Botox Cosmetic

Botox Cosmetic is a prescription medication used as a treatment to temporarily improve the appearance of wrinkles between the eyebrows, in the skin at the outer corner of your eyes, and forehead.

Botox Cosmetic is a toxin produced by bacteria. It belongs to a class of drugs called neurotoxins, which relax muscles by decreasing nerve signals to those muscles.

This medication comes in an injectable form and is injected into the muscle (IM) by a healthcare professional.

Common side effects include difficulty breathing and swallowing, dry mouth, and pain at the injection site.

Botox Cosmetic is a prescription medicine that is used for the temporary improvement of glabellar lines (wrinkles between the eyebrows, known as frown lines), in adults. It is also used for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults. In addition, Botox Cosmetic is used for the temporary improvement of forehead lines. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Allergan, Inc.

Botox Cosmetic can cause serious side effects including swallowing and breathing difficulties that can be life threatening. See the FDA Black Box Warning and "Drug Precautions" sections.

Other side effects include:

• dry mouth
• discomfort or pain at the injection site
• tiredness
• headache
• neck pain
• eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes
• urinary tract infection in people being treated for urinary incontinence  painful urination in people being treated for urinary incontinence 
• allergic reactions. Symptoms of an allergic reaction to Botox Cosmetic may include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. 

These are not all the possible side effects of Botox Cosmetic. Talk to your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products. Especially tell your doctor if you take:

• amikacin
• clindamycin (Cleocin)
• colistimethate (Coly-Mycin)
• gentamicin
• kanamycin
• lincomycin (Lincocin)
• neomycin (Neo-Fradin, Neo-Rx)
• polymyxin
• streptomycin
• tobramycin (Tobi)
• cholinesterase inhibitors such as ambenonium (Mytelase)
• donepezil (Aricept)
• galantamine (Razadyne)
• neostigmine (Prostigmin)
• physostigmine
• pyridostigmine (Mestinon, Regonol)
• rivastigmine (Exelon)
• tacrine (Cognex)
• magnesium sulfate
• medications for allergies, colds, or sleep
• muscle relaxants
• quinidine
• anti-platelets (aspirin-like products) and/or anti-coagulants (blood thinners) 

Also tell your doctor if you have received injections of any botulinum toxin product in the past four months. 

Tell your doctor have received injections of botulinum toxin, such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA) in the past. Be sure your doctor knows exactly which product you received.

This is not a complete list of Botox Cosmetic drug interactions. Ask your doctor or pharmacist for more information.

Botox Cosmetic may cause serious side effects that can be life threatening, including:

• Problems breathing or swallowing
• Spread of toxin effects

These problems can happen hours, days, to weeks after an injection of Botox Cosmetic. Call your doctor or get medical help right away if you have any of these problems after treatment with Botox Cosmetic.

Do not take Botox Cosmetic if you:

• are allergic to any of the ingredients in Botox Cosmetic
• had an allergic reaction to any other botulinum toxin product such as Myobloc, Dysport, or Xeomin
• have a skin infection at the planned injection site
• are being treated for urinary incontinence and have a urinary tract infection (UTI)
• are being treated for urinary incontinence and find that you cannot empty your bladder on your own (and you are not routinely catheterized)

Botox Cosmetic may cause loss of strength or general muscle weakness, or vision problems within hours to weeks of taking Botox Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Botox Cosmetic contains human albumin, a derivative of human blood. There is an extremely remote risk for transmission of viral diseases. This risk is reduced by effective donor screening and product manufacturing processes. No cases of transmission of viral diseases have ever been identified.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Botox Cosmetic there are no specific foods that you must exclude from your diet when receiving Botox Cosmetic.

Before receiving Botox Cosmetic tell your doctor about all your medical conditions, including if you:

• have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome)
• have allergies to any botulinum toxin product
• had any side effect from any botulinum toxin product in the past
• have or have had a breathing problem, such as asthma or emphysema
• have or have had swallowing problems
• have or have had bleeding problems
• have plans to have surgery
• had surgery on your face
• have weakness of your forehead muscles, such as trouble raising your eyebrows
• have drooping eyelids
• have any other change in the way your face normally looks
• have recently received an antibiotic by injection 
• have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence. Symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever.
• have problems emptying your bladder on your own and are being treated for urinary incontinence

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. There are no well-controlled studies that have been done in pregnant women. Botox Cosmetic should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Botox Cosmetic is excreted in human breast milk or if it will harm your baby.

• Botox Cosmetic is an injection that your doctor will give you.
• Botox Cosmetic is injected into your affected muscles.

• Your doctor may change your dose of Botox Cosmetic, until you and your doctor find the best dose for you.
• Your doctor will tell you how often you will receive your dose of Botox Cosmetic injections.

Symptoms of overdose after Botox Cosmetic injection may include difficulty breathing, difficulty moving parts of the body, and weakness. These symptoms may not appear right away. Call your doctor or seek emergency medical attention right away if you experience any of these symptoms.

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of Botox Cosmetic 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, 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 an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.