Cetoconazol Aurovitas Actions

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Actions of Cetoconazol Aurovitas in details

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Pharmacology: When Cetoconazol Aurovitas 2% shampoo was applied dermally to intact or abraded skin of rabbits for 28 days at doses up to 50 mg/kg and allowed to remain 1 hr before being washed away, there were no detctable plasma Cetoconazol Aurovitas levels using an assay method having a lower detection limit 5 ng/mL.

Cetoconazol Aurovitas was not detected in plasma in 39 patients who shampooed 4-10 times/week to 6 months or in 33 patients who shampooed 2-3 times/week for 3-26 months (mean: 16 months). Twelve hours after a single shampoo, hair samples taken from 6 patients showed that high amounts of Cetoconazol Aurovitas were present on the hair but only about 5% had penetrated into the hair keratin. Chronic shampooing (twice weekly for 2 months) increased the Cetoconazol Aurovitas levels in the hair keratin 20% but did not increase levels on the hair. There were no detectable plasma levels.

An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for 5 consecutive days showed that the irritancy potential of Cetoconazol Aurovitas 2% shampoo was significantly less than that of 2.5% selenium sulfide shampoo.

A human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 22 female volunteers showed no contact sensitization of the delayed hypersensitvity type, no phototoxicity and no photoallergenic potential due to Cetoconazol Aurovitas.

Mode of Action: Interpretations of in vitro studies suggests that Cetoconazol Aurovitas impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. It is postulated that the therapeutic effect of Cetoconazol Aurovitas in dandruff is due to the reduction of Pityrosporum ovale (Malassezia ovale), but this has not been proven. Support for this hypothesis comes from a 4-week, double-blind, placebo-controlled clinical trial, in which the decrease in P. ovale on the scalp was significantly greater with Cetoconazol Aurovitas (36 patients) than with placebo (20 patients) and was comparable to that with selenium sulfide (42 patients). In the same study, Cetoconazol Aurovitas and selenium sulfide reduced the severity of adherent dandruff significantly more than the placebo did.

Cetoconazol Aurovitas produced significantly higher proportions of patients with at least 50% reductions in adherent dandruff (50% versus 15%) and in loose dandruff (67% versus 15%) than did the placebo.

Microbiology: Cetoconazol Aurovitas is a broad-spectrum synthetic antifungal agent which inhibits the growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: Dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeast: Candida albicans, C. tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur). Development of resistance by these microorganism to Cetoconazol Aurovitas has not been reported.

How should I take Cetoconazol Aurovitas?

Take Cetoconazol Aurovitas exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not stop taking Cetoconazol Aurovitas without checking first with your doctor.

Cetoconazol Aurovitas should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take Cetoconazol Aurovitas with food.

Keep using Cetoconazol Aurovitas for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

If you are taking Cetoconazol Aurovitas together with an antacid-containing aluminum, it should be taken with an acidic beverage (such as non-diet cola). Antacid-containing aluminum should be taken at least 1 hour before or 2 hours after taking Cetoconazol Aurovitas.

Dosing

The dose of Cetoconazol Aurovitas 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 Cetoconazol Aurovitas. 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.

Missed Dose

If you miss a dose of Cetoconazol Aurovitas, take 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. Do not double doses.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Cetoconazol Aurovitas administration

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Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use Cetoconazol Aurovitas topical to treat any skin condition that has not been checked by your doctor.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply a thin layer of the cream or gel to the affected skin area as directed. This medicine is usually used for only 2 to 4 weeks.

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying Cetoconazol Aurovitas topical.

Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to.

Use the shampoo twice per week, unless your doctor has told you otherwise. Apply enough shampoo to create a lather and massage the scalp for 1 minute. Rinse thoroughly and repeat, leaving the lather on for an additional 3 minutes. Then rinse it off completely. Allow at least 3 days to pass between uses of Cetoconazol Aurovitas shampoo.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medication.

Store Cetoconazol Aurovitas topical at room temperature away from moisture and heat.

Cetoconazol Aurovitas topical gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Cetoconazol Aurovitas pharmacology

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When Cetoconazol Aurovitas Cream, 2% was applied dermally to intact or abraded skin of Beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/ml.

After a single topical application to the chest, back and arms of normal volunteers, systemic absorption of Cetoconazol Aurovitas was not detected at the 5 ng/ml level in blood over a 72-hour period.

Two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to Cetoconazol Aurovitas Cream, 2%.

Microbiology

Cetoconazol Aurovitas is a broad spectrum synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare). Only those organisms listed in the INDICATIONS AND USAGE Section have been proven to be clinically affected. Development of resistance to Cetoconazol Aurovitas has not been reported.

Mode of Action

In vitro studies suggest that Cetoconazol Aurovitas impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes.



References

  1. DailyMed. "KETOCONAZOLE: 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).
  2. NCIt. "Ketoconazole: 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).
  3. EPA DSStox. "Ketoconazole: 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

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