Manufacturer
ALLERGAN PHARMACEUTICALS IRELAND
Contents
Clostridium botulinum toxin type A
Indication
Blepharospasm associated w/ dystonia, including benign essential blepharospasm, hemifacial spasm, VIIth nerve disorders & strabismus correction in patients ≥12 yr. Spasmodic torticollis (cervical dystonia) in adults. Dynamic equinus foot deformity due to spasticity in paed cerebral palsy patients ≥2 yr. Management of focal spasticity including wrist & hand disability due to upper limb spasticity associated w/ stroke in adults; severe hyperhidrosis of the axillae not responding to topical treatment w/ antiperspirant or antihidrotics. Prophylaxis of headache in adults w/ chronic migraine (headaches on ≥15 days/mth of which at least 8 days are w/ migraine). Urinary incontinence due to neurogenic detrusor overactivity associated w/ multiple sclerosis or spinal cord injury in adults who had an adequate response to or intolerant of anticholinergics. Overactive bladder w/ symptoms of urinary incontinence, urgency & frequency in adults who have an inadequate response to or intolerant of anticholinergics. Temporary improvement in upper facial rhytides appearance in adults. Temporary treatment of glabellar lines associated w/ corrugator &/or procerus muscle activity in adults <65 yr.
Instruction
Blepharospasm Initially 1.25-2.5 U inj into medial & lateral orbicularis oculi of upper lid & lateral orbicularis oculi of lower lid. Initial dose: Not to exceed 25 U/eye. Total dose: Not to exceed 100 U every 12 wk. Hemifacial spasm or VIIth nerve disorders as for unilateral blepharospasm. Cumulative dose: Not to exceed 200 U in 2 mth period. Strabismus Recommended vol: 0.05-0.15 mL/muscle. 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 VIIth nerve palsy of ≥1 mth 1.25-2.5 U in medial rectus muscle. Max: 25 U as single inj for any 1 muscle. Spasmodic torticollis (cervical dystonia) 25-200 U depending on muscle group. Total dose: Not to exceed 6 U/kg every 2 mth. Equinus due to spasticity in paed cerebral palsy 4 U/kg inj into each medial & lateral heads of gastrocnemius muscle. Max: up to 200 U at any single treatment session. Focal spasticity Adult Biceps brachii: 100-200 U up to 4 sites; flexor digitorum profundus & sublimis: 15-50 U 1-2 sites; flexor carpi radialis: 15-60 U 1-2 sites; flexor carpi ulnaris: 10-50 U 1-2 sites; adductor pollicis & flexor pollicis longus: 20 U 1-2 sites. Upper facial lines (glabellar lines, Crow's feet & forehead lines) Recommended vol: 0.1 mL inj site. Glabellar lines 4 U/0.1 mL administered in each of 5 sites, 2 in each corrugator muscle & 1 in procerus muscle w/ at least 3-mth interval. Total dose: 20 U. Crow's feet 2-6 U/inj site bilaterally at 3 sites in lateral aspect of orbicularis oculi. Total dose: 6-18 U/side. Forehead lines 2-6 U/inj site IM at 4 sites in frontalis muscle. Total dose: 8-24 U. Hyperhidrosis of the axilla 50 U intradermally to each axilla, evenly distributed in multiple sites 1-2 cm apart. Chronic migraine 155-195 U IM w/ 5 U/inj/site. Inj should be divided across 7 specific head/neck muscle areas. Neurogenic detrusor overactivity 200 U inj into detrusor muscle via flexible or rigid cystoscope. Overactive bladder 100 U inj into detrusor muscle via flexible or rigid cystoscope.
Drug interaction
Potentiated effect by aminoglycosides or spectinomycin or other drugs that interfere w/ neuromuscular transmission eg, turbocuraine-type muscle relaxants. Excessive weakness may be exacerbated by administration of another botulinum toxin prior to resolution of effects of previously administered botulinum toxin.
Malaysia
