Botulinum Toxin Type A

Botulinum Toxin Type A is used for:

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Temporarily improving the appearance of moderate to severe lines between the eyebrows in patients 65 years of age or younger. It may also be used for other conditions as determined by your doctor.

Botulinum Toxin Type A is a neurotoxin. It works by blocking nerve impulses to the muscles or sweat glands, temporarily paralyzing the muscle or gland.

Do NOT use Botulinum Toxin Type A if:

• you are allergic to any ingredient in Botulinum Toxin Type A
• you have an infection at the injection site

Contact your doctor or health care provider right away if any of these apply to you.

Before using Botulinum Toxin Type A :

Some medical conditions may interact with Botulinum Toxin Type A . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have nerve problems or disease (eg, amyotrophic lateral sclerosis, motor neuropathy), muscle problems or disease (eg, Lambert-Eaton syndrome, myasthenia gravis), heart problems, bleeding disorders, seizures, or severe weakness or wasting of the muscles at the injection site
• if you have inflammation, scarring, or other skin disorders at the injection site

Some MEDICINES MAY INTERACT with Botulinum Toxin Type A . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aminoglycosides (eg, gentamicin), anticholinesterase medicines (eg, neostigmine), lincosamides (eg, clindamycin), magnesium, neuromuscular blockers (eg, atracurium), polymyxin, or quinidine because the risk of toxic effects may be increased
• Anticoagulants (eg, warfarin) because the risk of bleeding at the injection site may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Botulinum Toxin Type A may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Botulinum Toxin Type A :

Use Botulinum Toxin Type A as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Botulinum Toxin Type A is usually given as an injection at your doctor's office, hospital, or clinic.
• If you miss a dose of Botulinum Toxin Type A , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Botulinum Toxin Type A .

Important safety information:

• Botulinum Toxin Type A may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Botulinum Toxin Type A with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT take more than the recommended dose or use Botulinum Toxin Type A more often than every 3 months without checking with your doctor.
• Botulinum Toxin Type A contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used Botulinum Toxin Type A .
• Botulinum Toxin Type A should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Botulinum Toxin Type A if you are pregnant. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Botulinum Toxin Type A while you are pregnant. It is not known if Botulinum Toxin Type A is found in breast milk. If you are or will be breast-feeding while you use Botulinum Toxin Type A , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Botulinum Toxin Type A :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; back pain; dizziness; drowsiness; dry eyes; dry mouth; eye irritation; facial pain; flu-like symptoms; headache; inability to focus eyes; increased cough; nausea; neck pain; pain, redness, swelling, or tenderness at the injection site; runny nose; sensitivity to light; sweating; upset stomach; weakness of the muscles at or near the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding at the injection site; chest pain; difficulty swallowing; drooping of the upper eyelid; eyelid swelling; fever; irregular heartbeat; paralysis; pneumonia; seizures; shortness or breath; speech changes or problems; unusual weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Botulinum Toxin Type A is usually handled and stored by a health care provider. If you are using Botulinum Toxin Type A at home, store Botulinum Toxin Type A as directed by your pharmacist or health care provider. Keep Botulinum Toxin Type A out of the reach of children and away from pets.

General information:

• If you have any questions about Botulinum Toxin Type A , please talk with your doctor, pharmacist, or other health care provider.
• Botulinum Toxin Type A is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Botulinum Toxin Type A . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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