Roflumilast

Roflumilast Topical is a prescription medication indicated for the treatment of plaque psoriasis, including intertriginous areas. Roflumilast Topical is also used to treat seborrheic dermatitis, and mild-to-moderate atopic dermatitis.

• Roflumilast is available under the following different brand names: Daliresp, Zoryve

Common side effects of Roflumilast topical include:

• diarrhea 
• application site pain
• headache 
• upper respiratory tract infections
• trouble sleeping 
• urinary tract infections (UTIs)
• nausea

Serious side effects of Roflumilast topical include:

• hives
• difficulty breathing 
• swelling of the face, lips, tongue, or throat 
• dizziness
• mood or behavior changes 
• anxiety
• depression 
• trouble sleeping 
• impulsive thoughts 
• thoughts of self-harm 
• rapid and unintended weight loss 
• pain or burning when urinating
• tremors

Rare side effects of Roflumilast topical include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Topical cream

• 0.15%
• 0.3%

Topical foam

• 0.3%

Plaque psoriasis

Adult dosage

• Apply once daily to affected areas and rub in completely
• Wash hands after application, unless the application is for treatment of hands

Pediatric dosage

• Children aged below 6 years: Safety and efficacy not established
• Children aged above 6 years
  • Apply once daily to affected areas and rub in completely
  • Wash hands after application, unless the application is for treatment of hands

Seborrheic dermatitis

Adult dosage

• Apply a thin layer once daily to affected areas on the skin and/or scalp when they are not wet

Pediatric dosage

• Children aged below 9 years: Safety and efficacy not established
• Children aged 9 years and older: Apply a thin layer once daily to affected areas on the skin and/or scalp when they are not wet

Atopic Dermatitis

Adult dosage

• 0.15% cream: Apply once daily to affected areas and rub in completely
• Wash hands after application, unless the application is for treatment of hands

Pediatric dosage

• Children aged below 6 years: Safety and efficacy not established
• Children aged above 6 years
• 0.15% cream: Apply once daily to affected areas and rub in completely
• Wash hands after application, unless the application is for treatment of hands

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Roflumilast topical has severe interactions with no other drugs
• Roflumilast topical has serious interactions with no other drugs
• Roflumilast topical has moderate interactions with at least 31 other drugs
• Roflumilast topical has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Moderate-to-severe liver impairment (Child-Pugh B or C)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Roflumilast topical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Roflumilast topical?”

Cautions

• Hepatic impairment
  • Contraindicated with moderate-to-severe impairment (Child-Pugh B or C)
  • No studies were conducted with topical roflumilast in patients with hepatic impairment; however, oral roflumilast 250 mcg/day for 14 days was studied in mild-to-moderate hepatic impairment (Child-Pugh A and B)
  • AUC of roflumilast and roflumilast N-oxide were increased by 51% and 24%, respectively, in Child-Pugh A and by 92% and 41%, respectively, in Child-Pugh B, as compared to age-, weight-, and gender-matched healthy individuals
  • Peak plasma concentration of roflumilast and roflumilast N-oxide were increased by 3% and 26%, respectively, in Child-Pugh A and by 26% and 40%, respectively, in Child-Pugh B, as compared to healthy individuals
• Drug interaction overview
• No formal drug-drug interaction studies were conducted with topical Roflumilast
• CYP Inhibitors
  • Caution, monitor
  • Coadministration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (eg, erythromycin, ketoconazole, fluvoxamine, cimetidine) may increase roflumilast systemic exposure
• Oral contraceptives
  • Caution, monitor
  • Coadministration of Roflumilast with oral contraceptives containing ethinyl estradiol may increase roflumilast systemic exposure

Pregnancy and Lactation

• Insufficient data available on use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Clinical considerations
  • Do not use during labor and delivery
  • There are no human studies that have investigated effects on preterm labor or labor at term; however, animal studies showed Roflumilast orally disrupted the labor and delivery process in mice
• Lactation
  • Data are not available regarding the presence of drugs or metabolites in human milk, its effects on breastfed infants, or its effects on milk production
  • Roflumilast and/or its metabolites are excreted into the milk of lactating rats; when a drug is present in animal milk, it is likely to be present in human milk
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for treatment and any potential adverse effects on the breastfed infant
• Clinical considerations
  • Minimize potential exposure to breastfeeding infants via breast milk by applying it to the smallest area of skin and for the shortest duration possible
  • To avoid direct infant exposure, advise breastfeeding women not to apply directly to the nipple or areola; if applied to the patient’s chest, avoid exposure via direct contact with the infant’s skin