Roflumilast topical

pronounced as ( roe flue′ mi last)

Brand Name(s): Zoryve®

Why is this medicine prescribed?

Roflumilast topical is used to treat:

  • plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body)
  • eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes)
  • seborrheic dermatitis (condition that causes flaking of the skin)

Roflumilast is in a class of medications called phophodiesterase 4 (PDE4) inhibitors. It works by blocking thie action of a certain natural substance in the body that is involved in causing inflammation.

Are there other uses for this medicine?

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

How should this medicine be used?

Roflumilast comes as a cream and foam to apply to the skin or scalp. Apply once a day. Apply roflumilast cream or foam at around the same time every day.

Use roflumilast topical products exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor.

To use the cream, apply a small amount to cover the affected area of skin and rub it in gently.

If you are using the foam, shake the can well. Apply a small amount to cover affected areas of dry skin on your body or scalp and rub it in gently.

Roflumilast foam may catch fire. Stay away from open fire, flames, and do not smoke while you are applying roflumilast foam, and for a short time afterward.

Wash your hands after applying roflumilast cream or foam.

This medication is only for use on the skin. Do not let roflumilast 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.

What special precautions should I follow?

Before using roflumilast topical,

  • 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 while using roflumilast topical. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have liver problems. Your doctor may tell you not to use roflumilast topical products.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using roflumilast topical products, call your doctor.

What special dietary instructions should I follow?

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

What should I do if I forget to take a dose?

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 roflumilast cream or foam to make up for a missed dose.

What should I do in case of overdose?

if someone swallows roflumilast cream or foam, 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.

What side effects can this medicine cause?

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

  • redness, itching, irritation, or pain in the place where you applied the medication
  • runny nose, nasal congestion, sore throat, or cough
  • nausea
  • diarrhea
  • headache

Roflumilast topical 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).

What should I know about storage and disposal of this medication?

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). Do not freeze.

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.

What other information should I know?

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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