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CONTROLOC TABLET 20mg

Product Information

Registration Status: Active

SIN11170P

CONTROLOC TABLET 20mg is approved to be sold in Singapore with effective from 1999-07-10. It is marketed by TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE LTD, with the registration number of SIN11170P.

This product contains Pantoprazole 20mg in the form of ENTERIC-COATED TABLET. It is approved for ORAL use.

This product is manufactured by Takeda GmbH in GERMANY.

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

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.

References

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

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