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BOTOX POWDER FOR SOLUTION FOR INJECTION 200 UNITS/VIAL

Product Information

Registration Status: Active

SIN14203P

BOTOX POWDER FOR SOLUTION FOR INJECTION 200 UNITS/VIAL is approved to be sold in Singapore with effective from 2012-07-27. It is marketed by ALLERGAN SINGAPORE PTE LTD, with the registration number of SIN14203P.

This product contains Botulinum Toxin Type A 200 Units in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for SUBCUTANEOUS, INTRAMUSCULAR, INTRADERMAL use.

This product is manufactured by Allergan Pharmaceuticals Ireland in IRELAND.

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

Purified botulinum toxin from Clostridium botulinum, purified from culture via dialysis and acid precipitation.

Indication

For the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia. Also for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents and for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above. Also used cosmetically to temporarily improve the appearance of moderate-to-severe frown lines between the eyebrows (glabellar lines) as well as for the treatment of excessive underarm sweating.

Mechanism of Action

Botulinum Toxin Type A blocks neuromuscular transmission by binding to acceptor sites on motor or sympathetic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings.

Pharmacokinetics

Absorption
The chemical complexity of Botulinum Toxin Type A combined with its extreme potency limits the opportunity to study its pharmacokinetic profile in humans. Therefore, no human pharmacokinetic studies have been performed. Botulinum Toxin Type A is injected directly into the target organ, a skeletal muscle. Thus, bioavailability of the intravenous or oral route is not of clinical relevance.
Distribution
Metabolism
Elimination

Toxicity

Based on toxicological studies, it has been estimated that the human LD50 by injection is approximately 2800 Units, equivalent to 28 individual vials of BOTOX (Botulinum Toxin Type A) Purified Neurotoxin Complex (100 Units) for a 70 kg adult. When injected intramuscularly, Botulinum Toxin Type A has been shown to be teratogenic or to have embryocidal effects in some animal species.

Active Ingredient/Synonyms

AbobotulinumtoxinA | BoNT/A | Bontoxilysin A | Botulinum neurotoxin type A precursor | BTX-A | IncobotulinumtoxinA | OnabotulinumtoxinA | Botulinum Toxin Type A |


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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