DYSPORT

IPSEN
Identification
- Active ingredient (INN)
- TOXINE BOTULINIQUE TYPE A
- Internal code
- 15 H 079
- Country of Origin
- France
- Pharmaceutical form
- Powder for Injectable Sol.
- Prescription List
- Highly Regulated (List I)
- Packaging
- b/01

DAWA Clinical Workbench v2.0
Information may not be accurate. Always consult a physician, pharmacist, or specialist before acting on any data shown here.
Description
In 2002, botulinum toxin A, also known as onabotulinumtoxinA or Botox, was the first type A botulism toxin to be introduced into the market for cosmetic use.
With a wide variety of applications and favourable safety profile, Botulinum toxin A injection is a minimally invasive and promising treatment for cosmetic imperfections, muscle spasms, and other conditions. 7, 20 A popular use for Botox is the treatment of facial wrinkles and lines, however, there are many uses for the botulinum toxin A in the treatment of dystonia, incontinence, migraine, blepharospasm, and hyperhidrosis. 15, 19.
Indications
Botulinum toxin
A is indicated for a variety of conditions, depending on the preparations.
Cosmetically, it is used for the treatment of facial fine lines and wrinkles, specifically for upper facial rhytides, including forehead, lateral canthus, and glabellar lines.
In addition to the above indications, botulinum toxin A is used for the following conditions: treatment of adults with symptomatic overactive bladder with or without incontinence, treatment of incontinence in adult patients who are not candidates for anticholinergic therapy, treatment of Neurogenic Detrusor Overactivity (NDO) in patients over 5 years who cannot undergo anticholinergic therapy.
A is indicated for the prevention of chronic migraines, for the treatment of muscle spasms, cervical dystonia, axillary hyperhidrosis, strabismus, 15 and disorders of the 7th cranial nerve.
Off-label, botulinum toxin A is used for a variety of conditions such as temporomandibular joint (TMJ) disorders and myofascial pain 12, neurogenic thoracic outlet syndrome, epicondylitis, post-stroke pain, post-herpetic neuralgia, diabetic neuropathy, trigeminal neuralgia, neuropathic pain, spinal cord injury, and bladder pain.
Pharmacodynamics
Botulinum toxin
A inhibits the release of acetylcholine, relieving muscle contraction and spasm associated with many conditions, such as incontinence and dystonia.
Cosmetically, botulinum toxin A paralyses muscles in the face to temporarily treat wrinkles. 9, 19 The maximum effects of muscle paralysis occur four to seven days after a dose.
When injected at therapeutic doses, botulinum toxin A causes partial chemical denervation of muscle tissue, causing local reduction of muscle activity.
Muscle atrophy may result, axonal sprouting may begin, and extrajunctional acetylcholine receptors can be formed.
Reinnervation of the muscle may occur, reversing muscle denervation caused by botulinum toxin A.
Absorption
The chemical complexity of botulinum toxin type A combined with its extreme potency limits the opportunity to study its pharmacokinetic profile in humans.
For this reason, human pharmacokinetic studies have not been performed.
Animal studies using radio labeled botulinum toxin suggest it is absorbed systemically after subcutaneous and intranasal administration.
Volume of Distribution
There are extremely limited data about the pharmacokinetics of botulinum toxin in humans.
An animal study demonstrated that botulinum toxin accumulates in the liver and spleen in rats and mice when injected Subcutaneous or administered intranasally.
Metabolism
information for botulinum A toxin is not readily available in the literature. 11, 15.
Route of Elimination
Elimination information for botulinum
A toxin is not readily available in the literature. 11, 15.
Half-life
There is no readily available data about the pharmacokinetics of botulinum toxin in humans.
The elimination half-life for non-metabolized botulinum toxin in blood and serum ranged from 230-260 min in a pharmacokinetic study of rats and mice.
Clearance
information for botulinum A toxin is not readily available in the literature. 11, 15.
Adverse Effects
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Toxicity
The intraperitoneal
LD50 of botulinum toxin A in mice is 160 ng/kg.
An overdose of botulinum toxin
A is expected to produce neuromuscular weakness, manifested by a variety of symptoms that may not appear immediately after injection.
Dysphagia, dysphonia, weakness, dyspnea or respiratory distress may indicate distant spread of botulinum toxin A effects.
If an overdose is suspected or confirmed, patients should be monitored for several weeks closely for local and distant neurologic effects.
Hospitalization or further medical evaluation and appropriate intervention should be provided immediately.