• Fungoral 2% indications
• Uses of Fungoral 2% in details
• Fungoral 2% description
• Fungoral 2% dosage
• Fungoral 2% interactions
• Fungoral 2% side effects
• Fungoral 2% contraindications

What is Fungoral 2%?

Fungoral 2% is used to treat infections caused by a fungus or yeast. It works by killing the fungus or yeast or preventing its growth.

Fungoral 2% cream is used to treat:

• Athlete's foot (tinea pedis; ringworm of the foot);
• Ringworm of the body (tinea corporis);
• Ringworm of the groin (tinea cruris; jock itch);
• Seborrheic dermatitis;
• "Sun fungus" (tinea versicolor; pityriasis versicolor); and
• Yeast infection of the skin (cutaneous candidiasis).

Fungoral 2% foam or gel is used to treat seborrheic dermatitis (scaly areas on your skin or scalp).

Fungoral 2% 1% shampoo is used to treat dandruff.

Fungoral 2% 2% shampoo is used to treat "sun fungus" (tinea versicolor; pityriasis versicolor).

Fungoral 2% may also be used for other fungus infections of the skin as determined by your doctor.

Most forms of Fungoral 2% are available only with your doctor's prescription. Some forms are available without a prescription. However, your doctor may have special instructions on the proper use for your medical condition.

Fungoral 2% indications

Fungoral 2% is an imidazole antifungal administered topically or by mouth. It is given by mouth in chronic mucocutaneous or vaginal candidiasis, in fungal infections of the gastrointestinal tract, in dermatophyte infections of the skin and fingernails not responding to topical treatment, and in systemic infections including blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, and paracoccidioidomycosis.

It has been given for the prophylaxis of fungal infections in immunocompromised patients, although fluconazole or itraconazole are usually preferred. It has been recommended that, because of its erratic absorption and slow therapeutic response, Fungoral 2% should not be used for the treatment of life-threatening fungal infections, including fungal meningitis, or for severe infections in immunocompromised patients. Also, because of the risk of hepatotoxicity the use of Fungoral 2% in nonsystemic fungal infections tends to be restricted to serious infections resistant to other treatment.

How should I use Fungoral 2%?

Use Fungoral 2% gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Fungoral 2% gel. Talk to your pharmacist if you have questions about this information.
• Wash your hands before and immediately after using Fungoral 2% gel.
• Spread a thin layer of Fungoral 2% gel onto the affected area with the tips of your fingers. Gently rub it in. Be sure to cover the entire affected area and the healthy skin around it.
• Do not touch your eyes or nose while you are applying Fungoral 2% gel.
• Wait for at least 20 minutes after you apply Fungoral 2% gel before you apply makeup or sunscreen.
• Do not wash the area where you applied Fungoral 2% gel for at least 3 hours after you apply it.
• If you miss a dose of Fungoral 2% gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fungoral 2% gel.

Uses of Fungoral 2% in details

Use: Labeled Indications

Fungal infections (systemic):

US labeling: Treatment of susceptible systemic fungal infections, including blastomycosis, histoplasmosis, paracoccidioidomycosis, coccidioidomycosis, and chromomycosis in patients who have failed or who are intolerant to other antifungal therapies

Limitations of use: Fungoral 2% should only be used when other effective antifungal therapy is not available or tolerated and the potential benefits outweigh the potential risks. Fungoral 2% tablets are not indicated for the treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.

Canadian labeling: Treatment of serious or life-threatening systemic fungal infections (eg, systemic candidiasis, chronic mucocutaneous candidiasis, coccidioidomycosis, paracoccidioidomycosis, histoplasmosis, and chromomycosis) where alternate therapy is inappropriate or ineffective; may be considered for severe dermatophytoses unresponsive to other therapy

Off Label Uses

Cushing syndrome

Data from a retrospective multicenter study support the use of Fungoral 2% in the management of patients with Cushing disease. The study authors found the side effects of Fungoral 2% to be acceptable; however, close monitoring of liver enzymes is advised. Additional trials may be necessary to further define the role of Fungoral 2% in this condition.

Based on the Endocrine Society

Fungoral 2% description

Fungoral 2% contains the following ingredients: D-Water, maltodextrin (corn), partially hydrolyzed sodium caseinate, lactalbumin hydrolysate, canola oil, medium-chain triglycerides (fractionated coconut oil), L-arginine, corn oil, magnesium chloride, potassium citrate, tribasic calcium phosphate, citric acid, soy lecithin, ascorbic acid, dibasic potassium phosphate, choline chloride, carrageenan, potassium chloride, taurine, L-carnitine, zinc sulfate, ferrous sulfate, α-tocopheryl acetate, niacinamide, calcium pantothenate, manganese sulfate, β-carotene, cupric sulfate, thiamine chloride HCl, pyridoxine HCl, riboflavin, vitamin A palmitate, folic acid, biotin, chromium chloride, sodium molybdate, potassium iodide, sodium selenate, phylloquinone, cyanocobalamin and vitamin D3.

Fungoral 2% is a ready-to-feed enteral product as a supplemental or sole-source nutrition complete and balanced nutrition for tube feeding. It is calorie dense at 1.3 cal/mL and contains a protein system of partially hydrolyzed proteins, including peptides and amino acids, to utilize the dual absorption system of the gut. Fungoral 2% is lactose- and gluten-free.

Caloric Distribution: See Table 1.

Analysis: See Table 2.

Fungoral 2% dosage

Fungoral 2% Dosage

Generic name: Fungoral 2% 200mg

Dosage form: tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

There should be laboratory as well as clinical documentation of infection prior to starting Fungoral 2% therapy. The usual duration of therapy for systemic infection is 6 months. Treatment should be continued until active fungal infection has subsided.

Adults

The recommended starting dose of Fungoral 2%® (Fungoral 2%) Tablets is a single daily administration of 200 mg (one tablet). If clinical responsiveness is insufficient within the expected time, the dose of Fungoral 2%® Tablets may be increased to 400 mg (two tablets) once daily.

Children

In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. Fungoral 2%® Tablets have not been studied in children under 2 years of age.

More about Fungoral 2% (Fungoral 2%)

• Side Effects
• During Pregnancy or Breastfeeding
• Dosage Information
• Drug Images
• Drug Interactions
• Support Group
• En Espanol
• 4 Reviews - Add your own review/rating

Consumer resources

• Fungoral 2%
• Fungoral 2% (Advanced Reading)

Professional resources

• Fungoral 2% (AHFS Monograph)
• Fungoral 2% (FDA)

Other formulations

• Fungoral 2%

  Topical

• Fungoral 2% A-D

Related treatment guides

• Blastomycosis
• Chromomycosis
• Coccidioidomycosis
• Histoplasmosis
• Paracoccidioidomycosis

Fungoral 2% interactions

See also:
What other drugs will affect Fungoral 2%?

Fungoral 2% is a potent inhibitor of the cytochrome P450 3A4 enzyme system. Coadministration of Fungoral 2% Tablets and drugs primarily metabolized by the cytochrome P450 3A4 enzyme system may result in increased plasma concentrations of the drugs that could increase or prolong both therapeutic and adverse effects.

Fungoral 2% Tablets inhibit the metabolism of terfenadine, resulting in an increased plasma concentration of terfenadine.

Fungoral 2% inhibits the metabolism of astemizole. Fungoral 2% potently inhibits the metabolism of cisapride resulting in a mean eight-fold increase in AUC of cisapride.

Fungoral 2% Tablets may alter the metabolism of cyclosporine, tacrolimus, and methylprednisolone, resulting in elevated plasma concentrations of the latter drugs.

Coadministration of Fungoral 2% Tablets with midazolam or triazolam has resulted in elevated plasma concentrations of the latter two drugs.

It is, therefore, advisable to monitor digoxin concentrations in patients receiving Fungoral 2%.

When taken orally, imidazole compounds like Fungoral 2% may enhance the anticoagulant effect of coumarin-like drugs.

a potential interaction involving the latter agents when used concomitantly with Fungoral 2% Tablets (an imidazole) can not be ruled out.

Concomitant administration of Fungoral 2% Tablets with phenytoin may alter the metabolism of one or both of the drugs.

Concomitant administration of rifampin with Fungoral 2% Tablets reduces the blood levels of the latter. INH (isoniazid) is also reported to affect Fungoral 2% concentrations adversely.

Fungoral 2% side effects

See also:
What are the possible side effects of Fungoral 2%?

Topically applied Fungoral 2% appears to have a low order of toxicity and is generally well tolerated. Adverse effects have been reported in up to 5% of patients receiving Fungoral 2% 2% cream and have consisted principally of local reactions such as severe irritation, pruritus, and stinging. A painful allergic reaction, consisting of localized swelling and inflammation, occurred in at least one patient receiving Fungoral 2% 2% cream and contact dermatitis occurred in another.

In several studies evaluating the potential of topical Fungoral 2% for causing dermal irritation, contact sensitization, or phototoxic or photoallergenic reactions in healthy adults, topical application of Fungoral 2% 2% cream caused mild transient erythema in some individuals, but did not cause contact sensitization of the delayed hypersensitivity type, irritation, phototoxicity, or photocontact sensitization.

Contact dermatitis has been reported following topical application of imidazole-derivative azole antifungals (e.g., clotrimazole, econazole, miconazole, oxiconazole, sulconazole, tioconazole). Cross-sensitization appears to occur among the imidazole derivatives; however, cross-sensitivity appears to be unpredictable. The fact that patients with contact sensitivity to one imidazole-derivative azole antifungal may be sensitive to other similar drugs should be considered.

Although hepatotoxicity has occurred during treatment with oral Fungoral 2%, it is unlikely that this adverse effect would occur with Fungoral 2% 2% cream since the drug does not appear to be appreciably absorbed following topical application to skin.

Adverse effects reported in patients receiving topical Fungoral 2% 2% as a shampoo applied to the skin include pruritus, application site reaction, and dry skin. Adverse effects reported in patients receiving Fungoral 2% shampoo to the scalp include increased hair loss, irritation, abnormal hair texture, scalp pustules, dry skin, pruritus, and oiliness or dryness of the hair and scalp. In some patients with permanently waved (“permed”) hair, use of Fungoral 2% 2% shampoo resulted in loss of the curl.

Fungoral 2% contraindications

See also:
What is the most important information I should know about Fungoral 2%?

Drug Interactions

Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with Fungoral 2%® Tablets. Coadministration with Fungoral 2% can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious adverse reaction may occur. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and sometimes resulting in life-threatening ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia.

Additionally, the following other drugs are contraindicated with Fungoral 2%® Tablets: methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine.

Enhanced Sedation

Coadministration of Fungoral 2%® Tablets with oral midazolam, oral triazolam or alprazolam has resulted in elevated plasma concentrations of these drugs. This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. Concomitant administration of Fungoral 2%® Tablets with oral triazolam, oral midazolam or alprazolam is contraindicated.

Myopathy

Coadministration of CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, and lovastatin is contraindicated with Fungoral 2%® Tablets.

Ergotism

Concomitant administration of ergot alkaloids such as dihydroergotamine and ergotamine with Fungoral 2%® Tablets is contraindicated.

Liver Disease

The use of Fungoral 2%® Tablets is contraindicated in patients with acute or chronic liver disease.

Hypersensitivity

Fungoral 2%® is contraindicated in patients who have shown hypersensitivity to the drug.

Active ingredient matches for Fungoral 2%:

Ketoconazole in Austria.

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. PubChem. "ketoconazole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "ketoconazole". http://www.drugbank.ca/drugs/DB01026 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology