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Lactulose
لاکتولوز
🍽️ Alimentary Tract And MetabolismOsmotic laxative
🤰 Pregnancy:Use with caution🤱 Breastfeeding:Use with caution👶 Children:Safety not established 🇮🇷 Registered in Iran⛔ 1 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA090503ATC A06AD11
Market / country: 🇺🇸 USA
🧮 Dose calculator
Constipation · Regimen source: FDA Lactulose · Pediatric Use
⛔ Safety and effectiveness in pediatric patients have not been established in this label; no dose is calculated. FDA Lactulose · Pediatric Use
🛡️ Safety & information
Contraindications
- ⛔ Patients who require a low-galactose diet. FDA Lactulose · Contraindications
Formulations
- 10 g / 15 mL — solution 🇺🇸 USA FDA Lactulose · Dosage and Administration
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Lactulose · Pregnancy
“Teratogenic Effects Pregnancy category B.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Lactulose · Nursing Mothers
“Because many drugs are excreted in human milk, caution should be exercised when lactulose solution is administered to a nursing woman.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Lactulose · Pediatric Use
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsNo data
The source for this drug has no section for this group.
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA090503
- DailyMed (FDA label)FDA Lactulose
- MedlinePlus (NIH)Lactulose
- WHO ATC/DDDA06AD11
- Darooyab (Iran)Lactulose
🇮🇷 Registered in Iran Darooyab · G-2598/Lactulose
Dosage forms with Iranian generic codes, per Darooyab.
- 01565 · LACTULOSE 10 G SACHET · ساشه لاکتولوز ۱۰ گرم
- 19734 · LACTULOSE 10G/15ML 120ML SYRUP · شربت لاکتولوز ۱۰ گرم / ۱۵ میلی‌لیتر ۱۲۰ میلی‌لیتر
- 00731 · LACTULOSE 10G/15ML 240ML SYRUP · شربت لاکتولوز ۱۰ گرم / ۱۵ میلی‌لیتر ۲۴۰ میلی‌لیتر
- 11540 · LACTULOSE 10G/15ML SUSP · سوسپانسیون لاکتولوز ۱۰ گرم / ۱۵ میلی‌لیتر
- 11474 · LACTULOSE 300ML SYRUP · شربت لاکتولوز ۳۰۰ میلی‌لیتر
- 52072 · LACTULOSE SYRUP ORAL 10 g/15mL 100 mL · شربت لاکتولوز ۱۰ گرم / ۱۵ میلی‌لیتر ۱۰۰ میلی‌لیتر
- 52075 · LACTULOSE SYRUP ORAL 10 g/15mL 250 mL · شربت لاکتولوز ۱۰ گرم / ۱۵ میلی‌لیتر ۲۵۰ میلی‌لیتر
- 52081 · LACTULOSE SYRUP ORAL 10 g/15mL 200 mL · شربت لاکتولوز ۱۰ گرم / ۱۵ میلی‌لیتر ۲۰۰ میلی‌لیتر
- 51935 · LACTULOSE SYRUP ORAL 10 g/15mL 15 mL · شربت لاکتولوز ۱۰ گرم / ۱۵ میلی‌لیتر ۱۵ میلی‌لیتر
- 52217 · LACTULOSE SYRUP ORAL 10 g/15mL 300 mL · شربت لاکتولوز ۱۰ گرم / ۱۵ میلی‌لیتر ۳۰۰ میلی‌لیتر
- 52150 · LACTULOSE SYRUP ORAL 10 g/15mL 500 mL · شربت لاکتولوز ۱۰ گرم / ۱۵ میلی‌لیتر ۵۰۰ میلی‌لیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Lactulose · Dosage and AdministrationFDA Lactulose · Pediatric UseFDA Lactulose · ContraindicationsFDA Lactulose · PregnancyFDA Lactulose · Nursing MothersFDA Lactulose · 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-2598/Lactulose
- Clinical review⚠ Unverified