Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
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ALTOSEC 40 mg/10 mL SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ALTOSEC 40 mg/10 mL (powder and solvent for injectable solution) COMPOSITION: • Each vial of powder contains Omeprazole (as a sodium salt) equivalent to 40 mg Omeprazole. • Each ampoule of solvent for injection contains 5.25 mg citric acid monohydrate, 4.2 g polyethylene glycol 400 and water for injection. PHARMACOLOGICAL CLASSIFICATION: A 11.4.3 Medicines acting on gastro-intestinal tract - other PHARMACOLOGICAL ACTION: Omeprazole is an inhibitor of the gastric proton pump (H+, K+ATPase) It inhibits both basal and stimulated gastric acid secretion by parietal cells, whether induced by acetylcholine, gastrin or histamine. Omeprazole has no effect on acetylcholine, histamine or gastrin receptors. Effects on Gastric Secretion Omeprazole infusion produces an immediate decrease in intra-gastric acidity and a mean decrease over 24 hours of approximately 90% Pharmacokinetics: Omeprazole is more than 95% bound to plasma proteins. Clearance from the circulation is by hepatic metabolism with a plasma half life of 30 to 90 minutes. Hepatic metabolism occurs primarily via the cytochrome P450 (CYP) isoform (CYP2C19). The inactive metabolites are excreted mainly in the urine (80%) whilst the remaining 20% are excreted via faeces. The average half-life of the terminal phase of the plasma concentration-time curve is approximately 40 minutes. There is no change in plasma half-life during treatment. The inhibition of acid secretion is related to the area under the plasma concentration-time curve (AUC) and not the actual plasma concentration at a given time. The systemic bioavailability of omeprazole is unchanged in patients with reduced renal function. The area under the plasma concentration-time cu Read the complete document