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Blue (diethylpropion hydrochloride NF) conlrolled release INDICATION Tenuate and Tenuate Dospan are indicated in the weeks! in a regimen ol weight reduction based on caloric restriction The limited usefulness ol agents ol this class should be measured against possible iisk factors inherent in then use such as those known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma Agitated states Patients with a history of drug WARNINGS II tolerance develops the recommended dose should not be exceeded m an attempt to increase the elfect rather the drug should be discontinued Tenuate may impair the ability ol the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle the patient should iheielore be cautioned accordingly Drug Dependence Tenuate has some chemical and pharmacologic similarities to the amphetamines and other related stimulant drugs that have been extensively abused There have been reports ol subiecis becoming psychologically dependent on diethylpropion The possibility ol abuse should be kept in mind when evaluating the desirability ot including a drug as part ot a weight reduction program Abuse ol amphetamines and related drugs may be associated with varying degrees ol psychologic dependence and social dyslunclion which in the case of certain drugs may be severe There are reports ol patients who have increased the dosage to many times that recommended Abrupt cessation lollowing prolonged hign dosage administration results in extreme fatigue and mental depres Sion changes are also noted on the sleep EEG Manilestaiions ol 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 Use in indicated adverse effects, the use ot Tenuate by women who are pregnant or may become pregnant requires that the potential benefits be weighed against the potential risks Use m Children Tenuate is PRECAUTIONS Caution is to be exercised in prescribing Tenuate tor patients with hypertension or with symptomatic cardiovascular disease, including arrhythmias Tenuate should not be administered to patients with severe hypertension Insulin reguiiements in diabetes mellitus may be altered in association with the use ot Tenuate and the concomitant dietary regimen Tenuate may decrease the hypo tensive effect of guanethidme The least amount feasible should be prescribed or dispensed at one time in order tominimize the possibility ot oveidosage Reports suggest that Tenuate may increase convulsions in some epileptics Therefore epileptics receiving Tenuate should be carefully monitored Titration of dose or discontinuance of ADVERSE REACTIONS: Cardidvascular Palpitation tachycardia elevation ol blood pressure precordial pain, arrhythmia One published report described T wave changes in the ECG of a healthy young male after ingestion of diethylpropion hydrochloride Central Nervous System Overstimulation nervousness restlessness, dizziness )itteriness, insomnia, anxiety euphoria depression dysphoria tremor dyskinesia mydriasis drowsiness malaise headache rarely psychotic episodes at recommended doses In a few epileptics an increase in convulsive episodes has been reported Gastrointestinal Dryness ol the mouth, unpleasant taste, nausea vomiting abdominal discomfort, diarrhea, constipation, other gastrointestinal disturbances Allergic Urticaria, rash, ecchymosis, erythema. 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