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Juvederm Voluma Xc Generic Name & Formulations
Legal Class
PP
General Description
Hyaluronic acid 20mg/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 Voluma Xc Indications
Indications
Cheek augmentation to correct age-related mid-face volume deficit.
Juvederm Voluma Xc Dosage and Administration
Adult
See full labeling. Inject 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. Give as small boluses (0.1–0.2mL) by deep inj (subcutaneous and/or supraperiosteal). Max limit: 20mL/60kg per year. May require touch-up treatments to achieve desired effect.
Children
Not established.
Juvederm Voluma Xc Contraindications
Contraindications
History of anaphylaxis or presence of multiple severe allergies. Allergies to Gram (+) bacterial proteins, lidocaine.
Juvederm Voluma Xc Boxed Warnings
Not Applicable
Juvederm Voluma 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 occur. Risk of infection. Defer if active inflammatory process or infection is present at specific sites. Use in non-mid-face areas: not established. Skin injury near treatment site. Known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders: not studied. Advise patients to avoid strenuous exercise, extensive sun or heat exposure within first 24hrs. Patients (<35yrs or >65yrs), pregnancy, nursing mothers: not established.
Juvederm Voluma Xc Pharmacokinetics
See Literature
Juvederm Voluma Xc Interactions
Interactions
Caution with concomitant immunosuppressants. Increased bruising or bleeding risk at inj sites with concomitant aspirin, NSAIDs, warfarin.
Juvederm Voluma Xc Adverse Reactions
Adverse Reactions
Inj site reactions (eg, tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, itching); rare: vision impairment, blindness, cerebral ischemia/hemorrhage, stroke, skin necrosis, facial structure damage, late-onset nodules.
Juvederm Voluma Xc Clinical Trials
See Literature
Juvederm Voluma Xc Note
Not Applicable
Juvederm Voluma Xc Patient Counseling
See Literature
