Phentermine (Page 2 of 2)

PRECAUTIONS

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 hydrochloride and the concomitant dietary regimen.

Phentermine hydrochloride 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed with phentermine hydrochloride to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

Pregnancy

Teratogenic Effects

Pregnancy category C. Animal reproduction studies have not been conducted with phentermine hydrochloride. It is also not known whether phentermine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Phentermine hydrochloride should be given to a pregnant woman only if clearly needed.

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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions to Phentermine

Cardiovascular: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease (see WARNINGS), 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.

DRUG ABUSE AND DEPENDENCE

Phentermine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of phentermine hydrochloride 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 with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.

OVERDOSAGE

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 (Regitine®, CIBA) has been suggested for possible acute, severe hypertension, if this complicates phentermine overdosage.

DOSAGE AND ADMINISTRATION

Exogenous Obesity: Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is one tablet (37.5 mg) daily, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients 1/2 tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give 1/2 tablet (18.75 mg) two times a day.

Late evening medication should be avoided because of the possibility of resulting insomnia.

Phentermine is not recommended for use in patients sixteen (16) years of age and under.

HOW SUPPLIED

Phentermine Hydrochloride Tablets, USP are supplied as follows:

37.5 mg — Each white, capsule shaped tablet imprinted with Image from Drug Label Contentand 316 on one side and scored on the other side contains 37.5 mg of Phentermine hydrochloride, USP (equivalent to 30 mg Phentermine base). Tablets are supplied in bottles of 100 with a child-resistant closure (NDC 0228-3016-11) and 1000 (NDC 0228-3016-96).

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Store at controlled room temperature 15°-30°C (59°-86°F).

Rx only

Manufactured by:
PUREPAC PHARMACEUTICAL CO.
Elizabeth, NJ 07207 USA
40-8817
Revised — February 2001

PHENTERMINE
phentermine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3016
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phentermine hydrochloride (Phentermine) Phentermine 37.5 mg
Inactive Ingredients
Ingredient Name Strength
citric acid
corn starch
lactose monohydrate
magnesium stearate
microcrystalline cellulose
stearic acid
Product Characteristics
Color white Score 2 pieces
Shape OVAL (capsule shaped) Size 10mm
Flavor Imprint Code R316
Contains
Coating false Symbol true
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0228-3016-11 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:0228-3016-96 1000 TABLET (1000 TABLET) in 1 BOTTLE None
Labeler — Actavis Elizabeth LLC

Revised: 01/2009 Actavis Elizabeth LLC

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