Zophrenal contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Risperidone is a monoaminergic antagonist with high affinity for the serotonin Type 2 (5HT2), dopamine Type 2 (D2), a1 and a2 adrenergic, and H1 histaminergic receptors. Risperidone showed low to moderate affinity for the serotonin 5HT1C, 5HT1D, and 5HT1A receptors, weak affinity for the dopamine D1 and haloperidol-sensitive sigma site, and no affinity for cholinergic muscarinic or b1 and β2 adrenergic receptors.

Each tablet of Zophrenal 1mg, 4mg contains 1mg, 4mg risperidone.

Adult Patients:

Zophrenal is an atypical antipsychotic indicated for:

Treatment of schizophrenia.

As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

Treatment of irritability associated with autistic disorder.

Pediatric Patients:

Schizophrenia: Safety and effectiveness of Zophrenal in children less than 13 years of age with schizophrenia have not been established.

Bipolar I Disorder: Safety and effectiveness of Zophrenal in children less than 10 years of age with bipolar disorder have not been established.

Autistic Disorder.

Pregnancy& breast-feeding

May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Limited data are available the presence of risperidone and its metabolite, 9- hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3 and 4.7% of the maternal weight-adjusted dosage.

Severe Renal and Hepatic Impairment in Adults: use a lower starting dose of 0.5 mg twice daily. May increase to dosages above 1.5 mg twice daily at intervals of one week or longer.