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OLZANID FILM COATED TABLET 10MG

Product Information

Registration Status: Active

SIN14274P

OLZANID FILM COATED TABLET 10MG is approved to be sold in Singapore with effective from 2012-04-12. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN14274P.

This product contains Olanzapine 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, andSalutas Pharma GmbH in GERMANY.

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

Olanzapine is an atypical antipsychotic, approved by the FDA in 1996. Olanzapine is manufactured and marketed by the pharmaceutical company Eli Lilly and Company, whose patent for olanzapine proper ends in 2011.

Indication

For the acute and maintenance treatment of schizophrenia and related psychotic disorders, as well as acute treatment of manic or mixed episodes of bipolar 1 disorder. Intramuscular olanzapine is indicated for the rapid control of agitated patients.

Mechanism of Action

Olanzapine's antipsychotic activity is likely due to a combination of antagonism at D2 receptors in the mesolimbic pathway and 5HT2A receptors in the frontal cortex. Antagonism at D2 receptors relieves positive symptoms while antagonism at 5HT2A receptors relieves negative symptoms of schizophrenia.

Pharmacokinetics

Absorption
Well absorbed, with approximately 40% of the dose metabolized before reaching the systemic circulation.
Distribution
* 1000 L
Metabolism
Hepatic
Elimination

Clearance

* 12 to 47 L/h

Toxicity

Symptoms of an overdose include tachycardia, agitation, dysarthria, decreased consciousness and coma. Death has been reported after an acute overdose of 0.45g, but also survival after an acute overdose of 1500g.

Active Ingredient/Synonyms

2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine | Olanzapin | Olanzapina | Olanzapine | Olanzapinum | Olanzapine |


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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