BOTOX (Allegran Inc) - General Information
Purified botulinum toxin from Clostridium botulinum, purified from culture via dialysis and acid precipitation.
Pharmacology of BOTOX (Allegran Inc)
A 150 kDa neurotoxic protein produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose and yeast extract. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. BOTOX (Allegran Inc) is not expected to be present in the peripheral blood at measurable levels following IM or intradermal injection at the recommended doses. The recommended quantities of neurotoxin administered at each treatment session are not expected to result in systemic, overt distant clinical effects, i.e. muscle weakness, in patients without other neuromuscular dysfunction. However, sub-clinical systemic effects have been shown by single-fiber electromyography after IM doses of botulinum toxins appropriate to produce clinically observable local muscle weakness.
BOTOX (Allegran Inc) for patients
BOTOX (Allegran Inc) Interactions
Co-administration of BOTOX® and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.
The effect of administering different botulinum neurotoxin serotypes at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
BOTOX (Allegran Inc) Contraindications
BOTOX® is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any BOTOX® ingredient in the formulation.
Additional information about BOTOX (Allegran Inc)
BOTOX (Allegran Inc) 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: BOTOX (Allegran Inc) 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.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Botulinum Toxin Type A
Synonyms: BoNT/A; Bontoxilysin A; Botulinum neurotoxin type A precursor; BTX-A
Drug Category: Anti-Wrinkle Agents; Antidystonic Agents; Neuromuscular Blocking Agents
Drug Type: Biotech; Approved; Investigational
Other Brand Names containing Botulinum Toxin Type A: BOTOX (Allegran Inc); Dysport; BOTOX Cosmetic (Allegran Inc);
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.
Toxicity (Overdose): 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.
Protein Binding: Not Available
Biotransformation: Not Available
Half Life: Not Available
Dosage Forms of BOTOX (Allegran Inc): Powder, for solution Intramuscular
Chemical IUPAC Name: Not Available
Chemical Formula: C6760H10447N1743O2010S32
Botulinum Toxin Type A on Wikipedia: http://en.wikipedia.org/wiki/Botox
Organisms Affected: Humans and other mammals