pms-Risperidone Description





Full Prescribing Info
pms-RISPERIDONE (risperidone) tablets contain 0.25 mg, 0.5 mg, 1 mg, 2 mg or 4 mg risperidone per tablet.
pms-RISPERIDONE (risperidone) is also available as an oral solution containing 1 mg/mL risperidone as risperidone tartrate.
Patient Instructions for using the pms-RISPERIDONE dispensing pipette are provided (see Directions for Use of pms-RISPERIDONE Oral Solution under Cautions for Usage). Tests indicate that pms-RISPERIDONE oral solution is compatible with the following beverages: water, coffee, orange juice and low-fat milk. However, it is NOT compatible with cola or tea.
Proper name: risperidone.
Chemical name: 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl) piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido [1,2-a]pyrimidin-4-one.
Molecular formula: C23H27FN4O2.
Molecular mass: 410.49 g/mol.
Physicochemical properties: Risperidone is a white or almost white powder.
It is practically insoluble in water (pH = 8.7), freely soluble in dichloromethane, and soluble in methanol and 0.1N HCl.
Ionization Constant: pKa1 = 8.24; pKa2 = 3.11.
Partition Coefficient: log P = 3.04.
Melting Point: 169°C-173°C.
Excipients/Inactive Ingredients: Tablet: Colloidal Silicon Dioxide, Corn Starch, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol and Sodium Lauryl Sulphate.
0.5 mg, 2 mg, 4 mg: Talc.
0.25 mg, 0.5 mg, 2 mg, 4 mg: Polyvinyl Alcohol.
0.25 mg, 0.5 mg, 1 mg, 2 mg: Titanium Dioxide.
1 mg: Hydroxypropyl Methylcellulose, Polydextrose, Triethyl Citrate.
Colorants are present in the tablets as follows: 0.25 mg: Iron Oxide Yellow.
0.5 mg: Iron Oxide Red.
1 mg: none present.
2 mg: FD & C Yellow No.6 Aluminum Lake.
4 mg: D & C Yellow No.10 Aluminum Lake, FD & C Blue No.2 Aluminum Lake.
Oral solution: Benzoic Acid, Purified Water, Sodium Hydroxide, Sorbitol Solution, Tartaric Acid.
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