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SEROQUEL XR TABLET 400MG

Product Information

Registration Status: Active

SIN13505P

SEROQUEL XR TABLET 400MG is approved to be sold in Singapore with effective from 2008-07-29. It is marketed by ASTRAZENECA SINGAPORE PTE LTD, with the registration number of SIN13505P.

This product contains Quetiapine 400mg in the form of TABLET, EXTENDED-RELEASE. It is approved for ORAL use.

This product is manufactured by AstraZeneca UK Limited (Manufacture in UNITED STATES, and QC testing 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

Quetiapine is indicated for the treatment of schizophrenia as well as for the treatment of acute manic episodes associated with bipolar I disorder. The antipsychotic effect of quetiapine is thought by some to be mediated through antagonist activity at dopamine and serotonin receptors. Specifically the D1 and D2 dopamine, the alpha 1 adrenoreceptor and alpha 2 adrenoreceptor, and 5-HT1A and 5-HT2 serotonin receptor subtypes are antagonized. Quetiapine also has an antagonistic effect on the histamine H1 receptor.

Indication

For the treatment of schizophrenia and related psychotic disorders.

Mechanism of Action

Quetiapine'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
Rapidly and well absorbed.
Distribution
* 10±4 L/kg
Metabolism
Hepatic. The major metabolic pathways are sulfoxidation, mediated by cytochrome P450 3A4 (CYP3A4), and oxidation of the terminal alcohol to a carboxylic acid. The major sulfoxide metabolite of quetiapine is inactive. Quetiapine also undergoes hydroxylation of the dibenzothiazepine ring, O-deakylation, N-dealkylation, and phase II conjugation. The 7-hydroxy and 7-hydroxy- N-delakylated metabolites appear to be active, but are present in very low concentrations.
Elimination

Toxicity

Symptoms of overdose include drowsiness and sedation, tachycardia, and hypotension.

Active Ingredient/Synonyms

2-[2-(4-Dibenzo[b,F][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol | Quetiapina | Quetiapine | Quetiapine fumarate | Quetiapine hemifumarate | Quetiapinum | Quetiapine |


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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