Prochlorperazine Maleate Prochlorperazine 10 MG Oral Tablet
INDICATIONS AND USAGE For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ). The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.
Sandoz Inc
ROUND YELLOW GG953 10
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HOW SUPPLIED Prochlorperazine maleate tablets, USP for oral administration are available as: 5 mg: (as prochlorperazine base) round, pale-yellow, film coated, unscored tablets, debossed GG 952 on one side and debossed 5 on the reverse side and supplied as follows: NDC 0781-5020-01 in bottles of 100 tablets NDC 0781-5020-05 in bottles of 500 tablets NDC 0781-5020-10 in bottles of 1000 tablets 10 mg: (as prochlorperazine base) round, pale-yellow, film coated, unscored tablets, debossed GG 953 on one side and debossed 10 on the reverse side and supplied as follows: NDC 0781-5021-01 in bottles of 100 tablets NDC 0781-5021-05 in bottles of 500 tablets NDC 0781-5021-10 in bottles of 1000 tablets STORAGE Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.
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