Abobotulinumtoxina Intramuscular

Name: Abobotulinumtoxina Intramuscular

Uses For abobotulinumtoxina

AbobotulinumtoxinA is used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). abobotulinumtoxina is also used cosmetically to improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines). It is also used to treat upper and lower limb spasms.

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

abobotulinumtoxina is available only with your doctor's prescription and will be administered by your doctor.

Before Using abobotulinumtoxina

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 abobotulinumtoxina, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to abobotulinumtoxina 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 have not been performed on the relationship of age to the effects of abobotulinumtoxinA in children with cervical dystonia or upper limb spasms, and in children younger than 2 years of age with lower limb spasms. Safety and efficacy have not been established.

Use of abobotulinumtoxinA 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 abobotulinumtoxinA in the elderly. However, elderly patients are more sensitive to the effects of abobotulinumtoxina than younger adults and are more likely to have falls, weakness, or side effects related to the eyes, which may require caution in patients receiving abobotulinumtoxinA for lower limb spasticity and glabellar lines.

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 abobotulinumtoxina. 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 and 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 (eg, asthma, emphysema) or
  • Dysphagia (trouble swallowing) or
  • Ptosis (droopy eyelid)—Use with caution. May make these conditions worse.
  • Cow's milk protein allergy, history of or
  • Infection at the injection site—Should not be used in patients with these conditions.

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 to prevent migraines, side effects such as headache, neck pain, and drooping eyelid may occur.

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.

When this medication is used for overactive bladder, side effects such as urinary tract infections, burning/painful urination, fever, or difficulty urinating 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 rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.

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

List Abobotulinumtoxina Solution, Reconstituted (Recon Soln) side effects by likelihood and severity.

Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as cow's milk protein found in some products), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor your medical history, especially of: bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, signs of infection near the injection site, urinary tract infection, inability to urinate, muscle/nerve disorders (such as Lou Gehrig's disease-ALS, myasthenia gravis), seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia), treatment with any botulinum toxin product (especially in the last 4 months).

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.

Some brands of this medication contain albumin made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get serious infections from the medication. Consult your doctor or pharmacist for more information.

Older adults using this drug for overactive bladder may be more sensitive to the side effects of this drug, especially urinary effects.

Children using this drug for muscle spasms may be more sensitive to the side effects of this drug, including 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.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: certain antibiotics (e.g., aminoglycosides such as gentamicin, polymyxin), anticoagulants (e.g., warfarin), Alzheimer's disease drugs (e.g., galantamine, rivastigmine, tacrine), myasthenia gravis drugs (e.g., ambenonium, pyridostigmine), quinidine.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. An antitoxin is available but must be used before symptoms of overdose become apparent. Symptoms of overdose may be delayed, and may include serious muscle weakness, breathing problems and paralysis.

Notes

It is important to understand the risks and benefits of this therapy. Discuss any questions or concerns with your health care professional.

Missed Dose

Not applicable.

Storage

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.Information last revised May 2017. Copyright(c) 2017 First Databank, Inc.

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