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ciclopirox olamine
Overview
What is Ciclopirox Olamine?
Ciclopirox Olamine Cream USP, 0.77% is for topical use.
Each gram of ciclopirox olamine cream USP contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible vanishing cream base consisting of cetyl alcohol, cocamide DEA, lactic acid, mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, stearyl alcohol, and benzyl alcohol (1%) as preservative.
Ciclopirox olamine cream contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1
)-pyridone, 2-aminoethanol salt.
The CAS Registry Number is 41621-49-2. The chemical structure is:
What does Ciclopirox Olamine look like?
What are the available doses of Ciclopirox Olamine?
Sorry No records found.
What should I talk to my health care provider before I take Ciclopirox Olamine?
Sorry No records found
How should I use Ciclopirox Olamine?
Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to
,
,
, and
; candidiasis (moniliasis) due to
; and tinea (pityriasis) versicolor due to
.
Gently massage ciclopirox olamine cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
What interacts with Ciclopirox Olamine?
Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
What are the warnings of Ciclopirox Olamine?
Flucytosine Capsules USP must be given with extreme caution to patients with bone marrow depression. Patients may be more prone to depression of bone marrow function if they: 1) have a hematologic disease, 2) are being treated with radiation or drugs which depress bone marrow, or 3) have a history of treatment with such drugs or radiation. Bone marrow toxicity can be irreversible and may lead to death in immunosuppressed patients. Frequent monitoring of hepatic function and of the hematopoietic system is indicated during therapy.
Ciclopirox olamine cream is not for ophthalmic use.
Keep out of reach of children.
What are the precautions of Ciclopirox Olamine?
If a reaction suggesting sensitivity or chemical irritation should occur with the use of ciclopirox olamine cream, treatment should be discontinued and appropriate therapy instituted.
Information for Patients
- Use the medication for the full treatment time even though symptoms may have improved and notify the physician if there is no improvement after four weeks.
- Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing) indicative of possible sensitization.
- Avoid the use of occlusive wrappings or dressings.
The patient should be told to:
Carcinogenesis, Mutagenesis, Impairment of Fertility
A 104-week dermal carcinogenicity study in mice was conducted with ciclopirox cream applied at doses up to 1.93% (100 mg/kg/day or 300 mg/m /day). No increase in drug related neoplasms was noted when compared to control.
The following 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 Fe , 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 cell transformation assay in BALB/c 3T3 cells was negative for cell transformation. In an 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 1.2 times the maximum recommended human dose based on body surface area comparisons).
Pregnancy
Nursing Mothers
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 ciclopirox olamine cream is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 10 years have not been established.
What are the side effects of Ciclopirox Olamine?
In all controlled clinical studies with 514 patients using ciclopirox olamine cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.
What should I look out for while using Ciclopirox Olamine?
Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
Ciclopirox olamine cream is not for ophthalmic use.
Keep out of reach of children.
What might happen if I take too much Ciclopirox Olamine?
Sorry No Records found
How should I store and handle Ciclopirox Olamine?
Ciclopirox Olamine Cream USP, 0.77% is supplied in Box of 30 g (NDC 68071-4162-3)
