LOMAIRA (phentermine hydrochloride)

Pharmacokinetics Specific Populations Renal Impairment Phentermine was not studied in patients with renal impairment. The literature reported cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions is 62%-85%. Exposure increases can be expected in patients with renal impairment. Use caution when administering phentermine to patients with renal impairment.

CLINICAL STUDIES In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with “anorectic” drugs lost more weight on the average than those treated with placebo and diet. 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....

ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: - Primary pulmonary hypertension (see Warnings ) - Valvular heart disease (see Warnings ) - Effect on the ability to engage in potentially hazardous tasks (see Warnings ) - Withdrawal effects following prolonged high dosage administration (see Drug Abuse and Dependence ) The following adverse reactions to phentermine have been identified: Cardiovascular Primary pulmonary hypertensi...

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 Precautions )
• Nursing (see Precautions )
• Known hypersensitiv...