Thioridazine

Thioridazine

INDICATIONS

Thioridazine 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 thioridazine treatment, thioridazine 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, 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 thioridazine 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 thioridazine 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 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 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.

The 10 mg tablets are orange, round, unscored, film-coated tablets debossed with M54 on one side and 10 on the other side. They are available as follows:

NDC 0378-0612-01
bottles of 100 tablets

NDC 0378-0612-10
bottles of 1000 tablets

The 25 mg tablets are orange, round, unscored, film-coated tablets debossed with M58 on one side and 25 on the other side. They are available as follows:

NDC 0378-0614-01
bottles of 100 tablets

NDC 0378-0614-10
bottles of 1000 tablets

The 50 mg tablets are orange, round, unscored, film-coated tablets debossed with M59 on one side and 50 on the other side. They are available as follows:

NDC 0378-0616-01
bottles of 100 tablets

NDC 0378-0616-10
bottles of 1000 tablets

The 100 mg tablets are orange, round, unscored, film-coated tablets debossed with M61 on one side and 100 on the other side. They are available as follows:

NDC 0378-0618-01
bottles of 100 tablets

NDC 0378-0618-10
bottles of 1000 tablets

STORE AT CONTROLLED ROOM TEMPERATURE 15°–30°C (59°–86°F). PROTECT FROM LIGHT.

Dispense in a tight, light-resistant container using a child-resistant closure.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505. REV JULY 2003.

Last reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

A A A

Mellaril - User Reviews

Mellaril User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Mellaril sorted by most helpful. Patient Discussions FAQs

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.


Emotional Wellness

Get tips on therapy and treatment.

Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations