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Risperidone

ریسپریدون

⚠ Unverified

🧠 Nervous SystemAtypical antipsychotic

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Dangerous / avoid ⚥ Females & males of reproductive potential:Use with caution 🇮🇷 Registered in Iran ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA020272 ATC N05AX08

Market / country: 🇺🇸 USA

Risperdal (US)

🧮 Dose calculator

Disease / regimen

Irritability associated with autistic disorder · Regimen source: FDA Risperdal · 2.3 FDA Risperdal · 1.3

• After a minimum of 4 days increase to the recommended dose (<20 kg: 0.5 mg/day; ≥20 kg: 1 mg/day) and maintain for at least 14 days; further increases at intervals of ≥2 weeks. FDA Risperdal · 2.3
• Effective range 0.5–3 mg/day. No dosing data below 15 kg. Total daily dose once daily, or half twice daily. FDA Risperdal · 2.3

Formulation

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Weight (kg) *

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🛡️ Safety & information

Contraindications

⛔ Known hypersensitivity to risperidone, paliperidone or any excipient. FDA Risperdal · 4

Warnings

• Boxed warning: increased mortality in elderly patients with dementia-related psychosis; not approved for this use. FDA Risperdal · Boxed Warning FDA Risperdal · 5.1
• Neuroleptic malignant syndrome FDA Risperdal · 5.3
• Tardive dyskinesia FDA Risperdal · 5.4
• Metabolic changes FDA Risperdal · 5.5
• Hyperprolactinemia FDA Risperdal · 5.6
• Orthostatic hypotension FDA Risperdal · 5.7
• Falls FDA Risperdal · 5.8

Monitoring

• Metabolic monitoring (glucose, lipids, weight) FDA Risperdal · 5.5

Renal adjustment

• eGFR < 30: Severe renal impairment (Clcr <30): start 0.5 mg twice daily; increase by ≤0.5 mg twice daily; above 1.5 mg twice daily at intervals of ≥1 week. FDA Risperdal · 2.4

Formulations

1 mg / mL oral solution — solution 🇺🇸 USA FDA Risperdal · 3
0.5 mg tablet — tablet 🇺🇸 USA FDA Risperdal · 3
1 mg tablet — tablet 🇺🇸 USA FDA Risperdal · 3
2 mg tablet — tablet 🇺🇸 USA FDA Risperdal · 3
3 mg tablet — tablet 🇺🇸 USA FDA Risperdal · 3
4 mg tablet — tablet 🇺🇸 USA FDA Risperdal · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Risperdal · 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 Risperdal · 8.2
“Risk Summary Limited data from published literature reports the presence of risperidone and its metabolite, 9-hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3% and 4.7% of the maternal weight-adjusted dosage.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Risperdal · 8.4
“Safety and effectiveness of RISPERDAL in children less than 13 years of age with schizophrenia have not been established.”
👴 Older adultsDangerous / avoid
Label: serious warning or avoid in older adults. FDA Risperdal · 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 Risperdal · 8.3
“Infertility Females Based on the pharmacologic action of risperidone (D 2 receptor antagonism), treatment with RISPERDAL 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 (5.6) ].”

🔗 Reference links

FDA (approval record)NDA020272
DailyMed (FDA label)FDA Risperdal
MedlinePlus (NIH)Risperidone Risperidone Injection
WHO ATC/DDDN05AX08
Darooyab (Iran)Risperidone

🇮🇷 Registered in Iran Darooyab · G-1343/Risperidone

Dosage forms with Iranian generic codes, per Darooyab.

01773 · RISPERIDONE 1MG TAB · قرص ریسپریدون ۱ میلی‌گرم
16293 · RISPERIDONE 1MG/ML SYRUP · شربت ریسپریدون ۱ میلی‌گرم / میلی‌لیتر
08127 · RISPERIDONE 25MG LA INJ · فرآورده تزریقی ریسپریدون ۲۵ میلی‌گرم طولانی‌اثر
01774 · RISPERIDONE 2MG TAB · قرص ریسپریدون ۲ میلی‌گرم
19736 · RISPERIDONE 37.5MG LA INJ · فرآورده تزریقی ریسپریدون ۳۷٫۵ میلی‌گرم طولانی‌اثر
01869 · RISPERIDONE 3MG TAB · قرص ریسپریدون ۳ میلی‌گرم
01870 · RISPERIDONE 4MG TAB · قرص ریسپریدون ۴ میلی‌گرم
50088 · RISPERIDONE SOLUTION ORAL 1 mg/1mL 100 mL · محلول خوراکی ریسپریدون ۱ میلی‌گرم / ۱ میلی‌لیتر ۱۰۰ میلی‌لیتر
50996 · RISPERIDONE INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE PARENTERAL 50 mg · پودر تزریقی ریسپریدون ۵۰ میلی‌گرم
52191 · RISPERIDONE SOLUTION ORAL 1 mg/1mL 30 mL · محلول خوراکی ریسپریدون ۱ میلی‌گرم / ۱ میلی‌لیتر ۳۰ میلی‌لیتر

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Risperdal · 3 FDA Risperdal · 2.3 FDA Risperdal · 1.3 FDA Risperdal · 2.1 FDA Risperdal · 8.4 FDA Risperdal · 2.2 FDA Risperdal · 4 FDA Risperdal · Boxed Warning FDA Risperdal · 5.1 FDA Risperdal · 5.3 FDA Risperdal · 5.4 FDA Risperdal · 5.5 FDA Risperdal · 5.6 FDA Risperdal · 5.7 FDA Risperdal · 5.8 FDA Risperdal · 2.4 FDA Risperdal · 8.1 FDA Risperdal · 8.2 FDA Risperdal · 8.3 FDA Risperdal · 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)✅ Present
Darooyab · G-1343/Risperidone
Clinical review⚠ Unverified

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