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ESBRIET HARD CAPSULE 267mg

Product Information

Registration Status: Active

SIN15124P

ESBRIET HARD CAPSULE 267mg is approved to be sold in Singapore with effective from 2016-12-01. It is marketed by ROCHE SINGAPORE PTE LTD, with the registration number of SIN15124P.

This product contains Pirfenidone 267mg in the form of CAPSULE. It is approved for ORAL use.

This product is manufactured by Catalent Pharma Solutions in UNITED STATES, LLC in FRANCE, andPackaging Coordinators LLC (Primary and Secondary Packager) in UNITED KINGDOM.

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.

Product Reference
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Description

Pirfenidone is an orally active small molecule drug that may inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines. Pirfenidone has demonstrated activity in multiple fibrotic conditions, including those of the lung, kidney and liver. It is being investigated by InterMune.

Indication

For the treatment of idiopathic pulmonary fibrosis (IPF).

Mechanism of Action

Pirfenidone is an orally active, small molecule that shows a wide range of biologic activity. In vitro evidence has shown that pirfenidone inhibits collagen synthesis, down-regulates profibrotic cytokines and decreases fibroblast proliferation. Pirfenidone leads to a reduction of TGF-beta2 mRNA levels and of the mature TGF-beta2 protein due to decreased expression and direct inhibition of the TGF-beta pro-protein convertase furin. In addition, pirfenidone reduces the protein levels of the matrix metalloproteinase (MMP)-11, a TGF-beta target gene and furin substrate involved in carcinogenesis.

Pharmacokinetics

Absorption
Rapidly absorbed following oral administration.
Distribution
Metabolism
Elimination

Toxicity

Generally well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms.

Active Ingredient/Synonyms

Pirfenidone | Pirfenidone |


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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