Ketole Soap

Ketole Soap 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.

Ketole Soap 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. Ketole Soap is lactose- and gluten-free.

Caloric Distribution: See Table 1.

Analysis: See Table 2.

Ketole Soap 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, Ketole Soap 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 Ketole Soap in nonsystemic fungal infections tends to be restricted to serious infections resistant to other treatment.

Ketole Soap is used to treat infections caused by a fungus or yeast. It works by killing the fungus or yeast or preventing its growth.

Ketole Soap 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).

Ketole Soap foam or gel is used to treat seborrheic dermatitis (scaly areas on your skin or scalp).

Ketole Soap 1% shampoo is used to treat dandruff.

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

Ketole Soap may also be used for other fungus infections of the skin as determined by your doctor.

Most forms of Ketole Soap 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.

Usual Adult Dose for Blastomycosis

Initial dose: 200 mg orally once a day

If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.

Duration of therapy: 6 months (usual duration for systemic infection)

Comments:

-Use of Ketole Soap is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.

-Ketole Soap should not be used for fungal meningitis (penetrates poorly into CSF).

-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Adult Dose for Chromomycosis

Initial dose: 200 mg orally once a day

If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.

Duration of therapy: 6 months (usual duration for systemic infection)

Comments:

-Use of Ketole Soap is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.

-Ketole Soap should not be used for fungal meningitis (penetrates poorly into CSF).

-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Adult Dose for Coccidioidomycosis

Initial dose: 200 mg orally once a day

If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.

Duration of therapy: 6 months (usual duration for systemic infection)

Comments:

-Use of Ketole Soap is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.

-Ketole Soap should not be used for fungal meningitis (penetrates poorly into CSF).

-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Adult Dose for Histoplasmosis

Initial dose: 200 mg orally once a day

If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.

Duration of therapy: 6 months (usual duration for systemic infection)

Comments:

-Use of Ketole Soap is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.

-Ketole Soap should not be used for fungal meningitis (penetrates poorly into CSF).

-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Adult Dose for Paracoccidioidomycosis

Initial dose: 200 mg orally once a day

If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.

Duration of therapy: 6 months (usual duration for systemic infection)

Comments:

-Use of Ketole Soap is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.

-Ketole Soap should not be used for fungal meningitis (penetrates poorly into CSF).

-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Pediatric Dose for Blastomycosis

2 years or older: 3.3 to 6.6 mg/kg orally once a day

Duration of therapy: 6 months (usual duration for systemic infection)

Comments:

-Ketole Soap should not be used unless the benefit outweighs the risks.

-Ketole Soap should not be used for fungal meningitis (penetrates poorly into CSF).

-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Pediatric Dose for Chromomycosis

2 years or older: 3.3 to 6.6 mg/kg orally once a day

Duration of therapy: 6 months (usual duration for systemic infection)

Comments:

-Ketole Soap should not be used unless the benefit outweighs the risks.

-Ketole Soap should not be used for fungal meningitis (penetrates poorly into CSF).

-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Pediatric Dose for Coccidioidomycosis

2 years or older: 3.3 to 6.6 mg/kg orally once a day

Duration of therapy: 6 months (usual duration for systemic infection)

Comments:

-Ketole Soap should not be used unless the benefit outweighs the risks.

-Ketole Soap should not be used for fungal meningitis (penetrates poorly into CSF).

-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Pediatric Dose for Histoplasmosis

2 years or older: 3.3 to 6.6 mg/kg orally once a day

Duration of therapy: 6 months (usual duration for systemic infection)

Comments:

-Ketole Soap should not be used unless the benefit outweighs the risks.

-Ketole Soap should not be used for fungal meningitis (penetrates poorly into CSF).

-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Pediatric Dose for Paracoccidioidomycosis

2 years or older: 3.3 to 6.6 mg/kg orally once a day

Duration of therapy: 6 months (usual duration for systemic infection)

Comments:

-Ketole Soap should not be used unless the benefit outweighs the risks.

-Ketole Soap should not be used for fungal meningitis (penetrates poorly into CSF).

-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Uses: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Acute or chronic liver disease: Contraindicated

If ALT increases to above upper limit of normal (ULN) or 30% above baseline, or if symptoms of liver injury develop: Interrupt therapy.

Dose Adjustments

-When used with drugs that reduce gastric acidity: Caution is recommended. Antifungal activity should be monitored and the Ketole Soap dose increased as required.

-When used with potent CYP450 3A4 inducers: Antifungal activity should be monitored and the Ketole Soap dose increased as required.

-When used with potent CYP450 3A4 inhibitors: Caution is recommended. Patients should be monitored closely for signs/symptoms of increased or prolonged effects of Ketole Soap and the Ketole Soap dose decreased as required; Ketole Soap plasma levels should be measured when appropriate.

Precautions

BOXED WARNINGS:

-LIMITED USE: Use of Ketole Soap is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.

-HEPATOTOXICITY: Serious hepatotoxicity (including cases resulting in death or requiring liver transplantation) reported with oral Ketole Soap. Some patients had no obvious risk factors for liver disease. Patients using Ketole Soap should be advised of the risk and should be monitored closely.

-QT PROLONGATION: Coadministration of Ketole Soap with dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, or ranolazine is contraindicated. Ketole Soap can elevate plasma levels of these drugs and may prolong QT intervals, sometimes resulting in life-threatening ventricular dysrhythmias (such as torsades de pointes).

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:

-Take with a meal.

-Administer Ketole Soap with an acidic drink (such as non-diet cola) if gastric acidity is reduced (e.g., in patients with achlorhydria due to certain diseases, in patients using acid secretion suppressors or acid-neutralizing therapy); administer acid-neutralizing agents at least 1 hour before or 2 hours after Ketole Soap.

Storage requirements:

-Protect from moisture.

General:

-There should be laboratory as well as clinical documentation of infection before starting Ketole Soap therapy.

-Therapy should continue until active fungal infection has subsided.

-Ketole Soap requires acidity for dissolution and absorption; absorption impaired when gastric acid production is reduced.

-Ketole Soap may potentially interact with many drugs; such interactions may be serious and/or life-threatening; the manufacturer product information should be consulted.

Monitoring:

-Endocrine: Adrenal function in patients with adrenal insufficiency, with borderline adrenal function, or under prolonged periods of stress

-General: Antifungal activity and/or Ketole Soap plasma levels when certain drugs coadministered

-Hematologic: Laboratory tests such as prothrombin time, INR (at baseline)

-Hepatic: Laboratory tests such as serum GGT, alkaline phosphatase, ALT, AST, total bilirubin (at baseline); testing for viral hepatitides (at baseline); serum ALT (weekly for duration of therapy); full set of liver tests (if ALT increases to above ULN or 30% above baseline, or if symptoms of liver injury develop); for recurring liver injury (frequently if drug restarted after interruption due to increased ALT or symptoms of liver injury)

Patient advice:

-Report any signs/symptoms suggesting liver dysfunction (including unusual fatigue, anorexia, nausea and/or vomiting, abdominal pain, jaundice, dark urine, pale stools).

-Do not consume alcohol during therapy.

See also:
What is the most important information I should know about Ketole Soap?

Drug Interactions

Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with Ketole Soap Tablets. Coadministration with Ketole Soap 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 torsade de pointes, a potentially fatal arrhythmia.

Additionally, the following other drugs are contraindicated with Ketole Soap 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 Ketole Soap 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 Ketole Soap 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 Ketole Soap Tablets.

Ergotism

Concomitant administration of ergot alkaloids such as dihydroergotamine and ergotamine with Ketole Soap Tablets is contraindicated.

Liver Disease

The use of Ketole Soap Tablets are contraindicated in patients with acute or chronic liver disease.

Hypersensitivity

Ketole Soap Tablets are contraindicated in patients who have shown hypersensitivity to the drug.

Use Ketole Soap foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Ketole Soap foam. Talk to your pharmacist if you have questions about this information.
• Before applying the antifungal to the affected area, cleanse the skin with the cleanser unless your doctor tells you otherwise. If you are unsure how to use the cleanser, contact your doctor or pharmacist.
• Wash your hands in cool water and dry well before you use Ketole Soap foam. If your fingers are too warm, the antifungal will begin to melt right away when it touches your skin.
• To use the antifungal, hold the can upright. Dispense the medicine into the cap or onto a cool surface. Only dispense enough medicine sufficient to cover the affected area(s). Do not dispense the medicine directly onto the affected skin or your hands because it will melt too soon. If the can seems warm or the foam seems runny, hold the can under cold running water for a few minutes.
• Using your fingertips, gently massage Ketole Soap foam into the affected area(s) until the foam disappears. To treat your scalp or other skin areas with hair, move your hair away so that the medicine can be applied directly to the affected skin.
• After you use the antifungal, wipe any excess foam off of the container.
• Wash your hands immediately after you use Ketole Soap foam, unless your hands are part of the treated area.
• If you miss a dose of Ketole Soap foam, 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 Ketole Soap foam.

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: Ketole Soap should only be used when other effective antifungal therapy is not available or tolerated and the potential benefits outweigh the potential risks. Ketole Soap 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 Ketole Soap in the management of patients with Cushing disease. The study authors found the side effects of Ketole Soap to be acceptable; however, close monitoring of liver enzymes is advised. Additional trials may be necessary to further define the role of Ketole Soap in this condition.

Based on the Endocrine Society

See also:
What other drugs will affect Ketole Soap?

Ketole Soap is a potent inhibitor of the cytochrome P450 3A4 enzyme system. Coadministration of NIZORAL^® 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. Therefore, unless otherwise specified, appropriate dosage adjustments may be necessary. The following drug interactions have been identified involving NIZORAL^® Tablets and other drugs metabolized by the cytochrome P450 3A4 enzyme system:

Ketole Soap tablets inhibit the metabolism of terfenadine, resulting in an increased plasma concentration of terfenadine and a delay in the elimination of its acid metabolite. The increased plasma concentration of terfenadine or its metabolite may result in prolonged QT intervals.

Pharmacokinetic data indicate that oral Ketole Soap inhibits the metabolism of astemizole, resulting in elevated plasma levels of astemizole and its active metabolite desmethylastemizole which may prolong QT intervals. Coadministration of astemizole with Ketole Soap tablets is therefore contraindicated.

Human pharmacokinetics data indicate that oral Ketole Soap potently inhibits the metabolism of cisapride resulting in a mean eight-fold increase in AUC of cisapride. Data suggest that coadministration of oral Ketole Soap and cisapride can result in prolongation of the QT interval on the ECG. Therefore concomitant administration of Ketole Soap tablets with cisapride is contraindicated.

Ketole Soap tablets may alter the metabolism of cyclosporine, tacrolimus, and methylprednisolone, resulting in elevated plasma concentrations of the latter drugs. Dosage adjustment may be required if cyclosporine, tacrolimus, or methylprednisolone are given concomitantly with NIZORAL^® Tablets.

Coadministration of NIZORAL^® Tablets with midazolam or triazolam has resulted in elevated plasma concentrations of the latter two drugs. This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. These agents should not be used in patients treated with NIZORAL^® Tablets. If midazolam is administered parenterally, special precaution is required since the sedative effect may be prolonged.

Rare cases of elevated plasma concentrations of digoxin have been reported. It is not clear whether this was due to the combination of therapy. It is, therefore, advisable to monitor digoxin concentrations in patients receiving Ketole Soap.

When taken orally, imidazole compounds like Ketole Soap may enhance the anticoagulant effect of coumarin-like drugs. In simultaneous treatment with imidazole drugs and coumarin drugs, the anticoagulant effect should be carefully titrated and monitored.

Because severe hypoglycemia has been reported in patients concomitantly receiving oral miconazole (an imidazole) and oral hypoglycemic agents, such a potential interaction involving the latter agents when used concomitantly with Ketole Soap tablets (an imidazole) can not be ruled out.

Concomitant administration of Ketole Soap tablets with phenytoin may alter the metabolism of one or both of the drugs. It is suggested to monitor both Ketole Soap and phenytoin.

Concomitant administration of rifampin with Ketole Soap tablets reduces the blood levels of the latter. INH (Isoniazid) is also reported to affect Ketole Soap concentrations adversely. These drugs should not be given concomitantly.

After the coadministration of 200 mg oral Ketole Soap twice daily and one 20 mg dose of loratadine to 11 subjects, the AUC and C_max of loratadine averaged 302% (± 142 S.D.) and 251% (± 68 S.D.), respectively, of those obtained after co-treatment with placebo. The AUC and C_max of descarboethoxyloratadine, an active metabolite, averaged 155% (± 27 S.D.) and 141% (± 35 S.D.), respectively. However, no related changes were noted in the QT₀ on ECG taken at 2, 6, and 24 hours after the coadministration. Also, there were no clinically significant differences in adverse events when loratadine was administered with or without Ketole Soap.

Rare cases of a disulfiram-like reaction to alcohol have been reported. These experiences have been characterized by flushing, rash, peripheral edema, nausea, and headache. Symptoms resolved within a few hours.

See also:
What are the possible side effects of Ketole Soap?

Topically applied Ketole Soap 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 Ketole Soap 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 Ketole Soap 2% cream and contact dermatitis occurred in another.

In several studies evaluating the potential of topical Ketole Soap for causing dermal irritation, contact sensitization, or phototoxic or photoallergenic reactions in healthy adults, topical application of Ketole Soap 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 Ketole Soap, it is unlikely that this adverse effect would occur with Ketole Soap 2% cream since the drug does not appear to be appreciably absorbed following topical application to skin.

Adverse effects reported in patients receiving topical Ketole Soap 2% as a shampoo applied to the skin include pruritus, application site reaction, and dry skin. Adverse effects reported in patients receiving Ketole Soap 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 Ketole Soap 2% shampoo resulted in loss of the curl.