divalproex sodium 500 MG Delayed Release Tablet
INDICATIONS & USAGE Mania Divalproex sodium delayed-release tablets are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgement, aggressiveness, and possible hostility. The efficacy of divalproex sodium was established in 3 week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania (see CLINICAL PHARMACOLOGY , Clinical Trials ). The safety and effectiveness of divalproex sodium for long-term use in mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient. Epilepsy Divalproex sodium delayed-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed-release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. Migraine Divalproex sodium delayed-release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium delayed-release tablets are useful in the acute treatment of migraine headaches. Because valproic acid may be a hazard to the fetus, divalproex sodium delayed-release tablets should be considered for women of childbearing potential only after this risk has been thoroughly discussed with the patient and weighed against the potential benefits of treatment (see WARNINGS , Usage in Pregnancy and PRECAUTIONS , Information for Patients ). SEE WARNINGS FOR STATEMENT REGARDING FATAL HEPATIC DYSFUNCTION.
REMEDYREPACK INC.
OVAL PINK 93 7441
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HOW SUPPLIED Divalproex sodium delayed-release tablets USP, 125 mg are available as reddish-brown, film-coated, oval shaped tablets, imprinted “93” and “7439” with black ink, in bottles of 100. Divalproex sodium delayed-release tablets USP, 250 mg are available as beige, film-coated, oval shaped tablets, imprinted “93” and “7440” with black ink, in bottles of 100 and 500. Divalproex sodium delayed-release tablets USP, 500 mg are available as dark pink, film-coated, oval shaped tablets, imprinted “93” and “7441” with black ink, in bottles of 100 and 500. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
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