Nabota

Clostridium botulinum toxin type A

Blepharospasm associated w/ dystonia including benign essential blepharospasm, hemifacial spasm or VII^th nerve disorders in patients ≥12 yr; spasmodic torticollis (cervical dystonia) in adults; dynamic equinus foot deformity due to spasticity in ped cerebral palsy patients ≥2 yr; focal hyperhidrosis of axilla; urinary incontinence due to neurogenic detrusor overactivity eg, spinal cord injury or multiple sclerosis in adults. Correction of strabismus in patients ≥12 yr. Adult: Temporary treatment of glabellar lines associated w/ corrugator &/or procerus muscle activity in patients <65 yr. Management of focal spasticity including spasticity associated w/ stroke. Temporary improvement in appearance of upper facial rhytides (glabellar lines, crow's feet & forehead lines). Prophylaxis of headaches w/ chronic migraine.

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. Max: Initially 25 u/eye, total dosing should not exceed 100 u every 12 wk. Hemifacial spasm Treat as for unilateral blepharospasm w/ other affected facial muscles each being inj as needed. Cumulative dose in 2-mth period should not exceed 200 u. Strabismus 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 VII^th nerve palsy of ≥1 mth duration 1.25-2.5 u in medial rectus muscle. Max: 25 u as single inj for any 1 muscle. Residual or recurrent strabismus Subsequent dose: Re-examine patient 7-14 days after each inj. Should receive a dose comparable to initial dose. May increase up to 2-fold compared from previous dose for patients w/ incomplete paralysis of the target muscle. Max: 25 u as single inj for any muscle. Spasmodic torticollis (cervical dystonia) Individualized dosage. Max: 6 u/kg every 2 mth should not be exceeded. Ped cerebral palsy 4 u/kg up to max of 200 u at any single treatment session. May repeat dose but not more frequently than every 3 mth. Upper facial lines Individualized dosage. Usually 0.1 mL/inj site. Glabellar lines 4 u/0.1 mL in each 5 sites, 2 in each corrugator muscle & 1 in procerus muscle for a total dose of 20 u w/ interval no more frequent than every 3 mth. Crow's feet 2-6 u/inj site at 2-3 mm depth, for a total dose of 6-18 u/side inj bilaterally. Forehead lines 2-6 u/inj site every 1-2 cm for a total dose of 8-24 u inj IM at each 4 inj sites in frontalis muscle. Focal spasticity Adult Individualized dosage. Hyperhidrosis of the axilla 50 u to each axilla intradermally, evenly distributed in multiple site approx 1-2 cm apart. Chronic migraine 155-195 u IM, then 0.1 mL (5 u) inj should be divided across 7 specific head/neck muscle areas. Schedule retreatment every 12 wk. Neurogenic detrusor overactivity 200 u. Administer prophylactic antibiotics 1-3 days pretreatment, on treatment day & 1-3 day post treatment.

Hypersensitivity. Myasthenia gravis or Eaton-Lambert syndrome, presence of infection at the proposed inj site. Acute UTI & patients w/ acute urinary retention who are not routinely performing clean intermittent self-catheterization.

Distant spread of toxin effect. Prior surgical procedures near the inj site or vulnerable area. Inj in proximity to the lung, particularly apices. Electromyographic techniques. Presence of inflammation at the inj site or when weakness or atrophy is present. Patients w/ amyotrophic lateral sclerosis or disorders that produce peripheral neuromuscular dysfunction. Risk for transmission of Creutzfeldt-Jakob disease (albumin content). May lead to corneal exposure, persistent epithelial defects & corneal ulceration. At risk for angle-closure glaucoma (periorbital inj) including w/ anatomically narrow angles. Retrobulbar hemorrhages sufficient to compromise retinal circulation; ocular (globe) penetrations by needles. Dysphagia w/ dyspnea, aspiration pneumonia. Not likely to be effective in improving range of motion at a joint affected by a fixed contracture. Evaluate for potential causes of secondary hyperhidrosis. Performing cytoscopy; autonomic dysreflexia associated w/ procedure may occur. Assess post-void residual urine vol w/in 2 wk post-treatment & periodically as medically appropriate up to 12 wk in patients who are not catheterizing. Sedentary patients should resume activity gradually. May experience malaise lasting up to 6 wk after inj. Consider effects on neuromuscular junction w/ consequent effects on muscle activity on the suitability to drive or operate machinery. Not recommended during pregnancy & lactation. Adolescents <20 yr & childn <12 yr.

Denervation/muscle atrophy, resp depression &/or resp failure (noncosmetic indications), dyspnea, aspiration pneumonia (noncosmetic indications), dysarthria, dry mouth, strabismus, peripheral neuropathy, abdominal pain, diarrhea, nausea, vomiting, pyrexia, anorexia, blurred vision, visual disturbance, hypoacusis, tinnitus, vertigo, facial palsy, facial paresis, brachial plexopathy, radiculopathy, syncope, hypoesthesia, malaise, myalgia, myasthenia gravis, paresthesia, rash, erythema multiforme, pruritus, dermatitis psoriasiform, hyperhidrosis, & alopecia including madarosis.

Potentiated effect w/ aminoglycosides or other drugs that interfere w/ neuromuscular transmission eg, tubocurarine-type muscle relaxants or curare-like non-depolarising blockers. Spectinomycin; polymyxin, tetracycline & lincomycin.

Muscle Relaxants

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

Rx