Ketoconazole/hydrocortisone

Contraindications

See also:
What is the most important information I should know about Hydrocortisone (Ketoconazole/Hydrocortisone)?

You should not use this medication if you are allergic to Hydrocortisone (Ketoconazole/Hydrocortisone), or if you have a fungal infection anywhere in your body.

Before taking Hydrocortisone (Ketoconazole/Hydrocortisone), tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are taking Hydrocortisone (Ketoconazole/Hydrocortisone). Vaccines may not work as well while you are taking a steroid.

Do not stop using Hydrocortisone (Ketoconazole/Hydrocortisone) suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

See also:
What is the most important information I should know about Ketoconazole (Ketoconazole/Hydrocortisone)?

Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with Ketoconazole (Ketoconazole/Hydrocortisone) Tablets. Coadministration with Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) 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.

Coadministration of Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) Tablets with oral triazolam, oral midazolam or alprazolam is contraindicated.

Coadministration of CYP3A4 metabolized HMG-CoA reductase inhibitors such as simvastatin, and lovastatin is contraindicated with Ketoconazole (Ketoconazole/Hydrocortisone) Tablets.

Concomitant administration of ergot alkaloids such as dihydroergotamine and ergotamine with Ketoconazole (Ketoconazole/Hydrocortisone) Tablets is contraindicated.

The use of Ketoconazole (Ketoconazole/Hydrocortisone) Tablets are contraindicated in patients with acute or chronic liver disease.

Ketoconazole (Ketoconazole/Hydrocortisone) Tablets are contraindicated in patients who have shown hypersensitivity to the drug.

Undesirable effects

See also:
What are the possible side effects of Hydrocortisone (Ketoconazole/Hydrocortisone)?

Applies to Hydrocortisone (Ketoconazole/Hydrocortisone) topical: topical application cream, topical application ointment

Other dosage forms:

• topical application cream
• topical application cream, topical application lotion, topical application ointment, topical application solution
• topical application cream, topical application foam, topical application gel/jelly, topical application kit, topical application liquid, topical application lotion, topical application ointment, topical application pad, topical application paste, topical application solution, topical application spray, topical application stick

In addition to its needed effects, some unwanted effects may be caused by Hydrocortisone (Ketoconazole/Hydrocortisone) topical (the active ingredient contained in Hydrocortisone (Ketoconazole/Hydrocortisone) with Aloe). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking Hydrocortisone (Ketoconazole/Hydrocortisone) topical:

More common:

• Skin rash, encrusted, scaly, and oozing
• stinging

• Burning, itching, redness, skin rash, swelling, or soreness at the application site
• cough or hoarseness
• dry skin
• fever or chills
• itching in the genital or other skin areas
• lower back or side pain
• painful or difficult urination
• rash
• rash with flat lesions or small raised lesions on the skin
• skin irritation

• Blistering, burning, crusting, dryness, or flaking of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on facial or intertriginous areas

Some of the side effects that can occur with Hydrocortisone (Ketoconazole/Hydrocortisone) topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

• Diarrhea
• indigestion
• loss of appetite
• nausea or vomiting
• passing of gas
• stomach pain, fullness, or discomfort

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

See also:
What are the possible side effects of Ketoconazole (Ketoconazole/Hydrocortisone)?

Topically applied Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) 2% cream and contact dermatitis occurred in another.

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

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

Therapeutic indications

When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramusculat use of Solu-Hydrocortisone (Ketoconazole/Hydrocortisone) Sterile Powder is indicated as follows:

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.

Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).

Primary or secondary adrenocortical insufficiency (Hydrocortisone (Ketoconazole/Hydrocortisone) or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.

To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.

Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia.

Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

For the palliative management of leukemias and lymphomas.

Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy.

Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.

To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus.

Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.

Ketoconazole (Ketoconazole/Hydrocortisone) 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, Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) in nonsystemic fungal infections tends to be restricted to serious infections resistant to other treatment.

See also: Entyvio

Hydrocortisone (Ketoconazole/Hydrocortisone) is a steroid medicine that is used in the treatment of many different conditions, including allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, multiple sclerosis, or lung disorders.

Hydrocortisone (Ketoconazole/Hydrocortisone) is also used to replace steroids in people with adrenal insufficiency (decreased production of natural steroids by the adrenal glands).

Hydrocortisone (Ketoconazole/Hydrocortisone) affects your immune system and is often used to treat certain blood cell disorders such as anemia (low red blood cells) or thrombocytopenia (low platelets).

Hydrocortisone (Ketoconazole/Hydrocortisone) is also used in the treatment of certain cancers such as leukemia, lymphoma, and multiple myeloma.

Hydrocortisone (Ketoconazole/Hydrocortisone) may also be used for purposes not listed in this medication guide.

Ketoconazole (Ketoconazole/Hydrocortisone) is used to treat infections caused by a fungus or yeast. It works by killing the fungus or yeast or preventing its growth.

Ketoconazole (Ketoconazole/Hydrocortisone) 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).

Ketoconazole (Ketoconazole/Hydrocortisone) foam or gel is used to treat seborrheic dermatitis (scaly areas on your skin or scalp).

Ketoconazole (Ketoconazole/Hydrocortisone) 1% shampoo is used to treat dandruff.

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

Ketoconazole (Ketoconazole/Hydrocortisone) may also be used for other fungus infections of the skin as determined by your doctor.

Most forms of Ketoconazole (Ketoconazole/Hydrocortisone) 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.

Name of the medicinal product

Qualitative and quantitative composition

Solu-Hydrocortisone (Ketoconazole/Hydrocortisone) 100 mg contains Hydrocortisone (Ketoconazole/Hydrocortisone) sodium succinate equivalent to Hydrocortisone (Ketoconazole/Hydrocortisone) 100 mg, monobasic sodium phosphate 1 mg, dibasic sodium 9 mg and sodium hydroxide 10%.

Solu-Hydrocortisone (Ketoconazole/Hydrocortisone) 100 mg/2 mL contains Hydrocortisone (Ketoconazole/Hydrocortisone) sodium succinate equivalent to Hydrocortisone (Ketoconazole/Hydrocortisone) 100 mg/2 mL, monobasic sodium phosphate 1 mg, dibasic sodium 10 mg and sodium hydroxide 10%.

Solu-Hydrocortisone (Ketoconazole/Hydrocortisone) 250 mg/2 mL contains Hydrocortisone (Ketoconazole/Hydrocortisone) sodium succinate equivalent to Hydrocortisone (Ketoconazole/Hydrocortisone) 250 mg/2 mL, monobasic sodium phosphate 2 mg, dibasic sodium phosphate 25 mg and sodium hydroxide 10%.

Solu-Hydrocortisone (Ketoconazole/Hydrocortisone) 500 mg/4 mL contains Hydrocortisone (Ketoconazole/Hydrocortisone) sodium succinate equivalent to Hydrocortisone (Ketoconazole/Hydrocortisone) 500 mg/4 mL, monobasic sodium phosphate 5 mg, dibasic sodium phosphate 52 mg and sodium hydroxide 10%.

Hydrocortisone (Ketoconazole/Hydrocortisone) sodium succinate or pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy; monosodium salt,(11β) is an anti-inflammatory adrenocortical steroid. This highly water-soluble sodium succinate ester of Hydrocortisone (Ketoconazole/Hydrocortisone) permits the immediate IV administration of high doses of Hydrocortisone (Ketoconazole/Hydrocortisone) in a small volume of diluent and is particularly useful where high blood levels of Hydrocortisone (Ketoconazole/Hydrocortisone) are required rapidly.

When necessary, the pH of Solu-Hydrocortisone (Ketoconazole/Hydrocortisone) was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7-8.

Ketoconazole (Ketoconazole/Hydrocortisone) 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.

Ketoconazole (Ketoconazole/Hydrocortisone) 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. Ketoconazole (Ketoconazole/Hydrocortisone) is lactose- and gluten-free.

Caloric Distribution: See Table 1.

Analysis: See Table 2.

Special warnings and precautions for use

Use Hydrocortisone (Ketoconazole/Hydrocortisone) solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Hydrocortisone (Ketoconazole/Hydrocortisone) solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Hydrocortisone (Ketoconazole/Hydrocortisone) solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Hydrocortisone (Ketoconazole/Hydrocortisone) solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Hydrocortisone (Ketoconazole/Hydrocortisone) solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Hydrocortisone (Ketoconazole/Hydrocortisone) solution, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Hydrocortisone (Ketoconazole/Hydrocortisone) solution.

Use Ketoconazole (Ketoconazole/Hydrocortisone) foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) foam, unless your hands are part of the treated area.
• If you miss a dose of Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) foam.

Hydrocortisone (Ketoconazole/Hydrocortisone) is a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood/hormone/immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions.

Hydrocortisone (Ketoconazole/Hydrocortisone) is also used to treat low Hydrocortisone (Ketoconazole/Hydrocortisone) levels caused by diseases of the adrenal gland (such as Addison's disease, adrenocortical insufficiency). Corticosteroids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal.

Take this medication by mouth, with food or milk to prevent stomach upset, exactly as directed by your doctor. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise.

Follow the dosing schedule carefully. The dosage and length of treatment are based on your medical condition and response to treatment. Your doctor may direct you to take Hydrocortisone (Ketoconazole/Hydrocortisone) 1 to 4 times a day or take a single dose every other day. It may help to mark your calendar with reminders or use a pill box.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

If you have used Hydrocortisone (Ketoconazole/Hydrocortisone) regularly for a long time or in high doses, you may have withdrawal symptoms if the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. See also Precautions section.

Tell your doctor if your condition persists or worsens.

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: Ketoconazole (Ketoconazole/Hydrocortisone) should only be used when other effective antifungal therapy is not available or tolerated and the potential benefits outweigh the potential risks. Ketoconazole (Ketoconazole/Hydrocortisone) 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

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

Based on the Endocrine Society

Dosage (Posology) and method of administration

The initial dosage of Hydrocortisone (Ketoconazole/Hydrocortisone) Tablets may vary from 20 mg to 240 mg of Hydrocortisone (Ketoconazole/Hydrocortisone) per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Hydrocortisone (Ketoconazole/Hydrocortisone) should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Hydrocortisone (Ketoconazole/Hydrocortisone) for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.

In treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (20 mg of Hydrocortisone (Ketoconazole/Hydrocortisone) is equivalent to 5 mg of prednisolone).

Hydrocortisone (Ketoconazole/Hydrocortisone) Tablets are available in the following strengths and package sizes:

5 mg (white, round, scored, imprinted Hydrocortisone (Ketoconazole/Hydrocortisone) 5) Bottles of 50 NDC 0009-0012-01

10 mg (white, round, scored, imprinted Hydrocortisone (Ketoconazole/Hydrocortisone) 10) Bottles of 100 NDC 0009-0031-01

20 mg (white, round, scored, imprinted Hydrocortisone (Ketoconazole/Hydrocortisone) 20) Bottles of 100 NDC 0009-0044-01

Store at controlled room temperature 20° to 25°C (68° to 77°F).

Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc., NY, NY 10017. Revised: Sep 2013

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 Ketoconazole (Ketoconazole/Hydrocortisone) is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.

-Ketoconazole (Ketoconazole/Hydrocortisone) 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

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 Ketoconazole (Ketoconazole/Hydrocortisone) is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.

-Ketoconazole (Ketoconazole/Hydrocortisone) 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

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 Ketoconazole (Ketoconazole/Hydrocortisone) is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.

-Ketoconazole (Ketoconazole/Hydrocortisone) 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

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 Ketoconazole (Ketoconazole/Hydrocortisone) is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.

-Ketoconazole (Ketoconazole/Hydrocortisone) 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

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 Ketoconazole (Ketoconazole/Hydrocortisone) is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.

-Ketoconazole (Ketoconazole/Hydrocortisone) 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

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:

-Ketoconazole (Ketoconazole/Hydrocortisone) should not be used unless the benefit outweighs the risks.

-Ketoconazole (Ketoconazole/Hydrocortisone) 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

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:

-Ketoconazole (Ketoconazole/Hydrocortisone) should not be used unless the benefit outweighs the risks.

-Ketoconazole (Ketoconazole/Hydrocortisone) 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

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:

-Ketoconazole (Ketoconazole/Hydrocortisone) should not be used unless the benefit outweighs the risks.

-Ketoconazole (Ketoconazole/Hydrocortisone) 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

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:

-Ketoconazole (Ketoconazole/Hydrocortisone) should not be used unless the benefit outweighs the risks.

-Ketoconazole (Ketoconazole/Hydrocortisone) 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

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:

-Ketoconazole (Ketoconazole/Hydrocortisone) should not be used unless the benefit outweighs the risks.

-Ketoconazole (Ketoconazole/Hydrocortisone) 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

Data not available

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.

-When used with drugs that reduce gastric acidity: Caution is recommended. Antifungal activity should be monitored and the Ketoconazole (Ketoconazole/Hydrocortisone) dose increased as required.

-When used with potent CYP450 3A4 inducers: Antifungal activity should be monitored and the Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) and the Ketoconazole (Ketoconazole/Hydrocortisone) dose decreased as required; Ketoconazole (Ketoconazole/Hydrocortisone) plasma levels should be measured when appropriate.

BOXED WARNINGS:

-LIMITED USE: Use of Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone). Some patients had no obvious risk factors for liver disease. Patients using Ketoconazole (Ketoconazole/Hydrocortisone) should be advised of the risk and should be monitored closely.

-QT PROLONGATION: Coadministration of Ketoconazole (Ketoconazole/Hydrocortisone) with dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, or ranolazine is contraindicated. Ketoconazole (Ketoconazole/Hydrocortisone) 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.

Data not available

Administration advice:

-Take with a meal.

-Administer Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone).

Storage requirements:

-Protect from moisture.

General:

-There should be laboratory as well as clinical documentation of infection before starting Ketoconazole (Ketoconazole/Hydrocortisone) therapy.

-Therapy should continue until active fungal infection has subsided.

-Ketoconazole (Ketoconazole/Hydrocortisone) requires acidity for dissolution and absorption; absorption impaired when gastric acid production is reduced.

-Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) 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.

Interaction with other medicinal products and other forms of interaction

See also:
What other drugs will affect Hydrocortisone (Ketoconazole/Hydrocortisone)?

With simultaneous use of Hydrocortisone (Ketoconazole/Hydrocortisone) increases the toxicity of cardiac glycosides (because of the emerging hypokalemia increases the risk of arrhythmias); with acetylsalicylic acid - accelerates its excretion and reduces its concentration in blood plasma (with the abolition of Hydrocortisone (Ketoconazole/Hydrocortisone) concentration of salicylates in the blood increases, and increases the risk of side effects); with paracetamol - increased risk of hepatotoxic action of paracetamol (induction of hepatic enzymes and formation of a toxic metabolite of paracetamol); with cyclosporine - increased side effects of Hydrocortisone (Ketoconazole/Hydrocortisone) as a result of inhibition of its metabolism; with Hydrocortisone (Ketoconazole/Hydrocortisone) - increased side effects of Hydrocortisone (Ketoconazole/Hydrocortisone) as a result of reduction of its clearance.

Hydrocortisone (Ketoconazole/Hydrocortisone) Micronised Xepa-Soul Pattinson reduces the effectiveness of hypoglycemic; intensifies the effect of indirect anticoagulants of coumarin derivatives.

Hydrocortisone (Ketoconazole/Hydrocortisone) reduces the effect of vitamin D on the absorption of calcium ions into the lumen of the intestine. Ergocalciferol and parathyroid hormone hinder the development of osteopathy caused by GCS.

Hydrocortisone (Ketoconazole/Hydrocortisone) Micronised Xepa-Soul Pattinson increases the metabolism of isoniazid, meksiletina (especially in "fast acetylators"), which leads to a decrease in their plasma concentrations; increases (with prolonged therapy) the content of folic acid reduces the concentration of praziquantel in blood.

Hydrocortisone (Ketoconazole/Hydrocortisone) in high doses reduces the effect somatropina.

Hypokalemia caused by GCS, may increase the severity and duration of muscle blockade on the background of muscle relaxants.

Antacids reduce the absorption of the GCS.

At simultaneous application with SCS thiazides, carbonic anhydrase inhibitors, other GCS, amphotericin B increase the risk of hypokalemia, drugs containing sodium ions - swelling and increase blood pressure.

NSAIDs and ethanol increases the risk of gastrointestinal ulcerations and bleeding, in combination with NSAIDs to treat arthritis may reduce the dose of GCS due to summation of therapeutic effect. Indomethacin displacing the SCS from its association with albumin, increases the risk of its side effects.

Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis.

The therapeutic effect of GCS is reduced under the influence of inducers of microsomal liver enzymes (including phenytoin, barbiturates, ephedrine, theophylline, rifampin) due to increased rate of metabolism of these substances.

Inhibitors of the function of the adrenal cortex (including mitotan) may necessitate higher doses of GCS.

Clearance GCS increased against the background of preparations of thyroid hormones.

Immunosuppressants increase the risk of infection and lymphoma or other lymphoproliferative disorders associated with Epstein-Barr virus.

Estrogens (including oral contraceptives containing estrogen) reduce the clearance of GKS, lengthens T1/2 and their therapeutic and toxic effects. The appearance of hirsutism and acne promotes the simultaneous use of other steroid hormone funds - androgens, estrogens, anabolic steroids, oral contraceptives.

Tricyclic antidepressants may increase the severity of depression caused by GCS (not shown for the treatment of these side effects).

The risk of developing cataracts increases with the application against other GCS antipsychotic funds (neuroleptics), carbutamide and azathioprine. Simultaneous of Hydrocortisone (Ketoconazole/Hydrocortisone) Micronised Xepa-Soul Pattinson with the appointment of m-cholinoblockers, as well as with means having m-anticholinergic action (including antihistamines, tricyclic antidepressants), with nitrates improves the intraocular pressure.

With simultaneous application of SCS with live vaccines and antiviral compared to other types of immunization increases the risk of activation of viruses and development of infections.

See also:
What other drugs will affect Ketoconazole (Ketoconazole/Hydrocortisone)?

Ketoconazole (Ketoconazole/Hydrocortisone) 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:

Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) tablets is therefore contraindicated.

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

Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone).

When taken orally, imidazole compounds like Ketoconazole (Ketoconazole/Hydrocortisone) 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 Ketoconazole (Ketoconazole/Hydrocortisone) tablets (an imidazole) can not be ruled out.

Concomitant administration of Ketoconazole (Ketoconazole/Hydrocortisone) tablets with phenytoin may alter the metabolism of one or both of the drugs. It is suggested to monitor both Ketoconazole (Ketoconazole/Hydrocortisone) and phenytoin.

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

After the coadministration of 200 mg oral Ketoconazole (Ketoconazole/Hydrocortisone) twice daily and one 20 mg dose of loratadine to 11 subjects, the AUC and Cmax of loratadine averaged 302% (± 142 S.D.) and 251% (± 68 S.D.), respectively, of those obtained after co-treatment with placebo. The AUC and Cmax 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 Ketoconazole (Ketoconazole/Hydrocortisone).

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.