The Color of Lactulose
Lactulose solution is typically clear, colorless to pale brownish-yellow in appearance. 1
Physical Characteristics of Lactulose
- Lactulose is available as a viscous, unflavored solution that ranges from clear and colorless to pale brownish-yellow in color 1
- The FDA-approved lactulose solution contains 667 mg lactulose/mL (10 g/15 mL) 1
- Under recommended storage conditions (15° to 30°C or 59° to 86°F), a normal darkening of color may occur, which is characteristic of sugar solutions but does not affect its therapeutic action 1
Storage Considerations Affecting Color
- Prolonged exposure to temperatures above 86°F (30°C) or direct light may cause extreme darkening and turbidity of the solution, which may be pharmaceutically objectionable 1
- Freezing temperatures may cause the solution to change to a semi-solid state that is too viscous to pour, though normal viscosity returns upon warming to room temperature 1
- Proper storage in a tight, light-resistant container as defined by USP standards is recommended to maintain the solution's appearance and efficacy 1
Pharmaceutical Form and Composition
- Lactulose is a synthetic disaccharide (β-galactosido-fructose) that is not digested in the small intestine 2
- It exerts an osmotic laxative effect in the colon to promote peristalsis 2
- Lactulose is supplied in various bottle sizes including 8 fl oz (237 mL), 16 fl oz (473 mL), and 32 fl oz (946 mL) 1
Clinical Context
- Lactulose is FDA-approved for the treatment of constipation at a dose of 10-20 g (15-30 mL or 1-2 packets) daily 2
- The dose may be increased to 40 g (60 mL or 2-4 packets) daily if needed 2
- Besides constipation, lactulose is also used in the treatment of hepatic encephalopathy 3
- When fermented by gastrointestinal bacteria, lactulose produces short chain fatty acids that lower colonic pH 3