Dysport

Clostridium botulinum type A toxin-haemagglutinin complex

Symptomatic treatment of focal spasticity of upper limbs; lower limbs in adults affecting ankle joint due to stroke or traumatic brain injury (TBI) in adults; dynamic equinus foot deformity in ambulant & upper limbs in paed cerebral palsy patients ≥2 yr. Symptomatic treatment of spasmodic torticollis, blepharospasm, hemifacial spasm, axilliary hyperhidrosis, moderate to severe glabellar lines. Temporary improvement in appearance of moderate to severe lateral canthal lines (crow's feet lines) in adults <65 yr.

Focal spasticity of upper limb Adult 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. Inj may be repeated every 12-16 wk or as required to maintain response, but not more frequently than every 12 wk. Paed ≥2 yr Max: 16 U/kg or 640 U for unilateral upper limb; 21 U/kg or 840 U for bilateral. Concomitant treatment of upper & lower limb Total dose: 30 U/kg or 1,000 U. Lower limb spasticity affecting ankle joint Adult Doses of 1,000-1,500 U distributed among selected muscles: Soleus muscle: 300-550 U; medial & lateral gastrocnemius head: 100-450 U; tibilias posterior: 100-250 U; flexor digitorum longus, flexor digitorum brevis, flexor hallucis longus: 50-200 U; flexor hallucis 50-100 U. Focal spasticity in paed cerebral palsy patient ≥2 yr Single lower limb: 15 U/kg or 1,000 U; both lower limbs: 30 U/kg or 1,000 U; single upper limb: 16 U/kg or 640 U; both upper limbs: 21 U/kg or 840 U; upper & lower limbs: 30 U/kg or 1,000 U. Dynamic equinus foot deformity to ambulant paed cerebral palsy patient ≥2 yr Gastrocnemius: 5-15 U/kg; soleus: 4-6 U/kg; tibialis posterior: 3-5 U/kg. 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 & hemifacial spasm Adult & elderly Dose of 40 U/eye SC medially & laterally into the junction between preseptal & orbital parts of both upper & lower eye orbicularis oculi muscles. 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. IM Moderate to severe glabellar lines 50 U to be divided equally among 5 inj sites. Moderate to severe lateral canthal lines 30 U to be divided into 3 inj sites. Intradermal Axillary hyperhidrosis 100 u/axilla.

Hypersensitivity.

Allergic reactions. Not to be used to treat spasticity in patients who have developed fixed contracture. Inflammation at inj site or excessive weakness or atropy in target muscles. Dry eye; reduced tear production & blinking, corneal disorders; Patients w/ subclinical or clinical evidence of marked defective neuromuscular transmission eg, myasthenia gravis; underlying neurological disorders; preexisting swallowing or breathing problems. Monitor for swallowing, speech or resp disorders. Not to be inj to zygomaticus major/minor muscles to avoid lateral mouth drop & asymmetrical smile. Ab formation to botulinum toxin. Assess patient's facial anatomy prior to administration when treating glabellar lines. May affect ability to drive & use machines. Not recommended during pregnancy. Paed patients w/ significant neurologic debility, dysphagia or recent history of aspiration pneumonia or lung disease. Childn.

Dry mouth, exaggerated muscle weakness, dysphagia, aspiration/aspiration pneumonia, hypersensitivity, ptosis. Asthenia, flu-like illness & inj site reactions, gait disturbance, fatigue; muscular weakness, musculoskeletal pain & stiffness, pain in extremity, myalgia, neck pain; fall; urinary incontinence; rash, eyelid oedema, compensatory sweating; headache, dizziness, facial paresis; blurred vision, reduced vision acuity, diplopia increased lacrimation, eye twitching; dysphonia, dyspnoea.

Potentiated effect by drugs interfering w/ neuromuscular function eg, aminoglycosides, curare-like non-depolarising blockers, muscle relaxants.

Muscle Relaxants

M03AX01 - botulinum toxin ; Belongs to the class of other agents used as peripherally-acting muscle relaxants.

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