BOTOX® Therapeutic—BOTOX® Prescribing Information

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To view the full prescribing information for BOTOX^® neurotoxin, click the link below. This information is intended for healthcare professionals. If you have questions about the BOTOX^® prescribing information, ask your doctor.

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

BOTOX^® is indicated for the treatment of strabismus (crossed eyes) and blepharospasm (eyelid spasms) associated with dystonia (muscle tightening), including benign essential blepharospasm of VII nerve disorders in patients 12 years of age and above.

The efficacy of BOTOX^® treatment in deviations over 50 prism diopters, in restrictive strabismus, in Duane's syndrome with lateral rectus weakness, and in secondary strabismus caused by prior surgical over-recession of the antagonist has not been established. BOTOX^® is ineffective in chronic paralytic strabismus except when used in conjunction with surgical repair to reduce antagonist contracture.

IMPORTANT SAFETY INFORMATION

BOTOX^® injections should not be given to people who have an infection where the physician proposes to inject. They should not be given to people who are known to be sensitive to any ingredient in BOTOX^® product.

Serious heart problems and serious allergic reactions have been reported rarely. If you think you’re having an allergic reaction or other unusual symptoms, such as difficulty swallowing, speaking or breathing, call your doctor immediately.

Patients with certain neuromuscular disorders such as ALS, myasthenia gravis or Lambert-Eaton syndrome may be at increased risk of serious side effects.

In cervical dystonia, the most common side effects following injection include difficulty swallowing, upper respiratory infection, neck pain and headache.

In blepharospasm, the most common side effects following injection include ptosis, inflammation of the cornea and eye dryness.

In strabismus, the most common side effects following injection include ptosis and vertical deviation.

Please see full prescribing information for BOTOX^®.

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