• Indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m², or ≥ 27 kg/m² in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

The limited usefulness of agents of this class, including ADIPEX-P, should be measured against possible risk factors inherent in their use.

Co-administration with other drugs for weight loss is not recommended (safety and efficacy of combination not established).

Limit the dosage to 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m²).

Avoid use in patients with eGFR less than 15 mL/min/m² or end-stage renal disease requiring dialysis.

ADIPEX-P is contraindicated in patients with:

• 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
• Nursing

Risk of abuse and dependence. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Primary Pulmonary Hypertension (PPH): a rare, frequently fatal disease of the lungs has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of ADIPEX-P alone cannot be ruled out. There have been rare cases of PPH in patients who reportedly have taken phentermine alone.

Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss.

Use caution in prescribing ADIPEX-P for patients with even mild hypertension (risk of increase in blood pressure).

ADIPEX-P is related chemically and pharmacologically to amphetamine (d- and dll amphetamine) and to other related stimulant drugs that have been extensively abused. 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.

Concomitant alcohol use may result in an adverse drug reaction.

A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

ADIPEX-P may decrease the hypotensive effect of adrenergic neuron blocking drugs.

ADIPEX-P is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.

It is not known if ADIPEX-P is excreted in human milk; however, other amphetamines are present in human milk. 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.

GoToSource

• Use in patients under the age of 18. GoToSource 

• Prevention of post spinal hypotension. GoToSource 

• Adjunctive treatment for cocaine dependence. GoToSource

Valvular heart disease (damage to one of the four heart valves), ischemic colitis (inflammation of large intestine or colon) and pulmonary hypertension (type of high blood pressure affecting arteries in lungs and right side of heart). GoToSource

Subarachnoid hemorrhage (type of stroke caused by bleeding into the space surrounding the brain). GoToSource

Ventricular fibrillation (heart rhythm problem). GoToSource 

Rhabdomyolysis (destruction of muscle tissue). GoToSource  

Heart failure. GoToSource

Psychosis. GoToSource 

Prolonged or recurrent episodes of insomnia, nausea, headache, dry mouth and dizziness. GoToSource

Ischemic stroke. GoToSource  

Restlessness, nervousness, irritability and risk of addiction. GoToSource

Lawsuits filed for primary pulmonary hypertension.