Nirva

Nirva

clozapine

Manufacturer:

Amherst Lab

Distributor:

Medichem
Concise Prescribing Info
Contents
Clozapine
Indications/Uses
Management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia. Reduction in risk of recurrent suicidal behavior in schizophrenia or schizoaffective disorders. Psychotic disorders occurring during the course of Parkinson's disease where treatment has failed.
Dosage/Direction for Use
Individualized dosage. Treatment-resistant schizophrenia Starting dose: 12.5 mg once or bid on the 1st day, then continued w/ daily dosage increments of 25-50 mg/day to achieve target dose of 300-450 mg/day after 2 wk. Subsequent dose not to exceed 100 mg once or twice wkly. Therapeutic dose range: 300-450 mg/day in divided doses (may be divided unevenly, larger portion at bedtime). Max dose: 900 mg/day. Maintenance dose: Do not exceed 200 mg, once daily in the evening for at least 6 mth. Discontinuation of therapy: Gradual dose reduction over 1- to 2-wk period. Psychotic disorders occurring during the cause of Parkinson's disease where treatment has failed Starting dose: 12.5 mg in the evening. Subsequent dose increments by 12.5 mg w/ a max of 2 increments/wk up to a max of 50 mg. Mean effective dose: 25-37.5 mg/day. Increase increments by 12.5 mg/wk up to a max of 100 mg/day. Ending therapy: Gradual dose reduction by 12.5 mg increments over a period of at least 1 wk (preferably 2). Patient w/ history of seizures or suffering from renal or CV disorders Initially 12.5 mg once on the 1st day, increase dose slowly & in small increments. Elderly Initially 12.5 mg once daily on the 1st day, w/ subsequent dose increments of 25 mg/day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ myeloproliferative disorders, uncontrolled epilepsy, paralytic ileus, or history of clozapine-induced agranulocytosis or severe granulocytopenia; patients who are unable to undergo regular blood tests; history of toxic or idiosyncratic granulocytopenia/agranulocytosis; impaired bone marrow function; alcoholic & other toxic psychoses, drug intoxication, comatose conditions; circulatory collapse &/or CNS depression of any cause; severe renal or cardiac disorders (eg, myocarditis); active liver disease associated w/ nausea, anorexia or jaundice; progressive liver disease, hepatic failure. Concomitant use w/ long-acting depot antipsychotics which have myelosuppressive potential.
Special Precautions
Risk of agranulocytosis, fatal myocarditis; history of seizures or other predisposing factors. Concomitant use w/ benzodiazepines or other psychotropic drug. Perform WBC & differential blood counts w/in 10 days prior to initiating treatment & for at least 4 wk after discontinuation. Discontinue use if platelet count falls <50,000/mm3 in the event of thrombocytopenia; myocarditis, pericarditis/pericardial effusion, or cardiomyopathy is suspected. Consider bone marrow aspiration to determine agranulopoietic status. Carefully observe gradual titration in patients w/ known CV &/or pulmonary disease. Consider fasting blood glucose tests upon initiation & periodically thereafter in those w/ DM. Recurrences of neuroleptic malignant syndrome; tardive dyskinesia (particularly in elderly women); transient temp elevations >38°C w/ peak incidence w/in the 1st 3 wk of treatment. Pulmonary embolism; hepatic disease; prostatic enlargement & narrow-angle glaucoma; constipation; dementia or risk factors for stroke. Renal/cardiac disease; patients undergoing general anesth. May impair ability to drive or operate machinery. Pregnancy (3rd trimester). Not to be used during lactation. Childn. Elderly w/ dementia-related psychosis.
Adverse Reactions
Fever, chills/chills w/ fever, hypothermia, fatigue, weakness, pallor, malaise, sepsis; drowsiness/sedation, seizures, dizziness/vertigo, dystonia, epileptiform movements/myoclonic jerks, poor coordination, involuntary movement, histrionic movements, shakiness, Parkinsonism, tremor, disturbed sleep/nightmares, insomnia, somnolence, restlessness, hyperkinesia, hypokinesia/akinesia, agitation, rigidity, akathisia, confusion, lethargy, ataxia, slurred speech, loss of speech, stuttering, depression, anxiety, amentia, tics, delusions/hallucinations, dysarthria, amnesia/memory loss, paranoia, irritability, numbness, polydipsia, headache, delirium, abnormal EEG, exacerbation of psychosis, myoclonus, paresthesia, possible mild cataplexy, status epilepticus, obsessive compulsive symptoms; tachycardia, bradycardia, hypotension, HTN, ECG change/cardiac abnormality, syncope, chest pain/angina, edema, palpitations, phlebitis/thrombophlebitis, cyanosis, premature ventricular contraction, atrial or ventricular fibrillation; nausea, vomiting, salivary gland swelling, salivation, salivary hypersecretion, dry mouth, dry throat, throat discomfort, constipation, abdominal discomfort/heartburn, abdominal distention, dyspepsia, diarrhea, gastroenteritis, gastric ulcer, nervous stomach, acute pancreatitis, rectal bleeding, abnormal stools, fecal impaction, hematemesis, eructation, dysphagia, intestinal obstruction/paralytic ileus; anorexia, wt gain, wt loss, appetite increase, new onset diabetes, libido increase or decrease, impotence, priapism, abnormal ejaculation, hypercholesterolemia, hypertriglyceridemia, hyperglycemia, hyperuricemia, hyponatremia, creatine phosphokinase elevation; liver test abnormality, cholestasis, hepatitis, jaundice; dyspnea, nasal congestion, coughing, pneumonia/pneumonia-like symptoms, rhinorrhea, hyperventilation, wheezing, bronchitis, laryngitis, sneezing, aspiration, pleural effusion, pulmonary embolism, lower resp tract infection; urinary abnormalities, incontinence, urinary urgency/frequency, urinary retention, acute interstitial nephritis, dysmenorrhea, breast pain/discomfort, vaginal itch/infection; leukopenia/decreased WBC/neutropenia, granulocytopenia, thrombocytopenia, eosinophilia, thrombocytosis, agranulocytosis, leukocytosis, anemia, DVT, elevated Hb/hematocrit, erythrocyte sedimentation rate increased; sweating, rash, hot flashes, pruritus, eczema, bruise, dermatitis, petechiae, urticaria, erythema, hypersensitivity reactions: erythema multiforme, photosensitivity, vasculitis, Stevens-Johnson syndrome; muscle weakness, pain (back, neck, legs), muscle spasm, muscle pain, twitching & joint pain, myasthenic syndrome, rhabdomyolysis; visual disturbance, narrow angle glaucoma, mydriasis, eyelid disorder, bloodshot eyes, nystagmus, periorbital edema, tongue numb/sore, bitter taste, ear disorder, nosebleed.
Drug Interactions
Increased risk of agranulocytosis w/ bone marrow suppressants (eg, carbamazepine, chloramphenicol), sulfonamides (eg, co-trimoxazole), pyrazolone analgesics (eg, phenylbutazone), azapropazone, penicillamine, cytotoxic agents & long-acting depot inj of antipsychotics (eg, flupentixol, fluphenazine, haloperidol, pipotiazine, risperidone, zuclopenthixol). Increased plasma conc w/ ritonavir. Increased risk of circulatory collapse w/ benzodiazepines. Enhanced central effects (additive CNS depression, cognitive & motor performance interference) w/ alcohol, antihistamines, MAOIs, CNS depressants including narcotics. Potentiated action of anticholinergics (eg, atropine-like drugs). Potentiated hypotensive effects of antihypertensives. Increased risk of arrhythmia w/ type 1C antiarrhythmics (eg, flecainide, propafenone, encainide, quinidine). Increased plasma conc w/ highly protein bound drugs (eg, warfarin, digoxin); caffeine, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, ciprofloxacin & amprenavir; citalopram; erythromycin. Increased antimuscarinic effects of TCAs & antimuscarinics. Reduced plasma conc w/ omeprazole, rifampicin. Increased risk of extrapyramidal side effects & neurotoxicity w/ lithium. Increased metabolism w/ phenytoin. Enhanced effects w/ cimetidine. Decreased effectiveness when smoking.
MIMS Class
Antipsychotics
ATC Classification
N05AH02 - clozapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.
Presentation/Packing
Form
Nirva tab 100 mg
Packing/Price
30's (P1,770/box, P59/tab)
Form
Nirva tab 25 mg
Packing/Price
30's (P18.5/tab, P555/box)
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