MONTELUKAST SANDOZ FILM COATED TABLET 10MG

Product Information

Registration Status: Active

MONTELUKAST SANDOZ FILM COATED TABLET 10MG is approved to be sold in Singapore with effective from 2013-07-23. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN14385P.

This product contains Montelukast 10mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.

This product is manufactured by Sandoz Ilac Sanayi ve Ticaret A.S in TURKEY.

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.

Montelukast

Description

Montelukast is a leukotriene receptor antagonist (LTRA) used for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. It is usually administered orally. Montelukast blocks the action of leukotriene D4 on the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial tubes by binding to it. This reduces the bronchoconstriction otherwise caused by the leukotriene, and results in less inflammation. Because of its method of operation, it is not useful for the treatment of acute asthma attacks. Again because of its very specific locus of operation, it does not interact with other allergy medications such as theophylline. Montelukast is marketed in United States and many other countries by Merck & Co. with the brand name Singulair®. It is available as oral tablets, chewable tablets, and oral granules. In India and other countries, it is also marketed under the brand name Montair®, produced by Indian company Cipla.

Indication

For the treatment of asthma

Mechanism of Action

Montelukast selectively antagonizes leukotriene D4 (LTD4) at the cysteinyl leukotriene receptor, CysLT1, in the human airway. Montelukast inhibits the actions of LTD4 at the CysLT1 receptor, preventing airway edema, smooth muscle contraction, and enhanced secretion of thick, viscous mucus.

Pharmacokinetics

Absorption
Rapidly absorbed following oral administration (bioavailability is 64%)
Distribution
* 8 to 11 L
Metabolism
Hepatic
Elimination

Clearance

* 45 mL/min [healthy adults]

Toxicity

Side effects include headache, abdominal or stomach pain, cough, dental pain, dizziness, fever, heartburn, skin rash, stuffy nose, weakness or unusual tiredness.

Active Ingredient/Synonyms

(R-(e))-1-(((1-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid | 1-[[[(1 R)-1-[3-[(1e)-2-(7-chloro-2-Quinolinyl)ethenyl] phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]sulfanyl]methyl]cyclopropaneacetic acid | Montelukast | Montélukast | Montelukastum | Montelukast |


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