting enzyme (ACE) inhibitors, anticonvulsants, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H₂ antagonists, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (also referred to as NSAIDs), and quinolone anti-infectives without evidence of clinically significant adverse interactions.

Drug/Laboratory Test Interactions

Finasteride had no effect on circulating levels of cortisol, thyroid-stimulating hormone, or thyroxine, nor did it affect the plasma lipid profile (e.g., total cholesterol, low-density lipoproteins, high-density lipoproteins and triglycerides) or bone mineral density. In studies with finasteride, no clinically meaningful changes in luteinizing hormone (LH), follicle-stimulating hormone (FSH) or prolactin were detected. In healthy volunteers, treatment with finasteride did not alter the response of LH and FSH to gonadotropin-releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not affected.

In clinical studies with PROPECIA (finasteride, 1 mg) in men 18-41 years of age, the mean value of serum prostate-specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at Month 12. Further, in clinical studies with PROSCAR (finasteride, 5 mg) when used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. These findings should be taken into account for proper interpretation of serum PSA when evaluating men treated with finasteride.

WARNINGS

PROPECIA is not indicated for use in pediatric patients (see INDICATIONS AND USAGE; and PRECAUTIONS, Pediatric Use) or women (see also WARNINGS, EXPOSURE OF WOMEN - RISK TO MALE FETUS; PRECAUTIONS, Information for Patients and Pregnancy; and HOW SUPPLIED, Storage and Handling).

EXPOSURE OF WOMEN - RISK TO MALE FETUS

Women should not handle crushed or broken PROPECIA tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. (See also CONTRAINDICATIONS; PRECAUTIONS, Information for Patients and Pregnancy; and HOW SUPPLIED, Storage and Handling.)

PRECAUTIONS

General

Caution should be used in the administration of PROPECIA in patients with liver function abnormalities, as finasteride is metabolized extensively in the liver.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of a tumorigenic effect was observed in a 24-month study in Sprague-Dawley rats receiving doses of finasteride up to 160 mg/kg/day in males and 320 mg/kg/day in females. These doses produced respective systemic exposure in rats of 888 and 2192 times those observed in man receiving the recommended human dose of 1 mg/day. All exposure calculations were based on calculated AUC_{(0-24 hr)} for animals and mean AUC_{(0-24 hr)} for man (0.05 m g?hr/mL).

In a 19-month carcinogenicity study in CD-1 mice, a statistically significant (p￡0.05) increase in the incidence of testicular Leydig cell adenomas was observed at a dose of 250 mg/kg/day (1824 times the human exposure). In mice at a dose of 25 mg/kg/day (184 times the human exposure, estimated) and in rats at a dose of ³40 mg/kg/day (312 times the human exposure) an increase in the incidence of Leydig cell hyperplasia was observed. A positive correlation between the proliferative changes in the Leydig cells and an increase in serum LH levels (2-to 3-fold above control) has been demonstrated in both rodent species treated with high doses of finasteride. No drug-related Leydig cell changes were seen in either rats or dogs treated with finasteride for 1 year at doses of 20 mg/kg/day and 45 mg/kg/day (240 and 2800 times, respectively, the human exposure) or in mice treated for 19 months at a dose of 2.5 mg/kg/day (18.4 times the human exposure, estimated).

No evidence of mutagenicity was observed in an in vitro bacterial mutagenesis assay, a mammalian cell mutagenesis assay, or in an in vitro alkaline elution assay. In an in vitro chromosome aberration assay, using Chinese hamster ovary cells, there was a slight increase in chromosome aberrations. In an in vivo chromosome aberration assay in mice, no treatment-related increase in chromosome aberration was observed with finasteride at the maximum tolerated dose of 250 mg/kg/day (1824 times the human exposure) as determined in the carcinogenicity studies.

In sexually mature male rabbits treated with finasteride at 80 mg/kg/day (4344 times the human exposure) for up to 12 weeks, no effect on fertility, sperm count, or ejaculate volume was seen. In sexually mature male rats treated with 80 mg/kg/day of finasteride (488 times the human exposure), there were no significant effects on fertility after 6 or 12 weeks of treatment; however, when treatment was continued for up to 24 or 30 weeks, there was an apparent decrease in fertility, fecundity, and an associated significant decrease in the weights of the seminal vesicles and prostate. All these effects were reversible within 6 weeks of discontinuation of treatment. No drug-related effect on testes or on mating performance has been seen in rats or rabbits. This decrease in fertility in finasteride-treated rats is secondary to its effect on accessory sex organs (prostate and seminal vesicles) resulting in failure to form a seminal plug. The seminal plug is essential for normal fertility in rats but is not relevant in man.

Pregnancy

Teratogenic Effects: Pregnancy Category X

See CONTRAINDICATIONS.

PROPECIA is not indicated for use in women.

Administration of finasteride to pregnant rats on gestational days 6-20 at doses ranging from 100 mg/kg/day to 100 mg/kg/day (1-684 times the human exposure, estimated) resulted in dose-dependent development of hypospadias in 3.6 to 100% of male offspring. Pregnant rats produced male offspring with decreased prostatic and seminal vesicular weights, delayed preputial separation, and transient nipple development when given finasteride at ³30 m g/kg/day (0.2 times the human exposure, estimated) and decreased anogenital distance when given finasteride at ³3 mg/kg/day (0.02 times the human exposure, estimated). The critical period during which these effects can be induced in male rats has been defined to be days 16-17 of gestation. The changes described above are expected pharmacological effects of drugs belonging to the class of Type II 5a-reductase inhibitors and are similar to those reported in male infants with a genetic deficiency of Type II 5a-reductase. No abnormalities were observed in female offspring exposed to any dose of finasteride in utero.

No evidence of malformations has been observed in rabbit fetuses exposed to finasteride in utero from days 6-18 of gestation at doses up to 100 mg/kg/day (1908 times the recommended human dose of 1 mg/day, based on body surface area comparison). However, effects on male genitalia would not be expected since the rabbits were not exposed during the critical period of genital system development.

The in utero effects of finasteride exposure during the period of embryonic and fetal development were evaluated in the rhesus monkey (gestation days 20-100), a species more predictive of human development than rats or rabbits. Intravenous administration of finasteride to pregnant monkeys at doses up to 800 ng/day (at least 250 times the highest estimated exposure of pregnant women to finasteride from semen of men taking 1 mg/day, based on body surface area comparison) resulted in no abnormalities in male fetuses. In confirmation of the relevance of the rhesus model for human fetal development, oral administration of a 2 mg/kg/day dose of finasteride to pregnant monkeys resulted in external genital abnormalities in male fetuses. No other abnormalities were observed in male fetuses and no finasteride-related abnormalities were observed in female fetuses at any dose.

Nursing Mothers

PROPECIA is not indicated for use in women.

It is not known whether finasteride is excreted in human milk.

Pediatric Use

PROPECIA is not indicated for use in pediatric patients.

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical efficacy studies with PROPECIA did not include subjects aged 65 and over. Based on the pharmacokinetics of finasteride 5 mg, no dosage adjustment is necessary in the elderly for PROPECIA (see CLINICAL PHARMACOLOGY, Pharmacokinetics). However the efficacy of PROPECIA in the elderly has not been established.

OVERDOSE

In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in adverse reactions. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended.

CONTRAINDICATIONS

PROPECIA is contraindicated in the following:

Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5-reductase inhibitors to inhibit the conversion of testosterone to DHT, finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. (See also WARNINGS, EXPOSURE OF WOMEN - RISK TO MALE FETUS; and PRECAUTIONS, Information for Patients and Pregnancy.) In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.

Hypersensitivity to any component of this medication

CLINICAL PHARMACOLOGY

Finasteride is a competitive and specific inhibitor of Type II 5a-reductase, an intracellular enzyme that converts the androgen testosterone into DHT. Two distinct isozymes are found in mice, rats, monkeys, and humans: Type I and II. Each of these isozymes is differentially expressed in tissues and developmental stages. In humans, Type I 5a-reductase is predominant in the sebaceous glands of most regions of skin, including scalp, and liver. Type I 5a-reductase is responsible for approximately one-third of circulating DHT. The Type II 5a-reductase isozyme is primarily found in prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT.

In humans, the mechanism of action of finasteride is based on its preferential inhibition of the Type II isozyme. Using native tissues (scalp and prostate), in vitro binding studies examining the potential of finasteride to inhibit either isozyme revealed a 100-fold selectivity for the human Type II 5a-reductase over Type I isozyme (IC₅₀=500 and 4.2 nM for Type I and II, respectively). For both isozymes, the inhibition by finasteride is accompanied by reduction of the inhibitor to dihydrofinasteride and adduct formation with NADP+. The turnover for the enzyme complex is slow (t ½ approximately 30 days for the Type II enzyme complex and 14 days for the Type I complex).

Finasteride has no affinity for the androgen receptor and has no androgenic, antiandrogenic, estrogenic, antiestrogenic, or progestational effects. Inhibition of Type II 5a-reductase blocks the peripheral conversion of testosterone to DHT, resulting in significant decreases in serum and tissue DHT concentrations. Finasteride produces a rapid reduction in serum DHT concentration, reaching 65% suppression within 24 hours of oral dosing with a 1-mg tablet. Mean circulating levels of testosterone and estradiol were increased by approximately 15% as compared to baseline, but these remained within the physiologic range.

In men with male pattern hair loss (androgenetic alopecia), the balding scalp contains miniaturized hair follicles and increased amounts of DHT compared with hairy scalp. Administration of finasteride decreases scalp and serum DHT concentrations in these men. The relative contributions of these reductions to the treatment effect of finasteride have not been defined. By this mechanism, finasteride appears to interrupt a key factor in the development of androgenetic alopecia in those patients genetically predisposed.

A 48-week, placebo-controlled study designed to assess by phototrichogram the effect of PROPECIA on total and actively growing (anagen) scalp hairs in vertex baldness enrolled 212 men with androgenetic alopecia. At baseline and 48 weeks, total and anagen hair counts were obtained in a 1-cm²target area of the scalp. Men treated with PROPECIA showed increases from baseline in total and anagen hair counts of 7 hairs and 18 hairs, respectively, whereas men treated with placebo had decreases of 10 hairs and 9 hairs, respectively. These changes in hair counts resulted in a between-group difference of 17 hairs in total hair count (p<0.001) and 27 hairs in anagen hair count (p<0.001), and an improvement in the proportion of anagen hairs from 62% at baseline to 68% for men treated with PROPECIA.

Pharmacokinetics
Absorption

In a study in 15 healthy young male subjects, the mean bioavailability of finasteride 1-mg tablets was 65% (range 26-170%), based on the ratio of area under the curve (AUC) relative to an intravenous (IV) reference dose. At steady state following dosing with 1 mg/day (n=12), maximum finasteride plasma concentration averaged 9.2 ng/mL (range, 4.9-13.7 ng/mL) and was reached 1 to 2 hours postdose; AUC_{(0-24 hr)} was 53 ng?hr/mL (range, 20-154 ng?hr/mL). Bioavailability of finasteride was not affected by food.

Distribution

Mean steady-state volume of distribution was 76 liters (range, 44-96 liters; n=15). Approximately 90% of circulating finasteride is bound to plasma proteins. There is a slow accumulation phase for finasteride after multiple dosing.

Finasteride has been found to cross the blood-brain barrier.

Semen levels have been measured in 35 men taking finasteride 1 mg/day for 6 weeks. In 60% (21 of 35) of the samples, finasteride levels were undetectable (<0.2 ng/mL). The mean finasteride level was 0.26 ng/mL and the highest level measured was 1.52 ng/mL. Using the highest semen level measured and assuming 100% absorption from a 5-mL ejaculate per day, human exposure through vaginal absorption would be up to 7.6 ng per day, which is 750 times lower than the exposure from the no-effect dose for developmental abnormalities in Rhesus monkeys and 650-fold less than the dose of finasteride (5mg) that had no effect on circulating DHT levels in men (see PRECAUTIONS, Pregnancy).

Metabolism

Excretion

Following intravenous infusion in healthy young subjects (n=15), mean plasma clearance of finasteride was 165 mL/min (range, 70-279 mL/min). Mean terminal half-life in plasma was 4.5 hours (range, 3.3-13.4 hours; n=12). Following an oral dose of ¹⁴C-finasteride in man (n=6), a mean of 39% (range, 32-46%) of the dose was excreted in the urine in the form of metabolites; 57% (range, 51-64%) was excreted in the feces.

Mean terminal half-life is approximately 5-6 hours in men 18-60 years of age and 8 hours in men more than 70 years of age.

Special Populations
Pediatric

Finasteride pharmacokinetics have not been investigated in patients <18 years of age. Gender: PROPECIA is not indicated for use in women.

Geriatric: No dosage adjustment is necessary in the elderly. Although the elimination rate of finasteride is decreased in the elderly, these findings are of no clinical significance. See also Pharmacokinetics, Excretion, and PRECAUTIONS, Geriatric Use sections.

Race: The effect of race on finasteride pharmacokinetics has not been studied.

Renal Insufficiency: No dosage adjustment is necessary in patients with renal insufficiency. In patients with chronic renal impairment, with creatinine clearances ranging from 9.0 to 55 mL/min, AUC, maximum plasma concentration, half-life, and protein binding after a single dose of ¹⁴C-finasteride were similar to those obtained in healthy volunteers. Urinary excretion of metabolites was decreased in patients with renal impairment. This decrease was associated with an increase in fecal excretion of metabolites. Plasma concentrations of metabolites were significantly higher in patients with renal impairment (based on a 60% increase in total radioactivity AUC). However, finasteride has been well tolerated in men with normal renal function receiving up to 80 mg/day for 12 weeks where exposure of these patients to metabolites would presumably be much greater.

Hepatic Insufficiency: The effect of hepatic insufficiency on finasteride pharmacokinetics has not been studied. Caution should be used in the administration of PROPECIA in patients with liver function abnormalities, as finasteride is metabolized extensively in the liver.

Drug Interactions

(also see PRECAUTIONS, Drug Interactions)

Mean (SD) Pharmacokinetic Parameters in Healthy Men (ages 18-26)
	Mean ( SD)
	n=15
Bioavailability	65% (26-170%)*
Clearance (mL/min)	165 (55)
Volume of Distribution (L)	76 (14)
*Range

Mean (SD) Noncompartmental Pharmacokinetic Parameters After Multiple Doses of 1 mg/day in Healthy Men (ages 19-42)
	Mean ( SD)
	(n=12)
AUC (ng· hr/mL)	53 (33.8)
Peak Concentration (ng/mL)	9.2 (2.6)
Time to Peak (hours)	1.3 (0.5)
Half-Life (hours)*	4.5 (1.6)
*First-dose values; all other parameters are last-dose values

CLINICAL STUDIES
Studies in Men

The efficacy of PROPECIA was demonstrated in men (88% Caucasian) with mild to moderate androgenetic alopecia (male pattern hair loss) between 18 and 41 years of age. In order to prevent seborrheic dermatitis which might confound the assessment of hair growth in these studies, all men, whether treated with finasteride or placebo, were instructed to use a specified, medicated, tar-based shampoo (Neutrogena T/Gel^®** Shampoo) during the first 2 years of the studies.

There were three double-blind, randomized, placebo-controlled studies of 12-month duration. The two primary endpoints were hair count and patient self-assessment; the two secondary endpoints were investigator assessment and ratings of photographs. In addition, information was collected regarding sexual function (based on a self-administered questionnaire) and non-scalp body hair growth. The three studies were conducted in 1879 men with mild to moderate, but not complete, hair loss. Two of the studies enrolled men with predominantly mild to moderate vertex hair loss (n=1553). The third enrolled men having mild to moderate hair loss in the anterior mid-scalp area with or without vertex balding (n=326).

Studies in Men with Vertex Baldness

Of the men who completed the first 12 months of the two vertex baldness trials, 1215 elected to continue in double-blind, placebo-controlled, 12-month extension studies. There were 547 men receiving PROPECIA for both the initial study and first extension periods (up to 2 years of treatment) and 60 men receiving placebo for the same periods. The extension studies were continued for 3 additional years, with 323 men on PROPECIA and 23 on placebo entering the fifth year of the study.

In order to evaluate the effect of discontinuation of therapy, there were 65 men who received PROPECIA for the initial 12 months followed by placebo in the first 12-month extension period. Some of these men continued in additional extension studies and were switched back to treatment with PROPECIA, with 32 men entering the fifth year of the study. Lastly, there were 543 men who received placebo for the initial 12 months followed by PROPECIA in the first 12-month extension period. Some of these men continued in additional extension studies receiving PROPECIA, with 290 men entering the fifth year of the study (see Figure below).

Hair counts were assessed by photographic enlargements of a representative area of active hair loss. In these two studies in men with vertex baldness, significant increases in hair count were demonstrated at 6 and 12 months in men treated with PROPECIA, while significant hair loss from baseline was demonstrated in those treated with placebo. At 12 months there was a 107-hair difference from placebo (p<0.001, PROPECIA [n=679] vs placebo [n=672]) within a 1-inch diameter circle (5.1 cm²). Hair count was maintained in those men taking PROPECIA for up to 2 years, resulting in a 138-hair difference between treatment groups (p<0.001, PROPECIA [n=433] vs placebo [n=47]) within the same area. In men treated with PROPECIA, the maximum improvement in hair count compared to baseline was achieved during the first 2 years. Although the initial improvement was followed by a slow decline, hair count was maintained above baseline throughout the 5 years of the studies. Furthermore, because the decline in the placebo group was more rapid, the difference between treatment groups also continued to increase throughout the studies, resulting in a 277-hair difference (p<0.001, PROPECIA [n=219] vs placebo [n=15]) at 5 years (see Figure below).

Patients who switched from placebo to PROPECIA (n=425) had a decrease in hair count at the end of the initial 12-month placebo period, followed by an increase in hair count after 1 year of treatment with PROPECIA. This increase in hair count was less (56 hairs above original baseline) than the increase (91 hairs above original baseline) observed after 1 year of treatment in men initially randomized to PROPECIA. Although the increase in hair count, relative to when therapy was initiated, was comparable between these two groups, a higher absolute hair count was achieved in patients who were started on treatment with PROPECIA in the initial study. This advantage was maintained through the remaining 3 years of the studies. A change of treatment from PROPECIA to placebo (n=48) at the end of the initial 12 months resulted in reversal of the increase in hair count 12 months later, at 24 months (see Figure below).

At 12 months, 58% of men in the placebo group had further hair loss (defined as any decrease in hair count from baseline), compared with 14% of men treated with PROPECIA. In men treated for up to 2 years, 72% of men in the placebo group demonstrated hair loss, compared with 17% of men treated with PROPECIA. At 5 years, 100% of men in the placebo group demonstrated hair loss, compared with 35% of men treated with PROPECIA.

Effect on Hair Count † Number of Hairs in a 1-inch Diameter Circle Mean Change ± 1 S.E.

Patient self-assessment was obtained at each clinic visit from a self-administered questionnaire, which included questions on their perception of hair growth, hair loss, and appearance. This self-assessment demonstrated an increase in amount of hair, a decrease in hair loss, and improvement in appearance in men treated with PROPECIA. Overall improvement compared with placebo was seen as early as 3 months (p<0.05), with improvement maintained over 5 years.

Investigator assessment was based on a 7-point scale evaluating increases or decreases in scalp hair at each patient visit. This assessment showed significantly greater increases in hair growth in men treated with PROPECIA compared with placebo as early as 3 months (p<0.001). At 12 months, the investigators rated 65% of men treated with PROPECIA as having increased hair growth compared with 37% in the placebo group. At 2 years, the investigators rated 80% of men treated with PROPECIA as having increased hair growth compared with 47% of men treated with placebo. At 5 years, the investigators rated 77% of men treated with PROPECIA as having increased hair growth, compared with 15% of men treated with placebo.

An independent panel rated standardized photographs of the head in a blinded fashion based on increases or decreases in scalp hair using the same 7-point scale as the investigator assessment. At 12 months, 48% of men treated with PROPECIA had an increase as compared with 7% of men treated with placebo. At 2 years, an increase in hair growth was demonstrated in 66% of men treated with PROPECIA, compared with 7% of men treated with placebo. At 5 years, 48% of men treated with PROPECIA demonstrated an increase in hair growth, 42% were rated as having no change (no further visible progression of hair loss from baseline) and 10% were rated as having lost hair when compared to baseline. In comparison, 6% of men treated with placebo demonstrated an increase in hair growth, 19% were rated as having no change and 75% were rated as having lost hair when compared to baseline.

Other Results in Vertex Baldness Studies

A sexual function questionnaire was self-administered by patients participating in the two vertex baldness trials to detect more subtle changes in sexual function. At Month 12, statistically significant differences in favor of placebo were found in 3 of 4 domains (sexual interest, erections, and perception of sexual problems). However, no significant difference was seen in the question on overall satisfaction with sex life.

In one of the two vertex baldness studies, patients were questioned on non-scalp body hair growth. PROPECIA did not appear to affect non-scalp body hair.

Study in Men with Hair Loss in the Anterior Mid-Scalp Area

A study of 12-month duration, designed to assess the efficacy of PROPECIA in men with hair loss in the anterior mid-scalp area, also demonstrated significant increases in hair count compared with placebo.

Increases in hair count were accompanied by improvements in patient self-assessment, investigator assessment, and ratings based on standardized photographs. Hair counts were obtained in the anterior mid-scalp area, and did not include the area of bitemporal recession or the anterior hairline.

Summary of Clinical Studies in Men

Clinical studies were conducted in men aged 18 to 41 with mild to moderate degrees of androgenetic alopecia. All men treated with PROPECIA or placebo received a tar-based shampoo (Neutrogena T/Gel^®** Shampoo) during the first 2 years of the studies. Clinical improvement was seen as early as 3 months in the patients treated with PROPECIA and led to a net increase in scalp hair count and hair regrowth. In clinical studies for up to 5 years, treatment with PROPECIA slowed the further progression of hair loss observed in the placebo group. In general, the difference between treatment groups continued to increase throughout the 5 years of the studies.

Ethnic Analysis of Clinical Data from Men

In a combined analysis of the two studies on vertex baldness, mean hair count changes from baseline were 91 vs -19 hairs (PROPECIA vs placebo) among Caucasians (n=1185), 49 vs -27 hairs among Blacks (n=84), 53 vs -38 hairs among Asians (n=17), 67 vs 5 hairs among Hispanics (n=45) and 67 vs -15 hairs among other ethnic groups (n=20). Patient self-assessment showed improvement across racial groups with PROPECIA treatment, except for satisfaction of the frontal hairline and vertex in Black men, who were satisfied overall.

Study in Women

In a study involving 137 postmenopausal women with androgenetic alopecia who were treated with PROPECIA (n=67) or placebo (n=70) for 12 months, effectiveness could not be demonstrated. There was no improvement in hair counts, patient self-assessment, investigator assessment, or ratings of standardized photographs in the women treated with PROPECIA when compared with the placebo group (see INDICATIONS AND USAGE).

PATIENT INFORMATION

Women should not handle crushed or broken PROPECIA tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. (See also CONTRAINDICATIONS; WARNINGS, EXPOSURE OF WOMEN - RISK TO MALE FETUS; PRECAUTIONS, Pregnancy; and HOW SUPPLIED, Storage and Handling.)

Patient Information about

PROPECIA® (Pro-pee-sha)
Generic name: finasteride
(fin-AS-tur-eyed)

PROPECIA** is for use by MEN ONLY.

Please read this leaflet before you start taking PROPECIA. Also, read the information included with PROPECIA each time you renew your prescription, just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss PROPECIA when you start taking your medication and at regular checkups.

What is PROPECIA used for?

PROPECIA is used for the treatment of male pattern hair loss on the vertex and the anterior mid-scalp area.

PROPECIA is for use by MEN ONLY and should NOT be used by women or children.

What is male pattern hair loss?

Male pattern hair loss is a common condition in which men experience thinning of the hair on the scalp. Often, this results in a receding hairline and/or balding on the top of the head. These changes typically begin gradually in men in their 20s.

Doctors believe male pattern hair loss is due to heredity and is dependent on hormonal effects. Doctors refer to this type of hair loss as androgenetic alopecia.

Results of clinical studies:

For 12 months, doctors studied over 1800 men aged 18 to 41 with mild to moderate amounts of ongoing hair loss. Of these men, approximately 1200 with hair loss at the top of the head participated in additional extension studies, resulting in a total study time of up to five years. In general, men who took PROPECIA maintained or increased the number of visible scalp hairs and noticed improvement in their hair in the first year. Improvement, compared to the start of the study, was maintained through the remaining years of treatment. Hair counts in men who did not take PROPECIA continued to decrease.

In one study, patients were questioned on the growth of body hair. PROPECIA did not appear to affect hair in places other than the scalp.

Will PROPECIA work for me?

For most men, PROPECIA increases the number of scalp hairs in the first year of treatment, helping to fill in thin or balding areas of the scalp. In addition, men taking PROPECIA may note a slowing of hair loss. Although results will vary, generally you will not be able to grow back all of the hair you have lost. There is not sufficient evidence that PROPECIA works in the treatment of receding hairline in the temporal area on both sides of the head.

Male pattern hair loss occurs gradually over time. On average, healthy hair grows only about half an inch each month. Therefore, it will take time to see any effect.

You may need to take PROPECIA daily for three months or more before you see a benefit from taking PROPECIA. PROPECIA can only work over the long term if you continue taking it. If the drug has not worked for you in twelve months, further treatment is unlikely to be of benefit. If you stop taking PROPECIA, you will likely lose the hair you have gained within 12 months of stopping treatment. You should discuss this with your doctor.

PROPECIA is not effective in the treatment of hair loss due to androgenetic alopecia in postmenopausal women. PROPECIA should not be taken by women.

How should I take PROPECIA?

Follow your doctors instructions.

Take one tablet by mouth each day.
You may take PROPECIA with or without food.
If you forget to take PROPECIA, do not take an extra tablet. Just take the next tablet as usual.

PROPECIA will not work faster or better if you take it more than once a day.

Who should NOT take PROPECIA?

PROPECIA is for the treatment of male pattern hair loss in MEN ONLY and should not be taken by women (see A warning about PROPECIA and pregnancy).
PROPECIA should not be taken by children.
Anyone allergic to any of the ingredients.

A warning about PROPECIA and pregnancy.

Women who are or may potentially be pregnant:
- must not use PROPECIA
- should not handle crushed or broken tablets of PROPECIA.

If a woman who is pregnant with a male baby absorbs the active ingredient in PROPECIA, either by swallowing or through the skin, it may cause abnormalities of a male babys sex organs. If a woman who is pregnant comes into contact with the active ingredient in PROPECIA, a doctor should be consulted. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

What are the possible side effects of PROPECIA?

Like all prescription products, PROPECIA may cause side effects. In clinical studies, side effects from PROPECIA were uncommon and did not affect most men. A small number of men experienced certain sexual side effects. These men reported one or more of the following: less desire for sex; difficulty in achieving an erection; and, a decrease in the amount of semen. Each of these side effects occurred in less than 2% of men. These side effects went away in men who stopped taking PROPECIA. They also disappeared in most men who continued taking PROPECIA.

In general use, the following have been reported: allergic reactions including rash, itching, hives and swelling of the lips and face; problems with ejaculation; breast tenderness and enlargement; and testicular pain. You should promptly report to your doctor any changes in your breasts such as lumps, pain or nipple discharge. Tell your doctor promptly about these or any other unusual side effects.

PROPECIA can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done, you should tell your doctor that you are taking PROPECIA.

Storage and handling.

Keep PROPECIA in the original container and keep the container closed. Store it in a dry place at room temperature. PROPECIA tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

Do not give your PROPECIA tablets to anyone else. It has been prescribed only for you. Keep PROPECIA and all medications out of the reach of children.

THIS LEAFLET PROVIDES A SUMMARY OF INFORMATION ABOUT PROPECIA. IF AFTER READING THIS LEAFLET YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, TALK TO YOUR DOCTOR, PHARMACIST, OR HEALTH CARE PROVIDER.

1-888-637-2522, Monday through Friday, 8:30 A.M. TO 7:00 P.M. (ET).

www.propecia.com

Consumer

FINASTERIDE - ORAL (HAIR GROWTH)

(fin-AST-er-ide)

COMMON BRAND NAME(S): Propecia

USES: This medication is used to treat male pattern baldness (androgenetic alopecia) at the crown and in the middle of the scalp. It should be used by adult men only.

This medication works by decreasing the amount of a natural body hormone (DHT). Decreasing the amount of DHT leads to increased hair regrowth and slower hair loss. Hair growth on other parts of the body is not affected by finasteride.

Women and children should not use this medication.

Take this medication by mouth, with or without food, usually once daily, or as directed by your doctor.

If the tablet is crushed or broken, it should not be handled by a woman who is pregnant or by a woman who may become pregnant (see also Precautions section).

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. It may take up to 3 months to notice a benefit.

You must continue to take this medication to maintain your hair growth. When you stop taking finasteride, any gain in hair quantity is generally lost within 12 months.

Inform your doctor if your condition persists or worsens.

scrap; RX List.

I understand - Freddy & The Dreamers

Fri, 20 Nov 2009 16:23:45 +0900

understand - Freddy & The Dreamers

I understand just how you feel.. Your love for me, might not be will
It's over now but it was grand.. I understand.
I understand. If you ever change your mind,
Come back to me and you will find me waiting here at your command..
I understand. I understand. I miss you so.
Please believe me when I tell you..
I just can't stand to see you go, and you know If you ever change your mind,
Come back to me and you will find me waiting here at your command..
I understand.
I understand. I understand just how you feel.. I love you

우리가 서로 잘 모르지만...
가끔 터무니 없이 사람이 좋아지고 그리워지기도 할 때면 ...
저역시 문득 오래전부터 알던 친구인가 착각을 하게 됩니다.

세월을 잃어버린 아쉬움 같은걸 느끼는거...
하잘것 없는 자신을 돌아보는거 누구에게나 슬픈일이죠.

언제 ...어디에 계시더라도
늘...행복하셨으면 좋겠습니다.

music/yahoo, photo/blog-Aries21usa.11.19.2009

Sous le ciel de Paris / 이브 몽땅

Sat, 21 Nov 2009 09:02:41 +0900

Sous le ciel de Paris / 이브 몽땅

Sous le ciel de Paris
S'envole une chanson
Hum Hum
Elle est nee d'aujourd'hui
Dans le cœur d'un garcon
Sous le ciel de Paris
Marchent des amoureux

Hum Hum
Leur bonheur se construit
Sur un air fait pour eux
Sous le pont de Bercy
Un philosophe assis
Deux musiciens quelques badauds
Puis les gens par milliers
Sous le ciel de Paris
Jusqu'au soir vont chanter

Hum Hum
L'hymne d'un peuple epris
De sa vieille cite
Pres de Notre Dame
Parfois couve un drame
Oui mais a Paname
Tout peut s'arranger
Quelques rayons
Du ciel d'ete
L'accordeon
D'un marinier
L'espoir fleurit
Au ciel de Paris
Sous le ciel de Paris
Coule un fleuve joyeux

Hum Hum
Il endort dans la nuit
Les clochards et les gueux
Sous le ciel de Paris
Les oiseaux du Bon Dieu
Hum Hum
Viennent du monde entier
Pour bavarder entre eux
Et le ciel de Paris
A son secret pour lui
Depuis vingt siecles il est epris
De notre Ile Saint Louis
Quand elle lui sourit
Il met son habit bleu
Hum Hum
Quand il pleut sur Paris
C'est qu'il est malheureux
Quand il est trop jaloux
De ses millions d'amants

Hum Hum
Il fait gronder sur nous
Son tonnerr' eclatant
Mais le ciel de Paris
N'est pas longtemps cruel
Hum Hum
Pour se fair' pardonner
Il offre un arc en

image & music / scrap; http://inhu.egloos.com/tb/133361

사소한것에

Sat, 21 Nov 2009 12:05:27 +0900

사소한거에 목숨걸지말라는 유명한 글도 있었던거 같은데...
걸핏하면 핏대를 올리는 사람을 보면 좀 그렇다.
나도 잘 그랬었나? ㅋㅋ

사실 무덤덤 살아간다는건 어찌 보면
매사 초월해서 덕망있고 위품있어 좋아는 보이겠으나...
그때 그때 반응을 하지 않는다는게-하더라도 표현을 하지 않는게- 다 좋은건 아니라는 생각이 든다.

응? 내가 지금 왜 이말 하고 있는거지?

통신이 완전 두절된 상태로 한 사날 보내다 보니 정말 바빴었다는 느낌인데...
오잉? 블러그에 들어와 보니
또 이런 ...ㅠㅠ

지난달 cellphone 전화 사용내역을 보고 가족들과 대화하다 피식 웃었다.
난
겨우 23분 사용했다더라고...ㅋㅋ
주로 오는전화만 받기 바빴고.
그나마 놓치기도 해서 미안하기도 했던 시간.
용건만 간단히 하며 지냈나본데

오늘 아침은 문득 수다가 그립다.
이시간...내게 별로 필요치도 않는 광고...Fax 돌아가는 소리만 요란하구나....

그러나 난 여전히 이렇게 사소한것에 면면히 신경쓰며
그런대로 또 행복해 하며 ...

music/yahoo korea,written by blog-Aries21usa,11.19.2009

캐릭터 (Character)

Tue, 17 Nov 2009 08:00:19 +0900

사람마다 인상의 특징이 있게 마련인데...

누구나 남들에게 험악하지 않게...특별히 잘 보이고 싶은 열망이 아니라도
그저 좋은 인상으로 새겨졌으면 하는 맘들은 남아 있을것이다.

특이한 케릭터를 떠 올리거나 할 때 웃음나오는 사람들이 있다.
자기도 모르는 특징을 남들이 알아채 보여줄 때 그 사람의 반응이나 표정을 보게되서
한참을 더불어 웃던 시간...
아이들과 닌텐도 게임기에 얼굴 넣으며...
특징을 살려 다소 과장되어야 재밌게 그려지는것 같았다.

예를 들어 죽은깨가 한 둘 있으면 깨바가지로...ㅋㅋ
사각턱이라면 더욱 부운것처럼...
제일 우스운건 자기가 미남,미녀라고 자부하는이(?)를 약간 망가지게 만들면서 그사람 반응을
살피는거였다...

가족들은 그렇다치고
우리들의 캐릭터는 과연 어떤인상과 특징으로 서로에게 각인되어 질까?

	Placebo N=534	Doxazosin N=582	Finasteride N=565	Combination N=598
Baseline Mean (SD)	16.8 (6.0)	17.0 (5.9)	17.1 (6.0)	16.8 (5.8)
Mean ChangeAUA Symptom Score (SD)	-4.9 (5.8)	-6.6 (6.1)	-5.6 (5.9)	-7.4 (6.3)
Comparison to Placebo (95% CI)		-1.8 (-2.5, -1.1)	-0.7 (-1.4, 0.0)	-2.5 (-3.2, -1.8)
Comparison to Doxazosin alone (95% CI)				-0.7 (-1.4, 0.0)
Comparison to Finasteride alone (95% CI)				-1.8 (-2.5, -1.1)

Aries21usa의 블로그

나도 꽃 / 김용택

Je N′ai Que Mon Ame (나에겐 마음 밖에 없어) / Natasha St Pier

PROSCAR® (finasteride) Tablets

DRUG DESCRIPTION

INDICATIONS

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Storage and Handling

SIDE EFFECTS

4-Year Placebo-Controlled Study

Phase III Studies and 5-Year Open Extensions

Medical Therapy of Prostatic Symptoms (MTOPS) Study

Long-Term Data

Post-Marketing Experience

DRUG INTERACTIONS

WARNINGS

Exposure Of Women - Risk To Male Fetus

PRECAUTIONS

General

Effects on PSA and Prostate Cancer Detection

Drug/Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Pregnancy Category X

Nursing Mothers

Pediatric Use

Geriatric Use

OVERDOSE

CONTRAINDICATIONS

CLINICAL PHARMACOLOGY

Pharmacokinetics

Absorption

Distribution

Metabolism

Excretion

Special Populations

Drug Interactions

Clinical Studies

Effect on Symptom Score

Effect on Acute Urinary Retention and the Need for Surgery

Effect on Maximum Urinary Flow Rate

Effect on Prostate Volume

Prostate Volume as a Predictor of Therapeutic Response

Medical Therapy of Prostatic Symptoms

Summary of Clinical Studies

PATIENT INFORMATION

Consumer

Consumer (continued)

Consumer (continued)

다양한 종류의 아이스크림

불현듯 다녀오고 싶다.

PROPECIA®(finasteride) Tablets,1mg

DRUG DESCRIPTION

INDICATIONS

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

SIDE EFFECTS

DRUG INTERACTIONS

WARNINGS

PRECAUTIONS

OVERDOSE

CONTRAINDICATIONS

CLINICAL PHARMACOLOGY

PATIENT INFORMATION

Patient Information aboutPROPECIA® (Pro-pee-sha)Generic name: finasteride(fin-AS-tur-eyed)

Consumer

I understand - Freddy & The Dreamers

Sous le ciel de Paris / 이브 몽땅

사소한것에

캐릭터 (Character)

Patient Information about

PROPECIA® (Pro-pee-sha)
Generic name: finasteride
(fin-AS-tur-eyed)