DRUG INTERACTIONS
Monoamine Oxidase Inhibitors
Use of ADIPEX-P® is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.
Alcohol
Concomitant use of alcohol with ADIPEX-P® may result in an adverse drug reaction.
Insulin and Oral Hypoglycemic Medications
Requirements may be altered [see Warnings and Precautions (5.9)].
Adrenergic Neuron Blocking Drugs
ADIPEX-P® may decrease the hypotensive effect of adrenergic neuron blocking drugs.
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OVERDOSAGE
The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
Acute Overdosage
Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include tachycardia, arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning and usually terminates in convulsions and coma.
Management of acute phentermine hydrochloride 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 on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.
Chronic Intoxication
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. See Drug Abuse and Dependence (9.3).
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CONTRAINDICATIONS
- History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension)
- During or within 14 days following the administration of monoamine oxidase inhibitors
- Hyperthyroidism
- Glaucoma
- Agitated states
- History of drug abuse
- Pregnancy [see Use in Specific Populations (8.1)]
- Nursing [see Use in Specific Populations (8.3)]
- Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines
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DRUG ABUSE AND DEPENDENCE
Controlled Substance
Phentermine is a Schedule IV controlled substance.
Abuse
Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program.
Dependence
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 of these drugs to many times than 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. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.
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