Dysport

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

IM Focal spasticity Adult Upper limb: Doses of 500-1,000 u divided among selected muscles: Flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis, flexor pollicis longus, brachioradialis, pronator teres: 100-200 u; adductor pollicis: 25-50 u; brachialis, biceps brachii: 200-400 u; triceps brachii, pectoralis major, subscapularis, latissimus dorsi: 150-300 u. Max total dose: 1,000 u. Lower limb: Doses of 1,000-1,500 u divided among selected muscles: Soleus muscle: 300-550 u; gastrocnemius (medial & lateral head): 100-450 u; tibialis posterior: 100-250 u; flexor digitorum longus, flexor digitorum brevis, flexor halluces longus: 50-200 u; flexor hallucis brevis: 50-100 u. Max total dose: 1,500 u. Paed cerebral palsy patient ≥2 yr Max total dose/treatment session: Single lower limb: 15 u/kg or 1,000 u, both lower limbs: 30 u/kg or 1,000 u no sooner than 12 wk; single upper limb: 16 u/kg or 640 u, both upper limbs: 21 u/kg or 840 u no sooner than 16 wk; upper & lower limbs: 30 u/kg or 1,000 u no sooner than 12-16 wk. Upper limb focal spasticity Paed cerebral palsy patient ≥2 yr Recommended dose range/muscle/upper limb: Brachialis, biceps brachii: 3-6 u/kg; brachioradialis, flexor carpi ulnaris, flexor digitorum superficialis: 1.5-3 u/kg; pronator teres, flexor digitorum profundus, flexor pollicis longus: 1-2 u/kg; pronator quadratus, flexor pollicis brevis/opponens pollicis, adductor pollicis, pectoralis major: 0.5-1 u/kg; flexor carpi radialis: 2-4 u/kg. Total dose: Up to 16 u/kg or 640 u in single upper limb. Max total dose: 21 u/kg or 840 u if both upper limbs injected. Upper & lower limb focal spasticity Paed cerebral palsy patient ≥2 yr Max total dose/treatment session: 30 u/kg or 1,000 u. Consider retreatment no sooner than 12-16 wk. Dynamic equinus foot deformity due to focal spasticity Paed cerebral palsy patient ≥2 yr (ambulant) Recommended dose range/muscle/leg: Gastrocnemius: 5-15 u/kg; soleus: 4-6 u/kg; tibialis posterior: 3-5 u/kg. Total dose: Up to 15 u/kg in single lower or 30 u/kg if both lower limbs injected, Max total dose: 1,000 u. Spasmodic torticollis Adult & elderly Initially 500 u as divided dose & administered to 2-3 most active neck muscles. Rotational torticollis Administer 350 u into ipsilateral splenius capitis muscle & 150 u into sternomastoid muscle. Laterocollis Administer 350 u into ipsilateral splenius capitis muscle & 150 u into ipsilateral sternomastoid muscle. Retrocollis Administer 250 u into each splenius capitis muscles. Moderate to severe glabellar lines 50 u (0.25 mL of reconstituted soln) divided into 5 inj sites, administer 10 u (0.05 mL of reconstituted soln) into each of the 5 sites (2 inj into each corrugator muscle & 1 into procerus muscle near nasofrontal angle). Moderate to severe lateral canthal lines 30 u/side divided into 3 inj sites, administer 10 u (0.05 mL of reconstituted soln) into each inj point. SC Blepharospasm & hemifacial spasm Adult & elderly 40 u/eye. Max total dose: 120 u/eye. Inj repeated approx every 12 wk or as required. Intradermal Axillary hyperhidrosis Initially 100 u/axilla (armpit), up to 200 u/axilla may be administered in subsequent inj. Max: 200 u/axilla. Intradermal inj should be administered in 10 sites each receiving 10 u to deliver 100 u/armpit. Inj should not be repeated more frequently than every 12 wk.

Hypersensitivity.

Previous allergic reaction to a product containing botulinum toxin type A. Patients treated w/ therapeutic doses may present w/ excessive muscle weakness. Closely supervise patients w/ subclinical or clinical evidence of marked defective neuromuscular transmission (eg, myasthenia gravis). Increased risk of fall in adult patients especially elderly w/ focal spasticity affecting lower limbs. Possible dry eye; reduced tear production, blinking & corneal disorders may occur. Patients w/ disorder resulting in defective neuromuscular transmission, difficulty in swallowing or breathing. Patients w/ pre-existing swallowing or breathing problems. Do not exceed recommended posology & frequency of administration. Not to be used to treat spasticity in patients who developed fixed contracture. Patients w/ prolonged bleeding time, infection or inflammation at proposed inj site. Excessive weakness or atrophy in targeted muscle. Should only be used to treat a single patient during a single session. Possible Ab formation to botulinum toxin. Study patient's facial anatomy prior to administration when treating glabellar lines. Potential risk of muscle weakness or visual disturbances may temporarily impair the ability to drive or operate machinery. Pregnancy. Not recommended during lactation. Childn <2 yr. Ped patients who have significant neurologic debility, dysphagia or recent history of aspiration pneumonia or lung disease.

Dysphagia, dry mouth; muscle weakness; ptosis; headache; inj site reactions (eg, erythema, oedema, irritation, rash, pruritus, paraesthesia, pain, discomfort, stinging & haematoma). Asthenia, fatigue, flu-like illness, inj site bruising; musculoskeletal pain, pain in extremity; myalgia; fall; urinary incontinence; gait disturbance, fatigue; rash; dizziness, facial paresis; blurred vision, reduced visual acuity; dysphonia, dyspnoea; neck pain, musculoskeletal stiffness; diplopia, dry eye, increased lacrimation; eyelid oedema; asthenopia, eyelid ptosis, muscle twitching; paraesthesias, involuntary muscle contractions of eyelid; compensatory sweating; shoulder, upper arm & neck pain, shoulder & calf myalgia.

Effects may be potentiated by drugs interfering either directly or indirectly 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.

POM