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Botox

Generic Name: botulinum toxin type a (Intramuscular route)

BOT-yoo-li-num TOX-in type A

Commonly used brand name(s):

In the U.S.

  • Botox
  • Botox Cosmetic

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Musculoskeletal Agent

Pharmacologic Class: Neuromuscular Blocker, Non-Depolarizing

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Uses For Botox

Botulinum toxin type A is used to treat certain eye conditions, such as blepharospasm (a condition in which the eyelid will not stay open, because of a spasm of a muscle of the eye) or strabismus (a condition in which the eyes do not line up properly). This medicine is also used to treat abnormal head position and neck pain that are a result of cervical dystonia (muscle spasms of the neck) and some types of primary axillary hyperhidrosis of the armpits (severe sweating of the armpits) . Botulinum toxin type A is also used cosmetically to improve the appearance of deep facial lines or wrinkles .

Botulinum toxin type A is injected into the muscles that are affected. Depending on your condition, more than one treatment may be required.

This medicine is to be administered only by, or under the immediate supervision of, your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, botulinum toxin type A is used in certain patients with the following medical conditions:

  • Frey's syndrome (gustatory sweating) (red area and sweating on the cheek while eating)
  • Palmar hyperhidrosis (severe sweating of the palms)
  • Spasms of the arms, feet, hands, or legs caused by brain injury, multiple sclerosis, spinal cord injury, or stroke
  • Spasms of the arms and legs in stroke patients
  • Spasms of the face
  • Spasms of the hand, including writer's cramp and musician's cramp
  • Spasms of the arms and legs in patients with multiple sclerosis
  • Spasms of the vocal cords

Before Using Botox

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

In deciding to receive a medicine, the risks of receiving the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For botulinum toxin type A, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of botulinum toxin type A in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Elderly people are especially sensitive to the effects of some medicines. This may increase the chance of side effects during treatment.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Amyotrophic lateral sclerosis (Lou Gehrig's disease) or
  • Lambert-Eaton syndrome or
  • Motor neuropathy or
  • Myasthenia gravis—These medical problems may increase your risk for severe swallowing or breathing problems.
  • Heart problems or other medical conditions that may worsen with rapidly increasing activity—Treatment with botulinum toxin type A may give you better vision and the desire to become more active in your daily life; this may put a strain on your heart and body.
  • Infection where botulinum toxin type A is to be injected—Botulinum toxin type A should not injected into an area that is infected.
  • Infection with Clostridium botulinum toxin (botulism poisoning), history of—Persons with a history of infection with Clostridium botulinum toxin (botulism poisoning) may have produced antibodies that may interfere with botulinum toxin type A therapy and it may not work as well.
  • Nerve problems—May increase your chance of getting side effects.
  • Swallowing problems—Treatment with botulinum toxin type A may make this problem worse and increase your risk for serious side effects. Tell your doctor right away if you have severe swallowing problems.
  • Swelling where botulinum toxin type A is to be injected or
  • Weakness in the muscles where botulinum toxin type A is to be injected—Your doctor may decrease your dose or not inject the botulinum toxin type A until these problems are better.


Proper Use of botulinum toxin type a

This section provides information on the proper use of a number of products that contain botulinum toxin type a. It may not be specific to Botox. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form:
    • For certain eye conditions:
      • Adults and children 12 years of age and older—One or more injections into the muscles around the eyes one or more times, depending on the condition being treated.
      • Children up to 12 years of age—Use and dose must be determined by your doctor.
    • For muscle spasms of the neck (cervical dystonia):
      • Adults and children 16 years of age and older—One or more injections into the muscles of the neck one or more times, depending on the condition being treated.
      • Children up to 16 years of age—Use and dose must be determined by your doctor.
    • For severe sweating of the armpits (primary axillary hyperhidrosis):
      • Adults and children 16 years of age and older—One or more injections just below the skin in the armpit one or more times.
      • Children up to 16 years of age—Use and dose must be determined by your doctor.

Precautions While Using Botox

Rarely, serious reactions have occurred within days or weeks after receiving this medicine. If you start to have muscle weakness or trouble swallowing, talking, or breathing, call your doctor right away. In some situations, these problems could be life-threatening .

After you have received this medicine and your vision is better, you may find that you are a lot more active than you were before. You should increase your activities slowly and carefully to allow your heart and body time to get stronger. Also, before you start any exercise program, check with your doctor.

Botox Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common
  • Difficulty swallowing
Rare
  • Difficulty breathing or speaking
  • muscle weakness
More common—For blepharospasm
  • Dryness of the eye
  • inability to close the eyelid completely
Less common or rare—For blepharospasm
  • Decreased blinking
  • irritation of the cornea (colored portion) of the eye
  • turning outward or inward of the edge of the eyelid

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common—For blepharospasm
  • Blue or purplish bruise on eyelid
  • drooping of the upper eyelid
  • irritation or watering of the eye
  • sensitivity of the eye to light
More common—For cervical dystonia
  • Body aches or pain
  • chills
  • cough, fever, sneezing, or sore throat
  • difficulty in breathing
  • difficulty swallowing
  • ear congestion
  • headache
  • loss of voice
  • nasal congestion
  • neck pain
  • runny nose
  • unusual tiredness or weakness
More common—For horizontal strabismus
  • Drooping of the upper eyelid
  • eye pointing upward or downward instead of straight ahead
More common—For hyperhidrosis
  • Back, neck, or side pain
  • body aches or pain
  • chills
  • congestion
  • cough
  • diarrhea
  • dryness or soreness of throat
  • fear
  • fever
  • general feeling of discomfort or illness
  • headache
  • heavy bleeding from place where shot was given
  • hoarseness
  • itching skin
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • painful or difficult urination
  • runny nose
  • shivering
  • sore throat
  • sweating
  • tender, swollen glands in neck
  • trouble sleeping
  • trouble in swallowing
  • unusual tiredness or weakness
  • voice changes
  • vomiting
Less common or rare—For blepharospasm or strabismus
  • Skin rash
  • swelling of the eyelid skin
Less common or rare—For horizontal strabismus
  • Difficulty finding the location of objects
  • double vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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