Extina

Included as part of the PRECAUTIONS section.

Ketoconazole is a prescription medication used to treat fungal infections, including the following: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis for patients in which other treatments have failed or who are intolerant to other therapies.

Ketoconazole tablets are not for people with fungal nail infections.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that use the enzyme CYP3A4 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor)
• medications that block the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan, delavirdine, and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin, St John's wort, and nimodipine (Nimotop)
• methylprednisolone (Medrol)
• midazolam (Versed)
• triazolam (Halcion)
• digoxin (Lanoxin)
• warfarin (Coumadin, Jantoven)
• phenytoin (Dilantin)
• rifampin 
• alcohol

This is not a complete list of ketoconazole drug interactions. Ask your doctor or pharmacist for more information.

Take ketoconazole exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The ketoconazole dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your liver function
• your kidney function
• your age

The recommended dose for ketoconazole is 200 mg (one tablet) one daily. In very serious infections or if responsiveness is insufficient within the expected time, the dose of ketoconazole may be increased to 400 mg (two tablets) once daily.

In a small number of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. ketoconazole have not been studied in children under 2 years of age.

If you take too much ketoconazole, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

When used orally, ketoconazole has been associated with hepatic toxicity, including some fatalities. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored.

Coadministration of terfenadine with ketoconazole tablets is contraindicated. Rare cases of serious cardiovascular adverse events, including death, ventricular tachycardia and tordades de pointes have been observed in patients taking ketoconazole tablets concomitantly with terfenadine, due to increased terfenadine concentrations induced by ketoconazole tablets.

Pharmacokinetic data indicate that oral ketoconazole 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 tablets is therefore contraindicated.

Coadministration of cisapride with ketoconazole is contraindicated. Serious cardiovascular adverse events including ventricular tachycardia, ventricular fibrillation and torsades de pointes have occurred in patients taking ketoconazole concomitantly with cisapride.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use ketoconazole topical to treat any skin condition that has not been checked by your doctor.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply a thin layer of the cream or gel to the affected skin area as directed. This medicine is usually used for only 2 to 4 weeks.

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying ketoconazole topical.

Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to.

Use the shampoo twice per week, unless your doctor has told you otherwise. Apply enough shampoo to create a lather and massage the scalp for 1 minute. Rinse thoroughly and repeat, leaving the lather on for an additional 3 minutes. Then rinse it off completely. Allow at least 3 days to pass between uses of ketoconazole shampoo.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medication.

Store ketoconazole topical at room temperature away from moisture and heat.

Ketoconazole topical gel is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ketoconazole topical and call your doctor at once if you have a serious side effect such as:

• severe itching, burning, or irritation where the medicine is applied;

• oily or dry scalp, mild hair loss;

• redness, pain, or oozing of treated skin areas; or

• eye redness, swelling, or irritation.

Less serious side effects include:

• mild skin itching or irritation;

• dry skin; or

• headache.

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.

Use Extina as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• To gain the most benefit, do not miss doses.
• Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not use coverings (bandages, dressings) unless told to do so by the doctor.
• Put foam onto a cool surface or into a cap. Do not place foam in your hands.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

Extina® Foam should be applied to the affected area(s) twice daily for four weeks.

Hold the container upright, and dispense Extina® Foam into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of Extina® Foam with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that Extina® Foam may be applied directly to the skin (rather than on the hair).

Avoid contact with the eyes and other mucous membranes. Extina® Foam is not for ophthalmic, oral or intravaginal use.

None

Extina® Foam contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.

The chemical name for ketoconazole is piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl) -2-(1H-imidazol-l-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, cis- with the molecular formula C26H28Cl2N4O4 and a molecular weight of 531.43. The following is the chemical structure:

Extina® Foam contains 20 mg ketoconazole per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic or photo-carcinogenic potential of Extina® Foam.

In oral carcinogenicity studies in mice (18-months) and rats (24-months) at dose levels of 5, 20 and 80 mg/kg/day ketoconazole was not carcinogenic. The high dose in these studies was approximately 2.4 to 4.8 times the expected topical dose in humans based on a mg/m2 comparison. In a bacterial reverse mutation assay, ketoconazole did not express any mutagenic potential. In three in vivo assays (sister chromatid exchange in humans, dominant lethal and micronucleus tests in mice), ketoconazole did not exhibit any genotoxic potential.

At oral dose levels of 75 mg/kg/day (4.5 times the expected topical human dose in mg/m2), ketoconazole impaired reproductive performance and fertility when administered to male rats (increased abnormal sperm, decreased sperm mobility and decreased pregnancy in mated females).

See FDA-approved patient labeling. (17.3)

Instructions for Use

• Avoid fire, flame and/or smoking during and immediately following application.
• Do not apply Extina® Foam directly to hands. Dispense onto a cool surface, and apply to the affected areas using the fingertips.

Local Reactions

• Extina® Foam may cause skin irritation (application site burning and/or reactions)
• Extina® Foam may cause contact sensitization.
• As with any topical medication, patients should wash their hands after application.
• Inform a physician if the area of application shows signs of increased irritation and report any signs of adverse reactions.

Patient Package Insert

-See below-

June 2013

PATIENT INFORMATION
Extina® (ex-TEEN-ah) Foam (ketoconazole, 2%)

IMPORTANT: For skin use only. Do not use in the eyes, mouth or vagina.
Read the Patient Information that comes with Extina® Foam before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is Extina® Foam?

Extina® Foam is used on the skin (topical) to treat a skin condition called seborrheic dermatitis in patients 12 years and older. Seborrheic dermatitis can cause areas of flaky skin (scales) on the scalp, face, ears, chest or upper back.

Extina® Foam has not been studied in children less than 12 years old.

What should I tell my doctor before using Extina® Foam?

For female patients, tell your doctor if you:

• are pregnant or become pregnant. It is not known if Extina® Foam can harm a fetus (unborn baby).
• breastfeeding. It is not known if Extina® Foam passes into breast milk.

How should I use Extina® Foam?

• Apply Extina® Foam exactly as prescribed. Extina® Foam is usually applied to the affected skin areas two times a day (once in the morning and once at night) for 4 weeks. Talk to your doctor if your skin does not improve after 4 weeks of treatment with Extina® Foam.
• Keep the Extina® Foam can away from and do not spray it near fire, open flame, or direct heat. Extina® Foam is flammable. Never throw the Extina® Foam can into a fire, even if the can is empty.

Instructions for applying Extina® Foam

What are the possible side effects of Extina® Foam?

The most common side effects of Extina® Foam are reaction or burning on treated skin areas. Tell your doctor if you have any reaction on your treated skin such as redness, itching, or a rash. These are not all the side effects of Extina® Foam. Ask your doctor or pharmacist for more information.

How should I store Extina® Foam?

• Extina® Foam is flammable.
• Do not spray Extina® Foam near fire or direct heat. Never throw the can into a fire, even if the can is empty.
• Store the can of Extina® Foam at room temperature, 68° to 77°F (20°-25°C). Do not place the Extina® Foam can in the refrigerator or freezer. 
• Keep the Extina® Foam can away from all sources of fire and heat. Do not leave the Extina® Foam can in direct sunlight.
• Do not smoke while holding the Extina® Foam can or while spraying or applying the foam. 
• Do not pierce or burn the Extina® Foam can.
• Keep Extina® Foam and all medicines out of the reach of children.

General information about Extina® Foam

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Extina® Foam for any other condition for which it was not prescribed. Do not give Extina® Foam to other people, even if they have the same condition that you have. It may harm them.

This leaflet summarizes the most important information about Extina® Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Extina® Foam that is written for health professionals.

If you have questions about Extina® Foam you can also call: 1-866-897-5002 (Prestium). (this is a toll-free number)

What are the ingredients in Extina® Foam?

Active ingredients: ketoconazole
Inactive Ingredients: cetyl alcohol, citric acid, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Rx Only

This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

The Patient Information leaflet was last revised: June 2013

June 2013

Manufactured for
Prestium Pharma, Inc.
Newtown, PA 18940
By DPT Laboratories, Ltd San Antonio, TX 78215

Extina is a registered trademark of Stiefel Laboratories, Inc.

© 2013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.            140112-0613

PRINCIPAL DISPLAY PANEL
NDC 40076-051-00
100 g Rx only
FOR TOPICAL USE ONLY
Extina®
(ketoconazole) Foam, 2%

There may be other drugs that can affect Extina Foam. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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

Along with its needed effects, ketoconazole topical (the active ingredient contained in Extina) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ketoconazole topical:

• 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

Some side effects of ketoconazole topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dryness or oiliness of the hair and scalp
• headache

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

LactMed Record Number

361

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.