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PRODUCT INFORMATION
Botox
Approved Uses
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
• Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. 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, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing
BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product 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 ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and 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; have 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 (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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.
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 (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids and eyebrows, and swelling of your eyelids.
For more information refer to the Medication Guide or talk with your doctor.
Hjulberg ed: mer_To report a side effect, please call Allergan at 1-800-433-8871.
Fraxel Laser Treatment
Treatment Facts and Guidelines
Duration
Fraxel treatments usually last between 15-45 minutes
Treatment Regimen
Most patients see the best results with 1-5 Fraxel treatments
Results
Fraxel works with your body’s natural skin cells, so results typically take 1-3 weeks to take effect.
Comfort
Most Fraxel patients report the sensation of a "light sunburn" immediately after treatment, but treatment plans can vary, so ask your physician about the specifics of your treatment.
Safety and Side Effects
With a track record of over 800,000 treatments, Fraxel technology is proven to be safe and effective for multiple indications. But because skin types and conditions can vary, some side effects are possible.
THE MOST ADVANCED TRACK RECORD—FOR ADVANCED SKIN SCIENCE
Fraxel laser treatment removes years from the skin's appearance—without the degree of risks and side effects commonly associated with other procedures. That's because our team of scientists, physicians, clinicians and engineers are dedicated to developing safe, effective solutions for rejuvenating your skin. The Fraxel track record speaks for itself:
Excellent safety record with more than 800,000 treatments performed
Extensive clinical and tissue research
Ongoing clinical trials in our state-of-the-art Solta Medical Aesthetic Center located within Solta corporate headquarters
Ongoing testing and research by our on-site biomedical engineering team
Safe and effective on most skin types, on and off the face, for men and women
When you get a Fraxel treatment, you can feel confident you're receiving a safe, effective procedure. Fraxel is a treatment you can trust.
Fraxel re:pair
Potential side effects include prolonged redness, swelling, oozing, petichiae, delayed wound healing, scarring, crusting or scabbing, infection from
bacterial, viral or fungal agents, pigmentary changes, herpes reactivation
and acne flare-up.
Fraxel re:store DUAL 1550/1927 and Fraxel re:fine
Potential side effects include prolonged redness, swelling, blistering, scarring, infection, pigmentary changes (hyperpigmentation) , herpes reactivation and acne flare-up.
JUVÉDERM
JUVÉDERM® XC Indication and Important Safety Information
JUVÉDERM® XC Important Information
INDICATION
JUVÉDERM® XC injectable gels (JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC) are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to gram-positive bacterial proteins or lidocaine contained in these products.
WARNINGS
• Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
• Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
PRECAUTIONS
• In order to minimize the risk of potential complications, JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC injectable gels should only be used by healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy
• Healthcare professionals are encouraged to discuss the potential risks of soft-tissue injections with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications
• The safety and effectiveness for the treatment of anatomic regions other than moderate to severe facial wrinkles and folds with JUVÉDERM® XC, and the lips and perioral area for lip augmentation with JUVÉDERM® Ultra XC, have not been established in controlled clinical studies
• As with all transcutaneous procedures, dermal filler implantation carries a risk of infection. Follow standard precautions associated with injectable materials
• The safety for use during pregnancy, in breastfeeding females, and in patients under 18 years has not been established
• The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
• Use with caution in patients on immunosuppressive therapy
• Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
ADVERSE EVENTS
The most commonly reported side effects are temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. Most side effects are mild or moderate in nature, lasting 14 days or less.
To report a problem with JUVÉDERM® Ultra XC or JUVÉDERM® Ultra Plus XC, please call Allergan Product Surveillance at 1-800-624-4261.
For more information, please see JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.
JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC injectable gels are available by prescription only.
APPROVED USES
JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over 21.
JUVÉDERM® XC injectable gel is for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
JUVÉDERM® Ultra XC is for injection into the lips and perioral area for lip augmentation in adults over 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any JUVÉDERM® injectable gel formulation?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the gram-positive bacterial proteins used in these products.
What precautions should my doctor advise me about?
• Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied
• The safety of JUVÉDERM® XC and JUVÉDERM® Ultra XC injectable gels in patients under 18 years, and the safety of JUVÉDERM VOLUMA® XC in patients under 35 years or over 65 years has not been studied
• The safety and effectiveness of JUVÉDERM® XC for areas other than facial wrinkles and folds, and JUVÉDERM® Ultra XC for areas other than the lips and perioral area for lip augmentation, or facial wrinkles and folds, have not been established in clinical studies
• The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area have not been established in clinical studies
• Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation
• Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
• Patients who experience skin injury near the site of injection with these products may be at a
higher risk for side effects
• Tell your doctor if you are on immunosuppressive therapy used to decrease the body’s immune
response, as use of these products may result in an increased risk of infection
• Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site
• Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within
the first 24 hours following treatment
What are possible side effects?
The most common side effects include tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. With JUVÉDERM® XC and JUVÉDERM® Ultra XC injectable gels, most side effects are mild or moderate and last 14 days or less. For JUVÉDERM VOLUMA® XC, side effects are moderate (uncomfortable) and last 2 to 4 weeks.
One of the risks with using this product is unintentional injection into a blood vessel, and while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring.
As with all skin injection procedures, there is a risk of infection.
To report a side effect with JUVÉDERM® XC, JUVÉDERM® Ultra XC, or JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.
For more information, please see Juvederm.com or call Allergan Medical Information at 1-800-433-8871.
Available by prescription only.
Profound
Syneron-Candela Profound Lift
100% Response Rate based on results of a clinical study in 20 patients, measuring improvement in Fitzpatrick Wrinkle Scale at 3 months compared to baseline based on independent review of photographs
Creates Younger Skin claim based on Elastometry and Clinical Results After Bipolar Radiofrequency Treatment of Skin, Willey, Andrea et al. Dermatologic Surgery, 2010
©2015. All rights reserved. Profound, Syneron and the Syneron logo are trademarks of Syneron Medical Ltd. and may be registered in certain jurisdictions. Candela is a registered trademark of the Candela Corporation.
For more, visit www.syneron-candela.com
