PANTIN 20 PANTOPRAZOLE GASTRO-RESISTANT TABLET 20MG

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.

Active Ingredient / Synonyms

Pantoprazol | Pantoprazolum | Pantoprazole |

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.

Pharmacodynamics

Pantoprazole is a substituted benzimidazole indicated for the short-term treatment (up to 16 weeks) in the healing and symptomatic relief of erosive esophagitis. Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production.

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:

After administration of a single intravenous dose of 14C-labeled pantoprazole to healthy, normal metabolizer subjects, approximately 71% of the dose was excreted in the urine with 18% excreted in the feces through biliary excretion.

Half-life

1 hour

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.

References

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

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Approval Information

PANTIN 20 PANTOPRAZOLE GASTRO-RESISTANT TABLET 20MG was registered with Health Science Authority of Singapore by MEDICELL PHARMACEUTICAL (S) PTE LTD. It is marketed with the registration number of SIN15042P with effective from 2016-07-04.

This product contains 20mg of Pantoprazole in the form of ORAL TABLET.

The medicine was manufactured by Hetero Labs LTD in INDIA

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

Reclassified Info

Anatomical Therapeutic Chemical (ATC) Classification

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678BANEOCIN POWDERBacitracin|NeomycinPOMNOVARTIS (SINGAPORE) PTE LTDActive