A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Mellaril Indications, Dosage, Storage, Stability - Thioridazine HCl
Mellaril Indications, Dosage, Storage, Stability - Thioridazine HCl
INDICATIONS AND USAGE
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 treatment, Mellaril 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, 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 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; "
" 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; "" 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; "" imprinted on one side, "MELLARIL 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; "" imprinted on one side, "MELLARIL 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; "" imprinted on one side, "MELLARIL 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; "" imprinted on one side, "MELLARIL 150'' imprinted on the other side, in black.
Bottle of 100 .......................................... NDC 0078-0006-05
200 mg
Pink, coated tablets, "" imprinted on one side, "MELLARIL 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-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.
**Trademark of Medical Economics Company, Inc.
T2000-34 REV: JUNE 2000 PRINTED IN USA, 89001902, Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936, © 2000 Novartis
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