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EMANERA GASTRO-RESISTANT CAPSULE 20mg

Product Information

Registration Status: Active

SIN15234P

EMANERA GASTRO-RESISTANT CAPSULE 20mg is approved to be sold in Singapore with effective from 2017-05-12. It is marketed by SINGAPORE PHARMACEUTICAL PTE LTD, with the registration number of SIN15234P.

This product contains Esomeprazole 20mg in the form of CAPSULE. It is approved for ORAL use.

This product is manufactured by Krka in SLOVENIA.

It is a has been granted the exemption for supply without a presciption if it met certain criteria.

Reclassified Info

Product Reference
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Description

A highly effective inhibitor of gastric acid secretion used in the therapy of stomach ulcers and zollinger-ellison syndrome. The drug inhibits the H(+)-K(+)-ATPase (H(+)-K(+)-exchanging ATPase) in the proton pump of gastric parietal cells. [PubChem]

Indication

For the treatment of acid-reflux disorders (GERD), peptic ulcer disease, H. pylori eradication, and prevention of gastroinetestinal bleeds with NSAID use.

Mechanism of Action

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.

Pharmacokinetics

Absorption
90%
Distribution
* 16 L [healthy volunteers]
Metabolism
Mainly hepatic. Esomeprazole is completely metabolized by the cytochrome P450 system via CYP2C19 and CYP3A4. Metabolism produces inactive hydroxy and desmethyl metabolites, which have no effect on gastric acid secretion. Less than 1% of the parent drug is excreted in urine.
Elimination

Toxicity

Blurred vision, confusion, drowsiness, dry mouth, flushing headache, nausea, rapid heartbeat, sweating

Active Ingredient/Synonyms

(−)-omeprazole | (S)-(−)-omeprazole | (S)-omeprazole | Esomeprazol | Ésoméprazole | Esomeprazolum | Omeprazole S-form | Perprazole | Esomeprazole |


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.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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