botulinum toxin type A

Generic Name: onabotulinumtoxinA (Botox) (ON a BOT ue LYE num TOX in A)
Brand Name: Botox, Botox Cosmetic

What is onabotulinumtoxinA (Botox)?

OnabotulinumtoxinA (Botox), also called botulinum toxin type A, 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), muscle spasms in the arms and hands, and 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 Cosmetic is used to temporarily lessen the appearance of facial wrinkles.

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

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 a hoarse voice, 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, a breathing disorder, trouble swallowing, facial muscle weakness, a change in the appearance of your face, seizures, bleeding problems, heart disease, if you have had or will have surgery, or if you have ever received other botulinum toxin injections such as Dysport or Myobloc.

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 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. Tell your doctor if you have ever had a side effect after receiving a botulinum toxin in the past

If you have any of these other conditions, you may need a dose adjustment or special tests:

  • amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");

  • myasthenia gravis;

  • Lambert-Eaton syndrome;

  • a breathing disorder such as asthma or emphysema;

  • problems with swallowing;

  • facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);

  • a change in the normal appearance of your face;

  • a seizure disorder;

  • bleeding problems;

  • heart disease;

  • if you have had or will have surgery (especially on your face); or

  • if you have ever received other botulinum toxin injections such as Dysport or Myobloc (especially in the last 4 months).

Botox is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but 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 will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication..

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?

This medication is injected into a muscle. A doctor, nurse, or other healthcare provider will give you this injection. Botox injections should be spaced at least 3 months apart.

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

Your 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 or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, and weak or shallow breathing.

What should I avoid after receiving Botox?

Botox may impair your vision or depth perception. Be careful if you drive or do anything that requires you to be able to see clearly.

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 an injection.

Botox side effects

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

The botulinum toxin contained in Botox 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;

  • hoarse voice, 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;

  • crusting or drainage from your eyes;

  • severe skin rash or itching;

  • fast, slow, or uneven heartbeats; 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, redness, or swelling where the injection was given;

  • headache, muscle stiffness, neck or back pain;

  • fever, cough, sore throat, runny nose, flu symptoms,

  • dizziness, drowsiness, tired feeling;

  • nausea, diarrhea, stomach pain, loss of appetite;

  • dry mouth, dry eyes, ringing in your ears;

  • 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.

Botulinum toxin type A dosing information

Usual Adult Dose for Blepharospasm:

onabotulinumtoxinA (Botox):
1.25 to 2.5 units (0.05 to 0.1 mL) intramuscularly each into the medial and lateral pretarsal orbicularis oculi of the upper lid and into the lateral pretarsal orbicularis oculi of the lower lid. The cumulative dose of botulinum toxin type A in a 30 day period should not exceed 200 units.

Usual Adult Dose for Cervical Dystonia:

For use in the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain:

abobotulinumtoxinA (Dysport):
Recommended initial dose: 500 units given intramuscularly as a divided dose among affected muscles in patients with or without a history of prior treatment with botulinum toxin.

Below is a description of the average abobotulinumtoxinA dose, as well as the minimum & maximum dose injected into specific muscles in the pivotal clinical trials:
Muscle: Median Dose (Minimum & Maximum Dose)
Sternocleidomastoid: 125 units (50, 350)
Splenius capitis: 200 units (75, 450)
Trapezius: 102.6 units (50, 300)
Levator scapulae: 105.3 units (50, 200)
Semispinalis capitis: 131.6 units (50, 250)
Longissimus: 150 units (100, 200)

Limiting the dose injected into the sternocleidomastoid muscle may reduce the occurrence of dysphagia. Clinical studies with abobotulinumtoxinA in cervical dystonia suggest that the peak effect occurs between two and four weeks after injection. Simultaneous EMG-guided application of abobotulinumtoxinA may be helpful in locating active muscles not identified by physical examination alone.

Where dose modification is necessary for the treatment of cervical dystonia, uncontrolled open-label studies suggest that dose adjustment can be made in 250 unit steps according to the individual patient's response, with retreatment every 12 weeks or longer, as necessary, based on return of clinical symptoms. Uncontrolled open-label studies also suggest that the total dose administered in a single treatment should be between 250 units and 1000 units.

Retreatment, if needed, should not occur in intervals of less than 12 weeks. Doses above 1000 Units have not been systematically evaluated.

The starting dose of 500 units recommended for cervical dystonia is applicable to adults of all ages.

onabotulinumtoxinA (Botox):
In a phase 3 study of patients who had previously received and tolerated botulinum toxin type A, the mean dose administered was 236 units (25th to 75th percentile range 198 to 300 units) divided among the affected muscle groups. Limiting the total dose injected into the sternocleidomastoid muscles to 100 units or less may decrease the occurrence of dysphagia.

Usual Adult Dose for Strabismus:

onabotulinumtoxinA (Botox):
Vertical muscles and/or horizontal strabismus of less than 20 prism diopters: 1.25 to 2.5 units in any one muscle.

Horizontal strabismus of 20 to 50 prism diopters: 2.5 to 5 units in any one muscle.

Persistent VI nerve palsy of 1 month or longer duration: 1.25 to 2.5 units in the medial rectus muscle.

Paralysis of injected muscles typically occur 1 to 2 days after the initial injection, lasts 2 to 6 weeks, and resolves over a similar time period.

Usual Adult Dose for Hyperhidrosis:

onabotulinumtoxinA (Botox):
50 units injected intradermally in 0.1 to 0.2 mL aliquots to each axilla distributed evenly in multiple sites (10 to 15) 1 to 2 cm apart.

Inject each dose to a depth of approximately 2 mm and at a 45 degree angle to the skin surface with the bevel side up.

If injection sites are marked in ink do not inject directly through the ink mark to avoid a permanent tattoo mark.

Usual Adult Dose for Glabellar Lines:

abobotulinumtoxinA (Dysport):
50 units divided into 5 equal aliquots of 10 units each, should be administered to affected muscles to achieve clinical effect.
Retreatment should be no more frequently than every 3 months.

onabotulinumtoxinA (Botox):
4 units IM into each of five sites, two in each corrugator muscle and one in the procerus muscle for a total of 20 units.

Usual Adult Dose for Upper Limb Spasticity:

onabotulinumtoxinA (Botox):
Dosing in initial and sequential treatment sessions should be tailored to the individual based on the size, number and location of muscles involved, severity of spasticity, the presence of local muscle weakness, the patient's response to previous treatment, or adverse event history with onabotulinumtoxinA.

In clinical trials, doses of onabotulinumtoxinA ranging from 75 units to 360 units were divided among selected muscles at a given treatment session.

Recommended dose ranges per muscle:
Biceps Brachii: 100 to 200 units divided in 4 sites
Flexor Carpi Radialis: 12.5 to 50 units in 1 site
Flexor Carpi Ulnaris: 12.5 to 50 units in 1 site
Flexor Digitorum Profundus: 30 to 50 units in 1 site
Flexor Digitorum Sublimis: 30 to 50 units in 1 site

The lowest recommended starting dose should be used, and no more than 50 units per site should generally be administered. Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques is recommended.

Repeat treatment may be administered when the effect of a previous injection has diminished, but generally no sooner than 12 weeks after the previous injection. The degree and pattern of muscle spasticity at the time of reinjection may necessitate alterations in the dose and muscles to be injected.

Usual Pediatric Dose for Strabismus:

onabotulinumtoxinA (Botox):
The safety and efficacy of botulinum toxin type A for treatment of strabismus in children less than 12 years have not been established.

Vertical muscles and/or horizontal strabismus of less than 20 prism diopters: 1.25 to 2.5 units in any one muscle.

Horizontal strabismus of 20 to 50 prism diopters: 2.5 to 5 units in any one muscle.

Persistent VI nerve palsy of one month or longer duration: 1.25 to 2.5 units in the medial rectus muscle.

Paralysis of injected muscles typically occur 1 to 2 days after the initial injection, lasts 2 to 6 weeks, and resolves over a similar time period.

Usual Pediatric Dose for Cervical Dystonia:

onabotulinumtoxinA (Botox):
The safety and efficacy of botulinum toxin type A for the treatment of cervical dystonia in children less than 16 years have not been established.

In a phase 3 study of patients who had previously received and tolerated botulinum toxin type A, the mean dose administered was 236 units (25th to 75th percentile range 198 to 300 units) divided among the affected muscle groups. Limiting the total dose injected into the sternocleidomastoid muscles to 100 units or less may decrease the occurrence of dysphagia.

Usual Pediatric Dose for Blepharospasm:

onabotulinumtoxinA (Botox):
The safety and efficacy of botulinum toxin type A for the treatment of blepharospasm in children less than 12 years have not been established.

1.25 to 2.5 units (0.05 to 0.1 mL) intramuscularly each into the medial and lateral pretarsal orbicularis oculi of the upper lid and into the lateral pretarsal orbicularis oculi of the lower lid. The cumulative dose of botulinum toxin type A in a 30 day period should not exceed 200 units.

What other drugs will affect Botox?

Other medications such as cold or allergy medicine, muscle relaxers, sleeping pills, bronchodilators, bladder or urinary medicines, and irritable bowel medicines can increase some of the side effects of Botox. Tell your doctor if you regularly use any of these medications.

Tell your doctor about all other medications you use, especially:

  • an injected 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 (onabotulinumtoxinA).
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Revision Date: 2010-03-17, 3:56:50 PM.

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