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Clozaril
clozapine
Black Box Warnings .
Appropriate Use
restricted distribution program (Clozapine REMS) due to severe neutropenia risk; prescribers, pts, and pharmacies must enroll in the program; 1-844-267-8678 or www.clozapinerems.com for more information
Severe Neutropenia
may occur and lead to serious infection and death; obtain ANC at baseline, then regularly; ANC >1500 for general population or ANC >1000 for benign ethnic neutropenia pts required prior to tx start; advise pts to report s/sx severe neutropenia or infection
Orthostatic Hypotension, Bradycardia, Syncope
orthostatic hypotension, bradycardia, syncope, cardiac arrest have occurred; risk highest during initial titration period, particularly w/ rapid dose escalation; rxns can occur w/ 1st dose, at doses of 12.5 mg/day, or when restarting pts w/ even brief tx interruption; start 12.5 mg PO qd or bid, titrate slowly, and use divided doses to minimize risk; use w/ caution in pts w/ cardiovascular dz, cerebrovascular dz, or hypotension risk
Seizures
incidence incr. w/ dose; start 12.5 mg PO qd or bid, then titrate slowly and give in divided doses; caution if seizure hx or predisposing factors; advise pts to avoid activities where sudden loss of consciousness would cause serious risk to self or others
Myocarditis, Pericarditis, Cardiomyopathy, Mitral Valve Incompetence
fatal cases have occurred; D/C tx and obtain cardiac eval if myocarditis, pericarditis, or cardiomyopathy suspected; s/sx incl. chest pain, tachycardia, palpitations, dyspnea, fever, flu-like sx, hypotension, or ECG changes; pts w/ clozapine-related myocarditis, pericarditis, or cardiomyopathy generally should not be rechallenged
Dementia-Related Psychosis
not approved for dementia-related psychosis; incr. mortality risk in elderly dementia pts on conventional or atypical antipsychotics; most deaths due to cardiovascular or infectious events; extent to which incr. mortality attributed to antipsychotic vs. some pt characteristic(s) not clear
Adult Dosing .
Dosage forms: TAB: 25 mg, 100 mg
Restricted Distribution in US
- [1-844-267-8678 or www.clozapinerems.com for more info]
schizophrenia, tx-resistant
- [150-300 mg PO bid]
- Start: 12.5 mg PO qd-bid, incr. by 25-50 mg/day to target 300-450 mg/day in divided doses by day 14, then may incr. by up to 100 mg/day q3-7 days; Max: 900 mg/day; Info: see pkg insert for dose adjustments based on tx interruption; consider lower dose in CYP2D6 poor metabolizers; taper dose over 1-2wk to D/C
suicide prevention, schizophrenia-assoc.
- [150-300 mg PO bid]
- Start: 12.5 mg PO qd-bid, incr. by 25-50 mg/day to target 300-450 mg/day in divided doses by day 14, then may incr. by up to 100 mg/day q3-7 days; Max: 900 mg/day; Info: see pkg insert for dose adjustments based on tx interruption; consider lower dose in CYP2D6 poor metabolizers; taper dose over 1-2wk to D/C
renal dosing
- [see below]
- renal impairment: not defined; Info: consider decr. usual dose if significant impairment
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- hepatic impairment: not defined; Info: consider decr. usual dose if significant impairment
Peds Dosing .
- Dosage forms: TAB: 25 mg, 100 mg
Restricted Distribution in US
- [1-844-267-8678 or www.clozapinerems.com for more info]
schizophrenia, tx-resistant (off-label)
- [10 yo and older]
- Dose: 125-475 mg/day PO divided bid-tid; Start: 12.5 mg PO qd-bid, incr. by 12.5-25 mg/day q3-5 days as tolerated; Max: 700 mg/day; Info: if divided doses unequal, give larger dose qhs; see pkg insert for dose adjustments based on tx interruption; consider lower dose in CYP2D6 poor metabolizers; taper dose over 1-2wk to D/C
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance