Botox

Botox

Manufacturer:

Allergan

Distributor:

DKSH
Concise Prescribing Info
Contents
Clostridium botulinum toxin type A
Indications/Uses
Blepharospasm associated w/ dystonia, including benign essential blepharospasm, hemifacial spasm or 7th nerve disorders & correction of strabismus in patients ≥12 yr. Spasmodic torticollis (cervical dystonia) in adults. Dynamic equinus foot deformity due to spasticity in paed cerebral palsy patients ≥2 yr. Temporary treatment of glabellar lines associated w/ corrugator &/or procerus muscle activity in adult patients <65 yr. Management of focal spasticity, including the treatment of spasticity associated w/ stroke in adults. Focal hyperhidrosis of the axilla. Temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow's feet & forehead lines) in adults. Prophylaxis of headaches in adults w/ chronic migraine. Bladder dysfunction: Urinary incontinence due to neurogenic detrusor overactivity eg, spinal cord injury (SCI) or multiple sclerosis (MS) in adults, & overactive bladder w/ symptoms of urinary incontinence, urgency & frequency in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Dosage/Direction for Use
Blepharospasm Initially 1.25-2.5 U (0.05-0.1 mL at each site) inj into the medial & lateral orbicularis oculi of the upper lid & into the lateral orbicularis oculi of the lower lid. Initial dose: ≤25 U/eye. Additional sites in the brow area, lateral orbicularis & upper facial area may be injected if spasms interfere w/ vision. May repeat procedure & increase dose up to 2-fold if effect does not last for >2 mth. Cumulative dose in a 2-mth period: ≤200 U. Hemifacial spasm or cranial 7th nerve disorders Treated as for unilateral blepharospasm. Cumulative dose in a 2-mth period: ≤200 U. Strabismus Give several drops of local anesth & an ocular decongestant several min prior to inj is recommended. Recommended vol: 0.05-0.15 mL/muscle. For vertical muscles & horizontal strabismus of <20 prism diopters: 1.25-2.5 U (0.05-0.10 mL) in any one muscle. For horizontal strabismus of 20-50 prism diopters: 2.5-5 U (0.10-0.2 mL) in any one muscle. For paralysis of the external cranial persistent 6th nerve of ≥1 mth: 1.25-2.5 U (0.05-0.10 mL) in medial rectus muscle. Residual or recurrent strabismus: Patients re-examined 7-14 days after each inj to assess the effect of dose. May increase dose up to 2-folds. Max: 25 U/muscle as a single inj. Spasmodic torticollis (cervical dystonia) Dosing based on patient's head & neck position, localization of pain, muscle hypertrophy, body wt & response. Usual range: 95-360 U (w/ an approx mean of 240 U). No >50 U should be given at any one site. Max cumulative dose: Not exceeding 360 U in a 3-mth interval. Ped cerebral palsy 4 U/kg into the medial & lateral heads of gastrocnemius muscle of affected lower limb(s). Repeat doses when the clinical effect of a previous inj diminishes but not more frequently than every 3 mth. Max: 200 U at any single treatment session. Glabellar lines 4 U/0.1 mL in each of 5 sites, 2 inj in each corrugator muscle & 1 inj in the procerus muscle for a total dose of 20 U w/ treatment intervals of not more frequent than every 3 mth. Inj in the medial corrugator muscle as well as central eyebrow inj should be placed at least 1 cm above the bony supraorbital ridge. Crow's feet 4 U/0.1 mL at 3 sites per side (6 total inj points) in the lateral orbicularis oculi muscle for a total of 24 U/0.6 mL (12 U per side). 1st inj should be made at approx 1.5-2 cm temporal to the lateral canthus and just temporal to the orbital rim. Total dose: 24 U. Forehead lines 2-6 U/inj site by IM inj at 4 sites in frontalis muscle every 1-2 cm along either side of a deep forehead crease, 2-3 cm above the eyebrow. Total dose: Up to 24 U. Focal spasticity Individualized dosage. Upper limb spasticity associated w/ stroke Adult Biceps brachii: 100-200 U, 1-4 sites. Flexor digitorum profundus: 15-50 U, 1-2 sites. Flexor digitorum 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. Hyperhidrosis of the axilla Initially 50 U/axilla by intradermal inj, in multiple sites (10-15) approx 1-2 cm apart w/in the hyperhidrotic area. Should not be repeated more frequently than every 2 mth. Chronic migraine 155-195 U by IM inj. Re-treatment every 12 wk. Frontalis: 20 U, 4 sites. Corrugator: 10 U, 2 sites. Procerus: 5 U, 1 site. Occipitalis: 30 U, 6 sites, up to 40 U, 8 sites. Temporalis: 40 U, 8 sites up to 50 U, up to 10 sites. Trapezius: 30 U, 6 sites up to 50 U, up to 10 sites. Cervical Paraspinal Muscle Group: 20 U, 4 sites. Total dose: 155-195 U. Neurogenic detrusor overactivity 200 U inj w/ a flexible or rigid cystoscope approx 2 mm into the detrusor muscle 30 inj of 1 mL each. Should be spaced approx 1 cm apart, avoiding the trigone. Consider re-inj when clinical effect from previous inj diminished but no sooner than 3 mth prior to bladder inj. Overactive bladder 100 U/10 mL inj approx 2 mm into detrusor muscle via flexible or rigid cystoscope & 20 inj of each 0.5 mL (total vol of 10 mL) should be spaced approx 1 cm apart. Re-inj when clinical effect of the previous inj diminished, but not sooner than 3 mth from the prior bladder inj.
Contraindications
Hypersensitivity. Presence of infection at the proposed inj site. Bladder dysfunction: Patients w/ UTI & acute urinary retention not routinely performing clean intermittent self-catheterization (CIC).
Special Precautions
Caution when inj in or near vulnerable anatomic structures, or in proximity to the lung, particularly the apices. Presence of inflammation at inj site, weakness or atrophy is present in target muscle. Anaphylaxis & serum sickness. Preexisting neurologic disorders, peripheral motor neuropathic diseases (eg, amyotrophic lateral sclerosis or motor neuropathy) or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome). Swallowing, speech or resp disorders may arise. Preexisting CV disease. Cerebral palsy; seizures. Immunogenicity. Extremely remote risk for transmission of viral diseases. Corneal exposure, persistent epithelial defects & corneal ulceration especially in patients w/ 7th nerve disorders. Careful testing of corneal sensation in eyes previously operated; avoid inj into the lower medial lid area. Patients at risk for angle closure glaucoma including w/ anatomically narrow angles. Use ophthalmoscope to diagnose retrobulbar hemorrhages in treatment of strabismus. Dysphagia may occur in patients w/ smaller neck muscle mass or require bilateral inj. Do not use for focal lower limb spasticity in adult post-stroke patients if muscle tone reduction is not expected to result in improved function (eg, improvement in gait) or improved symptoms (eg, reduction in pain); patients w/ post-stroke spasticity. Ped patients w/ significant neurologic debility, dysphagia, or have recent history of aspiration pneumonia or lung disease. Evaluate for potential causes of secondary hyperhidrosis (eg, hyperthyroidism, pheochromocytoma). Patient w/ inflammation at the inj site, marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or the inability to substantially lessen glabellar lines by physically spreading them apart. Carefully perform cystoscopy; autonomic dysreflexia. Assess post-void residual urine vol w/in 2 wk post-treatment & periodically as medically appropriate up to 12 wk. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn. Elderly (post-stroke patients w/ significant co-morbidity & treatment).
Adverse Reactions
Eyelid ptosis, eye movement disorder; dysphagia; muscular weakness; pain; inj site discomfort; viral & ear infection; headache; eyelid edema; inj site bruising & pruritus, facial pain; UTI, bacteriuria; dysuria, urinary retention, residual urine vol; fatigue; insomnia.
Drug Interactions
Effects potentiated by aminoglycosides or other drugs that interfere w/ neuromuscular transmission (eg, neuromuscular blocking agents).
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
Botox powd for inj 100 U
Packing/Price
(vacuum-dried) 1's
Form
Botox powd for inj 50 U
Packing/Price
(vacuum-dried) 1's
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