CONTRAINDICATIONS____________________________
• Hypersensitivity to any botulinum toxin preparation or to any of the
components in the formulation (4.1, 5.4, 6)
• Infection at the proposed injection site (4.2)
• Intradetrusor Injections: Urinary Tract Infection or Urinary Retention
(4.3)
__________________WARNINGS AND PRECAUTIONS____________________
• Potency Units of BOTOX not interchangeable with other preparations of
botulinum toxin products (5.1, 11)
• Spread of toxin effects; swallowing and breathing difficulties can lead to
death. Seek immediate medical attention if respiratory, speech or
swallowing difficulties occur (5.2, 5.6)
• Care should be taken when injecting in or near vulnerable anatomic
structures. (5.3)
• Concomitant neuromuscular disorder may exacerbate clinical effects of
treatment (5.5)
• Use with caution in patients with compromised respiratory function (5.6,
5.7, 5.10)
• Corneal exposure and ulceration due to reduced blinking may occur with
BOTOX treatment of blepharospasm (5.8)
• Retrobulbar hemorrhages and compromised retinal circulation may occur
with BOTOX treatment of strabismus (5.9)
• Bronchitis and upper respiratory tract infections in patients treated for
upper limb spasticity (5.10)
• Urinary tract infections in patients treated for OAB (5.12)
• Urinary retention: Post-void residual urine volume should be monitored in
patients treated for OAB or detrusor overactivity associated with a
neurologic condition who do not catheterize routinely, particularly
patients with multiple sclerosis or diabetes mellitus.
___ADVERSE REACTIONS___________________________
The most common adverse reactions (≥5% and >placebo) are (6.1):
• OAB: urinary tract infection, dysuria, urinary retention
• Detrusor Overactivity associated with a neurologic condition: urinary tract
infection, urinary retention
• Chronic Migraine: neck pain, headache
• Spasticity: pain in extremity
• Cervical Dystonia: dysphagia, upper respiratory infection, neck pain, headache,
increased cough, flu syndrome, back pain, rhinitis
• Axillary Hyperhidrosis: injection site pain and hemorrhage, non-axillary
sweating, pharyngitis, flu syndrome
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at
1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
__________________________DRUG INTERACTIONS____________________________
• Patients receiving concomitant treatment of BOTOX and aminoglycosides
or other agents interfering with neuromuscular transmission (e.g., curarelike agents), or muscle relaxants, should be observed closely because the
effect of BOTOX may be potentiated (7)
_____________________USE IN SPECIFIC POPULATIONS____________________
• Pregnancy: Based on animal data, may cause fetal harm (8.1)
• Pediatric Use: Safety and efficacy are not established in patients under
18 years of age for the prophylaxis of headaches in chronic migraine,
treatment of OAB, detrusor overactivity associated with a neurologic
condition, upper limb spasticity, and axillary hyperhidrosis; in patients
under 16 years of age for treatment of cervical dystonia; and in patients
under 12 years of age for treatment of blepharospasm and strabismus (8.4)
• Hypersensitivity to any botulinum toxin preparation or to any of the
components in the formulation (4.1, 5.4, 6)
• Infection at the proposed injection site (4.2)
• Intradetrusor Injections: Urinary Tract Infection or Urinary Retention
(4.3)
__________________WARNINGS AND PRECAUTIONS____________________
• Potency Units of BOTOX not interchangeable with other preparations of
botulinum toxin products (5.1, 11)
• Spread of toxin effects; swallowing and breathing difficulties can lead to
death. Seek immediate medical attention if respiratory, speech or
swallowing difficulties occur (5.2, 5.6)
• Care should be taken when injecting in or near vulnerable anatomic
structures. (5.3)
• Concomitant neuromuscular disorder may exacerbate clinical effects of
treatment (5.5)
• Use with caution in patients with compromised respiratory function (5.6,
5.7, 5.10)
• Corneal exposure and ulceration due to reduced blinking may occur with
BOTOX treatment of blepharospasm (5.8)
• Retrobulbar hemorrhages and compromised retinal circulation may occur
with BOTOX treatment of strabismus (5.9)
• Bronchitis and upper respiratory tract infections in patients treated for
upper limb spasticity (5.10)
• Urinary tract infections in patients treated for OAB (5.12)
• Urinary retention: Post-void residual urine volume should be monitored in
patients treated for OAB or detrusor overactivity associated with a
neurologic condition who do not catheterize routinely, particularly
patients with multiple sclerosis or diabetes mellitus.
___ADVERSE REACTIONS___________________________
The most common adverse reactions (≥5% and >placebo) are (6.1):
• OAB: urinary tract infection, dysuria, urinary retention
• Detrusor Overactivity associated with a neurologic condition: urinary tract
infection, urinary retention
• Chronic Migraine: neck pain, headache
• Spasticity: pain in extremity
• Cervical Dystonia: dysphagia, upper respiratory infection, neck pain, headache,
increased cough, flu syndrome, back pain, rhinitis
• Axillary Hyperhidrosis: injection site pain and hemorrhage, non-axillary
sweating, pharyngitis, flu syndrome
To report SUSPECTED ADVERSE REACTIONS, contact Allergan at
1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
__________________________DRUG INTERACTIONS____________________________
• Patients receiving concomitant treatment of BOTOX and aminoglycosides
or other agents interfering with neuromuscular transmission (e.g., curarelike agents), or muscle relaxants, should be observed closely because the
effect of BOTOX may be potentiated (7)
_____________________USE IN SPECIFIC POPULATIONS____________________
• Pregnancy: Based on animal data, may cause fetal harm (8.1)
• Pediatric Use: Safety and efficacy are not established in patients under
18 years of age for the prophylaxis of headaches in chronic migraine,
treatment of OAB, detrusor overactivity associated with a neurologic
condition, upper limb spasticity, and axillary hyperhidrosis; in patients
under 16 years of age for treatment of cervical dystonia; and in patients
under 12 years of age for treatment of blepharospasm and strabismus (8.4)
No comments:
Post a Comment