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BOTOX
Migraine and headache
Miscellaneous dermatological conditions
Muscle spasms
Overactive bladder/enuresis
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Drug Name:

BOTOX Rx

Generic Name and Formulations:
OnabotulinumtoxinA 50 Units, 100 Units, 200 Units; per vial; vacuum-dried pwd for IM, intradermal, or intradetrusor inj after reconstitution and dilution; contains human albumin; preservative-free.

Company:
Allergan

Therapeutic Use:

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:

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.

Contraindications:

Infection at proposed inj site.

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.

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.

Pharmacological Class:

Neuromuscular blocker.

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 Availability:

NO

How Supplied:

Single-use vial—1

Indications for BOTOX:

Severe primary axillary hyperhidrosis when topical agents are inadequate.

Limitations Of use:

Not established for hyperhidrosis in other body areas.

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.

Contraindications:

Infection at proposed inj site.

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.

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.

Pharmacological Class:

Neuromuscular blocker.

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 Availability:

NO

How Supplied:

Single-use vial—1

Indications for BOTOX:

Treatment of upper limb spasticity in the flexor muscles of the elbow, wrist, finger and thumb in patients ≥18yrs. Treatment of lower limb spasticity in the flexor muscles of the ankle and toe in patients ≥18yrs. 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. Not intended to substitute usual standard of care rehabilitation regimens.

Adult:

Should be administered and managed by experienced physicians. Max cumulative dose: 400 Units in a 3-month interval. Individualize; see full labeling. Upper limb spasticity: usual range: 75–400 Units divided among selected muscles per treatment session; max 50 Units/site. Lower limb spasticity: 300–400 Units divided among 5 muscles; max 50 Units/site. 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 in any one muscle. Max 25 Units/muscle as a single injection. Premedicate with local anesthetic or ocular decongestant prior to inj: see full labeling.

Children:

Spasticity: <18yrs: not established. Cervical dystonia: <16yrs: not established. Strabismus or blepharospasm: <12yrs: not established.

Contraindications:

Infection at proposed inj site.

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.

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.

Pharmacological Class:

Neuromuscular blocker.

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; strabismus: retrobulbar hemorrhages, compromised retinal circulation.

Generic Availability:

NO

How Supplied:

Single-use vial—1

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).

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 anti-platelet 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:

<18yrs: not established.

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.

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): 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. Contains human albumin; monitor for possible viral disease and variant Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.

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.

Pharmacological Class:

Neuromuscular blocker.

Adverse Reactions:

Urinary tract infection, dysuria, urinary retention, hematuria, fatigue, insomnia; autonomic dysreflexia; hypersensitivity reactions (discontinue if occur), possible antibody formation.

Generic Availability:

NO

How Supplied:

Single-use vial—1

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