Actions of Hyphoral Tablets in details
Pharmacology: When Hyphoral Tablets 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 Hyphoral Tablets levels using an assay method having a lower detection limit 5 ng/mL.
Hyphoral Tablets 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 Hyphoral Tablets were present on the hair but only about 5% had penetrated into the hair keratin. Chronic shampooing (twice weekly for 2 months) increased the Hyphoral Tablets 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 Hyphoral Tablets 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 Hyphoral Tablets.
Mode of Action: Interpretations of in vitro studies suggests that Hyphoral Tablets impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. It is postulated that the therapeutic effect of Hyphoral Tablets 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 Hyphoral Tablets (36 patients) than with placebo (20 patients) and was comparable to that with selenium sulfide (42 patients). In the same study, Hyphoral Tablets and selenium sulfide reduced the severity of adherent dandruff significantly more than the placebo did.
Hyphoral Tablets 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: Hyphoral Tablets 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 Hyphoral Tablets has not been reported.
How should I take Hyphoral Tablets?
Take Hyphoral Tablets 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 Hyphoral Tablets without checking first with your doctor.
Hyphoral Tablets 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 Hyphoral Tablets with food.
Keep using Hyphoral Tablets 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 Hyphoral Tablets 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 Hyphoral Tablets.
Dosing
The dose of Hyphoral Tablets 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 Hyphoral Tablets. 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 oral dosage form (tablets):
- For fungal infections:
- Adults—At first, 200 milligrams (mg) once a day. Your doctor may increase your dose as needed.
- Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 3.3 to 6.6 milligrams (mg) per kilogram (kg) of body weight per day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For fungal infections:
Missed Dose
If you miss a dose of Hyphoral Tablets, 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.
Hyphoral Tablets administration
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 Hyphoral Tablets 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 Hyphoral Tablets 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 Hyphoral Tablets 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 Hyphoral Tablets topical at room temperature away from moisture and heat.
Hyphoral Tablets topical gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.
Hyphoral Tablets pharmacology
When Hyphoral Tablets 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 Hyphoral Tablets 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 Hyphoral Tablets Cream, 2%.
Microbiology
Hyphoral Tablets 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 Hyphoral Tablets has not been reported.
Mode of Action
In vitro studies suggest that Hyphoral Tablets impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes.
References
- 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).
- 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).
- 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).
Reviews
The results of a survey conducted on ndrugs.com for Hyphoral Tablets are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Hyphoral Tablets. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
