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Clozapine
کلوزاپین
🧠 Nervous SystemAtypical antipsychotic
🤰 Pregnancy:Use with caution🤱 Breastfeeding:Use with caution👶 Children:Safety not established👴 Older adults:Dangerous / avoid 🇮🇷 Registered in Iran⛔ 3 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA206433ATC N05AH02
Market / country: 🇺🇸 USA
Clozaril (US)
🧮 Dose calculator
Schizophrenia · Regimen source: FDA Clozapine · 2.2FDA Clozapine · 2
- • Increase by 25–50 mg/day to target 150–225 mg twice daily; max 450 mg twice daily. Neutrophil monitoring required. FDA Clozapine · 2FDA Clozapine · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to clozapine. FDA Clozapine · 4
- ⚠️ Boxed warning: severe neutropenia, orthostatic hypotension and syncope, seizures, myocarditis, mortality in elderly dementia patients. FDA Clozapine · Boxed Warning
- ⛔ Not established in children. FDA Clozapine · 8.4
Formulations
- 25 mg tablet (scored) — tablet 🇺🇸 USA FDA Clozapine · 3
- 100 mg tablet (scored) — tablet 🇺🇸 USA FDA Clozapine · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Clozapine · 8.1
“Risk Summary Neonates exposed to antipsychotic drugs, including clozapine, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery ( see Clinical Considerations ).”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Clozapine · 8.2
“Risk Summary Clozapine is present in human milk.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Clozapine · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsDangerous / avoid
Label: serious warning or avoid in older adults. FDA Clozapine · Boxed Warning
“Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA206433
- DailyMed (FDA label)FDA Clozapine
- MedlinePlus (NIH)Clozapine
- WHO ATC/DDDN05AH02
- Darooyab (Iran)Clozapine
🇮🇷 Registered in Iran Darooyab · G-1260/Clozapine
Dosage forms with Iranian generic codes, per Darooyab.
- 00334 · CLOZAPINE 100MG TAB · قرص کلوزاپین ۱۰۰ میلیگرم
- 01743 · CLOZAPINE 25MG TAB · قرص کلوزاپین ۲۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Clozapine · 3FDA Clozapine · 2.2FDA Clozapine · 2FDA Clozapine · 4FDA Clozapine · Boxed WarningFDA Clozapine · 8.4FDA Clozapine · 8.1FDA Clozapine · 8.2FDA Clozapine · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-1260/Clozapine
- Clinical review⚠ Unverified