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warnings and cautions
5.4 Development of Tolerance, Discontinuation in Case of Tolerance When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.
warnings and cautions
5.5 Effect on the Ability to Engage in Potentially Hazardous Tasks Phentermine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.
warnings and cautions
5.6 Risk of Abuse and Dependence Phentermine is related chemically and pharmacologically to amphetamine (d- and d l l-amphetamine) and other related stimulant drugs that have been extensively abused. 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. See Drug Abuse and Dependence ( 9 ) and Overdosage ( 10 ) . The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
warnings and cautions
5.7 Usage with Alcohol Concomitant use of alcohol with phentermine may result in an adverse drug reaction.
6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: - Primary pulmonary hypertension [see Warnings and Precautions ( 5.2 ) ] - Valvular heart disease [see Warnings and Precautions ( 5.3 ) ] - Effect on the ability to engage in potentially hazardous tasks [see Warnings and Precautions ( 5.5 ) ] - Withdrawal effects following prolonged high dosage administration [see Drug Abuse and Dependence ( 9.3 ) ] The following adverse reactions to phentermine have been identified: Cardiovascular Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events. Central Nervous System Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Allergic Urticaria. Endocrine Impotence, changes in libido. Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-800-325-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .