Product Information
Registration Status: ActiveSIN10127P
XANIDINE TABLET 300mg is approved to be sold in Singapore with effective from 1998-02-10. It is marketed by POLYMEDIC TRADING ENTERPRISE PTE LTD, with the registration number of SIN10127P.
This product contains Ranitidine 300mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by BERLIN PHARMACEUTICAL INDUSTRY CO LTD in THAILAND.
It is a has been granted the exemption for supply without a presciption if it met certain criteria.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
A non-imidazole blocker of those histamine receptors that mediate gastric secretion (H2 receptors). It is used to treat gastrointestinal ulcers. [PubChem]
Indication
Used in the treatment of peptic ulcer disease (PUD), dyspepsia, stress ulcer prophylaxis, and gastroesophageal reflux disease (GERD).
Mechanism of Action
The H2 antagonists are competitive inhibitors of histamine at the parietal cell H2 receptor. They suppress the normal secretion of acid by parietal cells and the meal-stimulated secretion of acid. They accomplish this by two mechanisms: histamine released by ECL cells in the stomach is blocked from binding on parietal cell H2 receptors which stimulate acid secretion, and other substances that promote acid secretion (such as gastrin and acetylcholine) have a reduced effect on parietal cells when the H2 receptors are blocked.
Pharmacokinetics
- Absorption
- Approximately 50% bioavailability orally.
- Distribution
- * 1.4 L/kg * 1.76 L/kg [clinically significant renal function impairment (creatinine clearance 25 to 35 mL/min)]
- Metabolism
- Hepatic. Ranitidine is metabolized to the N-oxide, S-oxide, and N-desmethyl metabolites, accounting for approximately 4%, 1%, and 1% of the dose, respectively.
- Elimination
Clearance
* 29 mL/min [clinically significant renal function impairment] * 3 mL/min/Kg [neonatal patients]
Toxicity
LD50=77mg/kg (orally in mice). Symptoms of overdose include muscular tremors, vomiting, and rapid respiration.
Active Ingredient/Synonyms
RAN | Ranitidina | Ranitidinum | Ranitidine |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.