Sizopin Tablet

Schizophrenia, Psychoses in Parkinson's disease Indicated for reducing risk of recurrent suicidal behavior in patients with schizophrenia, or schizoaffective disorder in patients who are judged to be at chronic risk to re-experience suicidal behavior Treatment-resistant schizophrenia, in patients who fail to respond adequately to standard antipsychotic treatment Psychotic disorders in people with Parkinson's disease, when standard treatment has failed to control symptoms.

Adults: Oral Schizophrenia Starting Dose: 12.5 mg once daily or twice daily Titration: increase the total daily dosage in increments of 25 mg to 50 mg per day, if well-tolerated. Target dose: 300 mg to 450 mg per day, in divided doses, by the end of 2 weeks. Subsequent increases: increase in increments of 100 mg or less, once or twice weekly. Maximum daily dose: 900 mg Psychoses in Parkinson's disease Initial: 12.5 mg/day at night, increase gradually in steps of 12.5 mg up to twice weekly. Usual range: 25-37.5 mg/day at bedtime. Max: 100 mg/day in 1-2 divided doses.

Renal impairment: Severe: Contraindicated.

Elderly: Lower initial dosage of 12.5-25 mg/day indicated; may be titrated more slowly than in younger adults

Hepatic impairment: Use with caution and avoid in symptomatic or progressive liver disease or hepatic failure.

May be taken with or without food.

History of bone marrow disorders including agranulocytosis, circulatory collapse, alcoholic or toxic psychosis, drug intoxication, uncontrolled epilepsy, severe renal, hepatic or cardiac disease; paralytic ileus. Pregnancy and lactation.

Severe Neutropenia: Clozapine can cause severe neutropenia, which can lead to serious and fatal infections. Clozapine is available only through a restricted program called the Clozapine REMS. Orthostatic Hypotension, Bradycardia, and Syncope: Risk is doserelated. Starting dose is 12.5 mg. Titrate gradually and use divided dosages. Seizure: Risk is dose-related. Titrate gradually and use divided doses. Use with caution in patients with history of seizure or risk factors for seizure. Myocarditis, Cardiomyopathy and Mitral Valve Incompetence: Can be fatal. Discontinue and obtain cardiac evaluation if findings suggest these cardiac reactions. Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Clozapine is not approved for this condition. Gastrointestinal Hypomotility with Severe Complications: Severe gastrointestinal adverse reactions have occurred with the use of CLOZARIL. If constipation is identified, close monitoring and prompt treatment is advised. Eosinophilia: Assess for organ involvement (e.g., myocarditis, pancreatitis, hepatitis, colitis, nephritis). Discontinue if these occur. QT Interval Prolongation: Can be fatal. Consider additional risk factors for prolonged QT interval (disorders and drugs). Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include: Hyperglycemia and Diabetes Mellitus: Monitor for symptoms of hyperglycemia, including polydipsia, polyuria, polyphagia, and weakness. Dyslipidemia: Undesirable alterations in lipids have occurred in patients treated with atypical antipsychotics. Weight Gain: Significant weight gain has occurred. Neuroleptic Malignant Syndrome (NMS): Immediately discontinue and monitor closely. Assess for co-morbid conditions. Hepatotoxicity: Can be fatal. Discontinue treatment if hepatitis or transaminase elevations combined with other symptoms occur. Fever: Evaluate fo

Not Classi Pregnancy Neonates exposed to antipsychotic drugs during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery; overall, available data from published epidemiologic studies of pregnant women exposed to clozapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to the mother associated with untreated schizophrenia and with exposure to antipsychotics, during pregnancy Animal data In animal reproduction studies, no adverse developmental effects were observed with drug administered to pregnant rats or rabbits during period of organogenesis, or to pregnant rats during pregnancy and lactation, at doses up to approximately 0.4 and 0.9 times the maximum recommended human dose (MRHD) of 900 mg/day, for rats and rabbits respectively, based on mg/m2 body surface area There is risk to mother from untreated schizophrenia, including increased risk of relapse, hospitalization, and suicide; schizophrenia is associated with increased adverse perinatal outcomes, including preterm birth; it is not known if this is a direct result of the illness or other comorbid factors Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder reported in neonates exposed to antipsychotic drugs during third trimester of pregnancy; these symptoms have varied in severity; monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately; some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization Lactation Clozapine is present in human milk; there are reports of sedation and a report of agranulocytosis in an infant exposed to clozapine through human milk; there is no information on effects of clozapine on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed-child from drug or from underlying maternal condition Infants exposed to drug should be monitored for excess sedation and neutropenia

Increased risk and/or severity of bone marrow suppression w/ bone marrow suppressants (e.g. carbamazepine, chloramphenicol), sulfonamides (e.g. co-trimoxazole), pyrazolone analgesics (e.g. phenylbutazone), penicillamine, cytotoxic agents or long-acting depot inj of antipsychotics. Concomitant use w/ benzodiazepines may increase risk of circulatory collapse, which may lead to cardiac and/or respiratory arrest. Additive CNS depression and cognitive and motor performance interference w/ MAOIs and CNS depressants, including antihistamines, benzodiazepines and opioid analgesics. May potentiate the effects of anticholinergics or antihypertensive. Increased plasma concentration of highly protein-bound substances (e.g. warfarin, digoxin). Decreased plasma concentrations w/ phenytoin. Concomitant use w/ lithium can increase the risk of the development of neuroleptic malignant syndrome. Decreased clozapine levels w/ CYP1A2 inducers (e.g. omeprazole). Increased clozapine levels w/ CYP1A2 inhibitors (e.g. fluvoxamine, caffeine, ciprofloxacin). Contraindicated (7) amisulpride dronedarone eliglustat irinotecan irinotecan liposomal nirmatrelvir/ritonavir thioridazine

>10% Hypersalivation (13-48%) Sedation/somnolence (21-46%) Weight gain (4-31%) Dizziness (14-27%) Tachycardia (17-25%) Constipation (14-25%) Insomnia (2-20%) Dizziness/vertigo (19%) Nausea (17%) Vomiting (17%) Dyspepsia (14%) Hypotension (9-13%) Fever (5-13%) 1-10% Headache (7-10%) Tremor (6%) Syncope (6%) Sweating (6%) Dry mouth (5-6%) Visual disturbances (5%) Disturbed sleep/nightmares (4%) Restlessness (4%) Hypokinesia/akinesia (4%) Agitation (4%) Hypertension (4%) Abdominal discomfort/heartburn (4%) Seizures (3%) Rigidity (3%) Akathisia (3%) Confusion (3%) Leukopenia/neutropenia (3%) Fatigue (2%) Diarrhea (2%) Urinary abnormalities (2%) Rash (2%) Potentially Fatal: Agranulocytosis, myocarditis, cardiomyopathy, cardiac arrhythmias, pericarditis/pericardial effusion, neuroleptic malignant syndrome, pulmonary embolism, lower resp tract infection.

Clozapine has relatively weak dopamine receptor-blocking activity at D1, D2, D3 and D5 receptors but has high affinity for the D4 receptor. It has also blocking effects on serotonin, ?-adrenergic histamine H1 and cholinergic receptors.

Sizopin 25mg Tablet manufactured by Sun Pharmaceutical (Bangladesh) Ltd.. Its generic name is Clozapine.