Fidaxomicin
فیداکسومایسین
🍽️ Alimentary Tract And MetabolismMacrocyclic antibiotic
Market / country: 🇺🇸 USA
Dificid (US)
🧮 Dose calculator
Clostridioides difficile diarrhoea · Regimen source: FDA Dificid · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to fidaxomicin. FDA Dificid · 4
Formulations
- 200 mg tablet — tablet 🇺🇸 USA FDA Dificid · 3
- 40 mg/mL oral suspension — suspension 🇺🇸 USA FDA Dificid · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Dificid · 8.1
“Risk Summary The limited available data on use of DIFICID in pregnant women are insufficient to inform any drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Dificid · 8.2
“Risk Summary There is no information on the presence of fidaxomicin or its main metabolite, OP-1118, in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Dificid · 8.4
“The safety and effectiveness of DIFICID for the treatment of CDAD have been established in pediatric patients 6 months to less than 18 years of age.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Dificid · 8.5
“No dose adjustment is recommended for elderly patients.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA201699
- DailyMed (FDA label)FDA Dificid
- MedlinePlus (NIH)Fidaxomicin
- WHO ATC/DDDA07AA12
- 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 Dificid · 3FDA Dificid · 2.2FDA Dificid · 2.3, Table 1FDA Dificid · 4FDA Dificid · SPL approval / marketing categoryFDA Dificid · 8.1FDA Dificid · 8.2FDA Dificid · 8.4FDA Dificid · 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 · search
- Clinical review⚠ Unverified