Generic Name and Formulations:
Clozapine 12.5mg, 25mg, 100mg, 150mg, 200mg; orally-disintegrating tabs; contains phenylalanine (0.87mg/12.5mg tab, 1.74mg/25mg tab, 6.96mg/100mg tab, 10.44mg/150mg tab, 13.92mg/200mg tab).
Company:
Jazz Pharmaceuticals plc
Indications for FAZACLO:
Refractory severe schizophrenia. To reduce risk of recurrent suicidal behavior in schizoaffective disorders.
Adult Dose for FAZACLO:
Dissolve tablet in mouth. Initially 12.5mg 1–2 times daily; may increase by 25–50mg/day to 300–450mg/day in divided doses by the end of 2 weeks. Then may increase once or twice weekly in increments of up to 100mg; max 900mg/day. Reeva luate periodically. Reduce gradually over 1–2 weeks if discontinuing; may discontinue abruptly if necessary (eg, leukopenia, myocarditis; may cause relapse or cholinergic rebound). Retitrate if stopped for ≥2 days. Caution when rechallenging (see literature). Suicidal behavior: usually 300mg/day; range 12.5mg–900mg/day; treat for at least 2 years.
Children's Dose for FAZACLO:
Not recommended.
Pharmacological Class:
Atypical.
Contraindications:
Concomitant bone marrow suppressants or other agranulocytosis-causing agents. Myeloproliferative disorders. Uncontrolled epilepsy. Severe or history of clozapine-induced agranulocytosis, granulocytopenia, or myocarditis. Paralytic ileus. Severe CNS depression. Coma.
Warnings/Precautions:
See literature. Monitor WBC and absolute neutrophil count (ANC) at baseline, weekly for 1st 6 months and for 4 weeks after discontinuing; if acceptable WBC and ANC maintained, may reduce monitoring to every 2 weeks after 6 months, then every 4 weeks after 12 months. Monitor for myocarditis if tachycardia occurs in 1st month; discontinue if myocarditis suspected. Hypokalemia, hypomagnesemia, recent MI, uncompensated heart failure, arrhythmias, CV disease, congenital QT prolongation: avoid (risk of torsades de pointes/sudden death). Monitor electrolytes esp. K+, Mg ++. Monitor for hyperglycemia. Diabetes. Seizures. Cardio- or cerebrovascular, pulmonary, renal, or hepatic disease (discontinued if jaundice or significant increases in liver enzymes occur). Glaucoma. GI or GU obstruction. Surgery. Exclude infection, agranulocytosis, neuroleptic malignant syndrome if fever occurs. Elderly (not for dementia-related psychosis). Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.B). Nursing mothers: not recommended.
Interactions:
See Contraindications. Caution with general anesthetics, benzodiazepines, psychotropics (possible respiratory/cardiac arrest), fluvoxamine, paroxetine, drugs that cause QT prolongation (eg, quinidine, amiodarone, sotalol, procainamide, chlorpromazine, thioridazine, moxifloxacin, methadone), drugs that can cause electrolyte imbalance (eg, diuretics). May potentiate alcohol, CNS drugs, antihypertensives, anticholinergics. Caution with drugs that affect or are affected by CYP2D6, 3A4, 1A2; clozapine levels increased by CYP450 inhibitors (eg, caffeine, cimetidine, erythromycin); clozapine levels decreased by CYP450 inducers (eg, rifampin, carbamazepine, phenytoin, nicotine). Do not use epinephrine to reverse hypotension.
Adverse Reactions:
Sedation, dizziness, headache, tremor, salivation, sweating, dry mouth, visual disturbances, tachycardia, orthostatic hypotension, syncope, GI upset, fever, anticholinergic toxicity (eg, GI paralysis), agranulocytosis, seizures, weight gain, hyperglycemia, myocarditis, eosinophilia, neuroleptic malignant syndrome, thrombosis, pulmonary embolism.
Note:
To register patients call FazaClo Patient Registry at (877) 329-2256.
How Supplied:
Orally-disintegrating tabs—100
