Cloril

Cloril

clozapine

Manufacturer:

Atlantic Lab

Distributor:

Atlantic Pharma
Concise Prescribing Info
Contents
Clozapine
Indications/Uses
Treatment-resistant schizophrenic patients who are non-responsive to or intolerant of classic neuroleptics.
Dosage/Direction for Use
Individualized dosage. Recommended dose: Initially 12.5 mg once daily or bid on day 1, followed by 25 mg once daily or bid on Day 2. If tolerated, daily dose may then be increased slowly in increments of 25-50 mg in order to achieve a dose level of up to 300 mg/day w/in 2-3 wk. May be further increased in increments of 50-100 mg at half wkly or wkly intervals. Elderly Initially, 12.5 mg once daily on the 1st day w/ 25 mg/day increments. Therapeutic dose range: 300-450 mg/day in divided dose. Total daily dose may be divided unevenly, w/ larger portion at bedtime. Max dose: 900 mg/day. Maintenance dose: Maintain treatment for at least 6 mth. Re-starting therapy in patients in whom the interval since the last dose of Cloril exceeds 2 days Re-initiate w/ 12.5 mg once or bid on day 1.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. History of toxic or idiosyncratic granulocytopenia or agranulocytosis, myeloproliferative disorders, uncontrolled epilepsy. Alcohol psychosis or other toxic psychosis, drug intoxication, comatose conditions; blood circulation collapse; CNS depression of any cause; hepatic, renal or cardiac failure. Do not use w/ drugs having a bone marrow suppression activity or long acting antipsychotics which may be potentially myelosuppressive from the body rapidly in situations where this may be required eg, granulocytopenia.
Special Precautions
May cause agranulocytosis. Reserved for use in schizophrenic patients who are nonresponsive or intolerant to classical neuroleptics; have WBC count ≥3,500/mm3 & normal differential blood count & whom WBC counts can be performed wkly during the first 18 wk, at least mthly thereafter throughout the treatment, & for 1 mth after complete discontinuation of therapy. Evaluate haematology twice wkly if during the first 18 wk of therapy, the WBC count falls to between 3,000-3,500/mm3 &/or ANC falls to between 1,500-2,000/mm3; after 18 wk of therapy, the WBC count falls to between 2,500-3,000 mm3 &/or the ANC falls to between 1,000-1,500/mm3. Discontinue treatment if WBC count of patients <3,000/mm3 or ANC <1,500/mm3 during the first 18 wk of therapy & WBC count of patients <2,500/mm3 or ANC <1,000/mm3 after the first 18 wk of therapy; if eosinophil count is >3,000/mm3; platelet count <50,000/mm3 restart therapy only after the eosinophil count has fallen <1,000/mm3. Perform daily WBC count & differential blood count; monitor for flu-like symptoms or other symptoms suggestive of infection. Hyperglycemia & DM. Regularly monitor patients w/ DM for worsening of glucose control; symptoms of hyperglycemia. Patients w/ risk factors for DM (eg, obesity, history of diabetes) should undergo fasting blood glucose test prior to treatment & periodically during treatment. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Orthostatic hypotension w/ or w/o syncope. Increased risk of myocarditis especially during the first 2 months of treatment. Closely observe patients w/ history of epilepsy. Perform liver function test in patients in whom symptoms of possible liver dysfunction develop during therapy. Prostatic enlargement & narrow-angle glaucoma. May cause transient temp elevations >38°C. Avoid immobilisation of patients. Avoid abrupt w/drawal. Pregnancy & lactation.
Adverse Reactions
Granulocytopenia, agranulocytosis, leucocytosis &/or eosinophilia, thrombocytopenia; fatigue, drowsiness & headache, confusion, restlessness, agitation, delirium, EEG changes, seizure threshold decrement, extrapyramidal symptoms, neuroleptic malignant syndrome; tachycardia, postural hypotension w/ or w/o syncope, ECG changes, circulatory collapse, cardiac arrhythmias, pericarditis, myocarditis (w/ or w/o eosinophilia); dry mouth, blurred vision & disturbances in sweating & temp regulation, hypersalivation; resp depression or arrest w/o circulatory collapse; nausea, vomiting, constipation, hepatitis, cholestatic jaundice, dysphagia, parotid gland enlargement, acute pancreatitis; urinary incontinence & retention, priapism, acute interstitial nephritis; skin reactions, benign hyperthermia, severe hyperglycemia, creatine phosphokinase elevation, wt gain.
Drug Interactions
Bone marrow suppressants. May enhance CNS suppressant effects w/ alcohol, MAOIs, opiates, antihistamines, benzodiazepines. Possible additive effects w/ anticholinergics, antihypertensives, hypotensives or resp depressants. May increase risk of NMS development w/ lithium or other CNS-active agents. Seizures may occur w/ valproic acid. CYP4501A2, CYP3A4 & CYP4502D6 inhibitors/inducers. Plasma conc may be elevated w/ SSRIs eg, paroxetine or fluvoxamine, cimetidine or erythromycin; caffeine, azole antimycotics & PIs; highly protein bound drugs (eg, warfarin & digoxin). Level may be decreased w/ phenytoin or carbamazepine or rifampicin. May reduce BP-increasing effect of norepinephrine or other α-adrenergics, & reverse the pressor effect of epinephrine. Increased risk of adverse events may occur w/ citalopram.
MIMS Class
ATC Classification
N05AH02 - clozapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.
Presentation/Packing
Form
Cloril tab 100 mg
Packing/Price
10 × 10's
Form
Cloril tab 25 mg
Packing/Price
10 × 10's
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