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Botox Generic Name & Formulations
Legal Class
Rx
General Description
OnabotulinumtoxinA 100 Units, 200 Units; per vial; vacuum-dried pwd for IM, intradermal, or intradetrusor inj after reconstitution and dilution; contains human albumin; preservative-free.
Pharmacological Class
Neuromuscular blocker.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Mechanism of Action
OnabotulinumtoxinA blocks neuromuscular transmission by binding to acceptor sites on motor or autonomic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. When injected intramuscularly at therapeutic doses, onabotulinumtoxinA produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity.
Botox Indications
Indications
Prophylaxis of headaches in adults with chronic migraine (≥15days/month with headache lasting 4hrs/day or longer).
Limitations of Use
Not established for prophylaxis of episodic migraine (≤14 headache days/month).
Botox Dosage and Administration
Adult
Should be administered and managed by experienced physicians. Max cumulative dose: 400 Units in a 3-month interval. Give intramuscularly a total dose of 155 Units, as 0.1mL (5 Units) injections per each site divided across 7 head/neck muscles (see full labeling). May repeat treatment every 12 weeks.
Children
<18yrs: not established.
Botox Contraindications
Contraindications
Infection at proposed inj site.
Botox Boxed Warnings
Boxed Warning
Distant spread of toxin effect.
Botox Warnings/Precautions
Warnings/Precautions
Not interchangeable with other botulinum toxin products. Risk of distant spread of toxic effect (esp. in children treated for spasticity); see full labeling. Increased risk of serious adverse reactions (including excessive weakness, dysphagia, aspiration pneumonia) with unapproved use. Pre-existing dysphagia or breathing difficulties. Neuromuscular disorders (eg, ALS, myasthenia gravis, Lambert-Eaton syndrome); monitor closely. Compromised respiratory status; monitor. Contains human albumin; monitor for possible viral disease and variant Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.
Botox Pharmacokinetics
See Literature
Botox Interactions
Interactions
May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds). May potentiate anticholinergic effects with concomitant anticholinergic drugs. Concomitant other botulinum toxin products or muscle relaxants may potentiate neuromuscular weakness.
Botox Adverse Reactions
Adverse Reactions
Inj site pain, neck pain, headache, worsening migraine, muscular weakness, musculoskeletal stiffness/pain, myalgia, eyelid ptosis, bronchitis, facial paresis; hypersensitivity reactions (discontinue if occur), possible antibody formation.
Botox Clinical Trials
See Literature
Botox Note
Not Applicable
Botox Patient Counseling
See Literature
Botox Generic Name & Formulations
Legal Class
Rx
General Description
OnabotulinumtoxinA 100 Units, 200 Units; per vial; vacuum-dried pwd for IM, intradermal, or intradetrusor inj after reconstitution and dilution; contains human albumin; preservative-free.
Pharmacological Class
Neuromuscular blocker.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Mechanism of Action
OnabotulinumtoxinA blocks neuromuscular transmission by binding to acceptor sites on motor or autonomic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. When injected intramuscularly at therapeutic doses, onabotulinumtoxinA produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity.
Botox Indications
Indications
Severe primary axillary hyperhidrosis when topical agents are inadequate.
Limitations of Use
Not established for hyperhidrosis in other body areas.
Botox Dosage and Administration
Adult
Should be administered and managed by experienced physicians. Give by intradermal inj. ≥18yrs: 50 Units per axilla, evenly distributed in multiple sites (10–15) approximately 1–2cm apart; max cumulative dose: 400 Units in a 3-month interval.
Children
<18yrs: not established.
Botox Contraindications
Contraindications
Infection at proposed inj site.
Botox Boxed Warnings
Boxed Warning
Distant spread of toxin effect.
Botox Warnings/Precautions
Warnings/Precautions
Not interchangeable with other botulinum toxin products. Risk of distant spread of toxic effect (esp. in children treated for spasticity); see full labeling. Increased risk of serious adverse reactions (including excessive weakness, dysphagia, aspiration pneumonia) with unapproved use. Pre-existing dysphagia or breathing difficulties. Neuromuscular disorders (eg, ALS, myasthenia gravis, Lambert-Eaton syndrome); monitor closely. Compromised respiratory status; monitor. Contains human albumin; monitor for possible viral disease and variant Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.
Botox Pharmacokinetics
See Literature
Botox Interactions
Interactions
May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds). May potentiate anticholinergic effects with concomitant anticholinergic drugs. Concomitant other botulinum toxin products or muscle relaxants may potentiate neuromuscular weakness.
Botox Adverse Reactions
Adverse Reactions
Inj site pain, hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, anxiety; hypersensitivity reactions (discontinue if occur), possible antibody formation.
Botox Clinical Trials
See Literature
Botox Note
Not Applicable
Botox Patient Counseling
See Literature
Botox Generic Name & Formulations
Legal Class
Rx
General Description
OnabotulinumtoxinA 100 Units, 200 Units; per vial; vacuum-dried pwd for IM, intradermal, or intradetrusor inj after reconstitution and dilution; contains human albumin; preservative-free.
Pharmacological Class
Neuromuscular blocker.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Mechanism of Action
OnabotulinumtoxinA blocks neuromuscular transmission by binding to acceptor sites on motor or autonomic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. When injected intramuscularly at therapeutic doses, onabotulinumtoxinA produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity.
Botox Indications
Indications
Spasticity in patients ≥2yrs. Cervical dystonia in patients ≥16yrs, to reduce severity of abnormal head position and neck pain. Strabismus or blepharospasm related to dystonia in patients ≥12yrs.
Limitations of Use
Not shown to improve upper extremity functional abilities or range of motion at a joint affected by fixed contracture.
Botox Dosage and Administration
Adult
Should be administered and managed by experienced physicians. Use needle electromyographic guidance, nerve stimulation, or ultrasound for localization of the involved muscles. Max cumulative dose: 400 Units in a 3-month interval. Individualize. Upper limb spasticity: usual range: 75–400 Units divided among selected muscles (see full labeling) per treatment session; max 50 Units/site. Lower limb spasticity: 300–400 Units divided among 5 muscles; max 50 Units/site. Both: may repeat treatment after effect of the previous injection diminishes, but no sooner than 12 weeks. Cervical dystonia: treatment-naive: use lower initial dose; adjust subsequent doses based on response; max 50 Units/site. Blepharospasm: initially 1.25–2.5 Units into each of 3 sites per affected eye. May repeat treatment after 3 months if insufficient response. Max cumulative dose: 200 Units per 30-day period. Strabismus: use electromyographic technique; initially 1.25–2.5 Units or 2.5–5 Units in any one muscle (see full labeling). Max 25 Units/muscle as a single injection. Premedicate with local anesthetic or ocular decongestant prior to inj: see full labeling.
Children
Should be administered and managed by experienced physicians. Spasticity: <2yrs: not established. Use needle electromyographic guidance, nerve stimulation, or ultrasound for localization of the involved muscles. Max cumulative dose (both lower limbs or combination of upper and lower limbs): 10 Units/kg or 340 Units in a 3-month interval, whichever is lower. Individualize; see full labeling. ≥2yrs: Upper limb: 3–6 Units/kg divided among affected muscles (see full labeling); max 50 Units/site. Total dose per treatment session: max 6 Units/kg or 200 Units, whichever is lower. Lower limb: 4–8 Units/kg divided among affected muscles (see full labeling); max 50 Units/site. Total dose per treatment session: max 8 Units/kg or 300 Units, whichever is lower. Both: may repeat treatment after effect of the previous injection diminishes, but no sooner than 12 weeks. Cervical dystonia: <16yrs: not established. Strabismus or blepharospasm: <12yrs: not established.
Botox Contraindications
Contraindications
Infection at proposed inj site.
Botox Boxed Warnings
Boxed Warning
Distant spread of toxin effect.
Botox Warnings/Precautions
Warnings/Precautions
Not interchangeable with other botulinum toxin products. Risk of distant spread of toxic effect (esp. in children treated for spasticity); see full labeling. Increased risk of serious adverse reactions (including excessive weakness, dysphagia, aspiration pneumonia) with unapproved use. Pre-existing dysphagia or breathing difficulties. Neuromuscular disorders (eg, ALS, myasthenia gravis, Lambert-Eaton syndrome); monitor closely. Compromised respiratory status; monitor. Contains human albumin; monitor for possible viral disease and variant Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.
Botox Pharmacokinetics
See Literature
Botox Interactions
Interactions
May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds). May potentiate anticholinergic effects with concomitant anticholinergic drugs. Concomitant other botulinum toxin products or muscle relaxants may potentiate neuromuscular weakness.
Botox Adverse Reactions
Adverse Reactions
Inj site reactions, dysphagia (may be severe), upper respiratory infection, neck or back pain, headache, increased cough, flu syndrome, rhinitis; hypersensitivity reactions (discontinue if occur), possible antibody formation; also spasticity: pain in extremity, bronchitis; blepharospasm: ptosis, corneal exposure/ulceration, epithelial defect (treat if occurs); strabismus: retrobulbar hemorrhages, compromised retinal circulation.
Botox Clinical Trials
See Literature
Botox Note
Not Applicable
Botox Patient Counseling
See Literature
Botox Generic Name & Formulations
Legal Class
Rx
General Description
OnabotulinumtoxinA 100 Units, 200 Units; per vial; vacuum-dried pwd for IM, intradermal, or intradetrusor inj after reconstitution and dilution; contains human albumin; preservative-free.
Pharmacological Class
Neuromuscular blocker.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Mechanism of Action
OnabotulinumtoxinA blocks neuromuscular transmission by binding to acceptor sites on motor or autonomic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. When injected intramuscularly at therapeutic doses, onabotulinumtoxinA produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity.
Botox Indications
Indications
Adults who have an inadequate response to or are intolerant of an anticholinergic drug: in overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency or urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, spinal cord injury, multiple sclerosis). Treatment of neurogenic detrusor overactivity in pediatric patients who have an inadequate response to or are intolerant of anticholinergics.
Botox Dosage and Administration
Adult
See full labeling. Should be administered and managed by experienced physicians. Max cumulative dose: 400 Units in a 3-month interval. Give prophylactic antibiotics 1–3 days pre-treatment, during, and 1–3 days post-treatment. Discontinue antiplatelet therapy at least 3 days before procedure. May premedicate with local or general anesthetic. Overactive bladder: Max dose: 100 Units/treatment; give 20 injections of 0.5mL each into the detrusor muscle via a flexible or rigid cystoscope, avoiding the trigone. Detrusor overactivity: Max dose: 200 Units/treatment, give 30 injections of 1mL (~6.7 Units) each into the detrusor muscle via a flexible or rigid cystoscope, avoiding the trigone. Both: observe at least 30mins post-injection. May consider re-treatment after effect of the previous injection diminishes but no sooner than 12 weeks.
Children
<5yrs: not established. See full labeling. Should be administered and managed by experienced physicians. Give prophylactic antibiotics 1–3 days pre-treatment, during, and 1–3 days post-treatment. Discontinue antiplatelet therapy at least 3 days before procedure. May premedicate with local or general anesthetic. ≥5yrs (<34kg): 6 Units/kg; (≥34kg): 200 Units/treatment. Give 20 injections of 0.5mL each into the detrusor muscle via a flexible or rigid cystoscope, avoiding the trigone. Observe at least 30mins post-injection. May consider re-treatment after effect of the previous injection diminishes but no sooner than 12 weeks.
Botox Contraindications
Contraindications
Infection at proposed inj site. Acute UTI. Patients with acute urinary retention and post-void residual urine volume >200mL, who are not routinely performing clean intermittent self-catheterization.
Botox Boxed Warnings
Boxed Warning
Distant spread of toxin effect.
Botox Warnings/Precautions
Warnings/Precautions
Not interchangeable with other botulinum toxin products. Risk of distant spread of toxic effect (esp. in children treated for spasticity); see full labeling. Increased risk of serious adverse reactions (including excessive weakness, dysphagia, aspiration pneumonia) with unapproved use. Neuromuscular disorders (eg, ALS, myasthenia gravis, Lambert-Eaton syndrome); monitor closely. Compromised respiratory status; monitor. Non-catheterizing patients (esp. multiple sclerosis, diabetes): monitor post-void residual (PVR) urine volume within 2 weeks post-treatment and periodically as needed up to 12 weeks; if PVR >200mL, initiate catheterization and continue until PVR <200mL. Catheterization may be required if voiding difficulties develop. Recurrent UTIs. Contains human albumin; monitor for possible viral disease and variant Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.
Botox Pharmacokinetics
See Literature
Botox Interactions
Interactions
May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds). May potentiate anticholinergic effects with concomitant anticholinergic drugs. Concomitant other botulinum toxin products or muscle relaxants may potentiate neuromuscular weakness.
Botox Adverse Reactions
Adverse Reactions
UTI, dysuria, urinary retention, hematuria, fatigue, insomnia; autonomic dysreflexia, hypersensitivity reactions (discontinue if occur), possible antibody formation. In children: UTI, leukocyturia, bacteriuria.
Botox Clinical Trials
See Literature
Botox Note
Not Applicable
Botox Patient Counseling
See Literature
