A clear, viscous liquid, colorless or pale brownish yellow solution.
Each sachet (15 mL) of Alvolaxus solution contains: Lactulose 10 g (Lactulose 66.7 g/100 mL).
Pharmacology: Pharmacodynamics: The bacterial degradation of lactulose resulting in an acidic pH inhibits the diffusion of NH3 into the blood by causing the conversion of NH3 to NH4+; also enhance the diffusion of NH3 from the blood into the gut where conversion to NH4+ occurs; procedures an osmotic effect in the colon with resultant distention promoting peristalsis; reduce blood ammonia concentration to reduce the degree of portal systemic encephalopathy.
Pharmacokinetics: Onset: Constipation: Up to 24-48 hours to produce a normal bowel movement.
Encephalopathy: At least 24-48 hours.
Absorption: Not appreciable.
Metabolism: Via colonic flora to lactic acid and acetic acid; requires colonic flora for drug activation.
Excretion: Primarily feces; urine (≤3%).
Toxicology: Preclinical safety data: Mutagenicity and carcinogenicity: Data on the long-term mutagenic potential of lactulose in animals or humans and on the long-term carcinogenic potential in human are not available. Administration of lactulose solution in concentrations of 3 and 10% v/w in the diet of mice for 18 months did not produce evidence of carcinogenicity.
Prevention and treatment of portal-systemic encephalopathy (PSE) including hepatic pre-coma and coma.
Treatment of constipation.
Restore regular bowel movements in hemorrhoidectomy patients.
Constipation: Oral: Adults: 10-20 g (15-30 mL) daily; may increase to 40 g (60 mL) daily if necessary.
Prevention of postal systemic encephalopathy (PSE): Oral: Infants: 1.7-6.7 g/day (2.5-10 mL/day) in divided doses; adjust dosage to produce 2-3 stools/day.
Children: 26.7-60 g/day (40-90 mL/day) in divided doses; adjust dosage to produce 2-3 stools/day.
Adult: 20-30 g (30-45 mL) 3-4 times/day; adjust dose every 1-2 days to produce 2-3 soft stools/day.
Treatment of acute PSE: Adults: Oral: 20-30 g (30-45 mL) every 1 hour to induce rapid laxation; reduce to 20-30 g (30-45 mL) 3-4 times/day after laxation is achieved titrate to produce 2-3 soft stools/day.
Use in patients requiring a low galactose diet.
Use with caution in patients with diabetes mellitus; solution contains galactose and lactose. Monitor periodically for electrolyte imbalance when lactulose is used >6 months or in patients predisposed to electrolyte abnormalities (eg. elderly). Hepatic disease may predispose patients to electrolyte imbalance. Infants receiving lactulose may develop hyponatremia and dehydration. Patients receiving lactulose and an oral anti-infective agent should be monitored for possible inadequate response to lactulose. During proctoscopy or colonoscopy procedures involving electrocautery, a theoretical risk of reaction between H2 gas accumulation and electrical spark may exist; though bowel cleaning with a nonfermentable solution is recommended.
Effects on ability to drive and use machine: No information.
Use in Children: Limited information on the use of lactulose for prevention and treatment of PSE in young children and adolescents is available. Safety and efficacy of the drug for treatment of chronic constipation in children have not been established.
Use in the Elderly: Geriatric, debilitated patients who receive lactulose for more than 6 months should have serum electrolytes (eg. potassium, chloride, carbon dioxide) measured periodically during therapy.
Pregnancy: (Pregnancy category B.) Adverse events have not been observed in animal reproduction studies.
Lactation: Excretion in breast milk unknown/use caution.
Endocrine and metabolic: Dehydration, hypernatremia, hypokalemia.
Gastrointestinal: Abdominal discomfort, abdominal distention, belching, cramping, diarrhea (excessive dose), flatulence, nausea, vomiting.
Laxatives: Additional laxatives should not be administered with lactulose solution, especially when lactulose therapy is initiated, because the loose stool produced may be falsely interpret as an indication that adequate dosage of lactulose has been achieved.
Anti-infective agents: Theoretically, orally administered neomycin and possibly other anti-infective agents, when administered concurrently with lactulose, could eliminate colonic bacteria that are necessary to metabolize lactulose and thereby prevent acidification of the contents of the colon. Limited data obtained from experiments in healthy individuals tend to support the theoretical incompatibility of these agents. There is, however, evidence that lactulose remains active when administered with neomycin to patients with PSE. In addition, there have been reports that concomitant therapy with lactulose and neomycin maybe more effective than either drug alone in the treatment of PSE. Therefore, until there is conclusive evidence that concurrent administration of lactulose and neomycin or other oral anti-infective agents is efficacious, patients receiving lactulose and oral anti-infective agent should be closely monitored for possible inadequate response to lactulose.
Antacids: Results of limited studies in rats and humans suggest that nonabsorbable antacids administered concomitantly with lactulose may inhibit the desired decrease in fecal pH in the colon. The potential lack of desired effect of lactulose should be considered before a nonabsorbable antacid is administered concomitantly with lactulose.
A06AD11 - lactulose ; Belongs to the class of osmotically acting laxatives.
Alvolaxus oral soln 10 g/15 mL
20 × 1's
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