Adult Dosing

Botox

Overactive bladder

• Recommended total dose: 100 units (divided into 20 intradetrusor injections of 5 units each)

Detrusor overactivity associated with a neurologic condition

• Recommended total dose: 200 units (divided into 30 intradetrusor injections)

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
• Recommended dose per muscle site
• Frontalis: 20 units divided in 4 sites
• Corrugator: 10 units divided in 2 sites
• Procerus: 5 units in 1 site
• Occipitalis: 30 units divided in 6 sites
• Temporalis: 40 untied divided in 8 sites
• Trapezius: 30 units divided in 6 sites
• Cervical paraspinal muscle group: 20 units divided in 4 sites

Upper limb spasticity

• Doses ranging from 75-360 units were divided among selected muscles at a given treatment session
• Do not exceed cumulative dose of 360 units in 3-month interval; not to exceed 50 units per site
• Recommended dose per muscle
• Biceps brachii: 100-200 units divided in 4 sites
• Flexor carpi radialis: 12.5-50 units in 1 site
• Flexor carpi ulnaris: 12.5-50 units in 1 site
• Flexor digitorum profundus: 30-50 units in 1 site
• Flexor digitorum sublimis: 30-50 units in 1 site

Note:

• Select dose based on muscles affected, severity of muscle activity, prior response to treatment, and adverse event history; Electromyographic guidance recommended

Cervical dystonia

• Mean dose administered: 198-300 units (average 236 units) divided among the affected muscles

Note:

• Base dosing on the patient’s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history; use lower initial dose in botulinum toxin naïve patients

Axillary hyperhidrosis

• 50 units per axilla

Blepharospasm

• 1.25 units-2.5 units into each of 3 sites per affected eye

Strabismus

• Vertical muscles and horizontal strabismus less than 20 diopters: 1.25 units-2.5 units initially in any one muscle
• Horizontal strabismus between 20 to 50 diopters: 2.5 units-5 units initially in any one muscle
• For persistent sixth nerve palsy of at least 1-month duration: 1.25 units-2.5 units initially in the rectus muscle

Note:

• Use lower initial dose if no prior botulinum toxin treatment
• Adjust dose based on response
• When treating adult patients for 1 or more indications, the maximum cumulative dose should generally not exceed 360 Units in a 3 month interval
• Bladder dysfunction indications: Administer prophylactic antibiotics (except aminoglycosides) beginning 1-3 days pretreatment and continue 1-3 days post treatment to reduce risk for procedure-related UTI

Botox cosmetic

Moderate to severe glabellar lines

• 20 units IM divided in 5 sites q3-4 month

Moderate to severe lateral canthal lines

• 24 units IM divided in 6 sites q3-4 month

Pediatric Dosing

• Safety and efficacy of Botox Cosmetic in pediatric patients have not been established

Botox

Cervical dystonia

• Safety and effectiveness in patients < 16 years have not been established

Blepharospasm

• Child 12-18 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
• Safety and effectiveness in patients < 12 years have not been established

Strabismus

• Child 12-18 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
• Safety and effectiveness in patients < 12 years have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

Botox

• Overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication
• Urinary incontinence due to detrusor overactivity associated with a neurologic condition
• Prophylaxis of headaches in adult patients with chronic migraine (> 15 days per month with headache lasting 4 hours a day or longer)
• Upper limb spasticity in adult patients
• Cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain
• Severe axillary hyperhidrosis inadequately managed by topical agents in adult patients
• Blepharospasm associated with dystonia in patients = > 12 years of age
• Strabismus in patients = > 12 years of age

Botox Cosmetic

• in adult for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
• in adult for temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to any botulinum toxin preparation
• Infection at the proposed injection site
• Intradetrusor injection: Urinary tract infection or urinary retention

• Effects of botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects
• 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
• 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

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined; caution advised

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined; caution advised

• Effects of botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects [US black box warning]
• 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 [US black box warning]
• Swallowing and breathing difficulties can be life threatening, and death have been reported [US black box warning]
• 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 [US black box warning]
• The potency units of onabotulinumtoxinA for injection are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method
• Therapy may lead to serious and/or immediate hypersensitivity reactions such as anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further therapy should be discontinued and appropriate medical therapy immediately instituted
• Closely monitor patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome). Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia
• Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation which may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles
• Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders
• Closely monitor patients with compromised respiratory status treated for upper limb spasticity
• Reduced blinking of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders
• During treatment of strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred
• Autonomic dysreflexia associated with intradetrusor injections may occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy
• Therapy increases the incidence of urinary tract infection. In treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs consider the risk benefit ratio
• Due to the risk of urinary retention, treat only patients who are willing and able to initiate catheterization post-treatment, if required. In patients who are not catheterizing, post-void residual (PVR) urine volume should be assessed within 2 weeks post-treatment and periodically as medically appropriate up to 12 weeks, particularly in patients with multiple sclerosis or diabetes mellitus
• As the product contains albumin, it carries an extremely remote risk for transmission of viral diseases

Pregnancy Category:C

Breastfeeding: It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.

• CNS: Fatigue, headache, migraine facial paresis, dizziness, drowsiness, asthenia, numbness, hypertonia, speech disorder, fever, flu syndrome
• GU: Urinary tract infection, dysuria, urinary retention, bacteriuria, dysuria
• RESP: Bronchitis, upper respiratory infection, increased cough, rhinitis, dyspnea
• HEMA: Hematuria
• CV: Hypertension
• GI: Constipation, nausea, oral dryness, dysphagia
• MUSC: Muscular weakness, muscle spasm, neck pain, musculoskeletal stiffness, myalgia, musculoskeletal pain, muscular weakness, pain in extremity, back pain
• EENT: Eyelid ptosis, diplopia, superficial punctate keratitis, eye dryness, lagophthalmos, photophobia, ectropion, entropion, local swelling of the eyelid skin
• HYPERSENSITIVITY: Injection site pain, soreness at injection site

• Neurotoxin; blocks neuromuscular transmission by binding to acceptor sites on motor or sympathetic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine
• Minimal systemic absorption
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Botox
• Botox cosmetic

US Availability

Botox

• PWDR for INJ: 50 units/vial
• PWDR for INJ: 100 units/vial
• PWDR for INJ: 200 units/vial

Botox cosmetic

• PWDR for INJ: 50 units/vial
• PWDR for INJ: 100 units/vial

Canadian Trade Name(s)

• Botox

Canadian Availability

Botox

• PWDR for INJ: 100 units/vial

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Cardiovascular

Antihypertensive Agents

Ganglionic Blockers