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Zoryve
roflumilast topical
Adult Dosing .
Dosage forms: CREAM: 0.15%, 0.3%; FOAM: 0.3%
psoriasis, plaque
- [apply (0.3% cream or foam) qd]
psoriasis, scalp
- [apply (0.3% foam) qd]
atopic dermatitis, mild-moderate
- [apply (0.15% cream) qd]
seborrheic dermatitis
- [apply (0.3% foam) qd]
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B or C: contraindicated
Peds Dosing .
- Dosage forms: CREAM: 0.05%, 0.15%, 0.3%; FOAM: 0.3%
psoriasis, plaque
- [0.3% cream form, 6 yo and older]
- Dose: apply qd
- [0.3% foam form, 12 yo and older]
- Dose: apply qd
psoriasis, scalp
- [12 yo and older]
- Dose: apply (0.3% foam) qd
atopic dermatitis, mild-moderate
- [2-5 yo]
- Dose: apply (0.05% cream) qd
- [6 yo and older]
- Dose: apply (0.15% cream) qd
seborrheic dermatitis
- [9 yo and older]
- Dose: apply (0.3% foam) qd
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B or C: contraindicated
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic impairment, Child-Pugh Class B-C
- labor and delivery
- breast administration (breastfeeding patients)
Drug Interactions .
Overview
roflumilast topical
PDE4 inhibitor topical
- CYP1A2 substrate
- CYP3A4 substrate
Caution Advised
- acyclovir
- adagrasib
- allopurinol
- alprazolam
- amiodarone
- amlodipine
- aprepitant
- asciminib
- atazanavir
- atorvastatin
- avacopan
- belumosudil
- berberine
- berotralstat
- bicalutamide
- caffeine
- caffeine citrate
- cannabidiol
- cannabis
- capivasertib
- capmatinib
- ceritinib
- chloramphenicol
- chlorzoxazone
- cilostazol
- cimetidine
- ciprofloxacin
- clarithromycin
- clofazimine
- cobicistat
- conivaptan
- crizotinib
- cyclosporine
- danazol
- danshen
- daridorexant
- darunavir
- deferasirox
- diazoxide
- diltiazem
- diosmin
- disulfiram
- dronedarone
- duvelisib
- echinacea
- efavirenz
- elinzanetant
- enasidenib
- entrectinib
- erythromycin
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethanol (alcoholic beverage)
- ethanol injection
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- everolimus
- famotidine
- fedratinib
- fexinidazole
- finerenone
- flibanserin
- fluconazole
- fluvoxamine
- fosamprenavir
- fosaprepitant
- fostamatinib
- gepotidacin
- ginkgo
- ginseng, Asian
- givosiran
- glecaprevir
- goldenseal
- grazoprevir
- idelalisib
- imatinib
- interferon beta 1a
- interferon beta 1b
- isavuconazonium
- isoniazid
- istradefylline
- itraconazole
- ivacaftor
- ketoconazole
- kratom
- lapatinib
- larotrectinib
- lazertinib
- lefamulin
- lenacapavir
- letermovir
- levoketoconazole
- lomitapide
- lonafarnib
- lopinavir/ritonavir
- lovastatin
- lurasidone
- maribavir
- mavorixafor
- methoxsalen
- mexiletine
- mifepristone
- nefazodone
- nelfinavir
- netupitant
- nicardipine
- nilotinib
- nirogacestat
- obeticholic acid
- osilodrostat
- pacritinib
- palbociclib
- pazopanib
- peginterferon alfa 2a
- pentoxifylline
- peppermint
- pibrentasvir
- pirtobrutinib
- posaconazole
- primaquine
- propafenone
- propranolol
- quercetin
- ranolazine
- remdesivir
- resveratrol
- ribociclib
- rilzabrutinib
- ritlecitinib
- ritonavir
- rucaparib
- safinamide
- selpercatinib
- sevabertinib
- spironolactone
- stiripentol
- ticagrelor
- tipranavir
- tolvaptan
- treosulfan
- tucatinib
- valacyclovir
- vemurafenib
- verapamil
- viloxazine
- vonoprazan
- voriconazole
- ziftomenib
- zileuton
Adverse Reactions .
Serious Reactions
may occur but none reported
Common Reactions
- URI
- diarrhea
- headache
- vomiting
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy, avoid use during labor and delivery; no human data available; risk of embryo-fetal toxicity, including stillbirth, and delivery retardation based on animal data with PO form
Lactation
Clinical Summary
avoid use on breast while breastfeeding, otherwise weigh risk/benefit on other areas; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for roflumilast: liver extensively; CYP450: 1A2, 3A4 substrate; Info: active metabolite; limited systemic absorption
Excretion: for roflumilast: urine 70%; Half-life: 3.6-5 days
Subclass: Atopic Dermatitis, Topical Nonsteroidal Agents ; Phosphodiesterase 4 (PDE4) Inhibitors, Dermatologic ; Psoriasis, Topical Nonsteroidal Agents ; Seborrheic Dermatitis/Dandruff
Mechanism of Action
for roflumilast: exact mechanism of action unknown; inhibits phosphodiesterase type 4 (PDE4), leading to increased intracellular cAMP levels
Formulary .
No Formulary Selected
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