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Mellaril

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Mellaril®*
(thioridazine HCl) Tablets, USP
(thioridazine HCl) Oral Solution, USP

Mellaril (thioridazine hcl) -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 (thioridazine hcl) , HAVE BEEN ASSOCIATED WITH TORSADE DE POINTES-TYPE ARRHYTHMIAS AND SUDDEN DEATH. DUE TO ITS POTENTIAL FOR SIGNIFICANT, POSSIBLY LIFE-THREATENING, PROARRHYTHMIC EFFECTS, MELLARIL (thioridazine hcl) 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. (SEE WARNINGS, CONTRAINDICATIONS, AND INDICATIONS).

DRUG DESCRIPTION

Mellaril® (thioridazine HCl) is 2-methylmercapto-10-[2-(N-methyl-2-piperidyl) ethyl] phenothiazine.

Mellaril® (thioridazine HCl) Structural Formula Illustration

10 mg, 15 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg Tablets

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.

What are the possible side effects of thioridazine (Mellaril, Mellaril-S)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using thioridazine and call your doctor at once if you have a serious side effect such as:

  • dizziness, fainting, fast or pounding heartbeat;
  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
    • ...

Read All Potential Side Effects and See Pictures of Mellaril »

What are the precautions when taking thioridazine hcl (Mellaril)?

Before taking thioridazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (e.g., chlorpromazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain severe nervous system problem (severe CNS depression), severe blood pressure problems.

This medication should not be given to a patient that is unconscious.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood problems (e.g., low white blood...

Read All Potential Precautions of Mellaril »

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

Additional Mellaril Information

Mellaril - User Reviews

Mellaril User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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