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|Botulinum Toxin Type A Parenteral-Local

BOTULINUM TOXIN TYPE A (Parenteral-Local)

Some commonly used brand names are:

In the U.S.—

• Botox

In Canada—

• Botox

Category

• Neuromuscular blocking agent

Description

Botulinum toxin type A (BOT-yoo-lye-num) is used to treat certain eye conditions, such as:

• Blepharospasm—A condition in which the eyelid will not stay open, because of a spasm of a muscle of the eye.
• Strabismus—A condition in which the eyes do not line up properly.

Botulinum toxin type A is injected into the surrounding muscle or tissue of the eye, but not into the eye itself. Depending on your condition, more than one treatment may be required.

Botulinum toxin type A is also used to treat muscle spasms of the neck (cervical dystonia) and some types of severe sweating of the armpits (hyperhidrosis).

This medicine is to be administered only by, or under the immediate supervision of, your doctor. It is available in the following dosage form:

• Parenteral-Local
• Injection (U.S. and Canada)

Before Receiving This Medicine

In deciding to receive a medicine, the risks of receiving the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For botulinum toxin type A, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to botulinum toxin type A. Also tell your health care professional if you are allergic to any other substances.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals. Tell your doctor if you are pregnant or if you plan to become pregnant while using this medication.

Breast-feeding—It is not known whether botulinum toxin type A passes into the breast milk. Tell your doctor if you are breast feeding.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of botulinum toxin type A in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Elderly people are especially sensitive to the effects of some medicines. This may increase the chance of side effects during treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other ophthalmic prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of botulinum toxin type A. Make sure you tell your doctor if you have any other medical problems, especially:

• Amyotrophic lateral sclerosis (Lou Gehrig"s disease) or
• Lambert-Eaton syndrome or
• Motor neuropathy or
• Myasthenia gravis—These medical problems may increase your risk for severe swallowing or breathing problems.

• Heart problems or other medical conditions that may worsen with rapidly increasing activity—Treatment with botulinum toxin type A may give you better vision and the desire to become more active in your daily life; this may put a strain on your heart and body

• Infection where botulinum toxin type A is to be injected—Botulinum toxin type A should not injected into an area that is infected.

• Infection with Clostridium botulinum toxin (botulism poisoning), history of—Persons with a history of infection with Clostridium botulinum toxin (botulism poisoning) may have produced antibodies that may interfere with botulinum toxin type A therapy and make it less effective

• Nerve problems—May increase your chance of getting side effects.

• Swallowing problems—Treatment with botulinum toxin type A may make this problem worse and increase your risk for serious side effects. Tell your doctor right away if you have severe swallowing problems.

• Swelling where botulinum toxin type A is to be injected or
• Weakness in the muscles where botulinum toxin type A is to be injected—Your doctor may decrease your dose or not inject the botulinum toxin type A until these problems are better.

Proper Use of This Medicine

Dosing—The dose of botulinum toxin type A will be different for different patients. The following information includes only the average doses of botulinum toxin type A.

• For injection dosage form:
  • For certain eye conditions:
    • Adults and children 12 years of age and older—One or more injections into the muscles around the eyes one or more times, depending on the condition being treated.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For muscle spasms of the neck (cervical dystonia):
    • Adults and children 16 years of age and older—One or more injections into the muscles of the neck one or more times, depending on the condition being treated.
    • Children up to 16 years of age—Use and dose must be determined by your doctor.
  • For severe sweating of the armpits (hyperhidrosis):
    • Adults and children 16 years of age and older—One or more injections just below the skin in the armpit one or more times.
    • Children up to 16 years of age—Use and dose must be determined by your doctor.

Precautions After Receiving This Medicine

After you have received this medicine and your vision is better, you may find that you are a lot more active than you were before. You should increase your activities slowly and carefully to allow your heart and body time to get stronger. Also, before you start any exercise program, check with your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur :

Other side effects may occur that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, botulinum toxin type A is used in certain patients with the following medical conditions:

• Deep facial lines or wrinkles
• Frey"s syndrome (gustatory sweating) (red area and sweating on the cheek while eating)
• Hyperhidrosis (severe sweating of the palms)
• Spasms of the arms, feet, hands, or legs caused by brain injury, multiple sclerosis, spinal cord injury, or stroke
• Spasms of the arms and legs in stroke patients
• Spasms of the face
• Spasms of the hand, including writer"s cramp and musician"s cramp
• Spasms of the arms and legs in patients with multiple sclerosis
• Spasms of the vocal cords

Revised: 02/23/2006

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