 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Phendimetrazine
PHENDIMETRAZINE TARTRATE TABLETS, USP Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2S.3S)-3, 4-Dimethyl-2-phenylmorpholine L-(*)-tartrate (1.1). Its molecular weight is 341.36. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol, insoluble in chloroform, acetone, ether and benzene. Each tablet, for oral administration, contains 35mg of phendimetrazine tartrate. In addition, each tablet contains the following inactive ingredients: Lactose USP, Magnesium Stearate NF, Colloidal Silicon Dioxide, Microcrystalline Cellulose NF, Starch NF (Modified Corn Starch). Additional inactive ingredients are present as follows: Phendimetrazine 35mg Gray Tablet Contains: Activated Charcoal USP. Sterotex Food Grade. Phendimetrazine 35mg Pink Tablet contains: FD&C Red #3. Phendimetrazine 35mg Speckled Tablet contains: Calcium Stearate NF, FD&C Blue #1, FD&C Yellow #5, and sucrose. Phendimetrazine 35mg Yellow Tablet contains: FD&C Yellow #5, Calcium Stearate NF. Phendimetrazine 35mg Blue Tablet contains: FD&C Blue #1.
Phendimetrazine tartrate is a phenylalkylamine sympathomimetic amine with pharmacological 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 has 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, however, 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. 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 over placebo-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, and the increased weight loss appears to be related in proof to variables other than the drug 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 low weeks
duration, thus the total impact of drug-induced weight
loss over that of diet
alone must be considered clinically limited.
Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below. (See WARNINGS and PRECAUTIONS.)
Usual Adult Dosage One tablet (35mg) b.i.d. or t.i.d. taken one hour before meals. Dosage should be individualized to obtain an adequate response with the lowest effective dosage. In some cases 1/2 tablet (17.5 mg ) per dose may be adequate. Dosage Should not exceed 2 tablets t.i.d. HOW SUPPLIED Phendimetrazine tartrate tablets are supplied as: 35MG Gray, Size 13 32 round, compressed, double scored Logo "CC 105'' Bottles of 1000 35MG Blue Size 0.220 x 0.500 oblong, compressed, single scored Logo "CC 135", Bottles of 1000 35MG Pink Size 5 16 round, compressed, single scored Logo "CC 105" Bottles of 1000 35MG Pink Size 13 32 round, compressed, double scored Logo "CC 105", Bottles of 100, 1000, and 5000 35MG Speckled Size 0.255 x 0.555 oblong, compressed, double scored Logo "CC 135", Bottles of 1000 35MG While Size 13 32 round, compressed, double scored Logo "CC 105", Bottles of 1000 35MG Yellow Size 9 32 round, compressed, single scored Logo "CC 107", Bottles of 100, 1000, and 5000 35MG Yellow Size 5 16 round, compressed, single scored Logo "CC 105", Bottles of 1000 35MG Yellow Size 13 32 round, compressed, single scored Logo "CC 105", Bottles of 1000 Store at controlled room temperature 15°-30° C (59°-86° F) Dispense in a light container as defined in the USP. Caution: Federal law prohibits
dispensing without prescription.
Cardiovascular: Palpitation, tachycardia, elevation of blood pressure. Central Nervous System: overstimulation, restlessness, dizziness, insomnia, tremor, headache, psychotic state, agitation, flushing, sweating, blurring of vision. Gastrointestinal: Dryness of the mouth, diarrhea, constipation, nausea, stomach pain. Genitourinary: Changes in libido, urinary frequency, dysuria. DRUG ABUSE AND DEPENDENCE Phendimetrazine tartrate is classified as a Schedule III controlled substance. Dependence Phendimetrazine Tartrate is related chemically and pharmacologically
to the amphetamines. Amphetamines and related stimulant
drugs have been extensively abused, and the possibility of abuse
of phendimetrazine should be kept in mind
when evaluating the desirability of including a drug
as part of a weight reduction
program. Abuse of amphetamines and related drugs may be associated
with intense psychological
dependence and severe
social dysfunction. There are, reports of patients who have increased
the dosage to many times that recommended. Abrupt cessation following
prolonged high dosage administration
results in extreme fatigue
and mental depression.
Changes are also noted on the sleep
EEG. Manifestations of chronic
intoxication is psychosis,
often clinically indistinguishable from schizophrenia.
Tolerance to the anorectic effect usually develops within a few weeks. When this occurs the recommended dose should not be exceeded in an attempt to increase the effect rather, the drug should be discontinued. Use of phendimetrazine within 14 days following the administration of monoamine oxidase inhibitors may result in a hypertensive crisis. Abrupt cessation of administration following prolonged high dosage results in extreme fatigue and depression. Because of the effect on the central nervous system phendimetrazine tartrate may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle. The patient should therefore be cautioned accordingly.
Caution is to be exercised in prescribing phendimetrazine for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of phendimetrazine and the concomitant dietary regimen. Phendimetrazine 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. Phendimetrazine tartrate 35 mg Yellow and Speckled tablets contain FD& C Yellow #5 (tartrazine) which may cause allergic type reactions (including bronchial asthma) in certain susceptible persons, although the overall incidence of FD& C Yellow #5 (tartrazine) sensitivity in the general population is low. It is frequently seen in patients who also have aspirin hypersensitivity. Usage In Pregnancy Safe use in pregnancy has not been established. Until more information is available, phendimetrazine tartrate should not be taken by women who are or may become pregnant unless, in the opinion of the physician, the potential benefits outweigh the possible hazards. Usage In Children Phendimetrazine tartrate
is not recommended for use in Children Under 12 years of age.
|
| |||