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Botulinum Toxin Type A Biopharmaceutic, Neuronox, was approved and launched for the Korean market in 2006. It is widely used not only in the cosmetic field, including facial wrinkle reduction, but also in the therapeutic field, for people with cervical dystonia, cerebral palsy, etc. It is registered in 23 countries and in the process of registration in other 25 countries. Its efficacy and duration has been proved to be equivalent to its competitors'. Neuronox® is being sold under different brand names as Siax, Botulift, Cunox, and Meditoxin, and consists of 50, 100 and 200 unit for various usage.
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Composition
Neuronox comes in dosage units of 50, 100 and 200. Each vial contains the active ingredient, Clostridium botulinum toxin type A 50 units (U), Stabilizer: Human serum albumin 0.25mg and Sodium chloride (EP) 0.45mg.
Applications/Indications
Not just cosmetic Botox, Neuronox also has therapeutic applications, Neuronox is used for the treatment of benign essential blepharspasm in patients 18 years of age and above. For the treatment of equinus foot deformity due to spasticity in pediatric cerebral palsy patients 2 years of age and above. And as many know Botox, for temporary improvement of serious glabellar wrinkles ranging from moderate to severe associated with corrugators muscle and/or procerus muscle activities in adults over the age of 18 and below the age of 65. The vials are generally stored in a freezer or refrigerator and they retain a shelf life of 24 months.
Dosages
For blepharospasm the initial recommended dose is 1.25 - 2.5 U (0.05 mL to 0.1 mL volume at each site) injected into the medial and lateral pre-tarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid. For pediatric cerebral palsy, a total dose of 4U/kg bodyweight is recommended for the affected gastrocnemius muscle in patients with hemiplegia. And in patients with diplegia, the recommended dose is 6U/kg bodyweight divided between both legs. The maximum dose administered must not exceed 200U/patient at a time. For Glabellar wrinkles reconstituted sterile saline. 20U is used and there are additional application instructions for best practice, actual amounts vary on the presentation of the client.
Effects
In Blepharospasm, the effects should appear within three days and peak after three weeks. For pediatric cerebral palsy applications, the expectation is improvement within four weeks of the injection. The effects vary for glabellar wrinkles due to the usually individualized dosages.
Precautions
There is the possibility of reactions at the site of an injection, and effects beyond the injection site, including but not limited to asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. Serious hypersensitivity has been reported as rare. There is a caution for people with pre-existing neuromuscular disorders, and for those with corneal exposure and ulceration in blepharospasm. Neuronox is not to be administered at all if a patient has a known allergy to any of the ingredients, or if the patients have neuromuscular junctional disorders or known to have adverse reactions. They should not be administered while taking muscle relaxants and some antibiotics. Further, the actual effects of prolonged use are not entirely explored. There is also additional advice for the specific therapeutic conditions mentioned, as this dex-x-x-scription is not comprehensive.
In the case of overdose
In the case of an overdose it has been advised that effects may not be immediate. It is further advised that the patient be monitored for muscle weakness and/or paralysis for a period of weeks after the occurrence. There is an anti-toxin available but the caution with the anti-toxin is that it will not reduce any already apparent effects.
Neuronox is registered in 23 countries with pending registrations in a further 25 countries. The Botulinum toxin is also sold under the brand names Siax, Botulift, Cunox, and Meditoxin. Additional to the botulinum toxin, Medytox has developed a toxin detection system and is working to create neutralizing antibodies for botulinum and anthrax toxins. They have already developed an anti-serum for neutralizing botulinum toxins in animal studies and are humanizing the findings via antibody engineering techniques. In 2012 Medytox also reports launching a new cosmetic filler to complement its core business of botulinum toxin, hyaluronic acid filler. The launch of the product arrives at the end of the clinical trials so that again Medytox can provide advanced knowledge to customers and patients.
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