"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"...
LOPROX Shampoo (ciclopirox shampoo) is not for ophthalmic, oral, or intravaginal use.
Keep out of reach of children.
Contact of LOPROX Shampoo (ciclopirox shampoo) with the eyes should be avoided. If contact occurs, rinse thoroughly with water.
Seborrheic dermatitis may appear at puberty, however, no clinical studies have been done in patients younger than 16 years. In patients with lighter hair color, hair discoloration has been rarely reported.
There is no relevant clinical experience with patients who have a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, recent or recurring herpes zoster, or persistent herpes simplex), who are immunocompromised (e.g., HIV-infected patients and transplant patients), or who have a diabetic neuropathy.
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
Long-term animal studies have not been performed to evaluate the carcinogenic potential of LOPROX Shampoo or ciclopirox.
The following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in the Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells, with and without metabolic activation (positive); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells in the presence of supplemental Fe3+, with and without metabolic activation (negative); gene mutation assays in the HGPRT-test with V79 Chinese hamster lung fibroblast cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA synthesis assay in A549 human cells) (negative). An in vitro cell transformation assay in BALB/c 3T3 cells was negative for cell transformation. In an in vivo Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at a dosage of 5000 mg/kg body weight.
A combined oral fertility and embryofetal developmental study was conducted in rats with ciclopirox olamine. No effect on fertility or reproductive performance was noted at the highest dose tested of 3.85 mg/kg/day ciclopirox (approximately 1.3 times the maximum recommended human dose based on body surface area comparisons).
Teratogenic effects: Pregnancy Category B
Oral embryofetal developmental studies were conducted in mice, rats, rabbits and monkeys. Ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80 and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits and monkeys, respectively (approximately 13, 42, 54 and 26 times the maximum recommended human dose based on body surface area comparisons, respectively).
Dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in PEG 400. Ciclopirox olamine was topically administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits, respectively (approximately 31 and 54 times the maximum recommended human dose based on body surface area comparisons, respectively).
There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. Because animal reproduction studies are not always predictive of human response, LOPROX Shampoo (ciclopirox shampoo) should be used during pregnancy only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LOPROX Shampoo (ciclopirox shampoo) is administered to a nursing woman.
Seborrheic dermatitis may appear at puberty, however, no clinical studies have been done in patients younger than 16 years.
In clinical studies, the safety and tolerability of LOPROX Shampoo (ciclopirox shampoo) in the population 65 years and older was comparable to that of younger subjects. Results of the efficacy analysis in those patients 65 years and older showed effectiveness in 25 of 85 (29%) patients treated with LOPROX Shampoo (ciclopirox shampoo) , and in 15 of 61 (25%) patients treated with the vehicle; due to the small sample size, a statistically significant difference was not demonstrated. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity to adverse effects in some older individuals cannot be ruled out.
Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Loprox Shampoo Information
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