Asenapine
آسناپین
🧠 Nervous SystemAtypical antipsychotic
Market / country: 🇺🇸 USA
Saphris (US)
🧮 Dose calculator
Schizophrenia · Regimen source: FDA Saphris · 2.2
- • Dissolve under the tongue; do not chew or swallow; no food or drink for 10 min. Increase to 10 mg after one week if tolerated; no added benefit shown. FDA Saphris · 2.2FDA Saphris · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Severe hepatic impairment (Child-Pugh C); history of hypersensitivity to asenapine (anaphylaxis, angioedema). FDA Saphris · 4
Warnings
- • Boxed warning: increased mortality in elderly patients with dementia-related psychosis — not approved for this use. FDA Saphris · Boxed Warning
- • Neuroleptic malignant syndrome; tardive dyskinesia; metabolic changes; hyperprolactinaemia; seizures; dysphagia; falls. FDA Saphris · 5
Formulations
- 5 mg sublingual tablet — sublingual tablet 🇺🇸 USA FDA Saphris · 3
- 10 mg sublingual tablet — sublingual tablet 🇺🇸 USA FDA Saphris · 3
- 2.5 mg sublingual tablet — sublingual tablet 🇺🇸 USA FDA Saphris · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Saphris · 8.1
“Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms.”
- 🤱 BreastfeedingNo data
The source for this drug has no section for this group.
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Saphris · 8.4
“Safety and efficacy of SAPHRIS in pediatric patients below the age of 10 years of age have not been evaluated.”
- 👴 Older adultsDangerous / avoid
Label: serious warning or avoid in older adults. FDA Saphris · Boxed Warning
“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)NDA022117
- DailyMed (FDA label)FDA Saphris
- MedlinePlus (NIH)AsenapineAsenapine Transdermal Patch
- WHO ATC/DDDN05AH05
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Saphris · 3FDA Saphris · 2.2FDA Saphris · 2.1FDA Saphris · 2.3FDA Saphris · 4FDA Saphris · Boxed WarningFDA Saphris · 5FDA Saphris · SPL approval / marketing categoryFDA Saphris · 8.1FDA Saphris · 8.4
- 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 · search
- Clinical review⚠ Unverified