Thioridazine 25 MG Oral Tablet
INDICATIONS AND USAGE Thioridazine hydrochloride tablets are indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life threatening, proarrhythmic effects with thioridazine treatment, thioridazine hydrochloride tablets should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Consequently, before initiating treatment with thioridazine hydrochloride tablets, it is strongly recommended that a patient be given at least two trials, each with a different antipsychotic drug product, at an adequate dose, and for an adequate duration (see WARNINGS and CONTRAINDICATIONS ). However, the prescriber should be aware that thioridazine hydrochloride tablets have not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.
Mylan Pharmaceuticals Inc.
ROUND ORANGE M 58 25
M 58 25 ROUND ORANGE
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HOW SUPPLIED
THIORIDAZINE HYDROCHLORIDE Tablets, USP are available containing 10 mg, 25 mg, 50 mg or 100 mg of
THIORIDAZINE HYDROCHLORIDE, USP. The 10 mg tablets are orange film-coated, round, unscored tablets debossed with M over 54 on one side and 10 on the other side. They are available as follows: NDC 0378-0612-01 bottles of 100 tablets The 25 mg tablets are orange film-coated, round, unscored tablets debossed with M over 58 on one side and 25 on the other side. They are available as follows: NDC 0378-0614-01 bottles of 100 tablets The 50 mg tablets are orange film-coated, round, unscored tablets debossed with M over 59 on one side and 50 on the other side. They are available as follows: NDC 0378-0616-01 bottles of 100 tablets The 100 mg tablets are orange film-coated, round, unscored tablets debossed with M over 61 on one side and 100 on the other side. They are available as follows: NDC 0378-0618-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. **Trademark of Medical Economics Company, Inc. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75069454 Revised: 9/2019 MX:THIO:R1
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