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XENICAL CAPSULE 120MG

Product Information

Registration Status: Active

SIN13046P

XENICAL CAPSULE 120MG is approved to be sold in Singapore with effective from 2005-01-31. It is marketed by DKSH SINGAPORE PTE LTD, with the registration number of SIN13046P.

This product contains Orlistat 120MG in the form of CAPSULE. It is approved for ORAL use.

This product is manufactured by F. Hoffman-La Roche Ltd in SWITZERLAND, andDelpharm Milano S.R.L. in ITALY.

It is a Pharmacy Only Medicine that can be obtained from a pharmacist at a retail pharmacy.

Product Reference
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Description

Orlistat is a drug designed to treat obesity. Its primary function is preventing the absorption of fats from the human diet, thereby reducing caloric intake. Orlistat works by inhibiting pancreatic lipase, an enzyme that breaks down triglycerides in the intestine. Without this enzyme, triglycerides from the diet are prevented from being hydrolyzed into absorbable free fatty acids and are excreted undigested.

Indication

For obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. Also used to reduce the risk for weight regain after prior weight loss. Use of orlistat is pending revision due to reports of liver-related adverse events.

Mechanism of Action

Orlistat is a reversible inhibitor of lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue site of gastric and pancreatic lipases. The inactivated enzymes are thus unavailable to hydrolyze dietary fat in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides are not absorbed, the resulting caloric deficit may have a positive effect on weight control.

Pharmacokinetics

Absorption
Systemic absorption of orlistat is minimal, however systemic absorption of the drug is not needed for activity.
Distribution
Metabolism
Metabolized primarily within the gastrointestinal wall forming relatively inactive metabolites. Metabolites M1 (4-member lactone ring hydrolyzed) and M3 (M1 with N-formyl leucine moiety cleaved) accounted for approximately 42% of total radioactivity in plasma. M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1000- and 2500-fold less than orlistat, respectively).
Elimination

Toxicity

The results of a massive overdose of Xenical are unknown, although the drug seems relatively harmless.

Active Ingredient/Synonyms

(-)-Tetrahydrolipstatin | Orlipastat | Orlipastatum | Tetrahydrolipstatin | Orlistat |


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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