Botox

DRUG DESCRIPTION

BOTOX (onabotulinumtoxinA) for injection is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.

The primary release procedure for BOTOX uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to Allergan's products BOTOX and BOTOX® Cosmetic. One Unit of BOTOX corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. Due to specific details of this assay such as the vehicle, dilution scheme, and laboratory protocols, Units of biological activity of BOTOX cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX is approximately 20 Units/nanogram of neurotoxin protein complex.

Each vial of BOTOX contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.

What are the possible side effects of botulinum toxin type A (Botox, Botox Cosmetic, Dysport)?

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...

Read All Potential Side Effects and See Pictures of Botox »

What are the precautions when taking botulinum toxin type a (Botox)?

Before using this medication, tell your doctor your medical history, especially of: any allergies, bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, signs of infection near the injection site, muscle/nerve disorders such as Lou Gehrig's disease (ALS) or myasthenia gravis, seizures, trouble swallowing (dysphagia), pneumonia (aspiration-type).

This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Caution is advised if using this drug in children for muscle...

Read All Potential Precautions of Botox »


Botox Consumer (continued)

SIDE EFFECTS: Because this medication is given at the site of your condition, most of the side effects occur close to where the medication is injected. Redness, bruising, infection, and pain at the injection site may occur.

Dizziness, mild difficulty swallowing, respiratory infections such as cold or flu, pain, nausea, headache, and muscle weakness may occur when this medication is used to relax muscles. Double vision, drooping or swollen eyelid, eye irritation, dry eyes, tearing, reduced blinking, and increased sensitivity to light may also occur.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly. You may require protective eye drops/ointments, an eye patch, or other treatment.

When this medication is used for excessive sweating, side effects such as non-underarm sweating, respiratory infections such as cold or flu, headache, fever, neck or back pain, and anxiety may occur.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: itching/swelling (especially of the face/tongue/throat), rash, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor your medical history, especially of: any allergies, bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, signs of infection near the injection site, muscle/nerve disorders such as Lou Gehrig's disease (ALS) or myasthenia gravis, seizures, trouble swallowing (dysphagia), pneumonia (aspiration-type).

This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Caution is advised if using this drug in children for muscle spasms, because they may be more sensitive to its possible side effects (such as difficulty breathing or swallowing). See Warning section. Discuss the risks and benefits with the doctor.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Use for the cosmetic treatment of wrinkles is not recommended during pregnancy.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding


Botox Patient Information Including Side Effects

Brand Names: Botox, Botox Cosmetic, Dysport

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

  • What is this drug (Botox)?
  • What are the possible side effects of botulinum toxin type A (Botox)?
  • What is the most important information I should know about botulinum toxin type A (Botox)?
  • What should I discuss with my healthcare provider before I receive botulinum toxin type A (Botox)?
  • How is botulinum toxin type A given (Botox)?
  • What happens if I miss a dose (Botox)?
  • What happens if I overdose (Botox)?
  • What should I avoid after receiving botulinum toxin type A (Botox)?
  • What other drugs will affect botulinum toxin type A (Botox)?
  • Where can I get more information?

What is this drug (Botox)?

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.

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

Botulinum toxin type A 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.

Botulinum toxin type A is also used to temporarily lessen the appearance of facial wrinkles.

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

What are the possible side effects of botulinum toxin type A (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 is the most important information I should know about botulinum toxin type A (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. You should not receive the Dysport brand of this medication if you are allergic to cow's milk.

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.

Related Drug Centers
  • Botox


Related Drugs Index: