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Wed, 10 Feb 2010 09:46:34 +0900

Gasstation에서

나도 언젠가...
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저렇게까지 당겨보진 않아서 다행.ㅋㅋ

차를 바꿔서 타면 헷갈리기도 한다.
내가 타 본 차들은
독일차들은 영상에서처럼 운전석 대각선쪽에... 일제차는 그 반대편에 있었던듯...
한국차는???
에고... 생각이 잘 안나는구나...모델에 따라 다르던가?

NICOTROL®(nicotine) Inhalant

Tue, 09 Feb 2010 06:37:05 +0900

DRUG DESCRIPTION

NICOTROL® Inhaler (nicotine inhalation system) consists of a mouthpiece and a plastic cartridge delivering 4 mg of nicotine from a porous plug containing 10 mg nicotine. The cartridge is inserted into the mouthpiece prior to use. Nicotine is a tertiary amine composed of a pyridine and a pyrrolidine ring. It is a colorless to pale yellow, freely water-soluble, strongly alkaline, oily, volatile, hygroscopic liquid obtained from the tobacco plant. Nicotine has a characteristic pungent odor and turns brown on exposure to air or light. Of its two stereoisomers, S(-)nicotine is the more active. It is the prevalent form in tobacco, and is the form in the NICOTROL Inhaler. The free alkaloid is absorbed rapidly through skin, mucous membranes, and the respiratory tract.

Chemical Name: S-3-(1-methyl-2-pyrrolidinyl) pyridine
Molecular Formula: C₁₀H₁₄N₂
Molecular Weight: 162.23
Ionization Constants: pKa₁ = 7.84, pKa₂ = 3.04 at 15°C
Octanol-Water Partition Coefficient: 15:1 at pH 7

Nicotine is the active ingredient; inactive components of the product are menthol and a porous plug which are pharmacologically inactive. Nicotine is released when air is inhaled through the Inhaler.

INDICATIONS

NICOTROL Inhaler is indicated as an aid to smoking cessation for the relief of nicotine withdrawal symptoms. NICOTROL Inhaler therapy is recommended for use as part of a comprehensive behavioral smoking cessation program.

DOSAGE AND ADMINISTRATION

Patients must desire to stop smoking and should be instructed to stop smoking completely as they begin using NICOTROL Inhaler. It is important that patients understand the instructions, and have their questions answered. They should clearly understand the directions for using the NICOTROL Inhaler and safely disposing of the used cartridges.

The initial dosage of NICOTROL Inhaler is individualized. Patients may selftitrate to the level of nicotine they require. Most successful patients in the clinical trials used between 6 and 16 cartridges a day. Best effect was achieved by frequent continuous puffing (20 minutes). The recommended duration of treatment is 3 months, after which patients may be weaned from the NICOTROL Inhaler by gradual reduction of the daily dose over the following 6 to 12 weeks. The safety and efficacy of the continued use of NICOTROL Inhaler for periods longer than 6 months have not been studied and such use is not recommended.

Dosing recommendations are summarized in the table below.

RECOMMENDED DOSING

	Duration	Recommended Cartridges/day
INITIAL TREATMENT	Up to 12 Weeks	6 – 16
Gradual Reduction (if needed)	6–12 Weeks	No tapering strategy has been shown to be superior to any other in clinical studies.

Initial Treatment (Up to 12 Weeks)

For best results, patients should be encouraged to use at least 6 cartridges per day at least for the first 3 to 6 weeks of treatment. In clinical trials, the average daily dose was > 6 (range 3 to 18) cartridges for patients who successfully quit smoking. Additional doses may be needed to control the urge to smoke with a maximum of 16 cartridges daily for up to 12 weeks. Regular use of NICOTROL Inhaler during the first week of treatment may help patients adapt to the irritant effects of the product. Some patients may exhibit signs or symptoms of nicotine withdrawal or excess which will require an adjustment of the dosage (see Individualization of Dosage).

Gradual Reduction of Dose (Up to 12 Weeks)

Most patients will need to gradually discontinue the use of NICOTROL Inhaler after the initial treatment period. Gradual reduction of dose may begin after twelve weeks of initial treatment and may last for up to twelve weeks. Recommended strategies for discontinuing use include suggesting to patients that they use the product less frequently, keep a tally of daily usage, try to meet a steadily reducing target or set a planned quit date for stopping use of the product.

Individualization of Dosage

The NICOTROL Inhaler provides the smoker with adequate amounts of nicotine to reduce the urge to smoke, and may provide some degree of comfort by providing a hand-to-mouth ritual similar to smoking, although the importance of such an effect in smoking cessation is, as yet, unknown.

The success or failure of smoking cessation is influenced by the quality, intensity and frequency of supportive care. Patients are more likely to quit smoking if they are seen frequently and participate in formal smoking cessation programs.

The goal of NICOTROL Inhaler therapy is complete abstinence. If a patient is unable to stop smoking by the fourth week of therapy, treatment should probably be discontinued.

Patients who fail to quit on any attempt may benefit from interventions to improve their chances for success on subsequent attempts. Patients who were unsuccessful should be counseled and should then probably be given a therapeutic holiday before the next attempt. A new quit attempt should be encouraged when conditions are more favorable.

Based on the clinical trials, a reasonable approach to assisting patients in their attempt to quit smoking is to begin initial treatment, using the recommended dosage (See DOSAGE AND ADMINISTRATION). Dosage can then be adjusted in those patients with signs or symptoms of nicotine withdrawal or excess. Patients who are successfully abstinent on NICOTROL Inhaler should be treated at the selected dosage for up to 12 weeks, after which use of the Inhaler should be gradually reduced over the next 6 to 12 weeks. Some patients may not require gradual reduction of dosage and may abruptly stop treatment successfully. The safe use of this product for longer than 6 months has not been established.

The symptoms of nicotine withdrawal overlap those of nicotine excess (See Pharmacodynamics and ADVERSE REACTIONS sections). Since patients using NICOTROL Inhaler may also smoke intermittently, it is sometimes difficult to determine if they are experiencing nicotine withdrawal or nicotine excess. Controlled clinical trials of nicotine products suggest that palpitations, nausea and sweating are more often symptoms of nicotine excess, whereas anxiety, nervousness and irritability are more often symptoms of nicotine withdrawal.

Safety And Handling

Disposal

See PATIENT INFORMATION sheet for instructions on handling and disposal. After using the NICOTROL Inhaler, carefully separate the mouthpiece, remove the used cartridge and throw it away, out of the reach of children and pets. Store the mouthpiece in the plastic storage case for further use. The mouthpiece is reusable and should be cleaned regularly with soap and water. The NICOTROL Inhaler cartridges can be detected on a radiogram.

HOW SUPPLIED

NICOTROL INHALER (nicotine inhalation system) is supplied as 168 cartridges each containing 10 mg (4 mg is delivered) nicotine. Each unit consists of 5 mouthpieces, 28 storage trays each containing 6 cartridges and 1 plastic storage case. A patient information leaflet is enclosed with the package.

Store at room temperature not to exceed 77°F (25°C). Protect cartridges from light.

SIDE EFFECTS

Assessment of adverse events in the 1,439 patients (730 on active drug) who participated in controlled clinical trials (including three dose finding studies) is complicated by the occurrence of signs and symptoms of nicotine withdrawal in some patients and nicotine excess in others. The incidence of adverse events is confounded by: (1) the many minor complaints that smokers commonly have, (2) continued smoking by many patients and (3) the local irritation from both the active drug and the placebo.

Local Irritation

NICOTROL Inhaler and the placebo were both associated with local irritant side effects. Local irritation in mouth and throat was reported by 40% of patients on active drug as compared to 18% of patients on placebo. Irritant effects were higher in the two pivotal trials with higher doses being 66% on active drug and 42% on placebo. Coughing (32% active versus 12% placebo) and rhinitis (23% active versus 16% placebo) were also higher on active drug. The majority of patients rated these symptoms as mild. The frequency of cough, and mouth and throat irritation declined with continued use of NICOTROL Inhaler. Other adverse events that occurred in over 3% of patients on active drug in placebo controlled pivotal trials considered possibly related to the local irritant effects of the NICOTROL Inhaler are taste comments, pain in jaw and neck, tooth disorders and sinusitis.

Withdrawal

Symptoms of withdrawal were common in both active and placebo groups. Common withdrawal symptoms seen in over 3% of patients on active drug included: dizziness, anxiety, sleep disorder, depression, withdrawal syndrome, drug dependence, fatigue and myalgia.

Nicotine-Related Adverse Events

The most common nicotine-related adverse event was dyspepsia. This was present in 18% of patients in the active group compared to 9% of patients in the placebo group. Other nicotine related events present in greater than 3% of patients on active drug include nausea, diarrhea, and hiccup.

Smoking Related Adverse Events

Smoking related adverse events present in greater than 3% of patients on active drug include chest discomfort, bronchitis, and hypertension.

Other Adverse Events

Adverse events of unknown relationship to nicotine occurring in greater than 3% of patients on active drug include headache (26% of patients on active and 15% of patients on placebo), influenza-like symptoms, pain, back-pain, allergy, paresthesias, flatulence and fever.

Drug Abuse And Dependence

NICOTROL Inhaler is likely to have a low abuse potential based on differences between the product and cigarettes in three characteristics commonly considered important in contributing to abuse: slower absorption, smaller fluctuations in blood levels and lower blood levels of nicotine. NICOTROL Inhaler, like many other nicotine-based smoking cessation therapies, does not produce arterial concentrations similar to cigarettes. However, nicotine withdrawal symptoms were noted in clinical trials at the time of NICOTROL Inhaler tapering and after NICOTROL Inhaler discontinuation.

Dependence might occur from transference of tobacco-related nicotine dependence to the NICOTROL Inhaler. The use of the inhaler beyond 6 months has not been evaluated in clinical trials and is not recommended. To minimize the risk of dependence, patients should be encouraged to withdraw gradually from NICOTROL Inhaler therapy after 3 months of usage (See DOSAGE AND ADMINISTRATION). If necessary, dose reduction can be achieved by gradual reduction of the dose over a 6 to 12 week period.

DRUG INTERACTIONS

Physiological changes resulting from smoking cessation, with or without nicotine replacement, may alter the pharmacokinetics of certain concomitant medications, such as tricyclic antidepressants and theophylline. Doses of these and perhaps other medications may need to be adjusted in patients who successfully quit smoking.

WARNINGS

Nicotine from any source can be toxic and addictive. Smoking causes lung disease, cancer and heart disease, and may adversely affect pregnant women or the fetus. For any smoker, with or without concomitant disease or pregnancy, the risk of nicotine replacement in a smoking cessation program should be weighed against the hazard of continued smoking, and the likelihood of achieving cessation of smoking without nicotine replacement.

Pregnancy, Warning

Tobacco smoke, which has been shown to be harmful to the fetus, contains nicotine, hydrogen cyanide, and carbon monoxide. The NICOTROL Inhaler does not deliver hydrogen cyanide and carbon monoxide. However, nicotine has been shown in animal studies to cause fetal harm. It is therefore presumed that NICOTROL Inhaler can cause fetal harm when administered to a pregnant woman. The effect of nicotine delivery by NICOTROL Inhaler has not been examined in pregnancy (See PRECAUTIONS). Therefore, pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches. If NICOTROL Inhaler is used during pregnancy, or if the patient becomes pregnant while using it, the patient should be apprised of the potential hazard to the fetus.

Safety Note Concerning Children

This product contains nicotine and should be kept out of the reach of children and pets. The amounts of nicotine that are tolerated by adult smokers can produce symptoms of poisoning and could prove fatal if the nicotine from the NICOTROL Inhaler is inhaled, ingested, or buccally absorbed by children or pets. A cartridge contains about 60% of its initial drug content when it is discarded, which is about 6 mg. Patients should be cautioned to keep both the used and unused cartridges of NICOTROL Inhaler out of the reach of children and pets.

All components of the NICOTROL Inhaler system should also be kept out of the reach of children and pets to avoid accidental swallowing and choking.

PRECAUTIONS

General

The patient should be urged to stop smoking completely when initiating NICOTROL Inhaler therapy (See DOSAGE AND ADMINISTRATION). Patients should be informed that if they continue to smoke while using the product, they may experience adverse effects due to peak nicotine levels higher than those experienced from smoking alone. If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the treatment should be discontinued (See WARNINGS). Physicians should anticipate that concomitant medications may need dosage adjustment (See DRUG INTERACTIONS). Sustained use (beyond 6 months) of NICOTROL Inhaler by patients who stop smoking has not been studied and is not recommended. (See Drug Abuse And Dependence).

Bronchospastic Disease

NICOTROL Inhaler has not been specifically studied in asthma or chronic pulmonary disease. Nicotine is an airway irritant and might cause bronchospasm. NICOTROL Inhaler should be used with caution in patients with bronchospastic disease. Other forms of nicotine replacement might be preferable in patients with severe bronchospastic airway disease.

Cardiovascular or Peripheral Vascular Diseases

The risks of nicotine replacement in patients with cardiovascular and peripheral vascular diseases should be weighed against the benefits of including nicotine replacement in a smoking cessation program for them. Specifically, patients with coronary heart disease (history of myocardial infarction and/or angina pectoris), serious cardiac arrhythmias, or vasospastic diseases (Buerger's disease, Prinzmetal's variant angina and Raynaud's phenomena) should be evaluated carefully before nicotine replacement is prescribed. Tachycardia and palpitations have been reported occasionally with the use of NICOTROL Inhaler as well as with other nicotine replacement therapies. No serious cardiovascular events were reported in clinical studies with NICOTROL Inhaler, but if such symptoms occur, its use should be discontinued.

NICOTROL Inhaler generally should not be used in patients during the immediate post-myocardial infarction period, nor in patients with serious arrhythmias, or with severe or worsening angina.

Renal or Hepatic Insufficiency

The pharmacokinetics of nicotine have not been studied in the elderly or in patients with renal or hepatic impairment. However, given that nicotine is extensively metabolized and that its total system clearance is dependent on liver blood flow, some influence of hepatic impairment on drug kinetics (reduced clearance) should be anticipated. Only severe renal impairment would be expected to affect the clearance of nicotine or its metabolites from the circulation (See Pharmacokinetics).

Endocrine Diseases

NICOTROL Inhaler therapy should be used with caution in patients with hyperthyroidism, pheochromocytoma or insulin-dependent diabetes, since nicotine causes the release of catecholamines by the adrenal medulla.

Peptic Ulcer Disease

Nicotine delays healing in peptic ulcer disease; therefore, NICOTROL Inhaler therapy should be used with caution in patients with active peptic ulcers and only when the benefits of including nicotine replacement in a smoking cessation program outweigh the risks.

Accelerated Hypertension

Nicotine therapy constitutes a risk factor for development of malignant hypertension in patients with accelerated hypertension; therefore, NICOTROL Inhaler therapy should be used with caution in these patients and only when the benefits of including nicotine replacement in a smoking cessation program outweigh the risks.

Information for Patient

A PATIENT INFORMATION sheet is included in the package of NICOTROL Inhaler cartridges dispensed to the patient. Patients should be encouraged to read the information sheet carefully and to ask their physician and pharmacist about the proper use of the product (See DOSAGE AND ADMINISTRATION). Patients must be advised to keep both used and unused cartridges out of the reach of children and pets.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Nicotine itself does not appear to be a carcinogen in laboratory animals. However, nicotine and its metabolites increased the incidences of tumors in the cheek pouches of hamsters and forestomach of F344 rats, respectively when given in combination with tumor-initiators. One study, which could not be replicated, suggested that cotinine, the primary metabolite of nicotine, may cause lymphoreticular sarcoma in the large intestine of rats. Neither nicotine nor cotinine was mutagenic in the Ames salmonella test. Nicotine induced reparable DNA damage in an E. coli test system. Nicotine was shown to be genotoxic in a test system using Chinese hamster ovary cells. In rats and rabbits, implantation can be delayed or inhibited by a reduction in DNA synthesis that appears to be caused by nicotine. Studies have shown a decrease in litter size in rats treated with nicotine during gestation.

Pregnancy

Pregnancy Category D

(See WARNINGS sections). The harmful effects of cigarette smoking on maternal and fetal health are clearly established. These include low birth weight, an increased risk of spontaneous abortion, and increased perinatal mortality. The specific effects of NICOTROL Inhaler therapy on fetal development are unknown. Therefore pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches.

Spontaneous abortion during nicotine replacement therapy has been reported; as with smoking, nicotine as a contributing factor cannot be excluded.

NICOTROL Inhaler therapy should be used during pregnancy only if the likelihood of smoking cessation justifies the potential risk of using it by the pregnant patient, who might continue to smoke.

Teratogenicity

Animal Studies

Nicotine was shown to produce skeletal abnormalities in the offspring of mice when toxic doses were given to the dams (25 mg/kg IP or SC).

Human Studies

Nicotine teratogenicity has not been studied in humans except as a component of cigarette smoke (each cigarette smoked delivers about 1 mg of nicotine). It has not been possible to conclude whether cigarette smoking is teratogenic to humans.

Other Effects

Animal Studies

A nicotine bolus (up to 2 mg/kg) to pregnant rhesus monkeys caused acidosis, hypercarbia, and hypotension (fetal and maternal concentrations were about 20 times those achieved after smoking one cigarette in 5 minutes). Fetal breathing movements were reduced in the fetal lamb after intravenous injection of 0.25 mg/kg nicotine to the ewe (equivalent to smoking 1 cigarette every 20 seconds for 5 minutes). Uterine blood flow was reduced about 30% after infusion of 0.1 μg/kg/min nicotine to pregnant rhesus monkeys (equivalent to smoking about six cigarettes every minute for 20 minutes).

Human Experience

Cigarette smoking during pregnancy is associated with an increased risk of spontaneous abortion, low birth weight infants and perinatal mortality. Nicotine and carbon monoxide are considered the most likely mediators of these outcomes. The effects of cigarette smoking on fetal cardiovascular parameters have been studied near term. Cigarettes increased fetal aortic blood flow and heart rate and decreased uterine blood flow and fetal breathing movements. NICOTROL Inhaler therapy has not been studied in pregnant women.

Labor and Delivery

NICOTROL Inhaler is not recommended for use during labor and delivery. The effect of nicotine on a mother or the fetus during labor is unknown.

Use in Nursing Mothers

Caution should be exercised when the NICOTROL Inhaler is administered to nursing mothers. The safety of NICOTROL Inhaler therapy in nursing infants has not been examined. Nicotine passes freely into breast milk; the milk to plasma ratio averages 2.9. Nicotine is absorbed orally. An infant has the ability to clear nicotine by hepatic first-pass clearance; however, the efficiency of removal is probably lowest at birth. Nicotine concentrations in milk can be expected to be lower with NICOTROL Inhaler when used as recommended than with cigarette smoking, as maternal plasma nicotine concentrations are generally reduced with nicotine replacement. The risk of exposure of the infant to nicotine from NICOTROL Inhaler therapy should be weighed against the risks associated with the infant's exposure to nicotine from continued smoking by the mother (passive smoke exposure and contamination of breast milk with other components of tobacco smoke) and from the NICOTROL Inhaler alone, or in combination with continued smoking.

Pediatric Use

Safety and effectiveness in pediatric and adolescent patients below the age of 18 years have not been established for any nicotine replacement product. However, no specific medical risk is known or expected in nicotine dependent adolescents. NICOTROL Inhaler should be used for the treatment of tobacco dependence in the older adolescent only if the potential benefit justifies the potential risk.

Geriatric Use

Clinical studies of NICOTROL Inhaler did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Other reports on clinical experience have not identified differences between older and younger patients. In general, dosage selection for an elderly patient should be cautious, usually starting at the low end of the dosage range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease.

OVERDOSE

Signs and Symptoms of Nicotine Toxicity

Signs and symptoms of an overdose of the NICOTROL Inhaler would be expected to be the same as those of acute nicotine poisoning including: pallor, cold sweat, nausea, salivation, vomiting, abdominal pain, diarrhea, headache, dizziness, disturbed hearing and vision, tremor, mental confusion, and weakness. Prostration, hypotension, and respiratory failure may ensue with large overdoses. Lethal doses produce convulsions quickly and death follows as a result of peripheral or central respiratory paralysis or, less frequently, cardiac failure.

Overdose from Inhalation

The oral LD₅₀ for nicotine is > 5 mg/kg in dogs and > 24 mg/kg in rodents. Death is due to respiratory paralysis. The oral minimum acute lethal dose for nicotine in adult humans is reported to be 40 to 60 mg ( < 1 mg/kg). The effects of using several cartridges in rapid succession are unknown (See WARNINGS, Safety Note Concerning Children).

One cartridge of NICOTROL Inhaler contains 10 mg nicotine, of which, approximately 4 mg is delivered nicotine. It is unlikely that an excessive nicotine overdose will occur via inhalation. Should such an overdose occur, however, with signs of nicotine poisoning, the patient should be instructed to contact his/her physician immediately. For additional emergency information, call your regional poison center or call the National Capital Poison Center toll free (1-800-222-1222).

Overdose from Ingestion

Persons ingesting NICOTROL Inhaler cartridges should be referred to a health care facility for management. In unconscious patients with a secure airway, instill activated charcoal via a nasogastric tube. A saline cathartic or sorbitol may be added to the first dose of activated charcoal. Repeated doses of activated charcoal should be administered as long as the cartridge remains in the gastrointestinal tract since it will continue to release nicotine for many hours. The NICOTROL Inhaler cartridges can be identified with a radiogram.

Management of Nicotine Poisoning

Other supportive measures include diazepam or barbiturates for seizures, atropine for excessive bronchial secretions or diarrhea, respiratory support for respiratory failure, and vigorous fluid support for hypotension and cardiovascular collapse.

CONTRAINDICATIONS

Use of NICOTROL Inhaler therapy is contraindicated in patients with known hypersensitivity or allergy to nicotine or to menthol.

CLINICAL PHARMACOLOGY

Pharmacologic Action

Nicotine, the chief alkaloid in tobacco products, binds stereo-selectively to nicotinic-cholinergic receptors at the autonomic ganglia, in the adrenal medulla, at neuromuscular junctions, and in the brain. Two types of central nervous system effects are believed to be the basis of nicotine's positively reinforcing properties. A stimulating effect is exerted mainly in the cortex via the locus ceruleus and a reward effect is exerted in the limbic system. At low doses the stimulant effects predominate while at high doses the reward effects predominate. Intermittent intravenous administration of nicotine activates neurohormonal pathways, releasing acetylcholine, norepinephrine, dopamine, serotonin, vasopressin, beta-endorphin, growth hormone, and ACTH.

Pharmacodynamics

The cardiovascular effects of nicotine include peripheral vasoconstriction, tachycardia, and elevated blood pressure. Acute and chronic tolerance to nicotine develops from smoking tobacco or ingesting nicotine preparations. Acute tolerance (a reduction in response for a given dose) develops rapidly (less than 1 hour), but not at the same rate for different physiologic effects (skin temperature, heart rate, subjective effects). Withdrawal symptoms such as cigarette craving can be reduced in most individuals by plasma nicotine levels lower than those from smoking.

Withdrawal from nicotine in addicted individuals can be characterized by craving, nervousness, restlessness, irritability, mood lability, anxiety, drowsiness, sleep disturbances, impaired concentration, increased appetite, minor somatic complaints (headache, myalgia, constipation, fatigue), and weight gain. Nicotine toxicity is characterized by nausea, abdominal pain, vomiting, diarrhea, diaphoresis, flushing, dizziness, disturbed hearing and vision, confusion, weakness, palpitations, altered respiration and hypotension. Both smoking and nicotine can increase circulating cortisol and catecholamines, and tolerance does not develop to the catecholaminereleasing effects of nicotine. Changes in the response to a concomitantly administered adrenergic agonist or antagonist should be watched for when nicotine intake is altered during NICOTROL Inhaler therapy and/or smoking cessation (See PRECAUTIONS: DRUG INTERACTIONS).

Pharmacokinetics

Absorption

Most of the nicotine released from the NICOTROL Inhaler is deposited in the mouth. Only a fraction of the dose released, less than 5%, reaches the lower respiratory tract. An intensive inhalation regimen (80 deep inhalations over 20 minutes) releases on the average 4 mg of the nicotine content of each cartridge of which about 2 mg is systemically absorbed. Peak plasma concentrations are typically reached within 15 minutes of the end of inhalation.

Absorption of nicotine through the buccal mucosa is relatively slow and the high and rapid rise followed by the decline in nicotine arterial plasma concentrations seen with cigarette smoking are not achieved with the inhaler. After use of the single inhaler the arterial nicotine concentrations rise slowly to an average of 6 ng/mL in contrast to those of a cigarette, which increase rapidly and reach a mean Cmax of approximately 49 ng/mL within 5 minutes.

The temperature dependency of nicotine release from the NICOTROL Inhaler was studied between 68°F and 104°F in eighteen patients. Average achievable steady state plasma levels after 20 minutes of an intensive inhalation regimen each hour at ambient room temperature are on the order of 23 ng/mL. The corresponding nicotine plasma levels achievable at 86°F and 104°F are on the order of 30 and 34 ng/mL. Nicotine peak plasma concentration (Cmax) at steady-state, after 20 minutes of an intensive inhalation regimen per hour, for 10 hours.

	Cmax (ng/mL)
	20°C /68°F N=18	30°C /86°F N=18	40°C/104°F N=18
Mean	22.5	29.7	34.0
S.D.	7.7	8.3	6.9
Min	11.1	17.6	24.1
Max	40.4	47.2	48.6

Ad libitum use of the NICOTROL Inhaler typically produces nicotine plasma levels of 6–8 ng/mL, corresponding to about 1/3 of those achieved with cigarette smoking.

Distribution

The volume of distribution following IV administration of nicotine is approximately 2 to 3 L/kg. Plasma protein binding of nicotine is < 5%. Therefore, changes in nicotine binding from use of concomitant drugs or alterations of plasma proteins by disease states would not be expected to have significant effects on nicotine kinetics.

Metabolism

More than 20 metabolites of nicotine have been identified, all of which are less active than the parent compound. The primary urinary metabolites are cotinine (15% of the dose) and trans-3-hydroxycotinine (45% of the dose). Cotinine has a half-life of 15 to 20 hours and concentrations that exceed nicotine by 10-fold. The major site for the metabolism of nicotine is the liver. The kidney and lung are also sites of nicotine metabolism.

Elimination

About 10% of the nicotine absorbed is excreted unchanged in the urine. This may be increased to up to 30% with high urine flow rates and urinary acidification below pH 5. The average plasma clearance is about 1.2 L/min in a healthy adult smoker. The apparent elimination half-life of nicotine is 1 to 2 hours.

Gender Differences

Intersubject variability coefficients of variation (C.V.) for the pharmacokinetic parameters (AUC and Cmax) were approximately 40% and 30% respectively, for males and females. There were no medically significant differences between females and males in the kinetics of NICOTROL Inhaler.

Clinical Trials

The efficacy of NICOTROL Inhaler therapy as an aid to smoking cessation was demonstrated in two single-center, placebo-controlled, double-blind trials with a total of 445 healthy patients. The number of NICOTROL Inhaler cartridges used was a minimum dose of 4 cartridges/day and a maximum dose of 20 cartridges/day. In both studies, the recommended duration of treatment was 3 months; however, the patients were permitted to continue to use the product for up to 6 months, if they wished. The quit rates are the percentage of all persons initially enrolled who continuously abstained after week 2. NICOTROL Inhaler was more effective than placebo at 6 weeks, 3 months and 6 months. The efficacy is shown in the following table.

Quit Rates by Treatment (N= 445 Patients in 2 Studies)

Group	Number of Patients	At 6 Weeks	At 3 Months	At 6 Months	At 12 Months*
Nicotrol Inhaler	223	44–45%	31–32%	20–21%	11–13%
Placebo	222	14–23%	8–15%	6–11%	5–10%
* Follow-up, patients not on treatment.

Patients who used NICOTROL Inhaler had a significant reduction in the “urge to smoke”, a major nicotine withdrawal symptom, compared with placebo-treated patients throughout the first week, (see Figure 1).

PATIENT INFORMATION
(NICOTINE INHALATION SYSTEM) 10 MG PER CARTRIDGE
(4 MG DELIVERED)
An Aid to Help You Stop Smoking

Read and follow carefully.

If you have questions or want more information, ask your doctor or pharmacist.

NICOTROL Inhaler helps you quit smoking by reducing your urge to smoke. Success in quitting with nicotine replacement therapy (such as NICOTROL Inhaler) usually involves behavior change.
- Your doctor may adjust the number of Inhaler cartridges during the first few weeks. As your body adjusts to not smoking, your doctor will either tell you to stop using the Inhaler or slowly reduce the dose.
- People who use Nicotrol Inhaler with a comprehensive behavioral smoking cessation program are more successful in quitting smoking. This program can include support groups, counseling or specific behavior change techniques.
Side Effects: Many people experience mild irritation of the mouth or throat and cough when they first use the Nicotrol Inhaler. Most people get used to these effects in a short time. Stomach upset may also occur.
Because you are already addicted to the nicotine in cigarettes, it is possible to stay dependent on the lower dose of nicotine found in the Nicotrol Inhaler. It is important to use the Inhaler for only as long as directed by your doctor to overcome your nicotine addiction and smoking habit.

NICOTROL Inhaler Contents

WARNINGS : Read before using NICOTROL Inhaler

Commit yourself - NO SMOKING! For the NICOTROL Inhaler to help, you must be firmly committed to quitting! Stop smoking as soon as you start using the Inhaler. Do not smoke or use any other tobacco products at any time while using the NICOTROL Inhaler.

Nicotine overdose can occur. If symptoms of overdose occur, call a doctor or Poison Control Center immediately. Overdose symptoms include: bad headaches, dizziness, upset stomach, drooling, vomiting, diarrhea, cold sweat, blurred vision, hearing difficulties, mental confusion, weakness and fainting.

Keep out of reach of children and pets. The NICOTROL Inhaler can cause serious illness in children and pets - even in very small amounts. If a child chews on or swallows NICOTROL Inhaler cartridges, call a doctor or Poison Control Center. After a cartridge is used, throw away out of reach of children and pets. Even used cartridges contain enough nicotine to seriously harm children and pets.

The NICOTROL Inhaler is a child resistant product. Please read carefully the instructions regarding how to open, close and lock.

Tell your doctor if you have:

heart problems (recent heart attack, irregular heartbeat, severe or worsening heart pain)
stomach ulcers
overactive thyroid

high blood pressure
allergies to drugs
diabetes requiring insulin
kidney or liver disease
wheezing or asthma

Tell your doctor about any medicines you are taking– the dosages may need to be changed. Check with your doctor before taking any new medicine while using NICOTROL Inhaler.

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Follow doctor's directions.
Stop smoking completely during the NICOTROL Inhaler treatment program.

Remove mouthpiece from plastic wrap.
Push the top and bottom together and turn the two pieces to line up the markings.
Pull the top and bottom apart.

Take out cartridge tray.
Peel back to release 1 cartridge.
Insert cartridge into Inhaler.
Push hard on the cartridge until it pops down into place.

Line up the markings again and push the two pieces back together so they fit tight.
Turn the top and bottom pieces so the markings do not line up and it is locked again.
Store cartridges in plastic case when not in use.

Inhale deeply into back of throat or puff in short breaths.
As you inhale or puff through the mouthpiece, nicotine turns into a vapor and is absorbed into your mouth and throat.
Use Inhaler longer and more often at first to help control cigarette cravings.

Nicotine in cartridges is used up after about 20 minutes of active puffing.
Try different schedules to help control cravings. Puffing on the Inhaler for 5 min. at a time will give you enough nicotine for 4 uses. In a few days you'll find what works best and know when nicotine in cartridges is used up.
Use Inhaler at room temperature (above 60°F), cold temperatures reduce amount of nicotine you inhale.

When cartridge is empty, take off top of mouthpiece.
Throw used cartridge away, out of reach of children and pets.
When not in use keep the mouthpiece in the locked position and always store mouthpiece and cartridges in plastic case, out of reach of children and pets.

Read and Follow

Side Effects: You may experience mild irritation of the mouth or throat and cough when you first use the Nicotrol Inhaler. You should get used to these effects in a short time. Stomach upset may also occur.
Do not use more than 16 cartridges each day unless directed to do so by your doctor.
Do not use longer than 6 months.
Store cartridges at room temperature, not to exceed 77°F (25°C).
If you keep cartridges in car, be careful: interiors heat up quickly.
Protect from light.
Clean mouthpiece regularly with soap and water.

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.
NICOTINE INHALER - ORAL
(NICK-oh-teen)
COMMON BRAND NAME(S): Nicotrol
USES: This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Using the inhaler can replace the hand-to-mouth habit of smoking.
Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using your nicotine inhaler and each time you get a refill. Follow all the directions for use carefully. If you have any questions, consult your doctor or pharmacist.
It is very important to stop smoking completely while using this nicotine product. Insert a cartridge into the mouthpiece and inhale the medication by quickly puffing on the mouthpiece for four 5-minute sessions or continually for about 20 minutes. Although using the inhaler is like smoking a cigarette, you do not need to inhale deeply as you would a cigarette for the medicine to work. The medicine works in the mouth and throat, not in the lungs.
Avoid acidic food and drink (e.g., citrus fruit, coffee, juices, carbonated drinks) for 15 minutes before inhaling this medication.
After using the inhaler for a total of 20 minutes, remove the used cartridge and throw it away out of reach of children and pets. The mouthpiece is reusable. Clean with soap and water.
When you quit smoking, start using a nicotine cartridge whenever you crave a cigarette. Usually, you will use at least 6 cartridges each day for the first 3 to 6 weeks or as directed by your doctor. Do not use more than 16 cartridges in a day. Your doctor may direct you to use this product on a regular schedule as well as at times when you have the urge to smoke. Regular use can help your body get used to the medication and decrease side effects such as sore throat. The best dose for you is the dose that decreases the urge to smoke without side effects from too much nicotine. Follow your doctor's orders carefully. Your dose will need to be adjusted to your needs, including smoking history and medical condition.
After you have stopped smoking and you have reached the best dose and schedule for you, continue at that dose. Usually, after about 3 months, your doctor will help you gradually reduce your dose until you are no longer smoking and no longer need nicotine replacement.
Since this medication contains nicotine, it may cause dependence, especially if it has been used regularly for an extended time or if it has been used in high doses. In such cases, withdrawal reactions (e.g., tobacco cravings, nervousness, irritability, headache) may occur if you suddenly stop this drug. To prevent withdrawal when stopping extended/regular treatment with this drug, gradually reduce the dosage as directed. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Tell your doctor if you have not been able to quit smoking after using this product for 4 weeks. Some smokers are unsuccessful the first time they try to quit. You may need to stop using this product and try again later. Many people who cannot quit the first time are successful the next time.
SIDE EFFECTS: Headache, nausea, mouth/tooth/throat pain, cough, runny/stuffy nose, change in taste, heartburn, hiccups, sweating, or diarrhea may occur. Common nicotine withdrawal symptoms can occur when you stop smoking and include dizziness, anxiety, depression, or trouble sleeping, among others. If any of these withdrawal symptoms or side effects persist or worsen, tell 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. Serious side effects are more likely if you continue to smoke while using this product. Do not smoke while you are using this medication.
Stop using this medication and tell your doctor immediately if any of these unlikely but serious side effects occur: severe dizziness, mental/mood changes (e.g., irritability, trouble sleeping, vivid dreams), numbness/tingling in hands/feet, swelling hands/ankles/feet.
Stop using this medication and seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, confusion, severe headache, fast/irregular/pounding heartbeat, slurred speech, weakness on one side of the body.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, 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 using this product, tell your doctor or pharmacist if you are allergic to it; or to menthol; or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled/worsening chest pain, recent heart attack, irregular heartbeat (serious arrhythmias).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel disease (e.g., Raynaud's disease, stroke), breathing problems (e.g., asthma, emphysema), diabetes, heart disease (e.g., chest pain, heart attack), high blood pressure, liver disease, severe kidney disease, stomach/intestinal sores (peptic ulcers), certain adrenal problem (pheochromocytoma), overactive thyroid (hyperthyroidism).
Nicotine and smoking may harm an unborn baby. If you are pregnant, try to stop smoking without using a nicotine replacement product if possible. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
Nicotine from smoking and from this medication passes into breast milk and could have undesirable effects on a nursing infant. Smoking near an infant can also harm the infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: medications for high blood pressure (e.g., beta blockers such as labetalol, prazosin), bronchodilators/decongestants (e.g., isoproterenol, phenylephrine), bupropion, other nicotine products (e.g., patch, tobacco).
Stopping smoking can change the way the liver removes certain drugs from the body (e.g., acetaminophen, caffeine, insulin, oxazepam, pentazocine, propoxyphene, propranolol, theophylline, tricyclic antidepressants such as amitriptyline/imipramine, "water pills"/diuretics such as furosemide). Tell all your doctors and pharmacists that you are quitting smoking.
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: This product may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center. Symptoms of overdose may include: confusion, drooling, seizure, slow/shallow breathing, hearing problems.
NOTES: Do not share this medication with others.
MISSED DOSE: If you are using this on a regular schedule and you miss a dose, use 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 at room temperature at or below 77 degrees F (25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
This medication will not work well if it is too cold. Keep the medication in an inside pocket or warm area during cold weather.
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
image/blog-Aries21usa.02.08.2010

오대양 육대주 - 별은 몇개?

Tue, 09 Feb 2010 10:56:01 +0900

오대양 육대주

초등학교에 다니는 딸애가 학교에 다녀와 숙제를 하는데
5대양 6대주를 적어 오라는것이었다.

"아빠"
"응"

"5대양 6대주가 뭐예요?"

한참을 생각하던 아빠가

"그런것이야 쉽지 받아 적어라" 하면서 답을 알려주는데
"5대양은 김양, 이양,박양, 최양, 강양, 이란다"

"그럼 6대주는 뭐예요?"
"응, 소주,맥주,양주,백세주,포도주,막걸리, 란다"

숙제를 잘 해간 딸에가 다음날 학교에서
선생님께 야단을 맞고 돌아와 아빠에게 하는말

"아빠, 숙제를 잘 못했다고 선생님께 혼났어요~!"
그러자 아빠가 하는말
.
.
.

"내 그럴줄 알았지... 사실은 막걸리가 아니고 탁주란다" ^^;

...5대양 6대주...

5대양- 태평양,대서양,인도양,남극해,북극해
6대주-아시아,아프리카,유럽,북아메리카,남아메리카, 오세아니아 입니다.

별이 몇개???

궁금이가 별을 세고 있었다
하나, 둘, 셋, 넷,....
이백다섯개, 이백여섯개...
아이참,왜 이렇게 많은거야~

그래도 별이 몇개인지 알고싶은 궁금이는
천문학자한테가서 별이 몇개냐고 지겹도록 물어봤다.

박사는 짜증이 나서 소리쳤다.
"그만두게....." 이보게 "

그러자 우리의 궁금이,
좋아하면서 뛰쳐나가며 하는말...
.
.
.
.
.

"구만두개였어.....구만두개...!!! " 90,002 ㅎㅎㅎㅎㅎ

scrap/http://kr.blog.yahoo.com/cherygo7/51835,
http://kr.blog.yahoo.com/cherygo7/51558
image/yahoo,blog-Aries21usa.02.08.2010

Time is not in motion...

Tue, 09 Feb 2010 12:34:32 +0900

Time changes not, but all things change in time.
For time is the force that holds events separate,
each in its own proper place.
Time is not in motion, but ye move through time
as your consciousness moves from one event to another.

시간은 변하지 않지만 모든 것들은 시간 속에서 변화한다.
왜냐하면 시간은 각각의 시간 그 자체의 적절한 순서 속에서
분리된 하나 하나의 사건들을 유지하는 힘이기 때문이다.
시간은 움직이지 않는다. 다만 너희가 시간 속에서 움직일 뿐이다.
마치 너희의 의식이 하나의 사건에서 다른 사건으로 움직이듯이,

-The Emerald Tablets of Thoth The Atlantean -

Music/Handel-Largo;Ombra Mai Fu(Andrea Bocelli)
photo/blog-Aries21usa.02.08.2010

덤덤히...

Tue, 09 Feb 2010 14:44:36 +0900

시간은 어찌보면 멈춰 있는거라는데...
한 주가 또 얼마나 빨리 지나가는지.
금요일 토요일 하도 비가 퍼부어서 또
비가 올까봐 노심초사 했었는데 다행히 구름만 예쁘게 비껴가고...
체감온도가 너무 낮아서 덜덜 떨며 플레이 하던날...
벌써 봄이 오려는지 온사방이 눈비 녹은 틈새로 초록으로 파릇파릇 했건만.

나가기 전에 날 보고 또 꼼지락거린다고 해서 티격태격 했는데...(꼭 그런다. 정말 못말리는 우리... 아니 무슨 시험보러 가는사람처럼 시동먼저 켜고 냅다 재촉...)
생각할 수록 조금 억울한 생각이 든다.

휴일 ...같이 싫컷 늦잠자고 일어나
조금 이상한 메뉴? -카레와 미역국-를 먹고싶다고 제안... 카레는 군대에서 너무 많이 먹어서
질렸다고 거의 지금껏 해 놓을때마다 손도 안대고 무안주더니만...어쨌든
뭐 그것도 못해주랴 싶어 부랴부랴 차려주니 혼자서 냠냠 짭짭...-난 갸우뚱... 그시각에
그게 그리도 맛있을까??? 하여간 이상한 식성?-
수저 던지자마자 자긴 근처에 무슨 볼 일이 잠깐 있다고
30분이내로 다녀오니 잘 챙기고 있으라고 윽박지르시고(?!) 퇴장.

말이 그렇지 두사람 먹은 간단한 상이라곤 하지만...
그거 치우는데 한참 걸린다... 안 해본사람은 절대 모름,
간단히 샤워하고 옷차려입는데 차림이 조금 맘에 안들어 두세개 벗었다 입었다 하다보니
조금 늦었는데...

또 표정을 보니 인내심의 한계를 보인다.
아니나 달라 차에 타자마자 또 왜 그게 그렇게도 안되느냐고 불평불만을...ㅉㅉ

성질 급한 사람축에 끼는 나보다 언제나 한 수 더 위인 그 양반

아 정말 치사(?)스러워서 ~!!!
- 이 단어가 여기 쓰는말로 적절한지 모르지만-

골프 코스까지 60여 마일을 움직이는 동안... 하나도 재잘거리지 않고 갔다.
화나 있는거 서로 모른척 하며...ㅠㅠ

차창밖의 풍경이 마치 수채화 같던데...
아니 그 아름다운날...
화창한 공기를 가르며 그깐일로 입이 나와서
꽁꽁묶여 다니면서까지...삐짐을...
분명 권태니 뭐니 그런거 모르고 사는건 맞는거 같다고 주장하는데
요즘의 우린 서로 무슨생각을 하고 어떤 hobby, interest 를 가지고 살아가는지..

흥...! 그러고 가시니 공이 잘 안맞으실수 밖에...ㅋㅋ
난 보란듯이 팡팡 치고 나가고...
챙겨간 간식은 잘도 잡수시고...에휴 얄미워...
그래도
그나마 요즘 싸움의 기술이 늘어서...우린 아니 난 이제 요령껏 화를 내는것 같기도...
놀다 보니 다 잊어버렸다. 돌아오는길엔 언제 그랬냐는듯
속도 없이 다시 주절주절...

그렇게 또 다 잊고...원순?지 뭔지... 아니 원수를 사랑하며
그냥 덤덤히...
사는대로 살아가야 한다.

(풋,,, 쓰다 보니 글이 또 뭐 이러냐...?!...)

music/ Only For You -Louise Tucker,blog-Aries21usa.02.08.2010

사후피임약/Plan B One-Step(levonorgestrel) Tablet, 1.5 mg, for Oral Use

Sat, 06 Feb 2010 10:13:41 +0900

DRUG DESCRIPTION

The Plan B One-Step tablet contains 1.5 mg of a single active steroid ingredient, levonorgestrel [18,19-Dinorpregn-4-en-20-yn-3-one-13-ethyl-17-hydroxy-, (17 α)-(-)-], a totally synthetic progestogen. The inactive ingredients are colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, and talc.

Levonorgestrel has a molecular weight of 312.45, and the following structural and molecular formulas:

INDICATIONS

Plan B® One-Step is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the tablet should be taken as soon as possible within 72 hours of intercourse.

Plan B One-Step is available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older.

Plan B One-Step is not indicated for routine use as a contraceptive.

DOSAGE AND ADMINISTRATION

Take Plan B One-Step orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse. Plan B One-Step can be used at any time during the menstrual cycle.

If vomiting occurs within two hours of taking the tablet, consideration should be given to repeating the dose.

HOW SUPPLIED

Dosage Forms And Strengths

The Plan B One-Step tablet is supplied as an almost white, round tablet containing 1.5 mg of levonorgestrel and is marked G00 on one side.

Storage And Handling

The Plan B One-Step (levonorgestrel) tablet 1.5 mg is available in a PVC/aluminum foil blister package. The tablet is almost white, round, and marked G00 on one side.

NDC 51285-088-88 (1 tablet unit of use package)

Store Plan B One-Step at 20°to 25°C (68°to 77°F) [see USP Controlled Room Temperature].

Mfg. by Gedeon Richter, Ltd., Budapest, Hungary for Duramed Pharmaceuticals, Inc., Subsidiary of Barr Pharmaceuticals, Inc., Pomona, New York 10970. Phone: 1-800-330-1271. Website: www.PlanBOneStep.com. Revised: July 2009.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Plan B One-Step was studied in a randomized, double-blinded multicenter clinical trial. In this study, all women who had received at least one dose of study medication were included in the safety analysis: 1,379 women in the Plan B One-Step group, and 1,377 women in the Plan B group (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). The mean age of women given Plan B One-Step was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the Plan B One-Step group and 1.4% in Plan B group were lost to follow-up.

The most common adverse events ( > 10%) in the clinical trial for women receiving Plan B One-Step included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4% of Plan B One-Step users.

Table 1 : Adverse Events in > 4% of Women, by % Frequency

Most Common Adverse Events (MedDRA)	Plan B One-Step N = 1359 (%)
Heavier menstrual bleeding	30.9
Nausea	13.7
Lower abdominal pain	13.3
Fatigue	13.3
Headache	10.3
Dizziness	9.6
Breast tenderness	8.2
Delay of menses ( > 7 days)	4.5

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Plan B (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders

Abdominal Pain, Nausea, Vomiting

General Disorders and Administration Site Conditions

Fatigue

Nervous System Disorders

Dizziness, Headache

Reproductive System and Breast Disorders

Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain

DRUG INTERACTIONS

Drugs or herbal products that induce enzymes, including CYP3A4, that metabolize progestins may decrease the plasma concentrations of progestins, and may decrease the effectiveness of progestin-only pills. Some drugs or herbal products that may decrease the effectiveness of progestin-only pills include:

barbiturates
bosentan
carbamazepine
felbamate
griseofulvin
oxcarbazepine
phenytoin
rifampin
St. John's wort
topiramate

Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.

Consult the labeling of all concurrently used drugs to obtain further information about interactions with progestin-only pills or the potential for enzyme alterations.

Drug Abuse And Dependence

Levonorgestrel is not a controlled substance. There is no information about dependence associated with the use of Plan B One-Step.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Ectopic Pregnancy

Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.

A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B One-Step. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One-Step.

Existing Pregnancy

Plan B One-Step is not effective in terminating an existing pregnancy.

Effects on Menses

Some women may experience spotting a few days after taking Plan B One-Step. Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception.

If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy.

STI/HIV

Plan B One-Step does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

Physical Examination and Follow-up

A physical examination is not required prior to prescribing Plan B One-Step. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One-Step.

Fertility Following Discontinuation

A rapid return of fertility is likely following treatment with Plan B One-Step for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Plan B One-Step to ensure ongoing prevention of pregnancy.

Patient Counseling Information

Take Plan B One-Step as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive failure.
If you vomit within two hours of taking the tablet, immediately contact your healthcare provider to discuss whether to take another tablet.
Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking Plan B One-Step, in order to be evaluated for an ectopic pregnancy.
After taking Plan B One-Step, consider the possibility of pregnancy if your period is delayed more than one week beyond the date you expected your period.
Do not use Plan B One-Step as routine contraception.
Plan B One-Step is not effective in terminating an existing pregnancy.
Plan B One-Step does not protect against HIV-infection (AIDS) and other sexually transmitted diseases/infections.
For women younger than age 17 years, Plan B One-Step is available only by prescription.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity: There is no evidence of increased risk of cancer with short-term use of progestins. There was no increase in tumorgenicity following administration of levonorgestrel to rats for 2 years at approximately 5 μg/day, to dogs for 7 years at up to 0.125 mg/kg/day, or to rhesus monkeys for 10 years at up to 250 μg/kg/day. In another 7 year dog study, administration of levonorgestrel at 0.5 mg/kg/day did increase the number of mammary adenomas in treated dogs compared to controls. There were no malignancies.

Genotoxicity: Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay, in vitro mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells, and in an in vivo micronucleus assay in mice.

Fertility: There are no irreversible effects on fertility following cessation of exposures to levonorgestrel or progestins in general.

Use In Specific Populations

Pregnancy

Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects.

Nursing Mothers

In general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma.

Pediatric Use

Safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents less than 17 years and for users 17 years and older. Use of Plan B One-Step emergency contraception before menarche is not indicated.

Geriatric Use

This product is not intended for use in postmenopausal women.

Race

No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen (another form of emergency contraception). There was a non-statistically significant increased rate of pregnancy among Chinese women in the Plan B One-Step trial. The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown.

Hepatic Impairment

No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B One-Step.

Renal Impairment

No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B One-Step.

OVERDOSE

There are no data on overdosage of Plan B One-Step, although the common adverse event of nausea and associated vomiting may be anticipated.

CONTRAINDICATIONS

Plan B One-Step is contraindicated for use in the case of known or suspected pregnancy.

CLINICAL PHARMACOLOGY

Mechanism of Action

Emergency contraceptive pills are not effective if a woman is already pregnant. Plan B One-Step is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.

Pharmacokinetics

Absorption

Following a single dose administration of Plan B One-Step in 30 women under fasting conditions, maximum plasma concentrations of levonorgestrel of 19.1 ng/mL were reached at 1.7 hours. See Table 2.

Table 2 : Pharmacokinetic Parameter Values Following Single Dose Administration of Plan B One-Step (levonorgestrel) tablet 1.5 mg to 30 Healthy Female Volunteers under Fasting Conditions

	Mean ± SD
	Cmax (ng/mL)	AUCτ (ng?hr/mL)*	AUCinf (ng?hr/mL)*	Tmax (hr)**	t½(hr)
Levonorgestrel	19.1 ( 9.7)	294.8 ( 208.8)	307.5 ( 218.5)	1.7 (1.0-4.0)	27.5 ( 5.6)
Cmax = maximum concentration AUCτ = area under the drug concentration curve from time 0 to time of last determinable concentration AUC_inf = area under the drug concentration curve from time 0 to infinity Tmax = time to maximum concentration t½ = elimination half life * N=29 **median (range)

Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption following single oral administration of Plan B One-Step has not been evaluated.

Distribution

The apparent volume of distribution of levonorgestrel is reported to be approximately 1.8 L/kg. It is about 97.5 to 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin.

Metabolism

Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate conjugates and, to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α, 5αtetrahydrolevonorgestrel and 16βhydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users.

Excretion

About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates.

Specific Populations

Pediatric

This product is not intended for use in the premenarcheal population, and pharmacokinetic data are not available for this population.

Geriatric

This product is not intended for use in postmenopausal women, and pharmacokinetic data are not available for this population.

Race

Hepatic Impairment

No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B One-Step.

Renal Impairment

No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B One-Step.

Drug-Drug Interactions

No formal drug-drug interaction studies were conducted with Plan B One-Step [see DRUG INTERACTIONS].

Clinical Studies

A double-blind, randomized, multicenter, multinational study evaluated and compared the efficacy and safety of three different regimens for emergency contraception. Subjects were enrolled at 15 sites in 10 countries; the racial/ethnic characteristics of the study population overall were 54% Chinese, 34% Caucasian, and 12% Black or Asian (other than Chinese). 2,381 healthy women with a mean age of 27 years, who needed emergency contraception within 72 hours of unprotected intercourse were involved and randomly allocated into one of the two levonorgestrel groups. A single dose of 1.5 mg of levonorgestrel (Plan B One-Step) was administered to women allocated into group 1. Two doses of 0.75 mg levonorgestrel 12 hours apart (Plan B) were administered to women in group 2. In the Plan B One-Step group, 16 pregnancies occurred in 1,198 women and in the Plan B group, 20 pregnancies occurred in 1,183 women. The number of pregnancies expected in each group was calculated based on the timing of intercourse with regard to each woman's menstrual cycle. Among women receiving Plan B One-Step, 84% of expected pregnancies were prevented and among those women taking Plan B, 79% of expected pregnancies were prevented. The expected pregnancy rate of 8% (with no contraceptive use) was reduced to approximately 1% with Plan B One-Step.

Emergency contraceptives are not as effective as routine contraception since their failure rate, while low based on a single use, would accumulate over time with repeated use [see INDICATIONS AND USAGE].

In the clinical study, bleeding disturbances were the most common adverse event reported after taking the levonorgestrel-containing regimens. More than half of the women had menses within two days of the expected time; however, 31% of women experienced change in their bleeding pattern during the study period; 4.5% of women had menses more than 7 days after the expected time.

PATIENT INFORMATION

Plan B One-Step
(levonorgestrel) Tablet, 1.5 mg, for Oral Use

What is Plan B® One-Step?

Plan B® One-Step is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and is not to be used routinely.

Plan B® One-Step can reduce your chance of pregnancy after unprotected sex (if your regular birth control was used incorrectly or fails, or if you have had sex without birth control). For example, if you were using a condom and it broke or slipped, if you did not use your regular birth control as you should have, or if you did not use any birth control, Plan B® One-Step may work for you.

What Plan B® One-Step is not.

Plan B® One-Step will not work if you are already pregnant and will not affect an existing pregnancy. Plan B® One-Step should not be used as regular birth control. It is important to have another reliable source of birth control that is right for you. Plan B® One-Step will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases.

When is the appropriate time to use Plan B® One-Step?

You can use Plan B® One-Step after you have had unprotected sex in the last 72 hours (3 days), and you do not want to become pregnant.

Plan B® One-Step can be used as a backup or emergency method to regular birth control if, for example,

Your regular birth control method was used incorrectly or failed (your partner's condom broke or slipped)
You made a mistake with your regular method
You did not use any birth control method

When is it not appropriate to use Plan B® One-Step?

Plan B® One-Step should not be used as a regular birth control method. It does not work as well as most other forms of birth control when they are used consistently and correctly. Plan B® One-Step is a backup or emergency method of contraception.
Plan B® One-Step should not be used if you are already pregnant because it will not work.
Plan B® One-Step should not be used if you are allergic to levonorgestrel or any other ingredients in Plan B® One-Step.
Plan B® One-Step does not protect against HIV (the virus that causes AIDS) or other sexually transmitted diseases (STDs). The best ways to protect yourself against getting HIV or other STDs are to use a latex condom correctly with every sexual act or not to have sex at all.

How does Plan B® One-Step work?

Plan B® One-Step is one pill with levonorgestrel, a hormone that has been used in many birth control pills for over 35 years. Plan B® One-Step contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Plan B® One-Step may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).

How can I get the best results from Plan B® One-Step?

You have only a few days to try to prevent pregnancy after unprotected sex. The sooner you take Plan B® One-Step, the better it works. Plan B® One-Step should be taken as soon as possible within 72 hours (3 days) after unprotected sex.

How effective is Plan B® One-Step?

The sooner you take Plan B® One-Step, the better it will work. Take Plan B® One-Step as soon as possible after unprotected sex. If it is taken as soon as possible within 72 hours (3 days) after unprotected sex, it will significantly decrease the chance that you will get pregnant. Seven out of every 8 women who would have gotten pregnant will not become pregnant.

How will I know if Plan B® One-Step worked?

Most women will have their next menstrual period at the expected time or within a week of the expected time. If your menstrual period is delayed beyond 1 week, you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional.

What if I am already pregnant and use Plan B® One-Step?

There is no medical evidence that Plan B® One-Step would harm a developing baby. If you take Plan B® One-Step (accidentally) after you are already pregnant or it does not work and you become pregnant, it is not likely to cause any harm to you or your pregnancy. The pregnancy will continue. Plan B® One-Step will not work if you are already pregnant.

What should I do if my menstrual period is delayed beyond 1 week and I have severe lower stomach (abdominal) pain?

If you have severe lower stomach (abdominal) pain about 3 to 5 weeks after taking Plan B® One-Step, you may have a pregnancy outside the uterus, which is called a tubal pregnancy. A tubal pregnancy requires immediate medical treatment, so you should see a healthcare professional right away.

Can I use Plan B® One-Step for regular birth control?

No. Plan B® One-Step should not be used for regular birth control. It is an emergency or backup method to be used if your regular birth control fails or is used incorrectly or if you have sex without birth control. You should protect yourself against STDs and pregnancy every time you have sex. If you have unprotected sex again after taking Plan B® One-Step, it will not help protect you from getting pregnant.

How often can I use Plan B® One-Step?

Plan B® One-Step is meant for emergency protection only, and is not designed to be used frequently. If you find that you need to use emergency contraception often, talk to your healthcare professional and learn about methods of birth control and STD prevention that are right for you.

Will I experience any side effects from Plan B® One-Step?

When used as directed, Plan B® One-Step is safe for women. Some women will have mild, temporary side effects, such as menstrual changes, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, breast pain and vomiting. These are similar to the side effects that some women have when taking regular birth control pills. Some women taking Plan B® One-Step will have menstrual changes such as spotting or bleeding before their next period. Some women may have a heavier or lighter next period, or a period that is early or late. If your period is more than a week late, you should get a pregnancy test.

What warnings should I know about when using Plan B® One-Step?

Plan B® One-Step does not protect against the AIDS virus (HIV) or other sexually transmitted diseases (STDs).

Do not use:

If you are already pregnant (because it will not work)
If you are allergic to levonogestrel or any of the ingredients in Plan B® One-Step
For regular birth control

When using this product, you may have:

Menstrual changes
Nausea
Lower stomach (abdominal) pain
Tiredness

Headache
Dizziness
Breast pain
Vomiting

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

What are the directions for using Plan B® One-Step?

Women 17 years of age and older:

Take Plan B® One-Step as soon as possible within 72 hours (3 days) after unprotected sex.
If you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.

Prescription only for women younger than age 17. If you are younger than age 17, see a healthcare professional.

What should I do if I have questions about Plan B® One-Step?

If you have questions or need more information about this product, call our toll-free number, 1-800-330-1271, visit our website at www.PlanBOneStep.com, or ask a healthcare professional.

Other information

Tablet is enclosed in a blister seal. Do not use if the blister seal is broken.

Store at room temperature 20 ?25 °C (68 ?77 °F).

You may report side effects to FDA at 1-800-FDA-1088.

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, potato starch, magnesium stearate, talc, corn starch, lactose monohydrate

Protect yourself in more ways than one!

If you are sexually active, but you are not ready for a pregnancy, it is important to use regular pregnancy protection. There are many types of birth control. Whichever type you choose, it is important to use your regular birth control method as directed. This ensures that you have effective protection against pregnancy every time you have sex.

But things do not always go as planned. For example, if you were using a condom and it broke or slipped, or if you did not use your regular birth control as you should have, or if you did not use any birth control, Plan B® One-Step may work for you. Plan B® One-Step is an emergency contraceptive that helps prevent pregnancy after unprotected sex or when your birth control fails or is not used correctly.

Remember, Plan B® One-Step is only for emergency pregnancy prevention. There are many other products that work for regular birth control that are available by prescription or over-the-counter.

There is also another form of protection to think about when you have sex: protection against sexually transmitted diseases (STDs). Some common STDs are HIV/AIDS, chlamydia, genital herpes, gonorrhea, hepatitis, human papilloma virus (HPV), genital warts, syphilis, and trichomonas. Some of these STDs can be very serious and can lead to infertility (inability to have a baby), problems during pregnancy, chronic illness, and even death.

All sexually active women are at risk of catching STDs because they may not know that their partner has an STD (the partner himself may not know). If your partner uses a latex condom correctly each and every time you have sex with him, this will help reduce, but not eliminate, the chance that you will catch an STD.

No other birth control methods will effectively protect you from STDs. The female condom may give you some STD protection, but it is not as effective as a male latex condom.

For more information on STDs, call the Centers for Disease Control and Prevention (CDC) AIDS/STD Hotline. The CDC phone numbers are 1-800-342-AIDS (2437) for English, 1-800-344-7432 for Spanish, or 1-800-243-7889 for hearing impaired, TDD.

Be sure to protect yourself against pregnancy and STDs by using some form of birth control plus a latex condom. Of course, not having sex is the most effective way to prevent pregnancy and stay free of STDs.

Plan B® One-Step is used to prevent pregnancy after unprotected sex.

Plan B® One-Step should not be used for regular birth control, if you are already pregnant (because it will not work), or if you are allergic to levonorgestrel or any of the ingredients in Plan B® One-Step.

The sooner you take Plan B® One-Step, the better it will work.

Plan B® One-Step does not protect against the AIDS virus (HIV) or other sexually transmitted diseases (STDs)

Common side effects associated with the use of Plan B® One-Step include menstrual changes, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, breast pain and vomiting.

약이름을 톰과 제리... 그런식으로 쉽게 짓지 않느냐고 반문하던이가 있었다.
새약이 만들어지면
약이름이 만들어 지는 경로가 따로 있긴 하다.
개인적으로 약이름이 참 잘 좋다고 생각되는 약중의 하나/ 더 간편하게 피임을 해결될 수 있는
약이긴 하지만...(여성용 사후피임약)
사전에 다른 방법으로 먼저 원치 않는 임신을 해결 하여야 할 것이며
언제나 복용할 시엔 의사와 상의. 주의를 요함.

나라마다 규정이 다르긴 하나 이전에 나온
*Plan B(levonorgestrel Tablets, 0.75 mg ) 18세 이상 처방없이 살 수 있다.(12시간에 걸쳐서 두 번 복용해야 함)

Available without a prescription for consumers 18 and older. Rx only for women age 17 and younger

image/blog-Aries21usa.02.04.2010
Scrap/Rx List.com

겨울의 향산(香山)

Sat, 06 Feb 2010 09:21:57 +0900

어제는 향산을 다녀왔어요.
날씨도 차갑고 향로봉까지 오르는데 무척 힘은 들었지만
그만큼 정상에 오른 기쁨도 컸습니다.

위는 향로봉 정상에 있는 리프트 관리소를 내려다 본 모습이고요
아래는 사찰 뒤에 있는 유리탑의 모습입니다.

명나라 시대에 황제의 사냥터로 건설되어서
이곳에는 황제의 행궁도 있어요.

북경에 오시면 한 번 다녀 가십시오 ^^

어려워

Wed, 10 Feb 2010 07:58:58 +0900

■ 남편이란 존재는 이래저래 애물 덩어리 !!

집에 두고오면.................근심 덩어리
같이 나오면....................짐 덩어리
혼자 내보내면.................걱정 덩어리
마주 앉아 있으면.............웬수 덩어리

■ 하늘의 별따기 보다 힘든 것 !!

앙드레 김에게 ................검은 옷 입히기
중 머리에.......................꽃핀 꽂기
장가 간 아들...................내 편(?) 만들기
펀드에 맡긴 돈................원금 되찾기

■ 선생님 시리즈

20대 선생님....................어려운 것만 가르친다
30대 선생님....................중요한 것만 가르친다
40대 선생님....................이론(원칙)만 가르친다
50대 선생님....................아는 것만 가르친다(명화샘에겐 해당사항 없음~~ㅎㅎ)

■ 잊었던 첫 사랑이 또 아픔을 주네 !!

잘 살면...........................배 아프고
못 살면..........................가슴 아프고
같이 살자고 하면.............머리 아프고

당신의 소금사막에 비가 내리면/테오에세이

Thu, 04 Feb 2010 14:30:39 +0900

당신의 소금 사막에 비가 내리면

/테오

아주 오래전 잉카 제국의 일부였으며 오랫동안 에스파냐의 지배를 받았던
남미의 비밀스러운 나라 볼리비아 여행 에세이.

전작 『당신의 아프리카에 펭귄이 방문했습니다』에서 아프리카 케이프타운의
매력을 정갈한 감성으로 그려냈던 작가가, 또다시 권태로운 삶으로 가득한 도시에서
시선을 돌려 남미 볼리비아 사람들의 다양한 방식의 행복을 진솔하게 풀어냈다.

저자는 훌쩍 여행을 떠나려고 큰 맘 먹고 휴가를 내고도 '성공적인 관광'만 하기에도
시간이 모자라는 이들에게 자기 여행을 나누며 삶을 진단하고 '다른' 행복을 이야기한다.
그가 향한 남미의 나라, 볼리비아에는 '사람'이 있었다. 그곳에 사는 사람, 그 사람들이
먹는 음식, 그 사람들의 습관으로 채워진 그의 여행은 도시의 메마른 삶에 지친 사람들의
어깨를 다독여 준다.

테오의 여행은 바로 '사람을 향한 여행'이다. 연인을 상실한 사람, 직장을 구하려는 사람,
삶이 권태로운 사람, 공부하기 싫은 학생, 일상이 덧없는 주부 등 수많은 사람들에게
그는 자신의 여행 이야기를 들려준다. 미래를 알려 주는 잉카 예언술, 죽음의 도로를
지나는 방법, 아마존의 빵 굽는 여자 아이, 도박하는 소년 라파엘에 관한 이야기 등,
그의 여행 이야기와 함께 잠시 지친 일상을 떠나 '다른 방식의 행복'을 경험해 보자.

Prologue 여행의 처음

여행을 시작합니다
잉카 예언술, 당신의 미래를 보여 줍니다
죽음의 도로
계곡 마을 꼬로이꼬
꼬추나 폭포
히피 호르헤
하늘 호수를 지키는 개, 티카
변호사 살인 사건
부엉이 나이트클럽
볼리비아 무적 함대, 바다를 지켜라!
게이꼬
티티카카 호수를 떠나는 방법
신부님 이야기
까사니 가는 길
문

누가 아마존 강변의 검은 오리를 죽였나?
식스또 할아버지의 비밀
아마존의 빵 굽는 소녀, 올리비아
아마존 이발소의 즉석 콘서트
넘어지지 마세요
잉카 사람들의 우주선 발사대
당신이 놓인 자리
차빠레를 배달해 주세요
차빠레 코카마켓
도박 소년 라파엘
정글 과일 카카오
정글 부엌
안데스 소녀 마이라
탄광 도시 뽀또시
낯선 펍
가시의 예수님
희망

우연이 교차하는 거리
까차파세스 소셜 클럽 - 보물을 찾아서
까차파세스 소셜 클럽 - 모험의 계속
까차파세스 소셜 클럽 - 보물의 저편
인생은 게임이에요
마르띵과 에두아르도
부뉴엘로
옷을 만들어 주세요
오래된 노래
뚜삐사
오래된 기차들의 무덤
녀석, 비꾸냐
내 이름은 솔레닷
할머니 나딸리
날아라 플라밍고
불끈불끈 선인장
당신은 여행자입니까?
소금 공장의 끌라우디오
소금 사막에 비가 내리면
달려라 소금 사막
소금 호텔
소금 호텔의 레스토랑
소금 호텔에 밤이 내리면
소금 호텔의 새벽

Epilogue 그대에게,

책중에서...

사막은 죽은 것들의 슬픔이 오래 보관되는 곳입니다.
온 생애가 박제되어 영원히 눕게 되는 장소.
사막이란 그런 곳입니다.
하물며 소금 사막이라면.

소금 사막을 걷다 새를 만납니다. 사막 위를 날아다녔던 새가 하얗게 누워 있습니다.
소금 사막을 걷다 죽은 새를 만나는 건 어려운 일이 아닙니다.
소금 사막은 죽은 것들을 오래 보관하기 때문입니다.

사막과 이별하고 싶지만 그럴 수 없습니다.
소금 사막이 놓아주지 않기 때문입니다.
몸이 썩지 않기 때문입니다.
그것은 다른 종류의 슬픔.

새에게 필요한 두 가지 자유.
떠나야 할 때 떠날 수 있는
떠나고 싶을 때 떠날 수 있는
자유.

소금 사막에 비가 내립니다.

떠날 수 있는 자유를 빼앗긴 것들은 죽음 이후에도 눈물을 흘립니다.
그렇게 쌓인 눈물이 모여 구름이 되면 소금 사막에 비가 내립니다.
소금 사막이 놓아주지 않아서, 진득하게 썩지 못해서, 떠날 수 없던 것들이
눈물을 흘려, 비로소 몸을 놓을 수 있게 되는 것입니다. 비가 내리는 것입니다.

그제야 사막을 떠날 수 있는 것입니다.
소금 사막에 비가 내리면 기적이 시작됩니다.
사막이 호수가 되고, 오랜 슬픔들이 호수를 떠나는 기적.

지상이라고는 믿기지 않는 꿈 같은 장소, 우유니 소금 사막.
그 소금 사막을 품고 있는 남미의 비밀스러운 나라,
볼리비아에 관한 여행 이야기.

이 책은 아주 오래전 잉카 제국의 일부였으며 오랫동안 에스파냐의 지배를 받았던
남미의 비밀스러운 나라 볼리비아 여행 에세이입니다. 여행은 떠나는 것이 아니라
향하는 것이라 말하는 한가한(?) 에세이스트 테오. 전작 《당신의 아프리카에 펭귄이
방문했습니다》에서 아프리카 케이프타운의 매력을 정갈한 감성으로 그려냈던 작가는
또다시 권태로운 삶으로 가득한 도시에서 시선을 돌려 남미 볼리비아 사람들의
다양한 방식의 행복을 진솔하게 풀어냈습니다.

사람을 향하는 여행을 한다는 작가 테오는 일상을 '이유'로 여행하지 못하는 사람들에게
여행은 일상을 '까닭'으로 떠나는 것이라 말합니다. 일상을 버리기 위해서가 아니라
일상을 위해 떠나는 것이 바로 여행이라고요.

여행을 통해 맛있는 바람을 가슴 가득 들이켜고, 낯선 여행지의 좁은 골목길에서
마주하는 사람들을 보며 일상을 정돈하고 자신의 먼 곳을 볼 수 있는 사람이 진짜 여행자라고요. 당신은 여행자입니까? 한때 시인을 꿈꿨던 작가 테오가 보내오는 볼리비아의 따뜻한 바람 속에서 당신을 부르는 여행의 소리를 듣게 되길 바랍니다.

일상을 이유로 여행하지 못하는 사람들에게
일상을 위해 떠나라고 이야기하는 여행자, 에세이스트 테오.
그의 사람을 향한 여행은 당신에게 '다른 종류의 행복'을 선사할 것이다.

목마른 여행자의 꿈 같은 오아시스, 볼리비아

남미에서 가장 높고 가장 고립된 나라, 볼리비아는 육지로 둘러싸인 남미의 티베트와
같은 곳이다. 가난한 나라이기에, 아직 국제적으로 힘이 약한 나라이기에 여느 사람들에게는
낯설게 느껴질 이곳은 아주 오래전 잉카 문명이 번영하던 곳이었다.

잉카의 뜨거운 태양이 내리쬐던 나라, 아직까지 인디언의 가치와 신앙이 숨 쉬고 있는
나라인 이곳은 토착민의 문화와 압도적인 안데스 산맥의 풍경, 그리고 신비스러운
고대 잉카 문명의 잔재들 때문에 자유를 동경하고 모험을 좋아하는 여행자들에게 꿈 같은
오아시스로 여겨지는 곳이다.

하늘과 닿아 있는 티티카카 호수, 잉카의 태양과 남미의 바람이 정제해 놓은 우유니의
소금 사막, 차빠레의 싱싱한 대정글을 품은 미지의 나라로 떠난 에세이스트 테오 역시
건조한 도시 생활에 지친, 꿈 같은 오아시스를 동경하던 사람이었다. 여행을 통해 사람들의
삶을 치유하는 여행자, 에세이스트 테오. 그가 볼리비아로 향한 진짜 이유는 무엇일까?

사람을 향한 여행, 그 여행에는 '다른 방식의 행복'이 있다

숨 가쁜 일상을 살아가는 사람들이 한 번쯤 하는 생각이 있다. 이렇게 사는 것이 맞는 걸까.
이렇게 살면 행복해질까. 십 년 후의 나는 어떤 모습일까. 물도 사람도 고이면 썩는 것이
이치이지만 많은 이들의 일상은 그 자신의 일탈을 쉽게 허용하지 않는다.

그래서 쉽게 지친다. 훌쩍 여행을 떠나려고 큰 맘 먹고 낸 휴가지만, 고작 1주일 정도로는
'성공적인 관광'만 하기에도 시간이 모자라다. 이런 이들에게 자기 여행을 나누며 삶을
진단하고 '다른' 행복을 이야기하는 것이 테오의 에세이다. 단 몇 개월 동안 십만 명이
넘는 사람들이 블로그를 통해 그와 일상을 나누고 있다.

연인을 상실한 사람, 직장을 구하려는 사람, 삶이 권태로운 사람, 공부하기 싫은 학생,
일상이 덧없는 주부. 그들에게 테오는 자기의 여행을 들려준다. 미래를 알려 주는 잉카
예언술, 죽음의 도로를 지나는 방법, 아마존의 빵 굽는 여자 아이, 도박하는 소년 라파엘에
관한 이야기를.
볼리비아, 그가 향한 남미의 나라에는 사람이 있었다.

그곳에 사는 사람, 그 사람들이 먹는 음식, 그 사람들의 습관으로 채워진 그의 여행은
도시의 메마른 삶에 지친 사람들의 어깨를 다독여 준다. 사람, 그것이 테오가 볼리비아로
여행을 떠난 이유인 것이다.

테오의 말에 의하면 여행은 떠남이 아니라 향함이다. 사람을 향한 여행. 삶이 아무리
힘겨워도 결국 사람에게는 희망이 있는 것이다. 도망칠 필요가 없는 것이다.

잠시 지친 일상을 떠나 그의 여행과 함께 '다른 방식의 행복'을 경험해 보자. 자기 여행을
굳이 '당신의 여행'이라고 말하는 이 이상한 에세이스트의 여행 이야기에 귀를 기울여 보자.

출처 : 예스24 ,교보문고,기타 ...

기분좋은 실수

Wed, 10 Feb 2010 07:09:04 +0900

외래를 보는데 50-60대 가량의 남자 환자가 왔다
간호원이 적어온 병력을 보니 23년 전 내가 대학병원교수로 있을 당시 대학에서 망막박리 수술을 나 한테서 받은 적이 있다고 적혀있다
환자 눈 상태를 대충 보니 오른쪽 눈이 심하게 외사시로 되어 있고 ,안구위축으로 인한 실명상태며 눈 마저 조금 꺼진 상태로 최악의 상태이다 .
반대쪽 왼쪽 눈에는 백내장이 조금 있어 시력이 0.6 정도 이나 외관상 보아서는 수술 받은 흔적 같은 것은 전혀 보이지 않는다 .
20년 전의 내가 해준 망막박리 수술이 잘못되어 찾아 왔구나 하는 생각이 드니 가슴이 철렁한다 ..
과거에 수술 해주었던 대학병원에 가서 수술 해 준 나를 찿으니 3년년 전에 개업을 하셨다고하기에 주소를 물어 나을 기여코 찿아 왔다는 것이다 .
얼굴을 보니 조금은 기억이 날 듯 말듯한 얼굴이나 20년이 흘렀으니 잘 기억할 수가 없으나
어쨋던 현재 그의 오르쪽 눈 상태를 보니 억창이 무너지는것이다 .
만약 망막 수술이 성공적으로 되었다면 눈이 이렇게는 안 되었을 텐데 하는 자책감과 미안함에
고개를 바로 처들고 그를 똑바로 보지도 못하면서 진찰을 시작 하는데 ...

요즈음은 사시수술 외는 안하고 오직 사시교정수술만 하고 있으니 먼저 눈에 들어오는 것은
오른쪽 눈의 외사시이다
아마도 망막 수술후 실명되어 와시시가 되어 사시수술을 하려고 나를 다시 찾아 온 것으로
착각을 하였다 .
비록 실명을 했을지언정 사시가 심해 외관상 교정 목적으로 사시수술은 해주어야 하지만
사시 수술을 해 달라고 하지 말아 주었으면 하는 심정으로
전에 망막박리 수술을 받은적이 있는 눈에 사시 수술을 하는 경우엔 통증 때문에
고통스럽기도 하고 괜히 수술을 시도 했다가 눈이 바로 오게하지도 못하면서
눈만 더 꺼지게 만들 수도 있으며 수술후에는 환자가 만족 할 만족 할 정도로 안될지도
모르는 어려운 수술이라 며 수술을 피해볼 생각으로 더 열심히 설명하였다.
환자 분의 나이도 있으시니 고통을 다시 받는니 그대로 사시는게 좋겠다고 말은 했으나
내가 과거 수술 잘못으로 그의 눈을 심한 외사시를 만든 것만 죄를 지은 것 같아 미안도하여
더 열심히 설명에, 설명을 더 해주었다.

그런데 이외로 환자는 항의로 따지려는 태도는 어디에도 보이질 않고 ,
마치 오랜 적 친구를 만난듯 기쁜 표정이다 .
나는 미안 한 듯 설명을 하지만 그는 도리어 기쁜듯이 내 설명을 잠자코 들어 주니
무언가 조금은 이상하다고 생각 했는데 ..
수술해 준 눈을 다시 좀 봐달라고 하여 외사시가 된 꺼진 오른쪽 눈을 다시 한번
더 진찰하려 하는데 그가 외친다,
"선생님 오른쪽 눈말고 , 왼쪽 눈"을 한다 .
선생님이 수술 해 준 ,지금 보이고 있는 왼쪽 눈을 가르치며 다시 한번 보아주세요 한다.

그러면서 하시는 말
어릴 적부터 오른쪽 눈 실명으로 한 쪽 눈 가지고 살아왔는데 , 어느날 갑자기 좌안에 안보여 거의 양눈이 봉사가 되기 일보 직전에 선생님을 만나,
망막박리 수술을 잘 받은 덕에 지금까지 23년간을 농사를 지으며 잘 보고 살아왔습니다 하며
고맙다는 인사말을 전한다 .
그 말을 듣는 순간 혹시나 하며 철렁하던 가슴이 뻥 뚫히며 기쁨에 거의 기절할 뻔 했다
그제사 간호원이 적어온 병력지를 다시 읽어보니 수술 망막박리 수술 받은쪽이 오른쪽인지,
왼쪽 인지가 쓰여있지 않았다.
요사이는 사시수술 만을 전문으로 해오기에 환자가 오면 먼저 사시인 눈에만 신경쓰던 버릇으로 일어난 실수이다 .
즉 외사시 심한, 오른쪽 눈이 , 바로 내가 망막 박리 수술을 해 준 쪽 눈 일거라고
미리 짐작한 나의 실수 때문이였다 .
순간의 실수를 하고도 스스로 이렇게 기뻐해 보긴 처음일게다

어쨋던 수술을 해 준 나를 잠시도 잊지 않고 기억했다가
23년이 지나서도 다시 찿아 준 환자분의 감사 인사를 받아보며
기분은 하늘을 나는 듯했다
바로 이런 맛에 . 때론 가슴이 철렁거리는 수술을 아직도 계속해야하는 것이리라..

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김여사 영상

NICOTROL®(nicotine) Inhalant

DRUG DESCRIPTION

INDICATIONS

DOSAGE AND ADMINISTRATION

Initial Treatment (Up to 12 Weeks)

Gradual Reduction of Dose (Up to 12 Weeks)

Individualization of Dosage

Safety And Handling

Disposal

HOW SUPPLIED

SIDE EFFECTS

Local Irritation

Withdrawal

Nicotine-Related Adverse Events

Smoking Related Adverse Events

Other Adverse Events

Drug Abuse And Dependence

DRUG INTERACTIONS

WARNINGS

Pregnancy, Warning

Safety Note Concerning Children

PRECAUTIONS

General

Bronchospastic Disease

Cardiovascular or Peripheral Vascular Diseases

Renal or Hepatic Insufficiency

Endocrine Diseases

Peptic Ulcer Disease

Accelerated Hypertension

Information for Patient

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Pregnancy Category D

Teratogenicity

Animal Studies

Human Studies

Other Effects

Animal Studies

Human Experience

Labor and Delivery

Use in Nursing Mothers

Pediatric Use

Geriatric Use

OVERDOSE

Signs and Symptoms of Nicotine Toxicity

Overdose from Inhalation

Overdose from Ingestion

Management of Nicotine Poisoning

CONTRAINDICATIONS

CLINICAL PHARMACOLOGY

Pharmacologic Action

Pharmacodynamics

Pharmacokinetics

Absorption

Distribution

Metabolism

Elimination

Gender Differences

Clinical Trials

PATIENT INFORMATION(NICOTINE INHALATION SYSTEM) 10 MG PER CARTRIDGE(4 MG DELIVERED) An Aid to Help You Stop Smoking

Consumer

오대양 육대주 - 별은 몇개?

Time is not in motion...

덤덤히...

사후피임약/Plan B One-Step(levonorgestrel) Tablet, 1.5 mg, for Oral Use

DRUG DESCRIPTION

INDICATIONS

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Dosage Forms And Strengths

Storage And Handling

SIDE EFFECTS

Clinical Trials Experience

Postmarketing Experience

Gastrointestinal Disorders

General Disorders and Administration Site Conditions

Nervous System Disorders

Reproductive System and Breast Disorders

PATIENT INFORMATION
(NICOTINE INHALATION SYSTEM) 10 MG PER CARTRIDGE
(4 MG DELIVERED)
An Aid to Help You Stop Smoking