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Serentil
  • Professionals
  • FDA PI

Serentil

Generic name: mesoridazine besylate
Dosage form: Tablets USP, Injection, USP and Oral Solution, USP
Drug class:Phenothiazine antipsychotics

Medically reviewed by Drugs.com. Last updated on Mar 22, 2022.

T2001-24

89011602

4085-42

Serentil®

(mesoridazine besylate) Tablets, USP

(mesoridazine besylate) Injection, USP

(mesoridazine besylate) Oral Solution, USP

Rx only

Prescribing Information

Warning

SERENTIL® (MESORIDAZINE BESYLATE) HAS BEEN SHOWN TO PROLONG THE QTc INTERVAL IN A DOSE RELATED MANNER, AND DRUGS WITH THIS POTENTIAL, INCLUDING SERENTIL, HAVE BEEN ASSOCIATED WITH TORSADE DE POINTES-TYPE ARRHYTHMIAS AND SUDDEN DEATH. DUE TO ITS POTENTIAL FOR SIGNIFICANT, POSSIBLY LIFE-THREATENING, PROARRHYTHMIC EFFECTS, Serentil 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.)

Serentil Description

SERENTIL® (mesoridazine besylate), the besylate salt of a metabolite of thioridazine, is a phenothiazine antipsychotic. Serentil is 10-[2(1-methyl-2-piperidyl)ethyl]-2-(methyl-sulfinyl)-phenothiazine [as the besylate].

Tablet, 10 mg, for oral administration

ACTIVE INGREDIENT: mesoridazine (as the besylate), 10 mg.

INACTIVE INGREDIENTS: acacia, carnauba wax, colloidal silicon oxide, FD&C Red No. 40 aluminum lake, lactose, microcrystalline cellulose, povidone, sodium benzoate, starch, stearic acid, sucrose, synthetic black iron oxide, talc, titanium dioxide and other ingredients.

Tablet, 25 mg, for oral administration

ACTIVE INGREDIENT: mesoridazine (as the besylate), 25 mg.

INACTIVE INGREDIE...