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Colchicine
کلشیسین
🦴 Musculo-Skeletal SystemAnti-gout agent
🤰 Pregnancy:Use with caution🤱 Breastfeeding:Use with caution👶 Children:Safety not established👴 Older adults:Use with caution 🇮🇷 Registered in Iran⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA022352ATC M04AC01
Market / country: 🇺🇸 USA
Colcrys (US)
🧮 Dose calculator
Gout · Regimen source: FDA Colcrys · 2.1
- • At the first sign of a flare. Not recommended in patients on prophylactic dose plus CYP3A4 inhibitors. FDA Colcrys · 2.1FDA Colcrys · 2.4
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Renal or hepatic impairment together with P-gp or strong CYP3A4 inhibitors (fatal toxicity). FDA Colcrys · 4
Formulations
- 0.6 mg tablet (scored) — tablet 🇺🇸 USA FDA Colcrys · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Colcrys · 8.1
“Pregnancy Category C.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Colcrys · 8.3
“Caution should be exercised, and breastfeeding infants should be observed for adverse effects when COLCRYS is administered to a nursing woman.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Colcrys · 8.4
“Gout is rare in pediatric patients; safety and effectiveness of colchicine in pediatric patients has 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 Colcrys · 8.5
“In general, dose selection for an elderly patient with gout should be cautious, reflecting the greater frequency of decreased renal function, concomitant disease or other drug therapy [see Dose Modification for Coadministration of Interacting Drugs (2.4) and Pharmacokinetics (12.3) ] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA022352
- DailyMed (FDA label)FDA Colcrys
- MedlinePlus (NIH)Colchicine
- WHO ATC/DDDM04AC01
- Darooyab (Iran)Colchicine
🇮🇷 Registered in Iran Darooyab · G-757/Colchicine
Dosage forms with Iranian generic codes, per Darooyab.
- 00348 · COLCHICINE 1MG TAB · قرص کلشیسین ۱ میلیگرم
- 07262 · COLCHICINE 500MCG TAB · قرص کلشیسین ۵۰۰ میکروگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Colcrys · 3FDA Colcrys · 2.1FDA Colcrys · 2.4FDA Colcrys · 2FDA Colcrys · 2.2FDA Colcrys · 2.3FDA Colcrys · 4FDA Colcrys · 8.1FDA Colcrys · 8.3FDA Colcrys · 8.4FDA Colcrys · 8.5FDA Colcrys · 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-757/Colchicine
- Clinical review⚠ Unverified