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Drugs reference index «onabotulinumtoxina Intramuscular»

onabotulinumtoxina (Intramuscular route)

on-a-BOT-yoo-li-num-TOX-in-A

Intramuscular routePowder for Solution
  • Distant Spread of Toxin Effect
    • Postmarketing reports indicate that the effects of onabotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses .

The effects of onabotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. Cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses .

Intradermal routePowder for Solution
  • Distant Spread of Toxin Effect
    • Postmarketing reports indicate that the effects of onabotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses .

The effects of onabotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. Cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses .

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

Uses For onabotulinumtoxina

OnabotulinumtoxinA is used to treat certain eye conditions, such as blepharospasm (a condition where the eyelid will not stay open because of a muscle spasm) or strabismus (a condition where the eyes do not line up properly). onabotulinumtoxina is also used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck) and some types of axillary hyperhidrosis (severe sweating of the armpits). OnabotulinumtoxinA is used cosmetically to improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines).

OnabotulinumtoxinA is a botulinum toxin A product. It works on the nervous system to relax the muscles.

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

onabotulinumtoxina is available only with your doctor's prescription and will be administered by 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, onabotulinumtoxinA is used in certain patients with the following medical conditions:

  • Frey's syndrome or gustatory sweating (red areas and sweating on the cheeks and ears after eating).
  • Palmar and plantar hyperhidrosis (severe sweating of the palms and feet).
  • Spasms of the arms in stroke patients.
  • Spasms of the face.
  • Spasms of the feet and hands, including writer's cramp.
  • Spasms of the arms and legs in patients with multiple sclerosis.

Before Using onabotulinumtoxina

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 onabotulinumtoxina, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to onabotulinumtoxina 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of onabotulinumtoxinA in children. However, safety and effectiveness have not been established in children younger than 12 years of age for blepharospasm or strabismus, or in children younger than 16 years of age for cervical dystonia, or in children younger than 18 years of age for hyperhidrosis. Use of onabotulinumtoxinA to treat glabellar lines is not recommended in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of onabotulinumtoxinA in the elderly.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal 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 onabotulinumtoxina. Make sure you tell your doctor if you have any other medical problems, especially:

  • Amyotrophic lateral sclerosis (Lou Gehrig's disease) or
  • Dermatochalasis (a skin problem) or
  • Lambert-Eaton syndrome (nerve-muscle disorder) or
  • Motor neuropathy (muscle or nerve problem) or
  • Myasthenia gravis (severe muscle weakness) or
  • Sebaceous skin, thick (oily or fatty skin) or
  • Surgery on the face, history of—May increase risk for more serious side effects.
  • Breathing problems (e.g., asthma or emphysema) or
  • Dysarthria (trouble with speaking) or
  • Dysphagia (trouble with swallowing) or
  • Dysphonia (voice problem) or
  • Heart attack, recent or history of or
  • Heart disease or
  • Heart rhythm problems or
  • Ptosis (droopy eyelid) or
  • Urinary incontinence (problems passing urine)—Use with caution. May make these conditions worse.
  • Infection at the injection site—Should not be used in patients with this condition.

Proper Use of onabotulinumtoxina

Your doctor will give you onabotulinumtoxina in a hospital or clinic. onabotulinumtoxina is given as a shot into one of your muscles.

onabotulinumtoxina should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor will only use onabotulinumtoxinA (Botox® or Botox® Cosmetic) to treat your condition. Other botulinum toxin products may not work the same way and require a different dose.

Precautions While Using onabotulinumtoxina

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Serious muscle reactions have occurred within hours to weeks after receiving onabotulinumtoxina. If you start to have muscle weakness, loss of bladder control, or trouble with swallowing, talking, or breathing, call your doctor right away. In some patients, these problems could be life-threatening and may require treatment in a hospital or clinic.

onabotulinumtoxina may make your muscles weak and cause vision problems. Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well.

onabotulinumtoxina may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using onabotulinumtoxina.

After you have received onabotulinumtoxina and your vision or muscle spasms are better, you may find that you are a lot more active than you were before. You should slowly increase your activities to allow time for your body to get stronger. Also, before you start an exercise program, check with your doctor.

One part of onabotulinumtoxina is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

onabotulinumtoxina 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 or nurse immediately if any of the following side effects occur:

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

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 the eyelids
  • drooping of the upper eyelids
  • irritation or watering of the eyes
  • sensitivity of the eyes to light
More common—for cervical dystonia
  • Body aches or pain
  • chills
  • cough, fever, sneezing, or sore throat
  • ear congestion
  • headache
  • loss of voice
  • nasal congestion
  • neck pain
  • runny nose
  • unusual tiredness or weakness
More common—for hyperhidrosis
  • Back, neck, or side pain
  • body aches or pain
  • chills
  • congestion
  • cough
  • diarrhea
  • dryness or soreness of the throat
  • fear
  • fever
  • general feeling of discomfort or illness
  • headache
  • heavy bleeding from the 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
  • sweating
  • tender, swollen glands in the neck
  • trouble sleeping
  • trouble swallowing
  • voice changes
  • vomiting
More common—for strabismus
  • Drooping of the upper eyelid
  • eye pointing upward or downward instead of straight ahead
Less common or rare—for blepharospasm
  • Skin rash
  • swelling of the eyelid skin
Less common or rare—for 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.

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

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