Juvederm Ultra

— THERAPEUTIC CATEGORIES —
  • Aesthetic medicine

Juvederm Ultra Generic Name & Formulations

General Description

Hyaluronic acid 24mg/mL; injectable gel implant.

Pharmacological Class

Dermal filler.

How Supplied

Single-use syringe—1 (w. needles)

Manufacturer

Generic Availability

NO

Juvederm Ultra Indications

Indications

Correction of moderate-to-severe facial wrinkles and folds (eg, nasolabial folds).

Juvederm Ultra Dosage and Administration

Adult

See full labeling. Inject slowly with least amount of pressure necessary. May use supplementary anesthesia during and post-inj. ≥18yrs: Individualize. Initial treatment: usually 1.6mL per site; repeat treatment: usually 0.7mL per site. Max limit: 20mL/60kg per year. May require touch-up treatments after 1–2 weeks to achieve desired effects.

Children

<18yrs: not established.

Juvederm Ultra Contraindications

Contraindications

History of anaphylaxis or presence of multiple severe allergies. Allergies to Gram (+) bacterial proteins.

Juvederm Ultra Boxed Warnings

Not Applicable

Juvederm Ultra 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-lip or non-perioral areas: 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 Ultra/Ultra Plus 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. Pregnancy, nursing mothers: not established.

Juvederm Ultra Pharmacokinetics

See Literature

Juvederm Ultra Interactions

Interactions

Caution with concomitant immunosuppressants. Increased bruising or bleeding at inj sites with concomitant aspirin, NSAIDs, warfarin.

Juvederm Ultra 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 Ultra Clinical Trials

See Literature

Juvederm Ultra Note

Not Applicable

Juvederm Ultra Patient Counseling

See Literature