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Mellaril

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Mellaril

Indications
Dosage
How Supplied

INDICATIONS

Mellaril® (thioridazine HCl) is 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 Mellaril (thioridazine hcl) treatment, Mellaril (thioridazine hcl) 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 Mellaril (thioridazine hcl) , it is strongly recommended that a patient be given at least 2 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 Mellaril (thioridazine hcl) has not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.

DOSAGE AND ADMINISTRATION

Since Mellaril (thioridazine HCl) is 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 50-100 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 200-800 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

Mellaril® (thioridazine HCl) Tablets

10 mg

Bright chartreuse, coated tablets; "S" imprinted on one side, "78-2'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0002-05
Bottle of 1000........................................NDC 0078-0002-09
Unit dose package of 100............NDC 0078-0002-06

15 mg

Pink, coated tablets; " S" imprinted on one side, "78-8'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0008-05

25 mg

Light tan, coated tablets; "S" imprinted on one side, "MELLARIL (thioridazine hcl) 25'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0003-05
Bottle of 1000........................................NDC 0078-0003-09
Unit dose package of 100............NDC 0078-0003-06

50 mg

White, coated tablets; "S" imprinted on one side, "MELLARIL (thioridazine hcl) 50'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0004-05
Bottle of 1000........................................NDC 0078-0004-09
Unit dose package of 100............NDC 0078-0004-06

100 mg

Light green, coated tablets; " ^4&" imprinted on one side, "MELLARIL (thioridazine hcl) 100'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0005-05
Bottle of 1000........................................NDC 0078-0005-09
Unit dose package of 100............NDC 0078-0005-06

150 mg

Yellow, coated tablets; "S" imprinted on one side, "MELLARIL (thioridazine hcl) 150'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0006-05

200 mg

Pink, coated tablets, " ^4&" imprinted on one side, "MELLARIL (thioridazine hcl) 200'' imprinted on the other side, in black.

Bottle of 100..........................................NDC 0078-0007-05
Unit dose package of 100............NDC 0078-0007-06

Store and Dispense

Below 86°F (30°C); tight container.

Mellaril® (thioridazine HCl) Oral Solution (Concentrate)

30 mg/mL

A clear, straw-yellow liquid with a cherry-like odor. Each mL contains 30 mg thioridazine hydrochloride, USP, alcohol, 3.0% by volume. Immediate container: amber glass bottles of 4 fl. oz. (118 mL) as follows: 4 fl. oz. bottles, in cartons of 12 bottles, with an accompanying dropper graduated to deliver 10 mg, 25 mg, and 50 mg of thioridazine hydrochloride, USP (NDC 0078-0001-31).

100 mg/mL

A clear, light-yellow liquid with a strawberry-like odor. Each mL contains 100 mg thioridazine hydrochloride, USP, alcohol, 4.2% by volume. Immediate container: amber glass bottles of 4 fl. oz. (118 mL), in cartons of 12 bottles, with an accompanying dropper graduated to deliver 100 mg, 150 mg, and 200 mg of thioridazine hydrochloride, USP (NDC 0078-0009-31).

Store and Dispense

Below 86°F (30°C); tight, amber glass bottle.

The oral solution (concentrate) may be diluted with distilled water, acidified tap water, or suitable juices. Each dose should be so diluted just prior to administration - preparation and storage of bulk dilutions is not recommended.

Mellaril (thioridazine hcl) -S® (thioridazine) Oral Suspension

5 mg/mL

An off-white suspension with a buttermint taste and a peppermint odor. Each mL contains thioridazine, USP, equivalent to 5 mg thioridazine hydrochloride, USP. Buttermint-flavored in pint bottles (NDC 0078-0068-33).

20 mg/mL

A yellow suspension with a buttermint taste and a peppermint odor. Each mL contains thioridazine, USP, equivalent to 20 mg thioridazine hydrochloride, USP. Buttermint-flavored in pint bottles (NDC 0078-0069-33).

Store and Dispense

Below 77°F (25°C); tight, amber glass bottle.

Additional information available to physicians. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. Revised: June 2000.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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