Type: Tablet. Generic Name: Clozapine 25mg & 100mg/tablet. Manufacturer/Distributor: Sun Pharma
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Indications of Sizopin 100 Tablet
Clozapine is used to treat schizophrenia in people who are resistant to or intolerant of traditional antipsychotic medications.
Parkinson's disease-related psychosis.
Pharmacology of Sizopin 100 Tablet
Clozapine is classed as a 'atypical' antipsychotic medicine because its dopamine receptor binding profile and effects on certain dopamine-mediated behaviors differ from those of other typical antipsychotic drug products. Clozapine, in particular, inhibits dopamine binding at the D1, D2, D3, and D5 receptors and has a high affinity for the D4 receptor. This evidence supports the theory that Clozapine is more active at limbic dopamine receptors than striatal dopamine receptors. This could explain Clozapine's relative lack of extrapyramidal side effects. Clozapine is also an antagonist at adrenergic, cholinergic, histaminergic, and dopaminergic receptors.
Dosage & Administration of Sizopin 100 Tablet
Schizophrenia: Adult over 16 years, 12.5 mg once or twice (elderly 12.5 mg once) on first day then 25-50 mg (elderly 25-37.5 mg) on second day then increased gradually (if well tolerated) in steps of 25-50 mg daily (elderly max. increment 25 mg daily) over 14-21 days up to 300 mg daily in divided doses (larger dose at night, up to 200 mg daily may be taken as a single dose at bedtime); if necessary may be further increased in steps of 50-100 mg once (preferably) or twice weekly; usual dose 200-450 mg daily (max. 900 mg daily)
Psychosis in Parkinson's disease: Adult over 16 years, 12.5 mg at bedtime then increased according to response in steps of 12.5 mg up to twice weekly; usual dose range 25-37.5 mg at bedtime, usual maximum 50 mg daily; exceptionally, dose may be increased further in steps of 12.5 mg weekly to maximum 100 mg daily in 1-2 divided doses.
Interaction of Sizopin 100 Tablet
Concurrent use of myelosuppressants can exacerbate myelosuppression. Clozapine has the potential to interact with other CNS active medications as well as alcohol. When taking benzodiazepines or other psychotropics, orthostatic hypotension can occur. Clozapine has a high protein binding affinity. Other medications that are also heavily protein bound may be able to displace it. Clozapine, on the other hand, may displace protein-bound medicines (e.g. warfarin, digoxin). Cimetidine may lower Clozapine levels in the blood.
Although using Carbamazepine and Clozapine at the same time is not recommended, discontinuing the concomitant Carbamazepine may result in a rise in plasma Clozapine levels. When Clozapine is used with medications like fluvoxamine, paroxetine, or sertraline, the dosage should be lowered. Hypotensive medications' effects may be amplified. The action of other anticholinergic drugs may also be enhanced. Adrenaline should be avoided in general due to the risk of reversal of the adrenaline effect due to Clozapine's alpha adrenergic inhibition.
Contraindications
Severe cardiac disorders (e.g. myocarditis); renal impairment (avoid if creatinine clearance is less than 10 mL/min); history of neutropenia or agranulocytosis; bone-marrow disorders; paralytic ileus; alcoholic and toxic psychoses; history of circulatory collapse; drug intoxication; coma or severe CNS depression; uncontrolled epilepsy; breast-feeding
Side Effects of Sizopin 100 Tablet
Constipation, dizziness or lightheadedness (mild), sleepiness, headache (mild), increased watering of the mouth, nausea or vomiting, and unexpected weight gain are all common adverse effects. Abdominal discomfort or heartburn, as well as mouth dryness, are less prevalent side effects.
Pregnancy & Lactation
Clozapine has not been adequately studied in pregnant women. Animal studies indicate that there are no significant impacts on the fetus. Clozapine can be used throughout pregnancy if the doctor thinks it's required. Clozapine appears to be released in breast milk, according to animal research. As a result, women who are on Clozapine should not breastfeed their children.
Precautions & Warnings
Medication should not be abruptly stopped; it should be weaned off over a period of 1-2 weeks. Monitor patient for psychosis and cholinergic rebound if symptoms require abrupt withdrawal (leukopenia, myocarditis, cardiomyopathy) (headache, nausea, vomiting, diarrhea). Patients above the age of 65 are more vulnerable to negative effects (including agranulocytosis, cardiovascular, anticholinergic, and tardive dyskinesia). Agranulocytosis is a serious and potentially fatal condition. WBC testing should be done weekly for the first six months of treatment; beyond that, if appropriate WBC numbers (WBC 3000/mm3, ANC 1500/mm3) are maintained, WBC counts should be checked every other week.WBCs must be checked once a week for the first four weeks after therapy is stopped. In patients receiving other marrow suppressive medications, use with caution. Clozapine has been linked to eosinophilia, which may necessitate a temporary or permanent discontinuation of treatment.
Clozapine can cause cognitive and/or motor impairment (sedation), which can make it difficult to perform tasks that need attentiveness (eg, operating machinery or driving). Patients at risk of seizures, such as those with a history of seizures, head trauma, brain injury, alcoholism, or concomitant therapy with drugs that may lower the seizure threshold, should be treated with caution. Has been linked to a benign, self-limiting fever (temperatures of 100.4°F, usually within the first three weeks). Dozapine, on the other hand, has been linked to severe febrile reactions, including neuroleptic malignant syndrome (NMS). Clozapine appears to have a very low risk of causing extrapyramidal symptoms.
Patients with urinary retention, benign prostatic hyperplasia, narrow-angle glaucoma, xerostomia, vision difficulties, constipation, or a history of intestinal blockage should use this medication with caution. Hyperglycemia can occur; in certain situations, it can be severe, leading to ketoacidosis, hyperosmolar coma, or death. In individuals with diabetes or other glucose regulation issues, use with caution; monitor for deteriorating glucose control. In individuals with hepatic disease or impairment, use with caution; hepatitis has been documented as a side.
Storage Conditions
Do not store at temperatures above 30°C. Keep out of the reach of youngsters and away from light.
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