Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
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LENNON LACTULOSE LEMON (SOLUTION) SCHEDULING STATUS: S0 PROPRIETARY NAME (and dosage form): LENNON LACTULOSE LEMON (SOLUTION) COMPOSITION: Each 5 mL LENNON LACTULOSE LEMON contains 6,750 g lactulose solution (66% w/v), equivalent to 3,297 g lactulose anhydrous. PHARMACOLOGICAL CLASSIFICATION: A 11.5 Laxatives. PHARMACOLOGICAL ACTION: LACTULOSE produces an osmotic effect in the colon resulting from biodegradation by colonic, bacterial flora into lactic, formic and acetic acid. Lactulose reduces intestinal absorption of ammonia. Pharmacokinetics: Lactulose passes almost completely unabsorbed from the gastro-intestinal tract and essentially unchanged into the large intestine where it is metabolised by saccharolytic bacteria mainly into lactic acid and small amounts of acetic and formic acids. Urinary excretion of unchanged lactulose has been reported to be 3% or less. INDICATIONS: • Constipation. • Hepatic encephalopathy. • Chronic portal hypertension. CONTRA-INDICATIONS: Lactulose is contra-indicated in: • Patients with cramps, colic, nausea, vomiting, or any undiagnosed abdominal conditions. • Patients on galactose-free diets. • Undiagnosed rectal bleeding. • Congestive heart failure or hypertension. • Diabetes mellitus. • Hypersensitivity to the ingredient. WARNINGS: Lactulose should not be given to children up to 6 years of age unless prescribed by a physician. Since children are not able to describe their symptoms precisely, proper diagnosis should precede the use of a laxative. This will avoid the complication of an existing condition (e.g. appendicitis) or the appearance of more severe side effects. INTERACTIONS: Chronic use or overuse of lactulose may reduce serum potassium concentrations by promoting excessive potassium loss from the intestinal tract and may interfere with Read the complete document