"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...
This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all administration instructions or all possible adverse or unintended effects.
Advise patients using ULTRAVATE lotion of the following information and instructions:
Important Administration Instructions
Instruct patients to discontinue ULTRAVATE lotion when psoriasis is controlled. ULTRAVATE lotion should not be used for longer than 2 weeks. Advise patients to contact the physician if no improvement is seen within 2 weeks. Inform patients that total dosage should not exceed 50 grams per week [see DOSAGE AND ADMINISTRATION].
Instruct patients to avoid bandaging, wrapping or otherwise occluding the treatment area(s), unless directed by physician. Advise patients to avoid use on the face, scalp, groin, or axillae [see DOSAGE AND ADMINISTRATION].
Effects on Endocrine System
ULTRAVATE lotion may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including ULTRAVATE lotion, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids [see WARNINGS AND PRECAUTIONS].
Local Adverse Reactions
Inform patients that topical corticosteroids may cause local adverse reactions, some of which may be irreversible. These reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids, including ULTRAVATE lotion [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 11/23/2015
This monograph has been modified to include the generic and brand name in many instances.
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