BOTOX 100 Units/Vial

Indications

Chronic Migraine
BOTOX^® (onabotulinumtoxinA) is indicated for the prophylaxis of headaches in adult patients with Chronic Migraine (≥ 15 days per month with headache lasting 4 hours a day or longer).

Limitations of Use
Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in 7 placebo-controlled studies.

Spasticity
BOTOX^® is indicated for the treatment of spasticity in patients 2 years of age and older.

Limitations of Use
BOTOX^® has not been shown to improve upper extremity functional abilities or range of motion at a joint affected by a fixed contracture.

Cervical Dystonia
BOTOX^® is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Blepharospasm and Strabismus
BOTOX^® is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above.

Primary Axillary Hyperhidrosis
BOTOX^® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

Important Limitations
The safety and effectiveness of BOTOX^® for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX^® for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.

Safety and effectiveness of BOTOX^® have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.