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OLMEZEN FILM-COATED TABLET 40MG

Product Information

Registration Status: Active

SIN15528P

OLMEZEN FILM-COATED TABLET 40MG is approved to be sold in Singapore with effective from 2018-08-17. It is marketed by PHARMAZEN MEDICALS PTE LTD, with the registration number of SIN15528P.

This product contains Olmesartan 40mg in the form of TABLET, FILM COATED. It is approved for ORAL use.

This product is manufactured by Medreich Limited in INDIA.

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

Olmesartan is an antihypertensive agent, which belongs to the class of medications called angiotensin II receptor blockers. It is indicated for the treatment of high blood pressure and is marketed under the name Olmetec®. The FDA label includes a black-box warning of injury and death to the fetus, so women of child-bearing age need to be warned and take the necessary precautions. Olmesartan is also contraindicated in diabetes mellitus patients taking aliskiren.

Indication

For the treatment of hypertension.

Mechanism of Action

Olmesartan is an ARB that selectively inhibits the binding of angiotensin II to AT1, which is found in many tissues such as vascular smooth muscle and the adrenal glands. This effectively inhibits the AT1-mediated vasoconstrictive and aldosterone-secreting effects of angiotensin II and results in a decrease in vascular resistance and blood pressure. Olmesartan is selective for AT1 and has a 12,500 times greater affinity for AT1 than the AT2 receptor. Also unlike the well-known ARB losartan, olmesartan does not have an active metabolite or possess uricosuric effects.

Pharmacokinetics

Absorption
Bioavailability is about 26%. Food does not affect the bioavailability of olmesartan.
Distribution
The volume of distribution is 17 L and olmesartan poorly crosses the blood brain barrier.
Metabolism
Olmesartan is rapidly and completely bioactivated by ester hydrolysis to olmesartan during absorption from the gastrointestinal tract. There is virtually no further metabolism of olmesartan.
Elimination

Clearance

* Total plasma cl=1.3 L/h * Renal cl=0.6 L/h

Toxicity

The main symptoms of overdose include low blood pressure and fast heartbeat.

Active Ingredient/Synonyms

4-(1-hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-1H-imidazole-5-carboxylic acid | 4-(hydroxy-1-methylethyl)-2-propyl-1-{[2'-(1H-tetrazol-5-yl)-1,1'-biphenyl-4-yl]methyl}-1H-imidazole-5-carboxylic acid | Olmesartan |


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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