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NOVATRETIN CAPSULE 25MG

Product Information

Registration Status: Active

SIN15270P

NOVATRETIN CAPSULE 25MG is approved to be sold in Singapore with effective from 2017-06-13. It is marketed by APEX PHARMA MARKETING PTE LTD, with the registration number of SIN15270P.

This product contains Acitretin 25mg in the form of CAPSULE. It is approved for ORAL use.

This product is manufactured by Micro-Sphere SA in NEW ZEALAND, andDouglas Manufacturing Ltd. (Primary and Secondary Packager) in SWITZERLAND.

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

An oral retinoid effective in the treatment of psoriasis. It is the major metabolite of etretinate with the advantage of a much shorter half-life when compared with etretinate. [PubChem]

Indication

For the treatment of severe psoriasis in adults.

Mechanism of Action

The mechanism of action of acitretin is unknown, however it is believed to work by targeting specific receptors (retinoid receptors such as RXR and RAR) in the skin which help normalize the growth cycle of skin cells.

Pharmacokinetics

Absorption
Oral absorption of acitretin is optimal when given with food, and is linear and proportional with increasing doses from 25 to 100 mg. Approximately 72% (range 47% to 109%) of the administered dose was absorbed after a single 50 mg dose of acitretin was given to 12 healthy subjects.
Distribution
Metabolism
Following oral absorption, acitretin undergoes extensive metabolism and interconversion by simple isomerization to its 13-cis form (cis-acitretin). Both parent compound and isomer are further metabolized into chain-shortened breakdown products and conjugates, which are excreted.
Elimination

Toxicity

Oral, rat: LD50 = >4000 mg/kg. Symptoms of overdose include headache and vertigo.

Active Ingredient/Synonyms

(all-e)-9-(4-Methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid | Acetretin | Acitretin | Acitretina | Acitretine | Acitretinum | all-trans-3,7-Dimethyl-9-(4-methoxy-2,3,6-trimethylphenyl)-2,4,6,8-nonatetraenoic acid | Etretin | Neotigason | Acitretin |


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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