Zoryve 0.3 % topical cream

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Medication name

Generic name:
Roflumilast - topical

Pronunciation
(roe-FLUE-mi-last)

Brand name(s)
Zoryve

Uses

This medication is used to treat certain skin conditions (plaque psoriasis, seborrheic dermatitis).

How to use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using roflumilast and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for use on the skin only. Apply this medication to the affected area and rub in completely as directed by your doctor, usually once daily. Wash your hands after applying, unless you are treating your hands. Avoid getting this medication in your eyes, mouth, or vagina. If this happens, rinse right away with plenty of water.

If you are using the foam, shake the can well before each use. The foam is flammable. Avoid fire, flame, and smoking while applying the foam and right after applying it.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition does not get better or if it gets worse.

Side effects

Diarrhea, nausea, headache, or pain at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including:

  • trouble sleeping
  • signs of infection (such as sore throat that doesn't go away, fever, chills)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • severe 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using roflumilast, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • liver disease

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. To avoid direct contact, do not apply this medication to the nipple and areola if breastfeeding. Consult your doctor before breastfeeding.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed dose

If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Apply your next dose at the regular time. Do not apply extra medicine to make up for the missed dose.

Storage

Store at room temperature. Keep all medications away from children and pets.

The foam is flammable. Do not puncture the foam can. Store the can upright away from heat. Do not freeze.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised December 2023.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.