Generic Name: onabotulinumtoxina (ON-a-BOT-ue-LYE-num-TOX-in-AY)
Brand Name: Botox Cosmetic
OnabotulinumtoxinA may spread from the injection site to other areas of the body, causing symptoms of a serious condition called botulism. These symptoms may occur hours to weeks after you receive onabotulinumtoxinA. Symptoms may include loss of strength; muscle weakness; double or blurred vision; drooping eyelids; hoarseness; change or loss of voice; loss of bladder control; or trouble speaking, breathing, or swallowing. The risk may be greater in children being treated for spasticity (muscle spasms), but these symptoms may also occur in adults. OnabotulinumtoxinA is not approved for use in children. Contact your doctor immediately if these symptoms occur.
Severe and sometimes fatal breathing or swallowing problems have been reported. The risk may be greater in patients who already have breathing or swallowing problems. Tell your doctor if you have or are at risk of developing breathing or swallowing problems.
OnabotulinumtoxinA is used for:
Temporarily improving the appearance of moderate to severe frown lines and lines around the eyes (crows feet) in adults. It may also be used for other conditions as determined by your doctor.
OnabotulinumtoxinA is a neurotoxin. It works by blocking nerve impulses to the muscles or sweat glands, temporarily paralyzing the muscle or gland.
Do NOT use onabotulinumtoxinA if:
- you are allergic to any ingredient in onabotulinumtoxinA or another botulinum product
- you have an infection at the injection site
- you are being treated for loss of bladder control and you also have a urinary tract infection
Contact your doctor or health care provider right away if any of these apply to you.
Before using onabotulinumtoxinA:
Some medical conditions may interact with onabotulinumtoxinA. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have nerve problems or disease (eg, amyotrophic lateral sclerosis, motor neuropathy), muscle problems or disease (eg, Lambert-Eaton syndrome, myasthenia gravis), bleeding disorders, seizures, severe weakness or wasting of the muscles at the injection site (eg, trouble raising your eyebrows, drooping eyelids), or very poor health
- if you have a history of heart problems (eg, irregular heartbeat, a recent heart attack), swallowing or breathing problems (eg, asthma), or eye problems (eg, glaucoma, drooping eyelid)
- if you have a skin infection or inflammation, scarring, or other skin disorders at the injection site
- if you plan to have surgery, especially surgery on your face, or if you have received onabotulinumtoxinA or any other botulinum toxin within the past 4 months
- if you have weakness in your forehead muscles, have had any change in the way your face normally looks, have any other facial conditions, or you have had surgery on your face
- if you are being treated for loss of bladder control, especially if you cannot empty your bladder on your own
- if you are taking an allergy or cold medicine
Some MEDICINES MAY INTERACT with onabotulinumtoxinA. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Aminoglycoside antibiotics (eg, gentamicin), muscle relaxants (eg, cyclobenzaprine), neuromuscular blockers (eg, atracurium), or sleep medicines (eg, zolpidem) because they may increase the risk of onabotulinumtoxinA's side effects
- Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), or aspirin because the risk of bleeding at the injection site may be increased
- Anticholinergic medicines (eg, scopolamine, oxybutynin) because the risk of their side effects may be increased by onabotulinumtoxinA
This may not be a complete list of all interactions that may occur. Ask your health care provider if onabotulinumtoxinA may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use onabotulinumtoxinA:
Use onabotulinumtoxinA as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- OnabotulinumtoxinA comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get onabotulinumtoxinA refilled.
- OnabotulinumtoxinA is usually given as an injection at your doctor's office, hospital, or clinic.
- If you miss a dose of onabotulinumtoxinA, contact your doctor.
Ask your health care provider any questions you may have about how to use onabotulinumtoxinA.
Important safety information:
- OnabotulinumtoxinA may cause loss of strength, weakness, blurred vision, or drooping eyelids. These effects may be worse if you take it with alcohol or certain medicines. Use onabotulinumtoxinA with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT use more than the recommended dose or use onabotulinumtoxinA more often than every 3 months without checking with your doctor.
- Tell your doctor or dentist that you take onabotulinumtoxinA before you receive any medical or dental care, emergency care, or surgery.
- Do not switch brands of onabotulinumtoxinA. Contact your doctor if you have any questions.
- OnabotulinumtoxinA contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used onabotulinumtoxinA.
- OnabotulinumtoxinA should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using onabotulinumtoxinA while you are pregnant. It is not known if onabotulinumtoxinA is found in breast milk. If you are or will be breast-feeding while you use onabotulinumtoxinA, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of onabotulinumtoxinA:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Anxiety; dry mouth; dry or irritated eyes; facial pain; flu-like symptoms; headache; inability to focus eyes; nausea; neck pain; pain, redness, swelling, or tenderness at the injection site; stiff or weak muscles at or near the injection site; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); bleeding at the injection site; burning, numbness, or tingling; chest, jaw, or arm pain; difficulty swallowing or breathing; drooping of the upper eyelid; eyelid swelling; fainting; irregular heartbeat; loss of bladder control; loss of strength; paralysis; seizures; severe or persistent eye dryness or irritation; severe or persistent muscle weakness or dizziness; shortness of breath; speech changes or problems; sudden severe nausea or vomiting; unusual sweating or weakness; vision changes (eg, double vision, blurred vision).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of onabotulinumtoxinA:
OnabotulinumtoxinA is usually handled and stored by a health care provider. If you are using onabotulinumtoxinA at home, store onabotulinumtoxinA as directed by your pharmacist or health care provider. Keep onabotulinumtoxinA out of the reach of children and away from pets.
- If you have any questions about onabotulinumtoxinA, please talk with your doctor, pharmacist, or other health care provider.
- OnabotulinumtoxinA is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take onabotulinumtoxinA or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about onabotulinumtoxinA. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to onabotulinumtoxinA. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using onabotulinumtoxinA.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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