InnoGen Pharmaceuticals


InnoGen Pharmaceuticals
Full Prescribing Info
Each film-coated tablet contains: Risperidone 2 mg.
Risperidone is a benzisoxazole antipsychotic reported to be an antagonist at dopamine (D2) and serotonin (5-HT2), adrenergic (α1 and α2) and histamine (H1) receptors. It is described as an atypical antipsychotic.
Pharmacology: Pharmacokinetics: Risperidone is readily absorbed after oral doses, peak plasma concentrations being reached within 1 to 2 hours. It is extensively metabolized in the liver by hydroxylation to its main active metabolite, 9-hydroxyrisperidone; oxidative N-dealkylation is a minor metabolic pathway. Hydroxylation is mediated by the cytochrome P450 isoenzyme CYP2D6 and is the subject of genetic polymorphism. Excretion is mainly in the urine and to a lesser extent, in the feces. Risperidone and 9-hydroxyrisperidone are about 88% and 77% bound to plasma protein respectively.
For the treatment of schizophrenia and other psychoses. For the treatment of psychotic disorders and non-psychotic symptoms associated with dementia in the elderly.
Dosage/Direction for Use
The usual initial dose of Risperidone is 2 mg in 1 or 2 divided doses on day one. This may be increased to 4 mg in 1 or 2 divided doses on day two and subsequently adjusted further as required in increments and decrements of 1 or 2 mg daily, or as prescribed by the physician.
Special Precautions
Risperidone is contraindicated in patients with pre-existing CNS depression or coma, bone marrow suppression, phaeochromocytoma, or prolactin-dependent tumors. It should be used with caution or not at all in patients with impaired liver, kidney, cardiovascular cerebrovascular and respiratory function and in those with angle-closure glaucoma, history of jaundice, parkinsonism, diabetes mellitus, hypothyroidism, myasthenia gravis, paralytic ileus, prostatic hyperplasia or urinary retention. Care is required in patients with epilepsy or history of seizures.
The sedative effects of risperidone are most marked during the first few days of administration; affected patients should not drive or operate machines.
Risperidone is generally not recommended late in pregnancy as such may be associated with intoxication of the neonates.
Use In Pregnancy & Lactation
Risperidone is generally not recommended late in pregnancy as such may be associated with intoxication of the neonates.
Adverse Reactions
Anxiety, dizziness, dystonic reactions, extrapyramidal reactions, headache, neuroleptic malignant syndrome, tardive dyskinesia; abnormal t-waves with prolonged ventricular repolarization, arrhythmias, orthostatic hypertension, amenorrhea, galactorrhea, gynecomastia, sexual dysfunction; weight gain; constipation, nausea, cholestatic jaundice, agranulocytosis, overflow incontinence, priapism, urinary retention, altered temperature regulation.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
N05AX08 - risperidone ; Belongs to the class of other antipsychotics.
FC tab 2 mg x 30's.
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