Ketoconazole Cream

Name: Ketoconazole Cream

Side effects

Stinging, swelling, irritation, or redness of the treated skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering, open sores.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Description

Ketoconazole Cream 2%, for topical administration only, contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water.

Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan- 4-yl]methoxy]phenyl]piperazine and has the following structural formula:

How supplied

Ketoconazole Cream 2% is supplied as follows:

15 gram NDC 0168-0099-15
30 gram NDC 0168-0099-30
60 gram NDC 0168-0099-60

Store below 77°F (25°C).

E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747

Overdose

No information provided.

Patient information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

What happens if i miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What should i avoid while using ketoconazole topical?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water.

Avoid covering treated skin areas with tight-fitting, synthetic clothing (such as nylon or polyester) that doesn't allow air to circulate to your skin. If you are treating your feet, wear clean cotton socks and sandals or shoes that allow for air circulation. Keep your feet as dry as possible.

Avoid using other skin or hair products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

What do I need to tell my doctor BEFORE I take Ketoconazole Cream?

  • If you have an allergy to ketoconazole or any other part of ketoconazole cream.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ketoconazole Cream?

  • Tell all of your health care providers that you take ketoconazole cream. This includes your doctors, nurses, pharmacists, and dentists.
  • Talk with your doctor before you use other drugs or products on your skin.
  • If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

Contraindications

Ketoconazole Cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

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