Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3255
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PHENTERMINE HYDROCHLORIDE (Capsule)
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| dailymed-instance:dosage |
Dosage should be individualized to obtain an adequate response with the lowest effective dose.<br/>Exogenous Obesity: The usual dosage is 15 to 30 mg at approximately 2 hours after breakfast for appetite control. Late evening medication should be avoided because of the possibility of resulting insomnia. Administration of one capsule (30 mg) daily has been found to be adequate in depression of the appetite for 12 to 14 hours. Phentermine is not recommended for use in patients 16 years of age and under.
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| dailymed-instance:descripti... |
Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder, which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Its molecular weight is 185.7 and the molecular formula is CHN���HCl. Chemically, the product is��,��-Dimethylphenethylamine hydrochloride. Phentermine hydrochloride has the following structural formula: Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD&C Blue #2, FD&C Red #40. FD&C Blue #1 and D&C Yellow #10 Lake.
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| dailymed-instance:clinicalP... |
Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved, for example. Adult obese subjects instructed in dietary management and treated with "anorectic" drugs lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials. The magnitude of increased weight loss of drug-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, andthe increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.
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| dailymed-instance:contraind... |
Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated states. Patients with a history of drug abuse. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).
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| dailymed-instance:supply |
Phentermine Hydrochloride Capsules USP, 30 mg (equivalent to 24 mg Phentermine) are available as No. 2 yellow opaque/yellow opaque, imprinted MUTUAL 274 on both the cap and body. Bottles of 30 unit of use NDC 53489-433-07Bottles of 60 unit of use NDC 53489-433-06Bottles of 100 NDC 53489-433-01Bottles of 250 NDC 53489-433-03Bottles of 500 NDC 53489-433-05Bottles of 1000 NDC 53489-433-10 Store at 20��to 25��C (68��to 77��F) [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... |
dailymed-ingredient:Crospovidone,
dailymed-ingredient:D&C_Yellow_#10_Lake,
dailymed-ingredient:FD&C_Blue_#1,
dailymed-ingredient:FD&C_Blue_#2,
dailymed-ingredient:FD&C_Red_#40,
dailymed-ingredient:FDA/E_172_Yellow_Iron_Oxide,
dailymed-ingredient:dibasic_calcium_phosphate_dihydrate,
dailymed-ingredient:gelatin,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:povidine,
dailymed-ingredient:titanium_dioxide
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| dailymed-instance:precautio... |
General: Caution is to be exercised in prescribing phentermine hydrochloride for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of phentermine and the concomitant dietary regimen. Phentermine may decrease the hypotensive effect of guanethidine.
The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed with phentermine hydrochloride to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.<br/>Pregnancy:<br/>Teratogenic Effects:<br/>Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.<br/>Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
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| dailymed-instance:overdosag... |
Manifestations of acute overdosage with phentermine include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning usually terminates in convulsions and coma. Management of acute phentermine intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases phentermine excretion. Intravenous phentolamine has been suggested for possible acute, severe hypertension, if this complicates phentermine overdosage.
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| dailymed-instance:genericMe... |
phentermine hydrochloride
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| dailymed-instance:fullName |
PHENTERMINE HYDROCHLORIDE (Capsule)
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| dailymed-instance:adverseRe... |
Cardiovascular: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease , palpitation, tachycardia, elevation of blood pressure. Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic episodes at recommended doses. Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Allergic: Urticaria. Endocrine: Impotence, changes in libido.
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| dailymed-instance:indicatio... |
Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavorial modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index���30 kg/m, or���27 kg/min the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds��2.2 = kg; inches��0.0254=meters. The limited usefulness of agents of this class should be measured against possible risk factors inherent in their use such as those described below.
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| dailymed-instance:name |
PHENTERMINE HYDROCHLORIDE
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