AdultPediatricDosing Form & Strengths tablet 250mcg 500mcg Chronic Obstructive Pulmonary Disease Indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations 500 mcg PO qDay Starting treatment with 250 mcg PO qDay for 4 weeks and increasing to 500 mcg qDay thereafter may reduce the rate of treatment discontinuation in some patients NOTE: 250 mcg/day is not the effective (therapeutic) dose Also see Administration Dosage Modifications Renal impairment No dosage adjustment required Hepatic impairment Mild (Child-Pugh class A): Not sufficiently studied; AUCs of roflumilast and roflumilast N-oxide are increased by 51% and 24%, respectively; benefits of administration must be weighed against risks Moderate-to-severe (Child-Pugh class B or C): Contraindicated Safety and efficacy not establishedInteraction CheckerEnter a drug name and roflumilastNo Results No Interactions Found Interactions FoundContraindicatedSerious - Use AlternativeSignificant - Monitor CloselyMinorAll Interactions Sort By: SeverityName Contraindicated (17)bosentanbosentan will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenesscarbamazepinecarbamazepine will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenesscarbamazepine will decrease the level or effect of roflumilast by affecting hepatic enzyme CYP1A2 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessdexamethasonedexamethasone will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenesseslicarbazepine acetateeslicarbazepine acetate will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessetravirineetravirine will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessfosphenytoinfosphenytoin will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessnafcillinnafcillin will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessnevirapinenevirapine will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessoxcarbazepineoxcarbazepine will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenesspentobarbitalpentobarbital will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessphenobarbitalphenobarbital will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessphenobarbital will decrease the level or effect of roflumilast by affecting hepatic enzyme CYP1A2 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessphenytoinphenytoin will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessprimidoneprimidone will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessprimidone will decrease the level or effect of roflumilast by affecting hepatic enzyme CYP1A2 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessrifabutinrifabutin will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessrifampinrifampin will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessrifampin will decrease the level or effect of roflumilast by affecting hepatic enzyme CYP1A2 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessrifapentinerifapentine will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessSt John's WortSt John's Wort will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenessSerious - Use Alternative (12)abametapirabametapir will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.apalutamideapalutamide will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.dabrafenibdabrafenib will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.enzalutamideenzalutamide will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.fexinidazolefexinidazole will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.idelalisibidelalisib will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substratesivosidenibivosidenib will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.lonafarniblonafarnib will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.ritonavirritonavir will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.secobarbitalsecobarbital will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.tucatinibtucatinib will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.voxelotorvoxelotor will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.Monitor Closely (43)amiodaroneamiodarone increases levels of roflumilast by Other (see comment). Modify Therapy/Monitor Closely. Comment: Coadministration with dual inhibitors of CYP3A4 and CYP1A2 may increase systemic exposure and result in increased adverse reactions.armodafinilarmodafinil will decrease the level or effect of roflumilast by affecting hepatic enzyme CYP1A2 metabolism. Modify Therapy/Monitor Closely. Concomitant therapy may reduce therapeutic effectiveness.cenobamatecenobamate will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.ceritinibceritinib will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.cigarette smokingcigarette smoking will decrease the level or effect of roflumilast by affecting hepatic enzyme CYP1A2 metabolism. Use Caution/Monitor.cimetidinecimetidine increases levels of roflumilast by Other (see comment). Modify Therapy/Monitor Closely. Comment: Coadministration with dual inhibitors of CYP3A4 and CYP1A2 may increase systemic exposure and result in increased adverse reactions.cobicistatcobicistat will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.efavirenzefavirenz will decrease the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration not recommended; strong cytochrome P450 enzyme inducers decrease systemic exposure to roflumilast and may reduce the therapeutic effectivenesselagolixelagolix decreases levels of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.encorafenibencorafenib, roflumilast. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.erythromycin baseerythromycin base increases levels of roflumilast by Other (see comment). Modify Therapy/Monitor Closely. Comment: Coadministration with dual inhibitors of CYP3A4 and CYP1A2 may increase systemic exposure and result in increased adverse reactions.erythromycin ethylsuccinateerythromycin ethylsuccinate increases levels of roflumilast by Other (see comment). Modify Therapy/Monitor Closely. Comment: Coadministration with dual inhibitors of CYP3A4 and CYP1A2 may increase systemic exposure and result in increased adverse reactions.erythromycin lactobionateerythromycin lactobionate increases levels of roflumilast by Other (see comment). Modify Therapy/Monitor Closely. Comment: Coadministration with dual inhibitors of CYP3A4 and CYP1A2 may increase systemic exposure and result in increased adverse reactions.erythromycin stearateerythromycin stearate increases levels of roflumilast by Other (see comment). Modify Therapy/Monitor Closely. Comment: Coadministration with dual inhibitors of CYP3A4 and CYP1A2 may increase systemic exposure and result in increased adverse reactions.fedratinibfedratinib will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.fluvoxaminefluvoxamine increases levels of roflumilast by Other (see comment). Modify Therapy/Monitor Closely. Comment: coadministration with dual inhibitors of CYP3A4 and CYP1A2 may increase systemic exposure and result in increased adverse reactions.ifosfamideroflumilast will increase the level or effect of ifosfamide by immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.indinavirindinavir will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.istradefyllineistradefylline will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.itraconazoleitraconazole will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.ketoconazoleketoconazole increases levels of roflumilast by Other (see comment). Modify Therapy/Monitor Closely. Comment: Coadministration with dual inhibitors of CYP3A4 and CYP1A2 may increase systemic exposure and result in increased adverse reactions.ketoconazole will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.lenacapavirlenacapavir will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.levoketoconazolelevoketoconazole increases levels of roflumilast by Other (see comment). Modify Therapy/Monitor Closely. Comment: Coadministration with dual inhibitors of CYP3A4 and CYP1A2 may increase systemic exposure and result in increased adverse reactions.levoketoconazole will increase the level or effect of roflumilast by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.lomustineroflumilast will increase the level or effect of lomustine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.lopinavirlopinavir will decrease the level or