Active Ingredients: Ketoconazole

Ketoconazole Shampoo 2%

(Generic Nizoral)

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What is Ketoconazole shampoo?

Ketoconazole shampoo 2% is a medicated shampoo that is FDA-approved to treat dandruff and a skin condition called tinea versicolor (or pityriasis versicolor), but it is also sometimes used off-label as part of a hair loss treatment plan by helping to reduce scalp inflammation. Since there may be an inflammatory component to certain kinds of hair loss, or some topical hair loss treatments may be mildly irritating, this anti-inflammatory shampoo may be useful. For this reason, some doctors prescribe this medication off-label as an add-on to other topical or oral hair loss treatments.

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How does Ketoconazole shampoo work?

Ketoconazole is considered an azole antifungal medication. It works by reducing fungus and yeast on areas where it is applied. Since an overgrowth of fungus or yeast on the scalp can be irritating or lead to dandruff development, keeping levels in check with a medicated shampoo may be helpful. Even if someone does not have dandruff, Ketoconazole may still exert an anti-inflammatory effect on the scalp.

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How should I use Ketoconazole shampoo?

Use your Ketoconazole shampoo as directed by your doctor and as written on your prescription and prescription information. For dandruff, the most common instructions are to use it every 3-4 days for up to 8 weeks to clear the fungus. You may be instructed to keep using Ketoconazole shampoo occasionally after this treatment phase to prevent dandruff recurrence. However, if you are using Ketoconazole shampoo for scalp inflammation, or for other reasons, you may be instructed to use it differently. Use Ketoconazole shampoo by applying it in the shower after you wet your hair. Put enough product in your hand to cover your scalp and clean your hair, then work into a lather focusing on your scalp and leave on for 5 minutes before rinsing clean. Afterward, continue your usual shower and hair regimen including conditioner or any other hair care products you normally use. Ketoconazole can be irritating to the eyes, so avoid getting the shampoo into the eyes or mouth and rinse thoroughly with water if it does contact these areas.

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How to store Ketoconazole shampoo?

Store your Ketoconazole in its closed original container at room temperature in a dry environment. Store Ketoconazole shampoo safely away from pets and children.

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What are the potential side effects of Ketoconazole shampoo?

Most people will not experience side effects from using Ketoconazole shampoo. But, some side effects that may occur infrequently include: dryness of the hair and scalp, hair texture changes, hair discoloration, scalp pimples, itching, stinging, burning, and irritation of the application site. Please refer to the Safety Info tab on the product page to review the full safety information and potential side effects of this medication.

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How long until I may see an effect from Ketoconazole shampoo?

You may be able to notice positive effects from Ketoconazole shampoo in as little as 2-3 weeks of use. Your exact timeline may deviate according to what you are treating or trying to achieve with the use of your Ketoconazole shampoo.

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Important Safety Information for Ketoconazole Shampoo

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Contraindications and warnings:

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• Ketoconazole shampoo is contraindicated in people who have a known hypersensitivity to the active ingredient (Ketoconazole) or the inactive ingredients in this medication.
• Ketoconazole shampoo can be irritating to the mucus membranes of the eyes, so avoid getting the shampoo into the mouth or eyes and rinse thoroughly with water if it does get into the eyes or mouth.

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Before taking this medication:

You should not use Ketoconazole shampoo if you are allergic to it, or:

• If you are a woman who is pregnant, may be pregnant, or breastfeeding. Ketoconazole is considered a pregnancy category C drug. Use during pregnancy should only occur if your doctor has determined that the potential benefit outweighs the potential risk. In humans, topical use of Ketoconazole shampoo does not lead to the active ingredient being detected in the plasma even after chronic use.

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Tell your healthcare provider about:

• Any health conditions that you have.
• If you are allergic to other azole antifungal medications including: clotrimazole, econazole, miconazole, itraconazole, and fluconazole.
• All other medications that you take, including over-the-counter medications or vitamins and supplements.
• Keep a list of all the medications you take to show your healthcare provider and pharmacist.

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Side Effects:

Get emergency medical help if you have signs of an allergic reaction to Ketoconazole shampoo:

• Hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
• A red or purple rash that spreads and causes blistering and peeling.
• Severe swelling.

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Ketoconazole side effects may include:

• Changes in the texture of hair
• Changes in the color of hair
• Removal of the curl from hair that has been permanently waved
• Burning sensation of the skin
• Itching
• Hypersensitivity reactions
• Rash
• Eye irritation
• Skin irritation
• Dry skin or hair
• Angioedema
• Dermatitis
• Alopecia
• Application site reactions

Tell your healthcare provider if you have any side effect that bothers you or does not go away. 

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This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Additional Resources

The following links provide further information on the potential risks and benefits of this medication:

• Official Ketoconazole PDR
• FDA Ketoconazole Shampoo Label

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Disclaimer 

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The drug and medical information provided is not meant to cover all adverse effects, drug interactions, warnings, medical uses, directions and precautions. The information provided is a medical resource and the judgment of your physician and/or healthcare practitioner should not be substituted. Strut has made every effort to ensure the information is accurate and current based on present medical literature. Strut does not make any guarantees regarding the drug and medical information, and does not assume responsibility regarding the content. The drug safety and drug information contained on the company website may be time sensitive and should not be utilized as a medical reference beyond the date hereof. The deficiency of a warning for prescription medications and vitamins provided in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. If you have questions or concerns about your medications, please do not hesitate to contact us and/or your medical practitioner, including your pharmacist. If using a compound prescription, these products have not been tested or approved by the FDA for their intended use. No claims are made as to the safety, efficacy or use of this compound. Active ingredients used are FDA-approved and follow strict United States Pharmacopeia (USP) guidelines when pursuant to a valid prescription.

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