Paliperidone
پالیپریدون
🧠 Nervous SystemAtypical antipsychotic
Market / country: 🇺🇸 USA
Invega (US)
🧮 Dose calculator
Schizophrenia · Regimen source: FDA Invega · 2.1
- • Increase above 6 mg only after reassessment, at >5-day intervals, in 3 mg steps. FDA Invega · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to paliperidone, risperidone or excipients. FDA Invega · 4
Warnings
- • Boxed warning: increased mortality in elderly patients with dementia-related psychosis. FDA Invega · Boxed Warning
- • Neuroleptic malignant syndrome; QT prolongation; tardive dyskinesia; metabolic changes; hyperprolactinaemia. FDA Invega · 5
Important interactions
- • Risperidone: paliperidone is its metabolite; consider additive exposure. FDA Invega · 2.4
Formulations
- 3 mg extended-release tablet (swallow whole) — tablet 🇺🇸 USA FDA Invega · 3
- 6 mg extended-release tablet (swallow whole) — tablet 🇺🇸 USA FDA Invega · 3
- 9 mg extended-release tablet (swallow whole) — tablet 🇺🇸 USA FDA Invega · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Invega · 8.1
“Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy 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 Invega · 8.2
“Risk Summary Limited data from published literature report the presence of paliperidone in human breast milk.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Invega · 8.4
“Safety and effectiveness of INVEGA in the treatment of schizophrenia were evaluated in 150 adolescent subjects 12–17 years of age with schizophrenia who received INVEGA in the dose range of 1.5 mg to 12 mg/day in a 6-week, double-blind, placebo-controlled trial.”
- 👴 Older adultsDangerous / avoid
Label: serious warning or avoid in older adults. FDA Invega · Boxed Warning
“Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Invega · 8.3
“Infertility Females Based on the pharmacologic action of paliperidone (D 2 receptor antagonism), treatment with INVEGA may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see Warnings and Precautions (5.7) ].”
🔗 Reference links
- FDA (approval record)NDA021999
- DailyMed (FDA label)FDA Invega
- MedlinePlus (NIH)PaliperidonePaliperidone Injection
- WHO ATC/DDDN05AX13
- Darooyab (Iran)Paliperidone
🇮🇷 Registered in Iran Darooyab · G-4786/Paliperidone
Dosage forms with Iranian generic codes, per Darooyab.
- 14603 · PALIPERIDONE 3MG TAB · قرص پالیپریدون ۳ میلیگرم
- 16426 · PALIPERIDONE 6MG TAB · قرص پالیپریدون ۶ میلیگرم
- 16427 · PALIPERIDONE 9MG TAB · قرص پالیپریدون ۹ میلیگرم
- 52748 · PALIPERIDONE TABLET, EXTENDED RELEASE ORAL 9 mg · قرص آهستهرهش پالیپریدون ۹ میلیگرم
- 51865 · PALIPERIDONE TABLET, EXTENDED RELEASE ORAL 3 mg · قرص آهستهرهش پالیپریدون ۳ میلیگرم
- 51202 · PALIPERIDONE PALMITATE INJECTION, SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 117 mg/0.75mL · فرآورده تزریقی پالیپریدون پالمیتات ۱۱۷ میلیگرم / ۰٫۷۵ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Invega · 3FDA Invega · 2.1FDA Invega · 2.2FDA Invega · 4FDA Invega · Boxed WarningFDA Invega · 5FDA Invega · 2.4FDA Invega · 8.1FDA Invega · 8.2FDA Invega · 8.4FDA Invega · 8.3FDA Invega · 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-4786/Paliperidone
- Clinical review⚠ Unverified