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Manufacturer |
Allergan |
Distributor |
Hong Kong: DKSH/Macau: The Glory Medicina |
Contents |
Clostridium botulinum toxin type A |
Indications |
Treatment of strabismus & blepharospasm associated w/ dystonia, including benign essential blepharospasm or VII nerve disorders in patients ≥12 yr. Reduction of subjective symptoms & objective signs of spasmodic torticollis (cervical dystonia) in adults. Dynamic equinus foot deformity due to spasticity in juvenile cerebral palsy patients ≥2 yr. Severe primary hyperhidrosis of the axilla. Temporary improvement of upper facial rhytides (glabellar lines, crow's feet & forehead lines). Treatment of wrist and hand disability due to upper limb spasticity associated w/ stroke in adults. Prophylaxis of headache in adult w/ chronic migraine.
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Dosage |
Strabismus Vertical muscles & horizontal strabismus of <20 prism diopters: 1.25-2.5 u in any 1 muscle. Horizontal strabismus of 20-50 prism diopters: 2.5-5 u in any 1 muscle. Persistent VII nerve palsy of ≥1 mth: 1.25-2.5 u in the medial rectus muscle. Max: 25 u as single inj for any 1 muscle. Blepharospasm Initially, inj 1.25-2.5 u into the medial & lateral pre-tarsal orbicularis oculi of the upper lid & into the lateral pre-tarsal orbicularis oculi of the lower lid. Max: <200 u/2 mth. VII nerve disorders As for unilateral blepharospasm. Max: <200 u/2 mth. Cervical dystonia 95-360 u. Initial dosing should begin at lowest effective dose. Max: 360 u/2 mth. Spasticity due to juvenile cerebral palsy 4 u/kg into each medial & lateral heads of the gastrocnemius muscle. Primary hyperhidrosis of the axillae 50 u intradermally to each axilla, evenly distributed in multiple sites 1-2 cm apart. Glabellar lines 4 u administered in each of 5 inj sites, 2 in each corrugator muscle & 1 in procerus muscle. Total dose: 20 u. Crow's feet 2-6 u administered bilaterally in 3 sites in the lateral aspect of the orbicularis oculi. Total dose: 6-18 u. Forehead lines 2-6 u administered in 4 sites in the frontalis muscle. Total dose: 8-24 u. Focal spasticity associated w/ stroke Flexor digitorum profundus, flexor digitorum sublimis, flexor carpi radialis, flexor carpi ulnaris: 50 u; adductor pollicis, flexor pollicis longus: 20 u. Prophylaxis of headache in adult with chronic migraine 5 u administered in 31-39 sites. Total dose: 155-195 u.
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Overdosage |
View Botox overdosage for action to be taken in the event of an overdose. |
Contraindications |
Myasthenia gravis or Eaton-Lambert syndrome, infection at proposed inj site.
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Warnings |
For additional cautionary notes to warn of the potential risk of using the medicine... click to view Botox detailed prescribing infomation |
Special Precautions |
Amyotrophic lateral sclerosis, disorders causing acetylcholine depletion at the neuromuscular junction, sedentary patients, inflammation at proposed inj site, excessive weakness in the target muscles, patient at risk of angle-closure glaucoma, lack of interchangeability between botulinum toxin products & spread of toxin effect. Pregnancy, lactation.
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Adverse Drug Reactions |
Localized pain, tenderness &/or bruising. Rarely skin rash (including erythema multiforme, urticaria & psoriasiform eruption), pruritus, allergic reaction.
View ADR Monitoring Form |
Drug Interactions |
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Pregnancy Category (US FDA) |
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. |
Caution For Usage |
For caution against possible variation of physical aspect of medicine... click to view Botox detailed prescribing infomation |
Storage |
View Botox storage conditions for details to ensure optimal shelf-life. |
Description |
View Botox description for details of the chemical structure and excipients (inactive components). |
Mechanism of Action |
View Botox mechanism of action for pharmacodynamics and pharmacokinetics details. |