"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"...
XOLEGEL contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle for topical administration.
Chemically, ketoconazole is (±)-cis-1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4yl]methoxy]phenyl]piperazine, with the molecular formula C26H28Cl2N4O4 and a molecular weight of 531.43.
Each gram contains: 20 mg ketoconazole USP, dehydrated alcohol (34%), ascorbic acid, butylated hydroxytoluene, citric acid monohydrate, glycerin, hydroxypropyl cellulose, polyethylene glycol 400, PPG-15 stearyl ether, propylene glycol, FD&C yellow No. 6, and FD&C yellow No.10.
XOLEGEL is a smooth, translucent to clear, amber gel.
What are the possible side effects of ketoconazole topical?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using ketoconazole topical and call your doctor at once if you have a serious side effect such as:
- severe itching, burning, or irritation where the medicine is applied;
- oily or dry scalp, mild hair loss;
- redness, pain, or oozing of treated skin areas; or
- eye redness, swelling, or irritation.
Less serious side effects include:
- mild skin itching or...
What are the precautions when taking ketoconazole (Xolegel)?
Before using ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, econazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 6/22/2012
This monograph has been modified to include the generic and brand name in many instances.
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