Country: Afrika Selatan
Bahasa: Inggeris
Sumber: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
R-LOC INJECTION SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): R-LOC INJECTION COMPOSITION: Each 2 mL ampoule contains ranitidine hydrochloride equivalent to Ranitidine 50 mg. Phenol 0,5% m/v (as preservative) PHARMACOLOGICAL CLASSIFICATION: A11.4.3 Medicines acting on gastro-intestinal tract. Antacids –other. PHARMACOLOGICAL ACTION: Ranitidine is a selective and competitive histamine H2-receptor antagonist. It does not exhibit anti-serotonergic or histamine H1-receptor blocking activities. Ranitidine inhibits basal and stimulated secretion of gastric acid, reducing both the volume of secretions, the acid and pepsin content but does not affect gastric mucous secretion. The elimination half-life of ranitidine is approximately 2-3 hours. Ranitidine is excreted via the kidneys in the free and metabolised forms. Its major metabolite is the N-oxide with smaller quantities of S-oxide and desmethyl ranitidine. INDICATIONS: R-LOC INJECTION is indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux oesophagitis and Zollinger-Ellison syndrome. R-LOC INJECTION may also be used as pre-medication prior to anaesthesia in order to reduce the volume and acid content of gastric secretion, thereby minimising the consequence of the acid aspiration syndrome. CONTRA-INDICATIONS: R-LOC INJECTION is contra-indicated in patients known to have hypersensitivity to any of the ingredients. R-LOC INJECTION should be avoided in patients with a history of porphyria. WARNINGS Treatment with R-LOC INJECTION may mask symptoms associated with carcinoma of the stomach and may, therefore, delay diagnosis of the condition. Accordingly where gastric ulcer is diagnosed the possibility of malignancy should be excluded before therapy with R-LOC INJECTION is instituted. INTERACTIONS Because of Baca dokumen lengkap