Difamilast Topical

Difamilast is used to treat atopic dermatitis (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Difamilast is in a class of medications called phophodiesterase 4 (PDE4) inhibitors. It works by blocking the action of a certain natural substance in the body that is involved in causing inflammation.

Difamilast comes as an ointment to apply to the skin. Apply twice a day. Apply difamilast at around the same times every day.

Apply difamilast exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Apply the ointment in a thin layer to affected areas and rub into the skin completely. Avoid areas of skin that may be infected.

Wash your hands after applying difamilast ointment.

This medication is only for use on the skin. Do not let difamilast products get into your eyes, mouth, or vaginal area.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

Before using difamilast,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had any medical conditions.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Do not apply the ointment to the nipple area or any area that the infant may have contact with if you are breast-feeding. If you become pregnant while using difamilast, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra cream to make up for a missed dose.

Difamilast may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• runny nose, nasal congestion, sore throat

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

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 sunlight, excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

If someone swallows difamilast, 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.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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