Product Information
Registration Status: ActiveDUONAZOLE ENTERIC-COATED TABLET 40MG is approved to be sold in Singapore with effective from 2017-06-28. It is marketed by GOLDPLUS UNIVERSAL PTE LTD, with the registration number of SIN15277P.
This product contains Pantoprazole 40mg in the form of TABLET, ENTERIC-COATED. It is approved for ORAL use.
This product is manufactured by Actavis Ltd. in MALTA, andBALKANPHARMA DUPNITSA AD in BULGARIA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Pantoprazole is a proton pump inhibitor drug used for short-term treatment of erosion and ulceration of the esophagus caused by gastroesophageal reflux disease.
Indication
Short-term (up to 16 weeks) treatment of erosive esophagitis.
Mechanism of Action
Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by forming a covalent bond to two sites of the (H+,K+ )- ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect is dose- related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.
Pharmacokinetics
- Absorption
- Pantoprazole is well absorbed. It undergoes little first-pass metabolism resulting in an absolute bioavailability of approximately 77%.
- Distribution
- * 11.0 to 23.6 L
- Metabolism
- Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP) system. The main metabolic pathway is demethylation, by CYP2C19, with subsequent sulfation; other metabolic pathways include oxidation by CYP3A4. There is no evidence that any of the pantoprazole metabolites have significant pharmacologic activity.
- Elimination
Clearance
* 7.6-14.0 L/h
Toxicity
Single intravenous doses of pantoprazole at 378, 230, and 266 mg/kg (38, 46, and 177 times the recommended human dose based on body surface area) were lethal to mice, rats and dogs, respectively. The symptoms of toxicity included hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor. There is limited experience regarding cases of human overdosage, and treatment should be symptomatic and supportive.
Active Ingredient/Synonyms
Pantoprazol | Pantoprazolum | Pantoprazole |
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.