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Thioridazine (Thioridazine Hydrochloride) - Indications and Dosage

 
 



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.

DOSAGE AND ADMINISTRATION

Since thioridazine hydrochloride tablets are associated with a dose related prolongation of the QTc interval, which is a potentially life threatening event, its use should be reserved for schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Dosage must be individualized and the smallest effective dosage should be determined for each patient (see INDICATIONS and WARNINGS).

Adults

The usual starting dose for adult schizophrenic patients is 50 mg to 100 mg three times a day, with a gradual increment to a maximum of 800 mg daily if necessary. Once effective control of symptoms has been achieved, the dosage may be reduced gradually to determine the minimum maintenance dose. The total daily dosage ranges from 200 mg to 800 mg, divided into two to four doses.

Pediatric Patients

For pediatric patients with schizophrenia who are unresponsive to other agents, the recommended initial dose is 0.5 mg/kg/day given in divided doses. Dosage may be increased gradually until optimum therapeutic effect is obtained or the maximum dose of 3 mg/kg/day has been reached.

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 51079-565-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).

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 51079-566-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).

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 51079-567-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).

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 51079-580-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103

S-4833 R13
2/11

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