Ketostar

Each gram contains ketoconazole 21 mg. Ketostar also contains sodium lauryl ether sulfate, disodium monolauryl ether sulfosuccinate, coconut fatty acid diethanolamide, laurdimonium hydrolyzed animal collagen, macrogol 120 methyl glucose dioleate, sodium chloride, hydrochloric acid, imidurea, perfume bouquet, sodium hydroxide, erythrosine and purified water.

Ketostar® Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.

Ketostar® (ketoconazole) Tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketostar® Tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.

Ketostar is an antifungal medication that prevents fungus from growing on your skin.

Ketostar is used to treat fungal infections of the skin such as athlete's foot, jock itch, ringworm, and seborrhea (dry, flaking skin).

Ketostar is available as a cream, gel, and as a shampoo. The shampoo is used for the treatment of dandruff.

Ketostar may also be used for purposes not listed in this medication guide.

There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole 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 Ketostar® (ketoconazole) Tablets is a single daily administration of 200 mg (one tablet). If clinical responsiveness is insufficient within the expected time, the dose of Ketostar® 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. Ketostar® Tablets have not been studied in children under 2 years of age.

How supplied

Ketostar® (ketoconazole) is available as white, scored tablets containing 200 mg of ketoconazole debossed “JANSSEN” and on the reverse side debossed “Ketostar”. They are supplied in bottles of 100 tablets (NDC 50458-220-10).

Store at controlled room temperature 15°-25°C (59°-77°F).

Protect from moisture.

Keep out of reach of children.

Janssen Pharmaceuticals, Inc, Titusville, New Jersey 08560. Revised: July 2013

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

Drug Interactions

Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with Ketostar® Tablets. Coadministration with ketoconazole 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 Ketostar® 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 Ketostar® 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 Ketostar® 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 Ketostar® Tablets.

Ergotism

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

Liver Disease

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

Hypersensitivity

Ketostar® is contraindicated in patients who have shown hypersensitivity to the drug.

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

• An extra patient leaflet is available with Ketostar. Talk to your pharmacist if you have questions about this information.
• Wash your hands in cool water and dry well before you use Ketostar. If your fingers are too warm, the medicine will begin to melt right away when it touches your skin.
• To use Ketostar, 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 Ketostar 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 Ketostar, wipe any excess foam off of the container.
• Wash your hands immediately after you use Ketostar, unless your hands are part of the treated area.
• If you miss a dose of Ketostar, 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 Ketostar.

Ketostar is used to treat fungal infections of the skin such as tinea corporis (ring worm), tinea cruris (fungal infections of the groin or buttocks), tinea pedis (fungal infection of the foot [athlete’s foot]), tinea manus (fungal infection of the hand). Ketoconazole shampoo is used to control flaking, scaling, and itching of the scalp caused by dandruff and tinea versicolor (fungal infection of the skin that causes brown or light colored spots on the chest, back, arms, legs, or neck).

See also:
What other drugs will affect Ketostar?

Drugs that affect the absorption, distribution, metabolism, and excretion of ketoconazole may alter the plasma concentrations of ketoconazole. For example, gastric acid suppressants (e.g., antacids, histamine H2-blockers, proton pump inhibitors) have been shown to reduce plasma concentrations of ketoconazole.

Ketoconazole is a substrate and potent inhibitor of CYP3A4. Therefore, the following drug interactions may occur when Ketostar® is co-administered with other drugs that interact with CYP3A4.

1. Ketostar® may decrease the elimination of drugs metabolized by CYP3A4, thereby increasing their plasma concentrations. Increased exposure to these drugs may cause an increase or prolongation of their therapeutic and/or adverse effects. Concomitant use with Ketostar® Tablets is contraindicated for drugs known to present a risk of serious side effects with increased exposure. For others, monitoring of plasma concentrations is advised when possible. Clinical signs and symptoms associated with these drugs should be monitored, with dosage adjusted as needed.
2. Inducers of CYP3A4 may decrease the plasma concentrations of ketoconazole. Ketostar® may not be effective in patients concomitantly taking one of these drugs. Therefore, administration of these drugs with Ketostar® is not recommended.
3. Other inhibitors of CYP3A4 may increase the plasma concentrations of ketoconazole. Patients who must take Ketostar® concomitantly with one of these drugs should be monitored closely for signs or symptoms of increased or prolonged pharmacologic effects of Ketostar®.

Table 1: Selected Drugs That Have Been Shown To or Are Predicted To Have Their Plasma Concentrations Altered By Ketostar®*

Table 2: Selected Drugs That Have Been Shown To or Are Predicted To Alter The Plasma Concentration Of Ketostar®

Effects of ketoconazole on other drugs

Systemic exposure to the following drugs is significantly increased by co

See also:
What are the possible side effects of Ketostar?

Applies to Ketostar: topical cream, topical foam, topical gel/jelly, topical shampoo, topical solution

As well as its needed effects, Ketostar (the active ingredient contained in Ketostar) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Ketostar, check with your doctor immediately:

Less common—For cream, shampoo, foam, or gel

• Itching, stinging, burning, or irritation not present before use of this medicine

• Acne
• bleeding from sore in the mouth
• blistering, crusting, irritation, itching, or reddening of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• cracked, dry, or scaly skin
• discoloration of the fingernails or toenails
• dizziness
• eye dryness, irritation, or swelling
• red rash with watery, yellow-colored, or pus filled blisters with or without thick yellow to honey-colored crusts
• skin dryness, pain, rash, redness, or swelling
• sore in the mouth or on the gums
• swelling of the face

• Hair loss and irritation

• Pain

• Blistering, burning, crusting, dryness, or flaking of the skin
• burning sensation of the skin
• burning, itching, redness, skin rash, swelling, or soreness at the application site
• discoloration of the hair
• dry skin
• fast heartbeat
• fever
• hives
• hoarseness
• irritation
• itching, scaling, severe redness, or soreness of the skin
• joint pain, stiffness, or swelling
• rash
• shortness of breath
• swelling of the eyelids, face, lips, hands, or feet
• thinning of the hair
• tightness in the chest
• troubled breathing or swallowing
• wheezing

Minor Side Effects

Some Ketostar side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common—For shampoo or gel

• Dryness or oiliness of the hair and scalp
• headache

• Abnormal hair texture
• mild dryness of the skin
• scalp pustules