Product Description.:
M 58, 25
tablet , film-coated , orange , round round
Biconvex
Mellaril?*
(thioridazine HCl) Tablets, USP
(thioridazine HCl) Oral Solution, USP
Mellaril-S?
(thioridazine) Oral Suspension, USP
For Oral Administration
WARNING
MELLARIL? (THIORIDAZINE HCl) HAS BEEN SHOWN TO PROLONG THE QTc INTERVAL IN A DOSE RELATED MANNER, AND DRUGS WITH THIS POTENTIAL, INCLUDING MELLARIL, HAVE BEEN ASSOCIATED WITH TORSADE DE POINTES-TYPE ARRHYTHMIAS AND SUDDEN DEATH. DUE TO ITS POTENTIAL FOR SIGNIFICANT, POSSIBLY LIFE-THREATENING, PROARRHYTHMIC EFFECTS, MELLARIL SHOULD BE RESERVED FOR USE IN THE TREATMENT OF SCHIZOPHRENIC PATIENTS WHO FAIL TO SHOW AN ACCEPTABLE RESPONSE TO ADEQUATE COURSES OF TREATMENT WITH OTHER ANTIPSYCHOTIC DRUGS, EITHER BECAUSE OF INSUFFICIENT EFFECTIVENESS OR THE INABILITY TO ACHIEVE AN EFFECTIVE DOSE DUE TO INTOLERABLE ADVERSE EFFECTS FROM THOSE DRUGS.
DESCRIPTION
Mellaril? (thioridazine HCl) is 2-methylmercapto-10-[2-(N-methyl-2-piperidyl) ethyl] phenothiazine.
Active Ingredient: thioridazine HCl, USP
10 mg Tablets
Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, gelatin, lactose, methylparaben, povidone, propylparaben, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.
15 mg Tablets
Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C Red #7, gelatin, lactose, methylparaben, povidone, propylparaben, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.
25 mg Tablets
Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, gelatin, lactose, methylparaben, povidone, propylparaben, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron oxide, synthetic iron oxide, talc, titanium dioxide, and other ingredients.
50 mg Tablets
Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, gelatin, lactose, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.
100 mg Tablets
Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Yellow #6, lactose, methylparaben, povidone, propylparaben, sodium benzoate, sorbitol, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.
150 mg Tablets
Inactive Ingredients: acacia, calcium sulfate dihydrate, carnauba wax, D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, lactose, methylparaben, povidone, propylparaben, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.
200 mg Tablets
Inactive Ingredients: acacia, ammonium calcium alginate, calcium sulfate dihydrate, carnauba wax, colloidal silicon dioxide, D&C Red #7, lactose, magnesium stearate, methylparaben, povidone, propylparaben, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide, and other ingredients.
30 mg/mL and 100 mg/mL Oral Solution (Concentrate)
Active Ingredient: thioridazine HCl, USP
30 mg/mL Oral Solution (Concentrate)
Inactive Ingredients: alcohol, 3.0%, flavor, methylparaben, propylparaben, purified water, and sorbitol solution. May contain sodium hydroxide or hydrochloric acid to adjust the pH.
100 mg/mL Oral Solution (Concentrate)
Inactive Ingredients: alcohol, 4.2%, flavor, glycerin, methylparaben, propylparaben, purified water, sorbitol solution, and sucrose. May contain sodium hydroxide or hydrochloric acid to adjust pH.
5 mg/mL and 20 mg/mL Oral Suspension
Active Ingredient: each mL contains thioridazine, USP, equivalent to 5 mg and 20 mg thioridazine HCl, USP, respectively.
5 mg/mL Oral Suspension
Inactive Ingredients: carbomer 934, flavor, polysorbate 80, purified water, sodium hydroxide, and sucrose.
20 mg/mL Oral Suspension
Inactive Ingredients: carbomer 934, D&C Yellow #10, FD&C Yellow #6, flavor, polysorbate 80, purified water, sodium hydroxide, and sucrose.
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 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 adequat