Actions of Clotrimazole Bionika in details
Pharmacology: Clotrimazole Bionika contains Clotrimazole, a new generation imidazole derivative possessing a potent and broad-spectrum antifungal, anticandidal and antitrichomonal activity. In vitro, depending on the concentration, Clotrimazole Bionika exhibits fungistatic or fungicidal activity against a wide range of isolates of deratophytes eg, Trichophyton rubrum, Trichophyton mentagrophyte, Epidermatophyton floccosum. Clotrimazole Bionika exhibits a high degree of anti-candidal action on pathogenic strains of Candida eg, Candida albicans; it also shows a good antimicrobial action on Malassezia furfur. Strains of fungi having a natural resistance to Clotrimazole Bionika are rare. No single step or multiple step resistance to Clotrimazole Bionika has developed during successive passages of Candida albicans.
Clotrimazole Bionika is known to possess anti-trichomonal and antibacterial activity particularly against some of the gram-positive organisms. Clotrimazole Bionika causes alteration in the cell wall permeability and leads to leakage of intracellular phosphorus compounds with concomitant breakdown of cellular nucleic acid and accelerated potassium influx. These rapidly and extensively developing changes contribute to fungicidal activity of Clotrimazole Bionika. Following the vaginal administration, Clotrimazole Bionika appears to be minimally absorbed.
Pharmacokinetics: Pharmacokinetic investigations after vaginal application have shown that only a small amount of Clotrimazole Bionika is absorbed. Due to rapid hepatic metabolism of absorbed Clotrimazole Bionika into pharmacologically inactive metabolites, the resulting peak plasma concentrations of Clotrimazole Bionika after vaginal application of a 500-mg dose were <10 ng/mL, reflecting that Clotrimazole Bionika applied intravaginally does not lead to measurable systemic effects or side effects.
How should I take Clotrimazole Bionika?
Apply enough Clotrimazole Bionika to cover the affected and surrounding skin areas, and rub in gently.
Keep Clotrimazole Bionika away from the eyes.
When Clotrimazole Bionika is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over the medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over Clotrimazole Bionika unless you have been directed to do so by your doctor.
To help clear up your infection completely, it is very important that you keep using Clotrimazole Bionika for the full time of treatment, even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using Clotrimazole Bionika every day for several weeks or more. If you stop using Clotrimazole Bionika too soon, your symptoms may return. Do not miss any doses.
Dosing
The dose of Clotrimazole Bionika will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Clotrimazole Bionika. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For topical dosage forms (cream, lotion, and solution):
- Fungal infections (treatment):
- Adults and children—Use two times a day, morning and evening.
- Fungal infections (treatment):
Missed Dose
If you miss a dose of Clotrimazole Bionika, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Clotrimazole Bionika administration
Oral: Allow troche to dissolve slowly in the mouth. Dissolution is complete in approximately 30 minutes.
Clotrimazole Bionika pharmacology
Clotrimazole Bionika is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and Malassezia furfur. The primary action of Clotrimazole Bionika is against dividing and growing organisms.
In vitro,Clotrimazole Bionika exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum,Microsporum canis and Candida species including Candida albicans. In general, the in vitro activity of Clotrimazole Bionika corresponds to that of tolnaftate and griseofulvin against the mycelia of dermatophytes (Trichophyton, Microsporum, and Epidermophyton), and to that of the polyenes (amphotericin B and nystatin) against budding fungi (Candida). Using an in vivo (mouse) and an in vitro (mouse kidney homogenate) testing system, Clotrimazole Bionika and micronazole were equally effective in preventing the growth of the pseudomycelia and mycelia of Candida albicans.
Strains of fungi having a natural resistance to Clotrimazole Bionika are rare. Only a single isolate of Candida guilliermondi has been reported to have primary resistance to Clotrimazole Bionika.
No single-step or multiple-step resistance to Clotrimazole Bionika has developed during successive passages of Candida albicans and Trichophyton mentagrophytes. No appreciable change in sensitivity was detected after successive passage of isolates of C. albicans, C krusei, or C. pseudotropicalis in liquid or solid media containing Clotrimazole Bionika. Also, resistance could not be developed in chemically induced mutant strains of polyene-resistant isolates of C. albicans. Slight, reversible resistance was noted in three isolates of C. albicans tested by one investigator. There is a single report that records the clinical emergence of C. albicans strain with considerable resistance to flucytosine and micronazole, and with cross-resistance to Clotrimazole Bionika, the strain remained sensitive to nystatin and amphotericin B.
In studies of the mechanism of action, the minimum fungicide concentration of Clotrimazole Bionika caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. Both these events began rapidly and extensively after addition of the drug.
Clotrimazole Bionika appears to be well absorbed in humans following oral administration and is eliminated mainly as inactive metabolites. Following topical and vaginal administration, however, Clotrimazole Bionika appears to be minimally absorbed.
Six hours after the application of radioactive Clotrimazole Bionika 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of Clotrimazole Bionika varied from 100 mcg/cm3 in the stratum corneum to 0.5 to 1 mcg/cm3 in the stratum reticulare, and 0.1 mcg/cm3 in the subcutis. No measurable amount of radioactivity (≤0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mL of the solution or 0.8 g of the cream. Only 0.5% or less of the applied radioactivity was excreted in the urine.
Following intravaginal administration of 100 mg 14C-Clotrimazole Bionika vaginal tablets to nine adult females, an average peak serum level, corresponding to only 0.03 μg equivalent/mL of Clotrimazole Bionika, was reached one to two days after application. After intravaginal administration of 5 g of 1% 14C-Clotrimazole Bionika vaginal cream containing 50 mg active drug, to five subjects (one with candidal colpitis), serum levels corresponding to approximately 0.01 μg equivalents/mL were reached between 8 and 24 hours after application.
References
- DailyMed. "BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- NCIt. "Clotrimazole: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
- EPA DSStox. "Clotrimazole: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
