Dysport

Dysport

Manufacturer:

Ipsen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Clostridium botulinum type A toxin-haemagglutinin complex
Indications/Uses
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 the appearance of moderate to severe glabellar & lateral canthal lines in adult <65 yr.
Dosage/Direction for Use
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. 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. Paed cerebral palsy patient ≥2 yr Max total dose/treatment session: Single lower limb: 15 u/kg, both lower limbs: 30 u/kg no sooner than 12 wk; single upper limb: 16 u/kg, both upper limbs: 21 u/kg no sooner than 16 wk; upper & lower limbs: 30 u/kg no sooner than 12-16 wk. Upper limb focal spasticity Paed cerebral palsy patient ≥2 yr 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 a single upper limb (Max: 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 a 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 a single lower or 30 u/kg if both lower limbs injected, Max: 1000 u. Spasmodic torticollis Adult & elderly Initially 500 u as divided dose & administered to the 2-3 most active neck muscles. Rotational torticollis Administer 350 u into the ipsilateral splenius capitis muscle & 150 u into the sternomastoid muscle. Laterocollis Administer 350 u into the ipsilateral splenius capitis muscle & 150 u into the ipsilateral sternomastoid muscle. Retrocollis Administer 250 u into each splenius capitis muscles. SC Blepharospasm & hemifacial spasm Adult & elderly Dose of 40 u/eye. Max: 120 u/eye. Inj repeated approx every 12 wk or as required. IM Moderate to severe glabellar lines 50 u (0.25 mL of reconstituted soln) divided into 5 inj sites, 10 u (0.05 mL of reconstituted soln) are to be administered into each of the 5 sites (2 inj into each corrugator muscle & 1 into the procerus muscle near the nasofrontal angle). Moderate to severe lateral canthal lines 30 u/side divided into 3 inj site, 10 u (0.05 mL of reconstituted soln) administered into each inj point. 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.
Contraindications
Special Precautions
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 adults especially elderly w/ focal spasticity being treated. Patients w/ disorder resulting in defective neuromuscular transmission, difficulty in swallowing or breathing. Preexisting swallowing or breathing problems. Do not exceed recommended dosage & frequency of administration. Do not use to treat spasticity in patients who developed a fixed contracture. Patients w/ prolonged bleeding time, infection or inflammation at proposed inj site. 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. Previous allergic reaction to a product containing botulinum toxin type A. 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.
Adverse Reactions
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, musculokeletal stiffness; diplopia, dry eye, increased lacrimation; eyelid oedema; asthenopia, eyelid ptosis, muscle twitching; paraesthesias, involuntary muscle contractions of the eyelid; compensatory sweating; pain in the shoulder, upper arm & neck, myalgia of the shoulder & calf.
Drug Interactions
Effects may be potentiated by drugs interfering either directly or indirectly w/ neuromuscular function (eg, aminoglycosides, curare-like non-depolarising blockers, muscle relaxants).
MIMS Class
Muscle Relaxants
ATC Classification
M03AX01 - botulinum toxin ; Belongs to the class of other agents used as peripherally-acting muscle relaxants.
Presentation/Packing
Form
Dysport powd for inj 300 u
Packing/Price
1's
Form
Dysport powd for inj 500 u
Packing/Price
1's
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