Botox Injection

Botox Injection is used for: Muscle spasm, Strabismus, Blepharospasm, Achalasia, Cervical dystonia, Limb spasticity, Overactive bladder, Chronic migraine, Severe Primary Axillary Hyperhidrosis, Glabellar and lateral Canthal lines (cosmetic purpose)

Glabellar lines: Inject 4 units (0.1 mL) into each of 5 sites, 2 in each corrugator muscle and 1 in procerus muscle for a total dose of 20 units Canthal lines: Inject 4 units (0.1 mL) into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 units/0.6 mL (12 units per side) Duration of activity is approximately 3-4 months. More frequent dosing not recommended. Blepharospasm 1.25-2.5 units IM; not to exceed 200 units in 30 days. Strabismus 1.25-5 units IM; <25 units per injection . Chronic Migraine Recommended total dose 155 units, as 0.1 mL (5 units) IM injections per each site divided across 7 head/neck muscles q12wk. Overactive Bladder Indicated for adults with overactive bladder symptoms (urge incontinence, urgency, frequency) who cannot use or do not adequately respond to anticholinergic medication. 100 units (divided into 20 intradetrusor injections of 5 units each) administered using cystoscopy. Persistent VII th nerve palsy of >1 mth 1.25-2.5 U in the medial rectus muscle. Max: 25 U as single inj for any 1 muscle. Spasmodic torticollis (cervical dystonia) 25-200 U depending on the muscle groups. Max total dose: 6 U/kg every 2 mth. Hyperhidrosis of the axilla 50 U intradermally to each axilla, evenly distributed in multiple sites 1-2 cm apart.

Blepharospasm and Strabismus Indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in children aged ?12 years Blepharospasm <12 years: Safety and efficacy not established >12 years:1.25-2.5 units IM; < 200 units in 30 days May increase dose 2-fold if response to initial treatment dose does not last longer than 2 months Little benefit obtained from injecting >5 units per site Strabismus <12 years: Safety and efficacy not established >12 years: 1.25-5 units IM; <25 units per injection Vertical muscles, and horizontal strabismus of <20 prism diopters: 1.25-2.5 units in any one muscle Persistent VI nerve palsy of >1 month of duration: 1.25-2.5 units in the medial rectus muscle Horizontal strabismus of 20-50 prism diopters: 2.5-5 units in any one muscle Incomplete paralysis of target muscle: May increase dose 2-fold if response to initial treatment dose Spasticity Indicated for spasticity in adults and pediatric patients aged >2 years Upper limb 3-6 units/kg divided among affected muscles Maximum total dose per treatment session: 6 units/kg or 200 units, whichever is lower Dosage range per muscle Biceps brachii: 1.5-3 units/kg divided in 4 injection sites Brachialis: 1-2 units/kg divided in 2 injection sites Brachioradialis: 0.5-1 units/kg divided in 2 injection sites Flexor carpi radialis: 1-2 units/kg divided in 2 injection sites Flexor carpi ulnaris: 1-2 units/kg divided in 2 injection sites Flexor digitorum profundus: 0.5-1 units/kg divided in 2 injection sites Flexor digitorum superficialis: 0.5-1 units/kg divided in 2 injection sites Lower limb 4-8 units/kg divided among affected muscles Maximum total dose per treatment session: 8 units/kg or 300 units, whichever is lower Dosage range per muscle Gastrocnemius medial head: 1-2 units/kg divided in 2 injection sites Gastrocnemius lateral head: 1-2 units/kg divided in 2 injection sites Soleus: 1-2 units/kg divided in 2 injection sites Tibialis posterior: 1-2 units/kg divided in 2 injection sites Detrusor Overactivity Associated with a Neurologic Condition Indicated for neurogenic detrusor overactivity (NDO) in children aged >5 years who have an inadequate response to or are intolerant of anticholinergic medications >5 years Administer doses as 0.5-mL injections across 20 sites into the detrusor (total volume: 10 mL) via cystoscopy Consider reinjection when clinical effect diminishes (median time to qualify for re-treatment was 207 days [30 weeks] for Botox 200 units), but no sooner than 12 weeks from prior bladder injection <34 kg: 6 units/kg per treatment session >34 kg: 200 units per treatment session

IM Preparation (Botulinum Toxin Type A) Chronic migraine or spasticity: Reconstitute 2 mL (100 unit/2 mL vial) or 4 mL (200 unit/4 mL) of 0.9% NaCl, preservative-free, with a final concentration of 5 Units per 0.1 mL Preparation for detrusor administration Reconstitute vials to result in a final concentration of 20 units/mL 200-unit vials: Add 10 mL of preservative-free 0.9% NaCl 100-unit vials: Add 5 mL of preservative-free 0.9% NaCl to one 100-unit vial (BW <34kg) or each of two 100-unit vials (BW >34 kg) Gently mix vial(s) Further dilution BW <34 kg: Refer to the prescribing information dilution instructions BW >34 kg: Draw 10 mL from vial(s) into one 10-mL syringe Use immediately; dispose of any unused saline IM Preparation (Botulinum Toxin Type A Cosmetic) Reconstitute 1.25 mL (50 units/vial) or 2.5 mL (100 units/vial) of 0.9% NaCl, preservative free (concentration: 4 units/0.1 mL) Slowly inject diluent into the vial; discard the vial if the vacuum does not pull the diluent into the vial Gently mix; administered within 24 hr after reconstitution Discard any remaining solution IM Administration (Botulinum Toxin Type A) Blepharospasm: Use sterile, 27- or 30-gauge needle without EMG guidance to inject into the medial & lateral pretarsal orbicularis oculi of upper lid and into the lateral pretarsal orbicularis oculi of lower lid Axillary Hyperhidrosis: standard staining techniques (eg, Minor's iodine starch test) are used to identify the hyperhidrotic area to be injected; pts should shave their underarms & refrain from using OTC deodorants/antiperspirants for 24 hr prior to such staining tests Strabismus: Inject into the extraocular muscles Detrusor administration via injection IM Administration (Botulinum Toxin Type A Cosmetic) Draw up the appropriate volume from reconstituted vial with a sterile syringe, preferably a tuberculin syringe, and expel any air bubbles Remove needle and attach a 30–33-gauge needle; confirm patency of needle Refer to prescribing information for specific instructions for administration Glabellar lines: At least 0.5 mL Lateral canthal lines: 0.6 mL Forehead lines treated in conjunction with glabellar lines: 1 mL Platysma bands 1 band on each side: At least 0.65 mL 1 band on one side, 2 bands on other side: At least 0.78 mL Two bands on each side: At least 0.9 mL

Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation Infection at the proposed injection site Intradetrusor Injections: Urinary tract infection or urinary retention

The effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects These symptoms may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties These symptoms have been reported hours to weeks after injection Swallowing and breathing difficulties can be life-threatening, and death have been reported The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur Potency Units of Botulinum Toxin Type A are not interchangeable with other preparations of botulinum toxin products Potential serious adverse reactions after Botulinum Toxin Type A injections for unapproved uses Concomitant neuromuscular disorder may exacerbate clinical effects of treatment Use with caution in patients with compromised respiratory function Corneal exposure and ulceration due to reduced blinking may occur with Botulinum Toxin Type A treatment of blepharospasm Retrobulbar hemorrhages and compromised retinal circulation may occur with Botulinum Toxin Type A treatment of strabismus Bronchitis and upper respiratory tract infections in patients treated for spasticity Urinary tract infections in patients treated for OAB Urinary retention: Post-void residual urine volume should be monitored in patients treated for OAB or adult detrusor overactivity associated with a neurologic condition who do not catheterize routinely, particularly patients with multiple sclerosis or diabetes mellitus.

Pregnancy There are no adequate data from postmarketing surveillance on the developmental risk associated with use in pregnant women In animal studies, administrations during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity Lactation Not known if excreted in breast milk; effect on nursing infant not known

Coadministration of abobotulinumtoxin A and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated Anticholinergic drugs: Use of anticholinergic drugs after abobotulinumtoxin A administration may potentiate systemic anticholinergic effects Administration of different botulinum neurotoxin products concomitantly or within several months of each other is unknown; excessive neuromuscular 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: Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of abobotulinumtoxin A

Side effects of Clostridium Botulinum Toxin Type A Neurotoxin (OnabotulinumtoxinA) : >10% (Botulinum Toxin Type A) Urinary tract infection (26-31%) Residual urine volume (3-17%) Urinary retention (17-18%) Somnolence and sedation (16%) Urinary retention (6-15%) Dizziness (4-12%) 1-10% (Botulinum Toxin Type A Cosmetic) Headache (9%) Eyelid ptosis (2-3%) Brow ptosis (2%) Skin tightness (2%) Facial paresis (1%) Muscular weakness (1%) Eyelid edema (1%) 1-10% (Botulinum Toxin Type A) Bacteriuria (9%) Dysuria (5-9%) Neck pain (8-9%) Headache (5%) Migraine (4%) Eyelid ptosis (4%) Hematuria (4%) Musculoskeletal stiffness (4%) Muscular weakness (4%) Myalgia (3%) Bronchitis (3%) Musculoskeletal pain (3%) Muscle spasms (2%) Hypertension (2%)

Neurotoxin from Clostridium botulinum; prevents ACh release from presynaptic membrane, causing temporary calming of muscle contractions by blocking the transmission of nerve impulses.

Botox 100 Units Injection manufactured by Allergan Pharmaceuticals Ltd.,Ireland. Its generic name is Clostridium Botulinum Toxin Type A Neurotoxin (OnabotulinumtoxinA). Botox is availble in Bangladesh. Farmaco BD drug index information on Botox Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.