Botox



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Generic Name: botulinum toxin type A
(BOT ue LYE num TOX in type A)

What is the most important information I should know about Botox?

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected.This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection.

Botulinum toxin injections should be given only by a trained medical professional, even when used for cosmetic purposes.

Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

You should not receive this medication if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.

Before receiving a botulinum toxin injection, tell your doctor if you have ALS ( Lou Gehrig's disease), myasthenia gravis, Lambert-Eaton syndrome, or heart disease.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

What is this drug?

Botox is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

Botox is used to treat cervical dystonia (severe spasms in the neck muscles), or severe underarm sweating (hyperhidrosis).

Botox is also used to treat certain eye muscle conditions caused by nerve disorders. This includes uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes do not point in the same direction.

Botox is also used to temporarily lessen the appearance of facial wrinkles.

Botox may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before I receive Botox?

You should not receive this medication if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive this medication.

  • amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease")
  • myasthenia gravis
  • Lambert-Eaton syndrome; or
  • heart disease.
  • Botox is made using human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

    FDA pregnancy category C. It is not known whether botulinum toxin is harmful to an unborn baby. Before you receive this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

    It is not known whether botulinum toxin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

    How is Botox given?

    Botox is given as an injection into a muscle. A doctor, nurse, or other healthcare provider will give you this injection.

    Botulinum toxin injections should be given only by a trained medical professional, even when used for cosmetic purposes.

    Your botulinum toxin injection may be given into more than one area at a time, depending on the condition being treated.

    While receiving botulinum toxin injections for an eye muscle conditions, you may need to use eye drops, ointment, a special contact lens or other device to protect the surface of your eye. Follow your doctor's instructions.

    If you are being treated for excessive sweating, shave your underarms about 24 hours before you will receive your injection. Do not apply underarm antiperspirants or deodorants for 24 hours before you receive the injection. Avoid exercise and hot foods or beverages within 30 minutes before the injection.

    It may take up to 2 weeks after injection before neck muscle spasm symptoms begin to improve. You may notice the greatest improvement at 6 weeks after injection.

    It may take only 1 to 3 days after injection before eye muscle spasm symptoms begin to improve. You may notice the greatest improvement at 2 to 6 weeks after injection.

    The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

    Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

    Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

    What happens if I miss a dose?

    Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

    What happens if I overdose?

    Seek emergency medical attention if you think you have received too much of this medicine.

    Overdose symptoms may include muscle weakness, trouble swallowing, and weak or shallow breathing.

    What should I avoid after receiving Botox?

    Avoid using underarm antiperspirants or deodorants for 24 hours after a botulinum toxin injection if you are being treated for excessive underarm sweating.

    Avoid going back to your normal physical activities too quickly after receiving a botulinum toxin injection.

    What are the possible side effects of Botox?

    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

    The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected.This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

    Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an injection:

    • trouble breathing, talking, or swallowing
    • drooping eyelids
    • unusual or severe muscle weakness (especially in a body area that was not injected with the medication)
    • loss of bladder control
    • problems with vision or depth perception
    • crusting or drainage from your eyes
    • severe skin rash or itching; or
    • chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling.

    Less serious side effects may include:

    • muscle weakness near where the medicine was injected
    • bruising, bleeding, pain, or tenderness where the injection was given
    • headache, muscle stiffness, neck or back pain
    • fever, cough, sore throat, runny nose, nausea, flu symptoms,
    • dizziness, drowsiness, anxiety
    • dry mouth, dry eyes
    • increased sweating in areas other than the underarms
    • itchy or watery eyes, increased sensitivity to light; or
    • eyelid swelling or bruising.

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    What other drugs will affect Botox?

    Before you receive this medication, tell your doctor if you are also taking:

    • an antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), paromomycin (Humatin, Paromycin), streptomycin, tobramycin (Nebcin, Tobi).

    This list is not complete and there may be other drugs that can interact with Botox. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

    Where can I get more information?

    Your doctor or pharmacist can provide more information about Botox.

    Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.