Ipsen Pharma


Zuellig Pharma


EP Plus Group
Concise Prescribing Info
Clostridium botulinum type A toxin-haemagglutinin complex
Symptomatic treatment of focal spasticity of upper limbs in adults & dynamic equinus foot deformity in ambulant paed cerebral palsy patients, blepharospasm, hemifacial spasm, spasmodic torticollis, axillary hyperhidrosis & moderate to severe glabellar lines in adults.
Dosage/Direction for Use
Arm spasticity Doses of 500-1,000 U distributed among selected muscles: FCR, FCU, FDP, FDS, flexor pollicis longus, brachioradialis, pronator teres: 100-200 U each; adductor pollicis: 25-50 U; brachialis, biceps brachii: 200-400 U each; triceps brachii, pectoralis major, subscapularis, latissimus dorsi: 150-300 U each. Spasmodic torticollis Adult & elderly Initially 500 U in divided doses & administered to 2-3 most active neck muscles. Rotational torticollis Administer 350 U into splenius capitis muscle & 150 U into sternomastoid muscle. Laterocollis 350 U into ipsilateral splenius capitis muscle & 150 U into ipsilateral sternomastoid muscle. Retrocollis 250 U into each of the splenius capitis muscle. Blepharospasm Adult & elderly Dose of 40 U/eye. In subsequent administration, may be increased to 60, 80 or up to 120 U/eye. Paed cerebral palsy spasticity Max dose/treatment: Unilateral lower limb inj: 15 U/kg, bilateral lower limb inj: 30 U/kg. Total dose administered should be divided between the affected spastic lower limb muscle. Axillary hyperhydrosis 100 U/axilla. Glabellar lines Adult & elderly 50 U IM to be divided equally among 5 inj sites.
Hypersensitivity. Pregnancy & lactation.
Special Precautions
Previous allergic reaction to botulinum toxin type A-containing product. Subclinical or clinical evidence of marked defective neuromuscular transmission. Patients w/ underlying neurological disorders eg, swallowing difficulties; history of dysphagia & aspiration. Childn <2 yr.
Adverse Reactions
Inj site reactions, ptosis, dysphagia; weakness of adjacent muscle to area of inj, eye & eyelid oedema, compensatory sweating, diplopia, dry eyes, tearing, arm, facial, leg & neck muscle weakness, dysphonia, accidental injury, abnormal gait, urinary incontinence, diarrhoea, vomiting, generalized weakness, fatigue, flu-like syndrome, pain/bruising at inj site.
Drug Interactions
Drugs affecting neuromuscular transmission eg, aminoglycosides.
MIMS Class
Muscle Relaxants / Other Eye Preparations
ATC Classification
M03AX01 - botulinum toxin ; Belongs to the class of other agents used as peripherally-acting muscle relaxants.
Dysport inj 300 U
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