ibuprofen/famotidine (Rx)

Brand and Other Names:Duexis
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Dosing & Uses

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Dosage Forms & Strengths

ibuprofen/famotidine

tablet

  • 800mg/26.6mg

Rheumatoid Arthritis

Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers

1 tablet PO q8hr

Osteoarthritis

Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers

1 tablet PO q8hr

Safety and efficacy not established

Rheumatoid Arthritis

Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers

1 tablet PO q8hr

Osteoarthritis

Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers

1 tablet PO q8hr

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Interactions

Interaction Checker

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              Serious - Use Alternative (19)

              • atazanavir

                ibuprofen/famotidine will decrease the level or effect of atazanavir by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Atazanavir solubility decreases as pH increases. Substantially reduced plasma concentrations of atazanavir are expected if H2-receptor antagonists (H2RA) are coadministered. For treatment-naïve patients, take atazanavir simultaneously with the H2RA or at least 10 h afterwards. See dosage adjustment recommendations if coadministered in treatment-experienced patients.

              • bosutinib

                ibuprofen/famotidine will decrease the level or effect of bosutinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • dapsone

                ibuprofen/famotidine will decrease the level or effect of dapsone by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • dasatinib

                ibuprofen/famotidine will decrease the level or effect of dasatinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • digoxin

                ibuprofen/famotidine will increase the level or effect of digoxin by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • indinavir

                ibuprofen/famotidine will decrease the level or effect of indinavir by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • itraconazole

                ibuprofen/famotidine will decrease the level or effect of itraconazole by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Administer acid neutralizing medicines at least 2 hours before or 2 hours after the intake of itraconazole.

              • ketoconazole

                ibuprofen/famotidine will decrease the level or effect of ketoconazole by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • mefloquine

                mefloquine increases toxicity of ibuprofen/famotidine by QTc interval. Avoid or Use Alternate Drug. Mefloquine may enhance the QTc prolonging effect of high risk QTc prolonging agents.

              • neratinib

                ibuprofen/famotidine will decrease the level or effect of neratinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • nimodipine

                ibuprofen/famotidine will increase the level or effect of nimodipine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • nisoldipine

                ibuprofen/famotidine will increase the level or effect of nisoldipine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • nitrendipine

                ibuprofen/famotidine will increase the level or effect of nitrendipine by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • pazopanib

                ibuprofen/famotidine will decrease the level or effect of pazopanib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Avoid coadministration of pazopanib with drugs that raise gastric pH; consider short-acting antacids in place of PPIs and H2 antagonists; separate antacid and pazopanib dosing by several hours

              • pimozide

                ibuprofen/famotidine, pimozide. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug.

                pimozide, ibuprofen/famotidine. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug.

              • ponatinib

                ibuprofen/famotidine decreases levels of ponatinib by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug.

              • risedronate

                ibuprofen/famotidine will increase the level or effect of risedronate by increasing gastric pH. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies only to delayed release formulation; accelerates pH-sensitive dissolution of delayed release risedronate

              • secretin

                ibuprofen/famotidine, secretin. Other (see comment). Avoid or Use Alternate Drug. Comment: Concomitant use of H2-receptor antagonists may cause a hyperresponse in gastrin secretion in response to stimulation testing with secretin, falsely suggesting gastrinoma. Discontinue H2-receptor antagonists at least 2 days before administering secretin to aid in the diagnosis of gastrinoma.

              • vandetanib

                ibuprofen/famotidine, vandetanib. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug.

                vandetanib, ibuprofen/famotidine. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug.

              Monitor Closely (55)

              • aliskiren

                ibuprofen/famotidine will decrease the level or effect of aliskiren by Other (see comment). Use Caution/Monitor. In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs with drugs that affect RAAS may increase the risk of renal impairment (including acute renal failure) and cause loss of antihypertensive effect. Monitor renal function periodically.

              • ampicillin

                ibuprofen/famotidine will decrease the level or effect of ampicillin by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • bimatoprost

                bimatoprost, ibuprofen/famotidine. unspecified interaction mechanism. Use Caution/Monitor. There are conflicting reports from studies of either increased or decreased IOP when ophthalmic prostaglandins are coadministered with NSAIDs (either systemic or ophthalmic).

              • budesonide

                ibuprofen/famotidine decreases effects of budesonide by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Enteric-coated budesonide dissolves at pH >5.5. Also, dissolution of extended-release budesonide tablets is pH dependent. Coadministration with drugs that increase gastric pH may cause these budesonide products to prematurely dissolve, and possibly affect release properties and absorption of the drug in the duodenum.

              • carbonyl iron

                ibuprofen/famotidine will decrease the level or effect of carbonyl iron by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • cefdinir

                ibuprofen/famotidine will decrease the level or effect of cefdinir by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • cefditoren

                ibuprofen/famotidine will decrease the level or effect of cefditoren by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • cefpodoxime

                ibuprofen/famotidine will decrease the level or effect of cefpodoxime by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • cefuroxime

                ibuprofen/famotidine will decrease the level or effect of cefuroxime by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • crizotinib

                ibuprofen/famotidine decreases levels of crizotinib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Drugs that elevate the gastric pH may decrease the solubility of crizotinib and subsequently reduce its bioavailability. However, no formal studies have been conducted. .

              • cyclosporine

                ibuprofen/famotidine, cyclosporine. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor. NSAIDs decrease prostaglandin synthesis, increasing the risk of nephrotoxicity.

              • dabrafenib

                ibuprofen/famotidine will decrease the level or effect of dabrafenib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Drugs that alter upper GI tract pH (eg, PPIs, H2-blockers, antacids) may decrease dabrafenib solubility and reduce its bioavailability

              • dexmethylphenidate

                ibuprofen/famotidine will increase the level or effect of dexmethylphenidate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Applies only to extended release formulation

              • erlotinib

                ibuprofen/famotidine decreases levels of erlotinib by Other (see comment). Use Caution/Monitor. Comment: Avoid combination when possible. If concurrent use is required erlotinib should be taken 10 hours after a H2-antagonist and at least 2 hours before the next dose of H2-antagonist.

              • ferric carboxymaltose

                ibuprofen/famotidine will decrease the level or effect of ferric carboxymaltose by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • ferric gluconate

                ibuprofen/famotidine will decrease the level or effect of ferric gluconate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • ferric maltol

                ibuprofen/famotidine will decrease the level or effect of ferric maltol by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • ferrous fumarate

                ibuprofen/famotidine will decrease the level or effect of ferrous fumarate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • ferrous gluconate

                ibuprofen/famotidine will decrease the level or effect of ferrous gluconate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • ferrous sulfate

                ibuprofen/famotidine will decrease the level or effect of ferrous sulfate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • fish oil triglycerides

                fish oil triglycerides will increase the level or effect of ibuprofen/famotidine by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.

              • fosamprenavir

                ibuprofen/famotidine will decrease the level or effect of fosamprenavir by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • gefitinib

                ibuprofen/famotidine decreases levels of gefitinib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Separate gefitinib and H2-antagonist doses by at least 6 hr.

              • glipizide

                ibuprofen/famotidine will increase the level or effect of glipizide by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • glyburide

                ibuprofen/famotidine will increase the level or effect of glyburide by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • iron dextran complex

                ibuprofen/famotidine will decrease the level or effect of iron dextran complex by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • iron sucrose

                ibuprofen/famotidine will decrease the level or effect of iron sucrose by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • latanoprost

                latanoprost, ibuprofen/famotidine. unspecified interaction mechanism. Use Caution/Monitor. There are conflicting reports from studies of either increased or decreased IOP when ophthalmic prostaglandins are coadministered with NSAIDs (either systemic or ophthalmic).

              • latanoprostene bunod ophthalmic

                latanoprostene bunod ophthalmic, ibuprofen/famotidine. unspecified interaction mechanism. Use Caution/Monitor. There are conflicting reports from studies of either increased or decreased IOP when ophthalmic prostaglandins are coadministered with NSAIDs (either systemic or ophthalmic).

              • ledipasvir/sofosbuvir

                ibuprofen/famotidine decreases levels of ledipasvir/sofosbuvir by Other (see comment). Use Caution/Monitor. Comment: Ledipasvir solubility decreases as pH increases; drugs that increase gastric pH are expected to decrease levels of ledipasvir; H2-receptor antagonists may be administered simultaneously with or 12 hr apart from ledipasvir/sofosbuvir at a dose that does not exceed doses comparable to famotidine 40 mg BID.

              • mesalamine

                ibuprofen/famotidine will decrease the level or effect of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely.

              • methylphenidate

                ibuprofen/famotidine will increase the level or effect of methylphenidate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Applies only to extended release formulation

              • mifepristone

                ibuprofen/famotidine, mifepristone. Either increases toxicity of the other by QTc interval. Use Caution/Monitor.

                mifepristone, ibuprofen/famotidine. Either increases toxicity of the other by QTc interval. Use Caution/Monitor.

              • mycophenolate

                ibuprofen/famotidine will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • nelfinavir

                ibuprofen/famotidine will decrease the level or effect of nelfinavir by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • nilotinib

                ibuprofen/famotidine decreases levels of nilotinib by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Avoid this interaction by administering H2 antagonists 10 hr after or 2 hr before nilotinib.

              • polysaccharide iron

                ibuprofen/famotidine will decrease the level or effect of polysaccharide iron by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • posaconazole

                ibuprofen/famotidine will decrease the level or effect of posaconazole by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • potassium iodide

                potassium iodide and ibuprofen/famotidine both increase serum potassium. Use Caution/Monitor.

              • prasugrel

                ibuprofen/famotidine, prasugrel. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Chronic use of NSAIDs with prasugrel may increase bleeding risk.

              • rilpivirine

                ibuprofen/famotidine, rilpivirine. increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Combination of rilpivirine and H2-receptor antagonists should be used with caution as coadministration may cause significant decreases in rilpivirine plasma concentrations (increase in gastric pH). Administer famotidine at least 12 hours before or at least 4 hours after rilpivirine.

              • rose hips

                ibuprofen/famotidine will decrease the level or effect of rose hips by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • saquinavir

                ibuprofen/famotidine will increase the level or effect of saquinavir by unspecified interaction mechanism. Use Caution/Monitor.

              • sodium sulfate/?magnesium sulfate/potassium chloride

                sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of ibuprofen/famotidine by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

              • sodium sulfate/potassium sulfate/magnesium sulfate

                sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of ibuprofen/famotidine by Other (see comment). Use Caution/Monitor. Comment: Coadministration with medications that cause fluid and electrolyte abnormalities may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.

              • sofosbuvir/velpatasvir

                ibuprofen/famotidine will decrease the level or effect of sofosbuvir/velpatasvir by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Velpatasvir solubility decreases as gastric pH increases (practically insoluble at pH >5). H2 receptor antagonists may be administered simultaneously with or 12 hr apart from sofosbuvir/velpatasvir at a dose that does not exceed doses comparable to famotidine 40 mg BID.

              • tafluprost

                tafluprost, ibuprofen/famotidine. unspecified interaction mechanism. Use Caution/Monitor. There are conflicting reports from studies of either increased or decreased IOP when ophthalmic prostaglandins are coadministered with NSAIDs (either systemic or ophthalmic).

              • tolbutamide

                ibuprofen/famotidine will increase the level or effect of tolbutamide by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.

              • travoprost ophthalmic

                travoprost ophthalmic, ibuprofen/famotidine. unspecified interaction mechanism. Use Caution/Monitor. There are conflicting reports from studies of either increased or decreased IOP when ophthalmic prostaglandins are coadministered with NSAIDs (either systemic or ophthalmic).

              • triamcinolone acetonide injectable suspension

                ibuprofen/famotidine, triamcinolone acetonide injectable suspension. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Concomitant use of NSAIDS and corticosteroids increases the risk of gastrointestinal side effects. .

              • vandetanib

                vandetanib increases levels of ibuprofen/famotidine by Other (see comment). Modify Therapy/Monitor Closely. Comment: Vandetanib inhibits the uptake of substrates of organic cation transporter type 2 (OCT2).

              • varenicline

                ibuprofen/famotidine will increase the level or effect of varenicline by decreasing renal clearance. Use Caution/Monitor.

              • vismodegib

                ibuprofen/famotidine will decrease the level or effect of vismodegib by Other (see comment). Use Caution/Monitor. Drugs that increase gastric pH alter vismodegib solubility and therefore reduce bioavailability; effect on efficacy unknown

              • voclosporin

                voclosporin, ibuprofen/famotidine. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

              • zanubrutinib

                ibuprofen/famotidine, zanubrutinib. Either increases effects of the other by anticoagulation. Modify Therapy/Monitor Closely. Zanubrutinib-induced cytopenias increases risk of hemorrhage. Coadministration of zanubritinib with antiplatelets or anticoagulants may further increase this risk.

              Minor (10)

              • alendronate

                ibuprofen/famotidine increases levels of alendronate by unspecified interaction mechanism. Minor/Significance Unknown. Monitor for increase in alendronate side effects.

              • aripiprazole

                ibuprofen/famotidine decreases levels of aripiprazole by unspecified interaction mechanism. Minor/Significance Unknown.

              • axitinib

                ibuprofen/famotidine will decrease the level or effect of axitinib by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown.

              • blessed thistle

                blessed thistle decreases effects of ibuprofen/famotidine by pharmacodynamic antagonism. Minor/Significance Unknown. Theoretical interaction.

              • ceftibuten

                ibuprofen/famotidine will decrease the level or effect of ceftibuten by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown.

              • cyanocobalamin

                ibuprofen/famotidine decreases levels of cyanocobalamin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • devil's claw

                devil's claw decreases effects of ibuprofen/famotidine by pharmacodynamic antagonism. Minor/Significance Unknown.

              • melphalan

                ibuprofen/famotidine decreases levels of melphalan by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

              • metformin

                ibuprofen/famotidine increases levels of metformin by decreasing renal clearance. Minor/Significance Unknown.

              • phytoestrogens

                ibuprofen/famotidine decreases levels of phytoestrogens by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

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              Adverse Effects

              1-10%

              Nausea (6%)

              Dyspepsia (5%)

              Diarrhea (5%)

              Constipation (4%)

              Headache (3%)

              Hypertension (3%)

              Upper abdominal pain (3%)

              Gastroesophageal reflux (2%)

              Vomiting (2%)

              Stomach discomfort (2%)

              Anemia (2%)

              Peripheral edema (2%)

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              Warnings

              Black Box Warnings

              Cardiovascular risk

              • Contains ibuprofen; may increase the risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal; risk may increase with duration of use
              • Patients with CV disease or risk factors may be at greater risk
              • Contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery

              Gastrointestinal risk

              • NSAIDs, including ibuprofen, increase the risk of serious GI adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal
              • Reactions can occur at any time without warning symptoms
              • Elderly patients are at greater risk

              Contraindications

              Hypersensitivity

              Pre-existing asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs

              Use during the perioperative period in the setting of CABG surgery

              Starting at 30 weeks gestation, NSAIDs should not be used by pregnant women as premature closure of the ductus arteriosus in the fetus may occur

              Cautions

              Hypertension can occur with NSAID treatment; monitor blood pressure

              Fluid retention and edema can occur with NSAID treatment; use with caution in patients with fluid retention or heart failure

              Antiplatelet effect; active and clinically significant bleeding from any source can occur; discontinue if active bleeding occurs

              Long-term NSAID administration can result in renal papillary necrosis and other renal injury; caution in patients at risk (eg elderly, existing renal impairment, heart failure, liver impairment, coadministration with diuretics or ACE inhibitors)

              Anaphylaxis may occur; especially in asthmatic patients experiencing rhinitis and bronchospasm; discontinue immediately if an anaphylactoid reaction occurs

              Serious/fatal skin reactions may occur and include exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis; discontinue if rash or other signs of local skin reaction occur

              Hepatic injury ranging from transaminase elevations to liver failure can occur; discontinue immediately if abnormal liver tests persist or worsen, if clinical signs and symptoms of liver disease develop, or if systemic manifestations occur

              Drug reaction with eosinophilia and systemic symptoms

              • Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
              • Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
              • Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
              • Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately
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              Pregnancy & Lactation

              Pregnancy

              Use of NSAIDs can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment

              Because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy

              Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases risk of premature closure of fetal ductus arteriosus

              Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment

              There are no available data with use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; however, there are published studies with each individual component of the drug combination

              Ibuprofen

              • Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
              • In animal reproduction studies, there were no clear developmental effects at doses up to 0.4-times the maximum recommended human dose (MRHD) in the rabbit and 0.5-times in the MRHD rat when dosed throughout gestation
              • In contrast, an increase in membranous ventricular septal defects was reported in rats treated on gestation days 9 & 10 with 0.8-times the MRHD
              • Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre-and post-implantation loss
              • Prostaglandins also have been shown to have an important role in fetal kidney development; in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses

              Famotidine

              • Limited published data do not report an increased risk of congenital malformations or other adverse pregnancy effects with use of H2-receptor antagonists during pregnancy; however, these data are insufficient to adequately determine a drug-associated risk
              • Reproductive studies with famotidine have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day (approximately 243 and 122 times the recommended human dose, respectively, based on body surface area) and in both species at intravenous (IV) doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine
              • Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, can cause premature closure of fetal ductus arteriosus
              • If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to lowest effective dose and shortest duration possible
              • If treatment is needed for a pregnant woman, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue therapy and follow up according to clinical practice

              Labor or Delivery

              • There are no studies on the effects of drug combination during labor or delivery; in animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

              Lactation

              No studies conducted with use of drug combination in lactating women; limited data from published literature report famotidine is present in human milk in low amounts

              Published literature also reports the presence of ibuprofen in human milk in low amounts; no information is available on effects of famotidine or ibuprofen on milk production or on a breastfed infant

              Famotidine is present in milk of lactating rats; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug combination or from underlying maternal condition

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Ibuprofen: NSAID; elicits analgesic and antipyretic effects by prostaglandin synthetase inhibition

              Famotidine: H2-receptor antagonist; inhibits gastric acid secretion, thereby lowering gastric pH

              Pharmacokinetics

              Protein Bound: extensive (ibuprofen); 15-20% (famotidine)

              Excretion

              Half-life: 2 hr (ibuprofen); 4 hr (famotidine)

              Renal clearance: 250-450 mL/min (famotidine)

              Urine: Ibuprofen metabolite (45-79%); free or conjugated drug (1-14%); famotidine (65-70% with 30% as unchanged)

              Absorption

              • Peak Plasma Time: 1.9 hr (ibuprofen); 2 hr (famotidine); food delays peak time
              • Peak Plasma Concentration: 45 mcg/mL (ibuprofen); 61 ng/mL (famotidine)
              • AUC: Food reduces AUC by 11-15%
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Duexis oral
              -
              800-26.6 mg tablet
              ibuprofen-famotidine oral
              -
              800-26.6 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              ibuprofen-famotidine oral

              IBUPROFEN/FAMOTIDINE - ORAL

              (EYE-bue-PROE-fen/fam-OH-ti-deen)

              COMMON BRAND NAME(S): Duexis

              WARNING: Nonsteroidal anti-inflammatory drugs (including ibuprofen) may rarely increase the risk of a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk may be greater in older adults or if you have heart disease or an increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not take this drug right before or after heart bypass surgery (CABG).This drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning at any time while taking this drug. Older adults may be at higher risk for this effect.Stop taking this product and get medical help right away if you notice any of these rare but serious side effects: stomach/abdominal pain that doesn't go away, black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes.Talk to your doctor or pharmacist about the benefits and risks of taking this drug.

              USES: This combination medication is used to relieve pain from rheumatoid arthritis and osteoarthritis while decreasing the risk of developing an ulcer from ibuprofen use. It contains ibuprofen and famotidine. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by blocking your body's production of certain natural substances that cause inflammation. This helps to decrease swelling and pain. Famotidine is an H2 blocker that works by reducing the amount of acid in your stomach. This helps prevent ulcers.Ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

              HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking ibuprofen/famotidine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually three times a day. Take it with a full glass of water (8 ounces/240 milliliters). Do not lie down for at least 10 minutes after taking this drug. If you have stomach upset while taking this medication, take it with food, milk, or an antacid.Swallow whole. Do not chew, crush, or split the medication. Splitting the medication may not provide enough famotidine to protect against ulcers.The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than prescribed.It may take up to two weeks of taking this drug regularly until you get the full benefit.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition persists or worsens.

              SIDE EFFECTS: See also Warning section.Upset stomach, nausea, vomiting, headache, diarrhea, constipation, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.If your doctor has prescribed this medication, remember that 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.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, hearing changes (such as ringing in the ears), mental/mood changes, unexplained stiff neck, signs of kidney problems (such as change in the amount of urine), vision changes, symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, dark urine, yellowing eyes/skin.Get medical help right away if you have any very serious side effects, including: fast/slow/irregular heartbeat, severe dizziness, fainting, seizure.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: fever, swollen lymph nodes, rash, 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 taking ibuprofen/famotidine, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as naproxen, celecoxib); or to other H2 blockers (such as cimetidine, ranitidine) 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 taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps), heart disease (such as previous heart attack), high blood pressure, liver disease, stroke, throat/stomach/intestinal problems (such as bleeding, heartburn, ulcers).Kidney problems can sometimes occur with the use of NSAID medications, including ibuprofen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, stroke, mental/mood changes (such as confusion), seizure, or unusual tiredness while using this drug.Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

              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.Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), cidofovir, lithium, corticosteroids (such as prednisone), "water pills" (diuretics such as furosemide).This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (including aspirin, NSAIDs such as celecoxib, ketorolac, or naproxen). These drugs are similar to ibuprofen and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Daily use of ibuprofen may decrease aspirin's ability to prevent heart attack/stroke. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain/fever. If you must take ibuprofen, talk to your doctor about taking immediate-release aspirin (not enteric-coated/EC) while taking ibuprofen. Take ibuprofen at least 8 hours before or at least 2 hours after your aspirin dose. Do not increase your daily dose of aspirin or change the way you take aspirin/other medications without your doctor's approval.Some products need stomach acid so that the body can absorb them properly. Famotidine decreases stomach acid, so it may change how well these products work. Some affected products include atazanavir, dasatinib, delavirdine, certain azole antifungals (such as itraconazole, ketoconazole), pazopanib, among others.

              OVERDOSE: 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. Symptoms of overdose may include: severe stomach pain, trouble breathing, extreme drowsiness.

              NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as blood pressure, complete blood counts, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Non-drug treatment for arthritis that is approved by your doctor (such as weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.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.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: 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.

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              Formulary

              FormularyPatient Discounts

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              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.