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Drugs reference index «botulinum toxin type B»

botulinum toxin type B
botulinum toxin type B


botulinum toxin type B

Generic Name: botulinum toxin type B (BOT ue LYE num TOX in type B)Brand Names: Myobloc

What is this drug?

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

Botulinum toxin type B is used to treat cervical dystonia (severe spasms in the neck muscles).

Botulinum toxin type B may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about botulinum toxin type B?

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. 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, or Lambert-Eaton syndrome.

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 botulinum toxin type B?You should not receive this medication if you are allergic to botulinum toxin.

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; or

  • Lambert-Eaton syndrome.

Botulinum toxin type B 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 know 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 botulinum toxin type B given?

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

It may take up about 4 weeks after injection before neck muscle spasm symptoms begin to improve.

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 botulinum toxin type B?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you receive a botulinum toxin injection.

Botulinum toxin type B side effects

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;

  • unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

  • loss of bladder control; or

  • chest pain.

Less serious side effects may include:

  • dry mouth, nausea, upset stomach;

  • pain where the injection was given;

  • headache, back or joint pain;

  • cough, runny nose, throat, flu symptoms;

  • pain or stiffness in your neck;

  • dizziness, drowsiness, anxiety; or

  • muscle weakness near where the medicine was injected.

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 B Dosing Information

Usual Adult Dose for Cervical Dystonia:

Initial: The dose should be individualized based on the patient's head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history. Patients with a prior history of tolerating botulinum toxin injections: 2500 to 5000 units (0.5 to 1.0 mL) divided among affected muscles.Patients with no history of botulinum toxin type B: use should be at a lower dose, with subsequent dosing based on individual response. Clinical improvement generally begins within the first two weeks after injection with studies showing the duration of effect to be between 12 and 16 weeks at doses of 5000 units or 10,000 units.

Usual Adult Dose for Hyperhidrosis:

One method being used:Initial: 2880 units per axilla intradermally for a total dose of 5760 units. Dilute 5000 unit vial with 1.0 mL of saline in the vial. This dilution technique, when performed in the vial, yields 288 units per 0.1 mL of solution due to the slight overfill in the vial. With this dilution, inject 20 injections of 0.05 mL per axilla may be administered (with an approximate depth of 2 to 3 millimeters), resulting in a total dose of 2880 units per axilla. Injections should be scattered approximately every 2 square centimeters. 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:

For glabellar lines and other facial wrinkles: 0.1 mL (500 units) intradermally.

Usual Pediatric Dose for Cervical Dystonia:

The safety and efficacy of botulinum toxin type B for treatment of strabismus in children less than 12 years have not been established.Initial: The dosage of botulinum toxin type B for the treatment of cervical dystonia should be individualized based on the patient's head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history. Patients with a prior history of tolerating botulinum toxin injections: 2500 to 5000 units (0.5 to 1.0 mL) intramuscularly divided among affected muscles.Patients with no history of botulinum toxin type B: use should be at a lower dose, with subsequent dosing based on individual response. Clinical improvement generally begins within the first two weeks after injection with studies showing the duration of effect to be between 12 and 16 weeks at doses of 5000 units or 10,000 units.

Usual Pediatric Dose for Hyperhidrosis:

One method being used:Initial: 2880 units per axilla intradermally for a total dose of 5760 units. Dilute 5000 unit vial with 1.0 mL of saline in the vial. This dilution technique, when performed in the vial, yields 288 units per 0.1 mL of solution due to the slight overfill in the vial. With this dilution, inject 20 injections of 0.05 mL per axilla may be administered (with an approximate depth of 2 to 3 millimeters), resulting in a total dose of 2880 units per axilla. Injections should be scattered approximately every 2 square centimeters. If injection sites are marked in ink do not inject directly through the ink mark (to avoid a permanent tattoo mark).

Usual Pediatric Dose for Glabellar Lines:

The safety and efficacy of botulinum toxin type B for treatment of strabismus in children less than 12 years have not been established.For glabellar lines and other facial wrinkles: 0.1 mL (500 units) intradermally.

What other drugs will affect botulinum toxin type B?

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 botulinum toxin type B. 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 botulinum toxin type B.
  • 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 1996-2006 Cerner Multum, Inc. Version: 1.05. Revision Date: 08/12/2009 10:48:50 AM.
  • Botulinum Toxin Type B MedFacts Consumer Leaflet (Wolters Kluwer)
  • Botulinum Toxin Type B Professional Patient Advice (Wolters Kluwer)
  • botulinum toxin type b Intramuscular Advanced Consumer (Micromedex) - Includes Dosage Information

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