Botulinum toxin (Botox)

Regulated restrictive practice · chemical restraint reference

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Botulinum toxin (Botox) · RP Check

§01

↗TGA PIT1✓

TGA-approved indications

treatment of overactive bladder with symptoms of urinary incontinence, urgency and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication
treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from a defined neurological illness (such as spinal cord injury or multiple sclerosis) in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication
prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine)
treatment of strabismus in patients twelve years and over
treatment of blepharospasm associated with dystonia, including benign blepharospasm and VIIth nerve disorders (specifically hemifacial spasm) in patients twelve years and over
treatment of cervical dystonia (spasmodic torticollis)
treatment of focal spasticity of the upper and lower limbs, including dynamic equinus foot deformity, due to juvenile cerebral palsy in patients two years and older
treatment of severe primary hyperhidrosis of the axillae
treatment of focal spasticity in adults
treatment of spasmodic dysphonia
temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow's feet and forehead lines) in adults
temporary improvement in the appearance of platysma continuous bands in healthy adults

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Adverse effects

Common (top 5)

↗TGA PIT1✓

Urinary tract infection
Headache
Neck pain
Dysuria
Muscular weakness

Serious

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↗TGA PIT1✓

Contraindications

botulinum toxin (botulinum toxin type A) purified neurotoxin complex is contraindicated in individuals with known hypersensitivity to any ingredient in the formulation.
botulinum toxin is contraindicated in patients with myasthenia gravis or Eaton Lambert Syndrome.
botulinum toxin is contraindicated in the presence of infection at the proposed injection site(s).
Intradetrusor injection of botulinum toxin ® is contraindicated in patients who have a urinary tract infection and in patients with acute urinary retention who are not routinely catheterising.
Due to the risk of urinary retention, intradetrusor injection of botulinum toxin ® is also contraindicated in patients who are not willing and/or able to initiate catheterisation post- treatment, if required

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Mechanism & pharmacology

“Clostridium botulinum type A neurotoxin blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the docking and release of acetylcholine from vesicles located within the nerve terminals.”
↗TGA PIT1✓

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Brand names in Australia

Botulinum toxin is marketed in Australia as Botox.

1 brand name is recorded against this substance from the TGA eBS Product Information repository. The full list is in the Also known as card.