Clozapine ODT
FAZACLO
Pronunciation: KLOE-za-peen
“Clothes pin”
“Red as a beet” crimson color theme → anticholinergic
Blind as a bat → dilated pupils and cycloplegia (M3 antimuscarinic)
“Mad as a hatter” → BBB-crossing anticholinergic
“Dry as a bone” → risk of severe constipation (M3)
Tachycardia (M2 antimuscarinic); myocarditis risk
Neutrophil in mouth → risk of agranulocytosis
Polka dots on pink → α1 blocker → syncope if titrated too quickly (hit the floor)
What it isClozapine orally disintegrating tablets (FAZACLO, 2004) — dissolves on the tongue for patients who cheek or cannot swallow tablets; the FAZACLO brand was later discontinued, but generic clozapine ODT remains available.
Why this oneSame molecule and receptor pharmacology as the parent card — the formulation (and its label) is the difference.
What limits itClass warnings of the parent molecule apply unchanged.
FDA-approved for
- treatment-resistant schizophrenia (2004)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Treatment-resistant schizophrenia | Adults | 12.5 mg QD or BID | 150–225 mg BID by end of 2 weeks | 450 mg BID (900 mg/day) |
| Reduce risk of recurrent suicidal behavior (schizophrenia/schizoaffective disorder) | Adults | 12.5 mg QD or BID | 150–225 mg BID | 450 mg BID (900 mg/day) |
Titration Increase by 25–50 mg/day; then increments up to 100 mg once or twice weekly.
Renal Dose reduction may be necessary in significant renal impairment.
Hepatic Dose reduction may be necessary in significant hepatic impairment.
Instructions
- Obtain baseline ANC (≥1500/µL, or ≥1000/µL with Benign Ethnic Neutropenia) before initiation
- Place ODT in mouth immediately; may disintegrate or chew; with or without water/food
- Taper gradually over 1–2 weeks on discontinuation
- Reduce dose with strong CYP1A2 inhibitors (one-third dose) and in CYP2D6 poor metabolizers
Available strengths
- ODT 12.5, 25, 100, 150, 200 mg
- tab 12.5, 25, 50, 100, 200 mg
- susp 50 mg/mL
Cautions
- Severe neutropenia (ANC monitoring/REMS)
- Orthostatic hypotension/bradycardia/syncope
- Seizures
- Myocarditis/cardiomyopathy
- GI hypomotility
- QT prolongation
- Metabolic changes (hyperglycemia, dyslipidemia, weight gain)
- Hepatotoxicity
- Anticholinergic toxicity
Adverse reactions
- Sedation
- Dizziness/vertigo
- Headache
- Tremor
- Tachycardia
- Hypotension
- Hypersalivation
- Constipation
- Weight gain
Pregnancy No established drug-associated malformation risk; third-trimester exposure risks neonatal extrapyramidal/withdrawal symptoms.
Lactation Undefined.
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 12.5 mg | ODT | 30 qd | not offered | |
| 25 mg | ODT | 30 qd | $49.74 | not offered |
| 100 mg | ODT | 30 qd | $127.94 | not offered |
| 150 mg | ODT | 30 qd | $449.13 | not offered |
| 200 mg | ODT | 30 qd | $636.10 | not offered |
Other forms: Clozapine (CLOZARIL) · Clozapine oral suspension (VERSACLOZ)
⚠ BOXED WARNING
- Increased mortality in elderly patients with dementia-related psychosis
Classes and tags
Clinical profile
Legacy pregnancy categoryB
Defining liabilitySevere neutropenia, myocarditis, seizures and potentially fatal gastrointestinal hypomotility.
Active metabolites
Open Clozapine ODT in the interactive console ↗
Memory aids: interaction avatars
