Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN-LANSOPRAZOLE 15 (Capsules) ASPEN-LANSOPRAZOLE 30 (Capsules) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ASPEN-LANSOPRAZOLE 15 (Capsules) ASPEN-LANSOPRAZOLE 30 (Capsules) COMPOSITION: Each Aspen-lansoprazole 15 capsule contains lansoprazole 15 mg. Each Aspen-lansoprazole 30 capsule contains lansoprazole 30 mg. PHARMACOLOGICAL CLASSIFICATION: A. 11.4.3 Medicines acting on the gastrointestinal tract. PHARMACOLOGICAL ACTION: Lansoprazole is an inhibitor of the gastric H+,K+-ATPase (proton pump). Lansoprazole inhibits gastric acid secretion in a dose related manner irrespective of the source of stimulation. Gastric secretory functions recover gradually following discontinuation of the medicine. Lansoprazole has no effect on histamine, gastrin or cholinergic receptors. Pharmacokinetics: Following oral administration, lansoprazole is well absorbed with a resultant bioavailability of approximately 78%. The bioavailability is decreased if lansoprazole is taken with food. Peak serum concentrations are achieved approximately 1- 2 hours following ingestion. Lansoprazole is highly protein bound (97%). Lansoprazole is extensively metabolised via the hepatic cytochrome P450 system to the inactive, sulfated metabolites, sulphone, sulphide and 5- hydroxylansoprazole. The half-life for lansoprazole is 1,4 to 1,5 hours. The main route of elimination is via the bile with 15-30% of lansoprazole being excreted via the kidneys as the hydroxylated metabolite. INDICATIONS: • Aspen-lansoprazole 30 is indicated for the short-term treatment of gastric and duodenal ulcers and reflux oesophagitis. • Aspen-lansoprazole 15 is indicated for: - The short-term management of mild functional dyspepsia. - The prevention of relapse of gastro-oesophageal reflux. • Aspen-lansoprazole is indicated for Helicobact Read the complete document