- Migraine and headache
- Miscellaneous dermatological conditions
- Muscle spasms
- Overactive bladder/enuresis
Migraine and headache:
Indications for: BOTOX
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).
Adult Dosage:
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 Dosage:
<18yrs: not established.
BOTOX Contraindications:
Infection at proposed inj site.
Boxed Warning:
Distant spread of toxin effect.
BOTOX 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 Classification:
Neuromuscular blocker.
BOTOX 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.
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.
Generic Drug Availability:
NO
How Supplied:
Single-use vial—1
Miscellaneous dermatological conditions:
Indications for: BOTOX
Severe primary axillary hyperhidrosis when topical agents are inadequate.
Limitations of Use:
Not established for hyperhidrosis in other body areas.
Adult Dosage:
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 Dosage:
<18yrs: not established.
BOTOX Contraindications:
Infection at proposed inj site.
Boxed Warning:
Distant spread of toxin effect.
BOTOX 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 Classification:
Neuromuscular blocker.
BOTOX 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.
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.
Generic Drug Availability:
NO
How Supplied:
Single-use vial—1
Muscle spasms:
Indications for: BOTOX
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.
Adult Dosage:
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 Dosage:
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:
Infection at proposed inj site.
Boxed Warning:
Distant spread of toxin effect.
BOTOX 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 Classification:
Neuromuscular blocker.
BOTOX 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.
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.
Generic Drug Availability:
NO
How Supplied:
Single-use vial—1
Overactive bladder/enuresis:
Indications for: BOTOX
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.
Adult Dosage:
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 Dosage:
<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:
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.
Boxed Warning:
Distant spread of toxin effect.
BOTOX 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 Classification:
Neuromuscular blocker.
BOTOX 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.
Adverse Reactions:
UTI, dysuria, urinary retention, hematuria, fatigue, insomnia; autonomic dysreflexia, hypersensitivity reactions (discontinue if occur), possible antibody formation. In children: UTI, leukocyturia, bacteriuria.
Generic Drug Availability:
NO
How Supplied:
Single-use vial—1
