SPL Set ID: d526af85-ee70-4657-a27e-d451027ffd9e
1 drug(s) with this SPL Set ID
Risperidone for extended-release injectable suspension contains risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23 H 27 FN 4 O 2 and its molecular weight is 410.48 g/mol. The structural formula is: Risperidone, USP is soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Risperidone for Extended-Release Injectable Suspension is a combination of extended-release microspheres for injection and diluent for parenteral use. The extended-release microspheres formulation is a sterile, white to off white, free-flowing powder that is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone, USP per vial. Risperidone, USP is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres. The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes 1 mg/mL citric acid anhydrous; 1.25 mg/mL disodium hydrogen phosphate dihydrate; 1 mg/mL polysorbate 20; 23 mg/mL sodium carboxymethyl cellulose; 6 mg/mL sodium chloride; 0.55 mg/mL sodium hydroxide and water for injection. The microspheres are suspended in the diluent prior to injection. Risperidone for extended-release injectable suspension is provided as a single-dose pack, consisting of a vial containing the microspheres, a pre-filled syringe containing the diluent, a vial adapter and two Terumo SurGuard 3 Needles (a 21 G TW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration). 051