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Juvederm Vollure Xc Generic Name & Formulations
Legal Class
PP
General Description
Hyaluronic acid 17.5mg/mL, 0.3% w/w lidocaine; injectable gel implant.
Pharmacological Class
Dermal filler.
How Supplied
Single-use syringe—1 (w. needles)
Manufacturer
Generic Availability
NO
Juvederm Vollure Xc Indications
Indications
Correction of moderate-to-severe facial wrinkles and folds (eg, nasolabial folds).
Juvederm Vollure Xc Dosage and Administration
Adult
See full labeling. Inject (into mid-to-deep dermis) slowly with least amount of pressure necessary. Wait 3 secs after injecting first small amount before proceeding with rest of the inj. May use supplementary anesthesia during and post-inj. >21yrs: Individualize. Initial treatment: usually 1.7mL per site. Max limit: 20mL/60kg per year. May require touch-up treatments to achieve desired effects.
Children
Not established.
Juvederm Vollure Xc Contraindications
Contraindications
History of anaphylaxis or presence of multiple severe allergies. Allergies to Gram (+) bacterial proteins.
Juvederm Vollure Xc Boxed Warnings
Not Applicable
Juvederm Vollure Xc Warnings/Precautions
Warnings/Precautions
Should only be used by trained and experienced healthcare practitioners. Obtain patient's complete medical history prior to initiation. Avoid intravascular inj; discontinue immediately if changes in vision, signs of stroke, blanching of skin or unusual pain during or shortly after procedure occurs. Risk of infection. Defer if active inflammatory process or infection is present at specific sites. Use in non-facial wrinkles and folds: not established. Possible risk of an inflammatory reaction at implant site if laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after Juvederm Vollure XC or if product is given before skin has healed completely after such a procedure. Known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders: not studied. Advise patients to avoid strenuous exercise, extensive sun or heat, and alcoholic beverages within first 24hrs. Patients (<22yrs), pregnancy, nursing mothers: not established.
Juvederm Vollure Xc Pharmacokinetics
See Literature
Juvederm Vollure Xc Interactions
Interactions
Caution with concomitant immunosuppressants. Increased bruising or bleeding at inj sites with concomitant aspirin, NSAIDs, warfarin.
Juvederm Vollure Xc Adverse Reactions
Adverse Reactions
Inj site reactions (eg, swelling, tenderness, firmness, bruising, lumps/bumps, redness, pain, discoloration, itching); rare: vision impairment, blindness, cerebral ischemia/hemorrhage, stroke, skin necrosis, facial structure damage.
Juvederm Vollure Xc Clinical Trials
See Literature
Juvederm Vollure Xc Note
Not Applicable
Juvederm Vollure Xc Patient Counseling
See Literature
