ADIPEX: DRUG ABUSE AND DEPENDENCE
ADIPEX-P® is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of ADIPEX-P® 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.
Usage with Alcohol: Concomitant use of alcohol with ADIPEX-P® may result in an adverse drug interaction.
ADIPEX: PRECAUTIONS
General
Caution is to be exercised in prescribing ADIPEX-P® (phentermine hydrochloride) for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of ADIPEX-P® and the concomitant dietary regimen.
ADIPEX-P® 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 ADIPEX-P® (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 ADIPEX-P®. It is also not known whether ADIPEX-P® can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
ADIPEX-P® 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.
ADIPEX-P® is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of ADIPEX-P® 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.
Usage with Alcohol: Concomitant use of alcohol with ADIPEX-P® may result in an adverse drug interaction.
ADIPEX: PRECAUTIONS
General
Caution is to be exercised in prescribing ADIPEX-P® (phentermine hydrochloride) for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of ADIPEX-P® and the concomitant dietary regimen.
ADIPEX-P® 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 ADIPEX-P® (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 ADIPEX-P®. It is also not known whether ADIPEX-P® can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
ADIPEX-P® 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.
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