Available for Android and iOS devices. Ketoconazole shampoo is also prescribed for a skin condition called pityriasis versicolor. Fort Collins, CO 80526 This commensal organism is part of the normal skin flora. Ketoconazole is an imidazole medicine used to treat fungal infections.Ketoconazole binds to the fungal p450 enzymes and stops the cells making ergosterol, the main component of the cell wall. A long-term feeding study of ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. While the differences in the rates of successful response between either of the two active treatments and placebo were statistically significant, the difference between the two active regimens was not. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Last updated on Aug 1, 2019. 3.36.6 mg/kg/day PO (not to exceed 400 mg/day PO); maximum dosage for topical preparations is dependent on indication and product. Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. >= 2 years: 3.36.6 mg/kg/day PO (not to exceed 400 mg/day PO); safety and efficacy have not been established for topical products. Ketoconazole belongs to a general class of drugs known as antifungal drugs. One application of the shampoo should be sufficient. Ketoconazole foam or gel is used to treat seborrheic dermatitis (scaly areas on your skin or scalp). 40, and purified water. 2% Foam: Apply to affected area(s) twice a day for 4 weeks. Ketoconazole is an antimycotic medication, otherwise known as an antifungal medicine.As it is incorporated in various different medications, the dosage of ketoconazole in any given formula will differ. -If an allergic reaction (e.g., generalized rash, skin reactions, severe swelling, dyspnea) develops, stop this drug and consult physician at once. 04006149 Rev. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora. Shampoo: 2% Tablets: 200 mg Available without a prescription Shampoo: 1% . To report SUSPECTED ADVERSE REACTIONS contact Thirty Madison, Inc. at 1-833-745-3377 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula: Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by Pityrosporum orbiculare (Malassezia furfur). Treatment of the infection may not immediately result in restoration of pigment to the affected sites. No plasma ketoc … Ketoconazole shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare).. You should use tablets rather than liquid form unless told otherwise by a vet. Patient advice: 1% Shampoo: Use topically every 3 or 4 days for up to 8 weeks and then only as needed to control dandruff. Adults: Initially, 200 mg P.O. < 2 years: Safety and efficacy have not been established. 2% Cream: Apply to affected area twice a day for 4 weeks or until clinical clearing. The amount of medicine that you take depends on the strength of the medicine. -The shampoo should not be used on a broken or inflamed scalp. Ketoconazole Shampoo, 2%, is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. We comply with the HONcode standard for trustworthy health information -. It is only available with a veterinarians prescription. -When using the foam or gel: Read the US FDA-approved patient labeling (Patient Information); wash hands after use; avoid fire, flame, and/or smoking during and immediately after use Ketoconazole belongs to the class of drugs called azole antifungals. Dosage Guidelines & Tips How to take Ketoconazole (Nizoral)? Dosage increases: Your doctor may increase your dosage to 400 mg taken once per day if needed. The dose of topical ketoconazole … Use the shampoo every 3 to 4 days for up to 8 weeks, or as directed by a doctor. -The shampoo should be applied to completely wet hair, lathered generously, and then rinsed thoroughly; this should be repeated. DOSAGE. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the … Ketoconazole Shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare).. 2% Gel: Apply to affected area once a day for 2 weeks. Comments: Use: For the topical treatment of tinea pedis due to T rubrum, T mentagrophytes, and E floccosum, 2% Cream: Apply to the affected and immediate surrounding area once a day for 2 weeks. -Foam: Holding container upright, dispense an amount sufficient to cover affected area(s) into the cap of the can or onto another cool surface; do not dispense directly onto hands (foam will immediately melt upon contact with warm skin); use fingertips to pick up small amounts of foam and massage into affected area(s) gently until foam disappears; if hair-bearing area, part hair and apply directly to skin (not on hair). Induced emesis and gastric lavage should not be performed to avoid aspiration. What is ketoconazole? Medically reviewed by Drugs.com. Apply the shampoo to the skin of the affected area and a wide margin surrounding this area. Storage conditions: Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. The doses used for different uses are listed below: For fungal infections. The following have been reported with the use of Ketoconazole Shampoo, 2%: hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning sensation and contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions. The dose of this medicine will be different for different patients. -The foam and the gel are indicated for use in immunocompetent patients. Uses: For the topical treatment of tinea corporis and tinea cruris due to Trichophyton rubrum, T mentagrophytes, and Epidermophyton floccosum; in the treatment of cutaneous candidiasis due to Candida species, 2% Cream: Apply to the affected and immediate surrounding area once a day for 6 weeks. Ketoconazole shampoo is helpful for persistent or more severe forms of dandruff. Safety and efficacy of the 2% cream and 2% shampoo have not been established in patients younger than 18 years. Dose reduction or discontinuation may be required based on patient adrenal and liver function (refer … New York, NY 10016 Treatment: Pityriasis versicolor: Once daily for 5 days. Note: Do not give ketoconazole to your dog unless you have permission from your vet. In three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Work up a good lather and leave it in place for 5 minutes. Adult dosage (ages 18 years and older) Typical dosage: 200 mg taken once per day for up to 6 months. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Ketoconazole dosage for dogs Ketoconazole comes in the form of 200mg tablets most commonly. Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 10 times the maximum recommended human oral dose). The most commonly known OTC brand is Nizoral, which is available in … This medicine may also be used for other fungus infections of the skin as determined by your doctor. - Flammable, keep away from heat and flame - Flammable, keep away from heat and flame Adult: Initially, 400-600 mg daily, may be increased by 200 mg daily increments every 7-28 days if tolerated, according to patient’s urinary free or plasma cortisol levels.Maintenance dose range: 600-800 mg daily. Percutaneous absorption peaked 1-3 h after topical treatment, and was minimal. It is often sold under the brand name Nizoral.While a veterinarian will prescribe this medicine in different circumstances, it is also available to purchase over the counter. Ketoconazole Shampoo, 2%, is intended for external use only. -A single application of the shampoo should be sufficient and then intermittently as needed. Other brands: Nizoral Topical, Nizoral A-D, Ketodan, Extina, ... +2 more. Comments: This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Development of resistance by these microorganisms to ketoconazole has not been reported. The usual dosage of Ketoconazole for dogs depends on the condition being treated and can range from 2.2 to 13 mg per pound of body weight given every 12 to 24 hours. Ketoconazole inhibits the growth of fungal organisms by interfering with the formation of the fungal cell wall. Follow your vets instructions closely for giving it to your dog. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp. Mode of Action: Interpretations of in vivo studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. Topical cream: apply 1 to 2 times daily to affected area. Talk to your doctor about … -Only use topically/externally; avoid contact with the eyes, nostrils, mouth, and vagina. 12 years or older: Ketoconazole shampoo is a red-orange liquid that a person can use to treat fungal infections on the scalp. However, if you notice this happening and you also notice your hair becoming thinner or that bald spot youve been watching for years has been getting bigger, then these are likely signs of a more serious pr… For internal infection it is given in pill form and often begin… -The shampoo should be applied to completely wet hair, lathered generously, and then rinsed thoroughly; this should be repeated. Ketoconazole 2% shampoo is used to treat "sun fungus" (tinea versicolor; pityriasis versicolor). Safety and effectiveness in children have not been established. Most people do. Leave shampoo in place for … This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Ketoconazole is not detected in plasma after chronic shampooing on the scalp. Mycological clearing rates were 84% and 78%, respectively, for the three-day and one-day regimens of the 2% shampoo and 11% in the placebo regimen. However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels. The following information includes only the average doses of this medicine. Support for the therapeutic effect in tinea versicolor comes from a three-arm, parallel, double-blind, placebo controlled study in patients who had moderately severe tinea (pityriasis) versicolor. Do you gasp in horror when you wash or brush your hair and pull out a clump of hair? It contains ketoconazole, which is a synthetic antifungal agent. Microbiology: Ketoconazole 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; yeasts: Candida albicans, C. tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur). Indications and dosages Severe fungal infections caused by susceptible organisms. Ketoconazole Shampoo 2pct Drug Medication Dosage Information It works by stopping the growth of the fungus.. Ketoconazole should not be used to treat fungal infections on the skin and nails due to the risk of serious side effects and drug interactions. Applies to the following strengths: 1%; 2%; 2% with cleanser, 2% Cream: Apply to the affected and immediate surrounding area once a day for 2 weeks. It contains an antifungal agent which kills the yeast-like germs (a type of fungus) which causes the flaking of the scalp. Cream: Apply q12hr for 4 weeks or until clear. -Shampoo: For the treatment of tinea (pityriasis) versicolor due to or presumed due to P orbiculare (M furfur). Yes, some hair loss and some hair falling out is normal, especially when washing or styling hair. -The shampoo should not be used on a broken or inflamed scalp. -When using the 1% shampoo: If product gets into the eyes, rinse thoroughly with water; if condition worsens or does not improve in 2 to 4 weeks or if rash develops, stop using this product and consult physician. Ketoconazole is an azole antifungal that works by preventing the growth of fungus.Ketoconazole 2% shampoo is also used to treat a skin condition known as … Shampoo: Apply twice weekly for 4 weeks, with at least 3 days between each shampoo. INDICATIONS AND USAGE. Lather, leave in place for 5 minutes, and then rinse off with water. The Ames Salmonella microsomal activator assay was also negative. Comments: 2% Gel: Apply to affected area once a day for 2 weeks. Just enough should be applied to adequately cover the infected site. -Gel: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F). Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 10 times the maximum recommended human oral dose). Last updated on March 17, 2020. Other related drugs in this class include itraconazole, miconazole and fluconazole. The only events that occurred in more than one patient in any one of the three treatment groups were pruritus, application site reaction, and dry skin; none of these events occurred in more than 3% of the patients in any one of the three groups. -Shampoo: 1%: Store between 2C and 30C (35F and 86F), protect from light and freezing; 2%: Store at 20C to 25C (68F to 77F), protect from light. Ketoconazole Shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare). The following adverse drug reactions have been identified during post-marketing experience with Ketoconazole Shampoo, 2%: there have been reports of hair discoloration and abnormal hair texture, itching, skin burning sensation, contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp. Uses: To control flaking, scaling, and itching associated with dandruff. Ketoconazole is available in 200 mg tablets that are administered orally. In an open study, 19 infants with a bipolar seborrhoeic rash were treated with ketoconazole 2% in cream once a day and evaluated over 10 days of treatment. In susceptible individuals the condition is often recurrent and may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Caution should be exercised when Ketoconazole Shampoo, 2%, is administered to a nursing woman. Ketoconazole 2% shampoo is a broad spectrum imidazole-dioxolane, 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 floc-cosum; … Applied to the skin it is used for fungal skin infections such as tinea, cutaneous candidiasis, pityriasis versicolor, dandruff, and seborrheic dermatitis. INDICATIONS AND USAGE. -Foam: Store at 20C to 25C (68F to 77F); do not refrigerate; do not expose containers to heat, store above 49C (120F), or store in direct sunlight. Teratogenic effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. -Stop this drug and contact healthcare provider if irritation occurs or the condition worsens. Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of Ketoconazole Shampoo, 2%. Select one or more newsletters to continue. Ketoconazole Shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (NDC 71713-097-04). Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms … OTC ketoconazole shampoos contain 1 percent or less of ketoconazole. -Cream: Store at 20C to 25C (68F to 77F). Ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months, or in 33 patients who shampooed 2-3 times per week for 3-26 months (mean: 16 months). Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, angioedema, or shortness of breath should discontinue Ketoconazole Shampoo, 2% and contact their physician immediately. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms … Dosage & Administration. -Patients should be reevaluated and the diagnosis reconsidered if no improvement is noted after completion of the treatment period. Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 10 times the maximum recommended human oral dose). -May see clinical improvement fairly soon after start of therapy; duration of 2 weeks recommended to reduce possibility of recurrence. Administration advice: In 11 double-blind trials in 264 patients using Ketoconazole Shampoo, 2%, for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. The chosen dosage and form of ketoconazole is highly dependent upon the condition being treated and the actions required. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. -Cream: In the treatment of tinea (pityriasis) versicolor due to Malassezia furfur (Pityrosporum orbiculare) Ketoconazole is used to treat certain serious fungal infections in the body. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Ketoconazole Shampoo, 2% may be irritating to mucous membranes of the eyes and contact with this area should be avoided. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. Consult WARNINGS section for additional precautions. 12 years or older: Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 1% Shampoo: Use topically every 3 or 4 days for up to 8 weeks and then only as needed to control dandruff. 2% Foam: Apply to affected area(s) twice a day for 4 weeks. Rinse your hair and scalp well with warm water, and dry your hair. General : -Patients should be reevaluated and the diagnosis reconsidered if no improvement is noted after completion of the treatment period. In Hong Kong, Ketoconazole is only available in topical application, including cream and shampoo. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Follow your doctor's orders or the directions on the label. Ketoconazole is effective only against fungal or yeast organisms. Shampoo: wet your hair and shampoo … Ketoconazole 1% shampoo is used to treat dandruff. Find patient medical information for ketoconazole topical on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp. All doses are given in 2 or 3 divided doses. Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. 0 05/19, Other brands: Nizoral Shampoo, Ketodan, Extina, Xolegel, prednisone, dexamethasone, hydrocortisone topical, nystatin topical, clotrimazole topical, ketoconazole topical, tacrolimus topical, terbinafine topical, terbinafine, Decadron. An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five consecutive days showed that the irritancy potential of Ketoconazole Shampoo, 2%, was significantly less than that of 2.5% selenium sulfide shampoo. -The foam and the gel are indicated for use in immunocompetent patients. Pityrosporum orbiculare (Malassezia furfur), Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans, C. tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur), We comply with the HONcode standard for trustworthy health information -, ANALYSIS(71713-097), LABEL(71713-097), MANUFACTURE(71713-097), PACK(71713-097). Comments: Nizoral Shampoo(Ketoconazole): Learn about Nizoral Shampoo's Dosage, Side Effects and indications Manufactured by: Tolmar, Inc. There are no adequate and well-controlled studies in nursing women. -Safety and efficacy of the foam and gel have not been established to treat fungal infections. Distributed by: Thirty Madison, Inc. Uses: Max: 1,200 mg daily. Ketoconazole decreases metabolism of midazolam PO, triazolam PO, or alprazolam and may result in prolonged hypnotic and sedative effects Coadministration of CYP3A4 metabolized HMG-CoA reductase inhibitors (eg, simvastatin, lovastatin) increases risk for myopathy (see Contraindications) Ketoconazole is an azole antifungal that works by preventing the growth of fungus.Ketoconazole 2% shampoo is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. It is postulated, but not proven, that the therapeutic effect of ketoconazole in tinea (pityriasis) versicolor is due to the reduction of Pityrosporum orbiculare (Malassezia furfur) and that the therapeutic effect in dandruff is due to the reduction of Pityrosporum ovale. Successful response rates in the primary efficacy population for each of both three-day and single-day regimens of Ketoconazole Shampoo, 2%, were statistically significantly greater (73% and 69%, respectively) than a placebo regimen (5%). Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental skin exposure. The rate of recurrence of infection is variable. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Safety and efficacy of the 2% foam, 2% gel, and 1% shampoo have not been established in patients younger than 12 years. -Shampoo: 1%: Store between 2C and 30C (35F and 86F), protect from light and freezing; 2%: Store at 20C to 25C (68F to 77F), protect from light. Available for Android and iOS devices. There had been mycological confirmation of fungal disease in all cases at baseline. 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 hypersensitivity type, no phototoxicity and no photoallergenic potential due to Ketoconazole Shampoo, 2%. Comments: General: Uses: To control flaking, scaling, and itching associated with dandruff. Ketoconazole Shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation. Use Ketoconazole (Nizoral) exactly as directed on the label, or as prescribed by your doctor. Comments: If your dose is different, do not change it unless your doctor tells you to do so. Ketoconazole, sold under the brand name Nizoral among others, is an antifungal medication used to treat a number of fungal infections.