Serentil (Mesoridazine Besylate) - Description and Clinical Pharmacology

T2001-24

89011602

4085-42

Serentil ^®

(mesoridazine besylate) Tablets, USP

(mesoridazine besylate) Injection, USP

(mesoridazine besylate) Oral Solution, USP

Rx only

Prescribing Information

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 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, 50 mg, for oral administration

ACTIVE INGREDIENT: mesoridazine (as the besylate), 50 mg.

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

Tablet, 100 mg, for oral administration

ACTIVE INGREDIENT: mesoridazine (as the besylate), 100 mg.

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

Ampuls, 1 mL, for Intramuscular administration

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

INACTIVE INGREDIENTS: edetate disodium USP, 0.5 mg; sodium chloride USP, 7.2 mg; carbon dioxide gas (bone dry) q.s.; water for injection USP, q.s. to 1 mL.

Concentrate, for oral administration

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

INACTIVE INGREDIENTS: alcohol, 0.61% by volume; citric acid; FD&C Red No. 40; flavors; methylparaben; propylparaben; purified water; sodium citrate; sorbitol.

CLINICAL PHARMACOLOGY

The basic pharmacological activity of Serentil^® (mesoridazine besylate) is similar to that of other phenothiazines.

      However, mesoridazine has been shown to prolong the QTc interval in a dose-dependent fashion. This effect may increase the risk of serious, potentially fatal, ventricular arrhythmias, such as torsade de pointes-type arrhythmias. Due to this risk, Serentil is indicated only for schizophrenic patients who have not been responsive to or cannot tolerate other antipsychotic agents (see WARNINGS and CONTRAINDICATIONS).

      However, the prescriber should be aware that Serentil has not been systematically evaluated in controlled trials in treatment of refractory schizophrenic patients and its efficacy in such patients is unknown.