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Serentil®
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.
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