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Galantamine
گالانتامین
🧠 Nervous SystemCholinesterase inhibitor
🤰 Pregnancy:Use with caution👶 Children:Safety not established👴 Older adults:Use with caution 🇮🇷 Registered in Iran⛔ 1 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA077604ATC N06DA04
Market / country: 🇺🇸 USA
Razadyne (US)
🧮 Dose calculator
Alzheimer's disease · Regimen source: FDA Galantamine · 2.2
- • Start 4 mg twice daily; after ≥4 weeks 8 mg twice daily; after another 4 weeks up to 12 mg twice daily. With meals and adequate fluids. Moderate hepatic impairment max 16 mg/day; severe not recommended. FDA Galantamine · 2.2FDA Galantamine · 2.3
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to galantamine. FDA Galantamine · 4
Warnings
- • Serious skin reactions (SJS); bradycardia and heart block; GI bleeding; urinary outflow obstruction; seizures; asthma/COPD; exaggerates succinylcholine-type relaxation in anaesthesia. FDA Galantamine · 5
Renal adjustment
- • eGFR < 60: CrCl 9–59: max 16 mg/day; below 9 not recommended. FDA Galantamine · 2.4
Formulations
- 4 mg tablet — tablet 🇺🇸 USA FDA Galantamine · 3
- 8 mg tablet — tablet 🇺🇸 USA FDA Galantamine · 3
- 12 mg tablet — tablet 🇺🇸 USA FDA Galantamine · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Galantamine · 8.1
“Risk Summary There are no adequate data on the developmental risk associated with the use of galantamine tablets in pregnant women.”
- 🤱 BreastfeedingNo data
The source for this drug has no section for this group.
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Galantamine · 8.4
“The safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Galantamine · 8.5
“Eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6519 patients have investigated galantamine tablets in the treatment of mild to moderate dementia of the Alzheimer’s type [see Adverse Reactions (6.1) and Clinical Studies (14) ] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA077604
- DailyMed (FDA label)FDA Galantamine
- MedlinePlus (NIH)Galantamine
- WHO ATC/DDDN06DA04
- Darooyab (Iran)Galantamine
🇮🇷 Registered in Iran Darooyab · G-3046/Galantamine
Dosage forms with Iranian generic codes, per Darooyab.
- 21701 · GALANTAMINE 12MG CAP · کپسول گالانتامین ۱۲ میلی‌گرم
- 04956 · GALANTAMINE 12MG TAB · قرص گالانتامین ۱۲ میلی‌گرم
- 16777 · GALANTAMINE 16MG ER CAP · کپسول آهسته‌رهش گالانتامین ۱۶ میلی‌گرم
- 16778 · GALANTAMINE 24MG ER CAP · کپسول آهسته‌رهش گالانتامین ۲۴ میلی‌گرم
- 04954 · GALANTAMINE 4MG TAB · قرص گالانتامین ۴ میلی‌گرم
- 16776 · GALANTAMINE 8MG ER CAP · کپسول آهسته‌رهش گالانتامین ۸ میلی‌گرم
- 04955 · GALANTAMINE 8MG TAB · قرص گالانتامین ۸ میلی‌گرم
- 51328 · GALANTAMINE (AS HYDROBROMIDE) SOLUTION ORAL 4 mg/1mL · محلول خوراکی گالانتامین (معادل هیدروبروماید) ۴ میلی‌گرم / ۱ میلی‌لیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Galantamine · 3FDA Galantamine · 2.2FDA Galantamine · 2.3FDA Galantamine · 4FDA Galantamine · 5FDA Galantamine · 2.4FDA Galantamine · SPL approval / marketing categoryFDA Galantamine · 8.1FDA Galantamine · 8.4FDA Galantamine · 8.5
- 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-3046/Galantamine
- Clinical review⚠ Unverified