Botox

Clostridium botulinum toxin type A

Blepharospasm associated w/ dystonia, including benign essential blepharospasm, hemifacial spasm or VIIth 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. Management of focal spasticity of the upper & lower limbs associated w/ stroke in adults. Severe, primary axillary hyperhidrosis inadequately managed by topical agents. Temporary treatment of glabellar lines associated w/ corrugator &/or procerus muscle activity & Crow's feet associated w/ orbicularis oculi muscle activities in adults <65 yr. Temporary improvement in the appearance of moderate to severe forehead lines in adults. Prophylaxis of headache in adults w/ chronic migraine (headaches on ≥15 days/mth of which at least 8 days are w/ migraine). Overactive bladder w/ symptoms of urinary incontinence, urgency & frequency in adults who have an inadequate response to or intolerant of anticholinergics. Urinary incontinence due to neurogenic detrusor overactivity eg, spinal cord injury or multiple sclerosis in adults w/ inadequate response to or intolerant of anticholinergics.

Blepharospasm Initially inj 1.25-2.5 u (0.05-0.1 mL/site) into the medial & lateral orbicularis oculi of the upper lid & into the lateral orbicularis oculi of the lower lid. Max initial dose: 25 u/eye. Max total dose: 100 u every 12 wk. Hemifacial spasm or VIIth nerve disorders As for unilateral blepharospasm. Max cumulative dose: 200 u in 2 mth period. Strabismus Recommended vol: 0.05-0.15 mL/muscle. Initial dose: 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 duration of ≥1 mth: 1.25-2.5 u in the medial rectus muscle. Subsequent dose: Incomplete paralysis of the target muscle: May be increased up to 2-fold compared to previous dose; max: 25 u/muscle as single inj. Spasmodic torticollis (cervical dystonia) Individualized dosage. Max total dose: 6 u/kg every 2 mth. Paed cerebral palsy Childn ≥2 yr 4 u/kg. Max: 200 u at any single treatment session. Focal spasticity: Upper limb spasticity: Adult Biceps brachii: 100-200 u, up to 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. Max dose: 360 u. Lower limb spasticity: Adult Gastrocnemius medial head: 75 u divided in 3 sites; gastrocnemius lateral head 75 u divided in 3 sites; soleus 75 u divided in 3 sites; tibialis posterior 75 u divided in 3 sites; flexor hallucis longus 50 u divided in 2 sites; flexor digitorum longus 50 u divided in 2 sites; flexor digitorum brevis 25 u in 1 site. Max dose: 400 u. Hyperhidrosis of the axillae 50 u/axillae. Repeat inj not more frequently than every 4 mth, when effects from previous inj subside. Upper facial lines (glabellar lines, Crow's feet lines, forehead lines) Recommended vol/inj: 0.1 mL/inj site. Glabellar lines 4 u/0.1 mL in each of 5 sites, 2 in each corrugator muscle & 1 in the procerus muscle for a total dose of 20 u, w/ inj not more frequent than 3-mth inj intervals. Crow's feet 2-6 u/inj site at 2-3 mm depth. Total dose: 6-18 u/side. Forehead lines Inj 4 u into 5 sites in the frontalis muscle. Total dose: 20 u. Recommended total dose for forehead lines (20 u) in conjunction w/ glabellar lines (20 u): 40 u. Simultaneous treatment w/ Crow's feet lines: Total dose: 64 u (ie, 20 u for forehead lines, 20 u for glabellar lines, & 24 u for Crow's feet lines). Retreatment time for forehead lines: Approx 4 mth. Chronic migraine 155-195 u IM w/ 5 u/inj site. Inj should be divided across 7 specific head/neck muscle areas. Recommended retreatment schedule: Every 12 wk. Overactive bladder 100 u inj into the detrusor muscle via a flexible or rigid cystoscope. Neurogenic detrusor overactivity 200 u inj into the detrusor muscle via a flexible or rigid cystoscope.

Hypersensitivity to botulinum toxin type A or any constituent of the formulation. Myasthenia gravis or Lambert-Eaton syndrome. Presence of infection at the proposed inj site. For treatment of bladder dysfunction: Acute UTI, acute urinary retention in patients not routinely performing clean intermittent self-catheterization.

Discontinue use if serious &/or immediate hypersensitivity reactions eg, anaphylactic & serum sickness occurs, when used either alone or in conjuction w/ other products. Do not use dosage recommendations & potency units applied to other botulinum toxin products. Avoid inj into vulnerable anatomic structures. Inj in or near vulnerable anatomic structures. Pneumothorax associated w/ inj procedure. Presence of inflammation at the proposed inj site or when excessive weakness or atrophy is present in the target muscle. Immediately seek medical care if swallowing, speech or resp disorders arise. Patients w/ history of underlying neurological disorders, dysphagia &/or aspiration. As expected for any inj procedure, localized pain, inflammation, paresthesia, hypoaesthesia, tenderness, swelling/edema, erythema, localized infection, bleeding &/or bruising have been associated w/ the inj. Needle-related pain &/or anxiety have resulted in vasovagal responses, including transient symptomatic hypotension & syncope. Not for improving range of motion at a joint affected by a fixed contracture. More frequent intervals or at higher doses may lead to greater incidence of Abs formation. Patients w/ peripheral motor neuropathic (eg, amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome). Patients not catheterizing should be assessed for post-void residual urine vol w/in 2 wk post-treatment & periodically as medically appropriate up to 12 wk. Risk of urinary retention. Increased UTI incidence. Autonomic dysreflexia associated w/ the procedure could occur in neurogenic detrusor overactivity patients. Reduced blinking following inj into the orbicularis muscle may lead to corneal exposure, persistent epithelial defect, & corneal ulceration, especially in patients w/ nerve VII disorders; carefully test for corneal sensation in eyes previously operated upon, avoid inj into the lower lid area, & employ vigorous treatment of any epithelial defect; patients at risk for angle closure glaucoma, including patients w/ anatomically narrow angles. Patients who have 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. Retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred from needle penetrations into the orbit in the treatment of strabismus. Inducing paralysis in ≥1 extraocular muscles may produce spatial disorientation, double vision, or past-pointing. Possible mild or severe dysphagia in patients w/ cervical dystonia. Increased risk of upper resp infection & dysphagia may be associated w/ inj into the levator scapulae. Risk of more severe dysphagia following inj may be increased in patients w/ subclinical dysphagia. Greater risk of dysphagia in patients w/ smaller neck muscle mass, or those who receive bilateral inj into the sternocleidomastoid muscle. Not for improving range of motion at a joint affected by a fixed contracture. Do not use for the treatment of 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), or to facilitate care. Adult patients w/ post-stroke spasticity who may be at increased risk of fall. Avoid symptomatic treatment of hyperhidrosis w/o the diagnosis &/or treatment of underlying disease. Chronic migraine. Paed patients who have significant neurologic debility, dysphagia, or have a recent history of aspiration pneumonia or lung disease. Focal lower limb spasticity treatment in elderly post-stroke patients.

Eyelid ptosis, eye movement disorder, dysphagia, muscular weakness, pain, viral infection, ear infection, inj site pain & bruising, eyelid edema, facial pain. Punctate keratitis, lagophthalmos, dry eye, photophobia, eye irritation, increased lacrimation, ecchymosis, rhinitis, upper resp tract infection, dizziness, hypertonia, hypoaesthesia, somnolence, headache, dry mouth, nausea, musculoskeletal stiffness, asthenia, malaise, flu-like illness, gait disturbance, paresthesia, rash, myalgia, pain in extremity, urinary incontinence, fall, pyrexia, arthralgia, peripheral edema, hot flush, hyperhidrosis, abnormal skin odor, pruritus, SC nodule, alopecia, inj site edema, hemorrhage, hypersensitivity & irritation, erythema, skin tightness, facial pain, brow ptosis, migraine, facial paresis, sinusitis, bronchitis, neck pain, musculoskeletal pain, muscle spasms & tightness.

Potentiated effect w/ aminoglycosides (eg, streptomycin, tobramycin, neomycin, gentamycin, netilmicin, kanamycin, amikacin), spectinomycin, polymyxins, tetracyclines, lincomycin or other drugs that interfere w/ neuromuscular transmission [eg, neuromuscular blockers, both depolarizing (succinylcholine) & nondepolarizing (tubocurarine derivatives), lincosamides, quinidine, Mg sulfate & anticholinesterases]. Excessive weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Muscle Relaxants / Other Dermatologicals

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

POM