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Phendimetrazine Tartrate Ext-Rel Capsules
Obesity
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Drug Name:

Phendimetrazine Tartrate Ext-Rel Capsules CIII

Generic Name and Formulations:
Phendimetrazine tartrate 105mg; ext-rel caps.

Company:
Sandoz

Therapeutic Use:

Indications for Phendimetrazine Tartrate Ext-Rel Capsules:

Management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of ≥30kg/m2 or ≥27kg/m2 in the presence of other risk factors (eg, controlled hypertension, diabetes, hyperlipidemia) who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.

Adult:

≥17yrs: 1 cap in the AM (30–60 minutes before morning meal).

Children:

<17yrs: not recommended.

Contraindications:

History of cardiovascular disease (eg, coronary artery disease, stroke, arrhythmias, CHF, uncontrolled hypertension, pulmonary hypertension). Hyperthyroidism. Glaucoma. Agitated states. History of drug abuse. Pregnancy (Cat.X). Nursing mothers. Concomitant other CNS stimulants, anorectic agents. During or within 14 days of MAOIs.

Warnings/Precautions:

Increased risk of pulmonary hypertension with repeated courses. Heart murmer, valvular heart disease: not recommended. Do not exceed max recommended dose. Obtain baseline cardiac evaluation prior to initiating therapy to detect pre-existing valvular heart disease or pulmonary hypertension. Mild hypertension. Diabetes. Prescribe minimal supply to avoid overdose. Renal impairment. Elderly.

Interactions:

See Contraindications. Hypertensive crisis with MAOIs. Anorectic agens use within prior year: not recommended. Insulin and oral hyperglycemic requirements may be altered. May decrease hypotensive effect of guanethidine, adrenergic neuron blocking drugs. Concomitant alcohol may result in adverse drug reaction.

Pharmacological Class:

Phenylalkylamine sympathomimetic amine.

Adverse Reactions:

Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevated BP, ischemic events, overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurred vision, dry mouth, GI upset, constipation, stomach pain, urinary frequency, dysuria, changes in libido; tolerance (discontinue when occurs), withdrawal effects (w. prolonged use).

How Supplied:

Caps—100, 1000

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