This brand name product contains botulinum toxin, which belongs to the assortment of muscle relaxants with a peripheral action mechanism. It has the force to block the release of acetylcholine in peripheral presynaptic cholinergic nerve endings because it can cleave SNAP-25. After the injection in the dermal tissue, the toxin rapidly absorbed through the cell surface receptors. Then the toxin transmits further through the membrane plasma due to receptors. After that, the toxin released into the cytosol, and in the process, the release of acetylcholine gradually slowed down. The clinical effect of Botox appears on the second or third day. The best effect can be reached after five to six weeks after the treatment session. The recovery process after the injection takes up to 13 weeks since the nerve endings grow and restore communication with the final plate. The visible effect after the injection (50 units —Allergan) in the armpits can last 8-12 months or more (in 30% of patients).
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The units of Allergan product (Botox) are different from the units of other botulinum-toxin-based facial drugs. They are not interchangeable with other similar products, which contain botulinum toxin. Using botulinum toxin—А in elderly patients Special dose correction is not required when performing a treatment on elderly patients. The primary dose of the brand name product should be the minimum recommended dose for a particular indication. For repeated injections, the lowest effective dose is recommended with a wider time interval between injections. Use with prudence in elderly patients and clients, who take concomitant medications. Botox should only be diluted with sterile physiological saline without preservatives (0.9% Sodium Chloride for Injection). With caution, inject into a wrinkle zone, especially in the area of “crow’s feet” to avoid getting into the blood vessels.
If, after the first course of treatments sessions during the 1st month after the injections, there is no significant clinical improvement, compared with the prior condition, the following steps should be taken:
In the case of ineffective treatment or reduction of the effect after the next repeated injections, other treatments should be used.
The injection of the Botox drug may cause side effects such as:
In the case of unusual side effects, the patient should immediately contact the doctor about possible changes in the treatment sessions.
Forbidden concurrent use with antibiotics, aminoglycosides, macrolides, tetracyclines, polymyxins is contraindicated since they enhance the effect of botulinum toxin.
The conducting of the treatment session with this drug possible no earlier than three months after surgery on the face. It is used in pediatrics for patients from 12 years old, except children, suffering from cerebral palsy – in this case, the drug is acceptable for children from 2 years old.
Active substance: botulinum toxin type-A (from Clostridium botulinum) 1 bottle contains botulinum toxin type-A (from Clostridium botulinum) 100 or 200 units-Allergan; excipients: human albumin, sodium chloride.
Do not use together with aminoglycoside antibiotics or spectinomycin, or other drugs, which prevent neuromuscular transmission (for example, with neuromuscular blockers).
The effect of using different serological types of botulinum neurotoxin simultaneously or with intervals of several months is unknown. Excessive neuromuscular weakness may be aggravated by the use of another botulinum toxin prior to the expiry of the pre-applied botulinum toxin. No interaction study was conducted. No clinically important interactions were reported.
The clinical effect of the drug appears on the 2nd or 3d day. The maximum effect can be visible after 5 to 6 weeks after the treatment session. Clinical data show that the Botox reduces discomfort and neurogenic inflammation, as well as increases the threshold of pain sensitivity of the skin to heat, in the study of triple sensitization caused by capsaicin. The recovery process after the injections take up to 12 weeks because the nerve endings grow and restore communication with the final plate. After subcutaneous injection in order to reach axillary sweat glands, in patients who received an injection of 50 units—Allergen in each armpit, the effect after the first injection lasts in average 7.5 months. However, in 27.5% of patients, the effect observes for 1 year or more. The recovery of sympathetic nerve endings innervating the sweat glands was not studied after the injection of the drug. Restoration of sympathetic nerve endings, which innervate sweat glands after subcutaneous injection of the drug has not been studied. Due to an internal injection into a detrusor, the Botox drug acts on the efferent pathways of detrusor activity restraining the release of acetylcholine. Also, Botox can restrain afferent neurotransmitters and sensory pathways.
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Units of Botox are not interchangeable with other brands of botulinum—toxin products. Doses, recommended in units of Allergan are different from doses of another similar product, which contain botulinum—toxin drug. Special safety measures should be taken during the preparation and injecting of the drug, as well as during inactivation and disposal of the unused solution. The recommended dose and frequency of injecting of Botox must be not exceeded, as it is a risk of overdose, excessive muscle weakness, the spread of the toxin further from the treated site and the formation of neutralizing antibodies. As with any injection, injuries may occur that are directly related to the procedure itself. The injection can cause localized infection, inflammation, paresthesia, pain, hypoesthesia, soreness, swelling, erythema and/or bleeding/bruising. Pain caused by a needle or fear can lead to such reactions as fainting, hypotension. Botox should be used with caution when treating patients with lesions of peripheral motor neurons (for example, with amyotrophic lateral sclerosis or motor neuropathy). The appearance of antibodies, which neutralize botulinum toxin type A may reduce the effectiveness of Botox treatment through inactivation of the biological activity of the toxin.
The shelf life is no more than 3 years from the production date, indicated on the package, at the temperature not lower than 2°C and not higher than 8°C. Also, the drug can store in the freezer at temperatures below -5 °C. Reconstituted Botox should store in a refrigerator (2° to 8°C) no more than 4 hours.