Please see important Safety Information about BOTOX® Cosmetic below.
Please see important Safety Information about JUVÉDERM® below.
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BOTOX® Cosmetic (onabotulinumtoxinA)
BOTOX® Cosmetic is a prescription medication that is injected into muscles and used to imporve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours ot weeks) after injection of BOTOX® Cosmetic:
Problems swallowing, speaking, or breathing, due to a weakening of associated muscles, can be severe and result in the loss of life. You are at the hightest risk if these problems are pre-existing before injectino. Swallowing problems may last for several months.
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
The dose of BOTOX® Cosmetic is not the same as, or comparable to, another botulinum toxin product.
There has not been a confirmated serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frwon lines.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get the medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not take BOTOX® Cosmetic if you: are allergice to any of the increditens in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergice reaction to any other botulinum toxin products such as Myobloc® (rimabotulinumtoxinB ), Dysport® (abobotulinumtoxina), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as amyotrphic lateral scierosis (ALS or Lou Gehrig’s disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breast-feed (it is not known if BOTOX® Cosmetic passes into breast milk).
Human albumin and spread of viral diseases. BOTOX® Cosmetic contains albumin, a protein component of human blood. The potential risk of spreading viral diseases [eg Creutzfeldt-Jakob Disease (CJD)] via human serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human serum albumin.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.
Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin, such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; or take a sleep medicine.
Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
A Brief Description of Indications for Use, Contraindications, Warnings, Precautions, and Adverse Evetns for JUVÉDERM® Injectable Gel
Indication: In the United States JUVÉDERM® injectable gel (including JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC, and JUVÉDERM® Ultra Plus XC) is indicated for correction of moderate to severe facial wrinkles and folds (such as naslabial folds).
Contraindications: JUVÉDERM® injectable gel should not be used in patients who have severe allergies marked by a history of anaphylaxis or history or presence of multiple severe allergies. JUVÉDERM® should not be used in patients with a history of allergies to Gram-positive bacterial proteins. JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC should not be used in patients with a history of allergies to lidocaine.
Warnings: JUVÉDERM® injectable gel should not be injected into blood vessels. If there is an active inflammatory process or infection at specific injection sites, treatment should be deferred until the underlying process is controlled.
Precautions: The safety of JUVÉDERM® for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established. The safety and effectiveness of JUVÉDERM® injectable gel for the treatment of areas other than facial wrinkles and folds (such as lips) have not been established in controlled clinical studies. Patients who are using substances that can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may experience increased bruising or bleeding at injection site. Patients should inform their physician before treatment if they are using these types of substances. As with al skin-injection procedures, there is a risk of infection. JUVÉDERM® should be used with caution in patients on immusuppressive therapy, or therapy used to decrease the body’s immune response, as there may be an increased risk of infection. The safety of JUVÉDERM® in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied. If laser treatment, chemcial peel, or any other procedure based on active dermal response is considered after treatment with JUVÉDERM® injectable gel, or if JUVÉDERM® is administered before the skin has healed ocmpletely after such a procedure, there is a possible risk of an inflammatory reaction at the treatment site.
Adverse events: The most commonly reported side effects are temporary injection-site redness, swelling, pain/tenderness, firmess, lumps/bumps, and bruising. Most side effects are mild or moderate in nature, and their duration is short lasting (7 days or less).
Important: For full safety information, please visit www.juvederm.com or call Allergan Product Support at 1-877-345-5372.
Caution: Rx only.
BOTOX® Cosmetic Prescribing Information, November 2011