DRUGS & SUPPLEMENTS
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Fungopirox cream, USP is for topical use.
Each gram of Fungopirox cream, USP contains 7.70 mg of ciclopirox (as Fungopirox) in a water miscible vanishing cream base consisting of Purified Water USP, Octyldodecanol NF, Light Mineral Oil NF, Stearyl Alcohol NF, Cetyl Alcohol NF, Polysorbate 60 NF, Myristyl Alcohol NF, Sorbitan Monostearate NF, Lactic Acid USP, and Benzyl Alcohol NF (1%) as preservative.
Fungopirox cream, USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as Fungopirox). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt.
The CAS Registry Number is 41621-49-2. The chemical structure is
Fungopirox cream, USP has a pH of 7.
Ciclopirox is a broad-spectrum, antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Ciclopirox exhibits fungicidal activity in vitro against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermorphyton floccosum, Microsporum canis, and Candida albicans.
Pharmacokinetic studies in men with tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm2 on the back followed by occlusion for 6 hours. The biological half-life was 1.7 hours and excretion occurred via the kidney. Two days after application only 0.01% of the dose applied could be found in the urine. Fecal excretion was negligible.
Penetration studies in human cadaverous skin from the back, with Fungopirox cream, USP with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application. The levels in the dermis were still 10 to 15 times above the minimum inhibitory concentrations.
Autoradiographic studies with human cadaverous skin showed that ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, while a portion of the drug remains in the stratum corneum.
Draize Human Sensitization Assay, 21-Day Cumulative Irritancy study, Phototoxicity study, and Photo-Draize study conducted in a total of 142 healthy subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity, and no photo-contact sensitization due to Fungopirox cream, USP.
INDICATIONS AND USAGE
Fungopirox cream, USP is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.
Fungopirox cream, USP is contraindicated in individuals who have shown hypersensitivity to any of its components.
Fungopirox cream, USP is not for ophthalmic use.
Keep out of reach of children.
If a reaction suggesting sensitivity or chemical irritation should occur with the use of Fungopirox cream, USP, treatment should be discontinued and appropriate therapy instituted.
In all controlled clinical studies with 514 patients using Fungopirox cream, USP 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 Fungopirox cream, USP and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.
DOSAGE AND ADMINISTRATION
Gently massage Fungopirox cream, USP 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 Fungopirox cream, USP the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
Fungopirox cream, USP is supplied in 15 gram, 30 gram, and 90 gram tubes.
Information for Patients
The patient should be told to:
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Depending on the reaction of the Fungopirox after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Fungopirox not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Fungopirox addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology