Neuronox

Neuronox

Manufacturer:

Medytox

Distributor:

Medyceles
Concise Prescribing Info
Contents
Clostridium botulinum toxin type A
Indications/Uses
Hemifacial spasm (idiopathic). Strabismus in patients ≥12 yr. Spasmodic torticollis. Cervical dystonia. Upper limb post-stroke spasticity in patients ≥20 yr. Benign essential blepharospasm in patients ≥18 yr. Dynamic equinus foot deformity due to spasticity in ped cerebral palsy patients ≥2 yr. Temporary improvement of serious glabellar wrinkles ranging from moderate to severe associated w/ corruptors muscle &/or procerus muscle activities in adults over 20 to <65 yr.
Dosage/Direction for Use
Blepharospasm Initially 1.25-2.5 U (0.05-0.1 mL at each site) inj into the medial & lateral pre-tarsal orbicularis oculi of the upper lid & into the lateral pre-tarsal orbicularis oculi of the lower lid. May repeat procedure & increase dose up to 2-fold if effect does not last for >2 mth. Cumulative dose in a 30-day period: ≤200 U. Ped cerebral palsy Patients w/ hemiplegia 4 U/kg into the affected gastrocnemius muscle. Patients w/ diplegia 6 U/kg divided between both legs. Max: ≤200 U at any single treatment time. Glabellar wrinkles 4 U/0.1 mL in each of 5 sites, 2 inj in each corrugator muscle for each eye & 1 inj in the procerus muscle for a total dose of 20 U. Inj in the medial end of corrugator muscle & in midpoint between eyebrow inj should be placed at least 1 cm apart from supraorbital ridge. Muscle spasticity 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. Hemifacial spasm & strabismus Initially 1.25-2.5 U per inj site in the affected muscle, may be given in multiple inj. Max: 25 U per affected area for initial treatment, can be increased up to max of 100 U for the succeeding treatment sessions. Re-inj when clinical effect from the previous inj starts to wear-off but not more often than every 3 mth. Cervical dystonia Individualized dosage. Re-inj when clinical effect from the previous inj starts to wear-off but not more often than every 12 wk. Spasmodic torticollis Initially up to 50 U per inj site in the affected muscle, may be given in multiple inj. Max: 200 U for initial treatment, can be increased up to max of 300 U for the succeeding treatment sessions. Re-inj when clinical effect from the previous inj starts to wear-off but not more often than every 10 wk.
Contraindications
Hypersensitivity. Systemic neuromuscular junctional disorders (eg, severe myasthenia gravis, Lambert-Eaton syndrome, amyotrophilateral sclerosis). Severe resp dysfunction (when using Neuronox for cervical dystonia). Concomitant use w/ muscle relaxants (Na tubocurarine, dantrolen Na), spectinomycin, aminoglycosides (gentamycin sulfate, neomycin sulfate), polypeptide antibiotics, tetracyclines, lincosamides, anticholinergics, benzodiazepines, & benzamides. Pregnancy & lactation.
Special Precautions
Discontinue if serious &/or immediate hypersensitivity reactions occurs. Peripheral motor neuropathic diseases (eg, amyotrophic lateral sclerosis or motor neuropathy) or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome). Dysphagia, aspiration pneumonia. CV disease (eg, arrhythmia & MI). Use ophthalmoscope to diagnose retrobulbar hemorrhages in treatment of strabismus. Corneal exposure, persistent epithelial defect & corneal ulceration, especially in patients w/ VII nerve disorders. Careful testing of corneal sensation in eyes previously operated; avoid inj into the lower medial lid area to avoid ectropion. Caution when inj in or near vulnerable anatomic structures, or in proximity to the lung, particularly the apices. Patients w/ upper limb spasticity, reduced lung function & upper resp tract infections; detrusor overactivity. Cerebral palsy. History of facial nerve paralysis or the symptoms of eyelid ptosis, history of treatment of glabellar pan eg, face lifting & permanent implant, or w/ scars which may affect the treatment results, satisfactorily not improved w/ physical method since the lines are not flattened even using hands. Pregnancy & lactation is contraindicated. Childn <18 yr (blepharospasm), >11 yr (ped cerebral palsy).
Adverse Reactions
Localized pain, tenderness &/or bruising, traction, swelling, hot feeling or hypertonia at inj site or adjacent muscles; local weakness of the inj muscle; eyelid drooping; ptosis, superficial punctuate keratitis & eye dryness; dysphasia, soreness at inj site, localized lassitude & symptomatic, systemic lassitude, malaise; nasopharyngitis, upper resp tract infection, pyrexia, gait disturbances, pain in extremity, musculoskeletal & connective tissue disorders; febrile convulsion, constipation, lower limb fracture; headache, hyperglycemia, articulation sprain, pyuria; cough, diarrhea, vomiting, backache, peripheral edema, abdominal distension, dyspepsia, nausea, hematoma of inj site, acute cholecystitis.
Drug Interactions
Potentiated effects by aminoglycosides or other drugs that interfere w/ neuromuscular transmission eg, tubocurarine-type muscle relaxants. Concomitant use w/ aminoglycosides or spectinomycin is contraindicated. Polymyxins, tetracyclines & lincomycin.
MIMS Class
ATC Classification
M03AX01 - botulinum toxin ; Belongs to the class of other agents used as peripherally-acting muscle relaxants.
Presentation/Packing
Form
Neuronox powd for inj 50 U
Packing/Price
(vacuum-dried) 1's
Form
Neuronox powd for inj 100 U
Packing/Price
(vacuum-dried) 1's
Form
Neuronox powd for inj 200 U
Packing/Price
(vacuum-dried) 1's
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