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SYNMETHASONE TABLET 0.5mg

Product Information

Registration Status: Active

SIN04254P

SYNMETHASONE TABLET 0.5mg is approved to be sold in Singapore with effective from 1990-04-23. It is marketed by SINGAPORE PHARMACEUTICAL PTE LTD, with the registration number of SIN04254P.

This product contains Betamethasone 0.5mg in the form of TABLET. It is approved for ORAL use.

This product is manufactured by SYNCO (HK) LTD in HONGKONG, and in CHINA.

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

A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724)

Indication

Topical use (cream, lotion and ointment): for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical use (foam): relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp. Systemic use: for the treatment of edocrine disorders, rheumatic disorders, collagen diseases, dermatological diseases, allergic states, ophthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, gastrointestinal diseases, tuberculous meningitis and trichinosis.

Mechanism of Action

Betamethasone is a glucocorticoid receptor agonist. This leads to changes in genetic expression once this complex binds to the GRE. The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding. Betamethasone binds to plasma transcortin, and it becomes active when it is not bound to transcortin.

Pharmacokinetics

Absorption
Minimal if applied topically.
Distribution
Metabolism
Hepatic
Elimination

Toxicity

Symptoms of overdose include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Active Ingredient/Synonyms

16beta-Methyl-1,4-pregnadiene-9alpha-fluoro-11beta,17alpha,21-triol-3,20-dione | 16β-Methyl-1,4-pregnadiene-9α-fluoro-11β,17α,21-triol-3,20-dione | 9-Fluoro-16beta-methylprednisolone | 9-Fluoro-16β-methylprednisolone | 9alpha-Fluoro-16beta-methylprednisolone | 9α-Fluoro-16β-methylprednisolone | beta-Methasone alcohol | Betadexamethasone | Betametasona | Betamethasone | Betamethasonum | Betamethasonvalerat Mikron | Rinderon | Betamethasone |


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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