The reference site for Ketoconazole

Ketoconazole is a synthetic imidazole antifungal drug used primarily to treat fungal infections.

WHAT IS KETOCONAZOLE?

Ketoconazole is in a class of antifungals called imidazoles. It works by slowing the growth of fungi that cause infection.

It is used to treat yeast infections of the mouth, throat, and esophagus, as well as fungal infections throughout the whole body and serious fungal infections of the skin and nails.

The over-the-counter shampoo version of ketoconazole can also be used as a body wash for the treatment of tinea versicolor.

 

Brand Name(s): Nizoral
CAS nº: 65277-42-1
(kee-toe-koe-na-zole)

 

Product Info

The sections below will provide you with more specific information and guidelines related to ketoconazole and its correct use. Please read them carefully.

FDA Information

Ketoconazole was discovered in 1976 and released in the early 1980s, and was one of the first available oral treatment for fungal infections (griseofulvin was available before ketoconazole).

Why is this medication prescribed?

Ketoconazole is in a class of antifungals called imidazoles. It works by slowing the growth of fungi that cause infection.

It is used to treat yeast infections of the mouth, throat, and esophagus, as well as fungal infections throughout the whole body and serious fungal infections of the skin and nails.

The over-the-counter shampoo version of ketoconazole can also be used as a body wash for the treatment of tinea versicolor.

Other uses for this medicine

Ketoconazole is also sometimes used to treat prostate cancer (cancer that begins in a male reproductive organ), high blood levels of calcium in patients with certain conditions, Cushing’s syndrome (high blood levels of a natural substance called cortisol), and excessive hair growth in women.

Dosage and using this medicine

For patients using the cream form of this medicine:

Apply enough ketoconazole cream to cover the affected and surrounding skin areas, and rub in gently.

To help clear up your infection completely, it is very important that you keep using ketoconazole cream for the full time of treatment, even if your symptoms begin to clear up after a few days. Since fungus or yeast infections may be very slow to clear up, you may have to continue using this medicine every day for up to several weeks. If you stop using this medicine too soon your symptoms may return. Do not miss any doses.

For patients using the 1% shampoo form of this medicine:

Wet your hair and scalp well with water.

Apply enough shampoo to work up a good lather and gently massage it over your entire scalp.

Rinse your hair and scalp with warm water.

Repeat application.

Rinse your hair and scalp well with warm water, and dry your hair.

For patients using the 2% shampoo form of this medicine:

Wet your hair and scalp well with water.

Apply the shampoo to the skin of the affected area and a wide margin surrounding this area.

Work up a good lather and leave it in place for 5 minutes.

Rinse your hair and scalp well with warm water, and dry your hair.

DOSAGE

The dose of topical ketoconazole will be different for each patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of topical ketoconazole. If your dose is different, do not change it unless your doctor tells you to do so.

The number of doses you use each day, the time allowed between doses, and the length of time you use the medicine depend on the medical problem for which you are using topical ketoconazole.

For cream dosage form:

For cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, or pityriasis versicolor:
Adults – Apply once a day to the affected skin and surrounding area.
Children – Use and dose must be determined by your doctor.

For seborrheic dermatitis:
Adults – Apply two times a day to the affected skin and surrounding area.
Children – Use and dose must be determined by your doctor.

For 1% shampoo dosage form:

For dandruff:
Adults – Use every 3 or 4 days for up to 8 weeks. Then use only as needed to keep dandruff under control.
Children – Use and dose must be determined by your doctor.

For 2% shampoo dosage form:

For pityriasis versicolor:
Adults – Use once.
Children – Use and dose must be determined by your doctor.

What special precautions should I follow?

BEFORE TAKING KETOCONAZOLE:

Tell your doctor if you have liver disease, achlorhydria (decreased stomach acid production), or if you take antacids, stomach acid reducers, or stomach ulcer medicines.

Do not take ketoconazole if you are taking any of the following drugs: astemizole (Hismanal®), cisapride (Propulsid®), triazolam (Halcion®) or midazolam (Versed®). Dangerous or life-threatening events may occur if ketoconazole is taken with any of the medicines listed above.

You may not be able to take ketoconazole, or you may require a dosage adjustment, special monitoring, or special directions for use during your treatment.

Ketoconazole is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Additionally, this medication passes into breast milk and may be harmful to a nursing baby. For this reason, ketoconazole should not be taken by nursing mothers. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

What should I do if I forget a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed.

Do not take a double dose of this medication unless otherwise directed by your doctor.

What side effects can this medication cause?

Possible side effects from ketoconazole may include:

nausea
vomiting
diarrhea

Tell your doctor if any of these symptoms are severe or do not go away:

nausea
vomiting
abdominal pain
diarrhea
headache
dizziness
fatigue
itching

If you experience any of the following symptoms, call your doctor immediately:

allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives)
pale stools
yellowish skin or eyes
abdominal pain
unusual fatigue
dark urine

N.B. Recent studies have shown that oral administration of ketoconazole may cause a decrease in the number of sperm (male reproductive cells) produced and a decline in sperm mobility, especially if it is taken at high doses. Talk to your doctor about the risks of taking this medication if you are a man and would like to have children.

Ketoconazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Remember to throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of an emergency/overdose

In the case of an overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

Dizziness
ringing in the ears
headache
nausea
vomiting
diarrhea
abdominal pain

Product Images

PICTURES OF KETOCONAZOLE MEDICATIONS

Below you will find images and specific information on the principal types of ketoconazole that exist, including their respective brand name(s), strength, inscription codes and manufacturers.

The information below includes general information and guidelines for patients taking this medication and should never be used to substitute professional medical advice that can be provided by a qualified physician or family doctor.

 

Name: KETOCONAZOLE
Strength(s): 200 MG
Imprint: M 261
Manufacturer: MYLAN

Name: KETOCONAZOLE
Strength(s): 200 MG
Imprint: PLIVA 621
Manufacturer: PLIVA, INC.

Name: KETOCONAZOLE
Strength(s): 200 MG
Imprint: T 57
Manufacturer: TARO PHARM. USA

Name: KETOCONAZOLE
Strength(s): 200 MG
Imprint: 93 900
Manufacturer: TEVA USAç

Name: KETOCONAZOLE CREAM
Strength(s): 2%
Imprint: Ketoconazole Cream 2%
Manufacturer: TARO PHARM. USA

Name: NIZORAL®
Strength(s): 200 MG
Imprint: NIZORAL | JANSSEN
Manufacturer: JANSSEN PHARM.

Name: NIZORAL® SHAMPOO
Strength(s): 2%
Imprint: Nizoral Shampoo
Manufacturer: MC NEIL CONS.

Name: KETOCONAZOLE SHAMPOO
Strength(s): 2%
Imprint: Ketoconazole Shampoo 2%
Manufacturer: PERRIGO CO.

Name: KETOCONAZOLE CREAM
Strength(s): 2%
Imprint: Ketoconazole Cream 2%
Manufacturer: TEVA USA

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