Lactulose solution usp?

Lactulose Solution, USP refers to the USP-grade lactulose syrup used as an osmotic laxative and in hepatic encephalopathy. It is a non-digestible disaccharide (galactose–fructose).

Key points:
- Common strength: 3.35 g lactulose per 5 mL (equivalently 10 g per 15 mL). Many products are labeled as 10 g/15 mL.
- Appearance: Clear to slightly yellow, sweet-tasting syrup.
- Uses:
- Constipation relief (osmotic laxative)
- Management of hepatic encephalopathy by lowering colonic pH and reducing ammonia absorption
- Typical dosing (adult, though always follow clinician’s instructions):
- Constipation: usually 15–30 mL per day, may titrate up to 45–60 mL/day to achieve soft stools
- Hepatic encephalopathy: often 20–40 mL per day in divided doses, adjusted to obtain 2–3 soft stools per day
- Administration: Oral; can be taken alone or mixed with water/juice.
- Common adverse effects: Flatulence, abdominal cramping, diarrhea; possible electrolyte shifts with long-term use.
- Contraindications: Galactosemia; caution in diabetes due to sugar content; use under medical supervision for hepatic encephalopathy.
- Storage: Room temperature, protect from extreme heat and moisture.
- USP specifics: The lactulose solution marketed as “Lactulose Solution, USP” conforms to the USP monograph, which covers identity, assay (lactulose content), impurities/related substances, pH, loss on drying, microbial limits, packaging, etc. For exact limits, refer to the USP–NF text or the product’s label.

If you’re asking for a precise monograph excerpt or limits, tell me and I can summarize the key USP-NF requirements or point you to where to find them.