资料单张
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
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