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Ibuprofen / Famotidine

Pronunciation: EYE-bue-PROE-fen/fam-OH-ti-deen
Class: NSAID/Histamine H 2 antagonist combination

Trade Names

Duexis
- Tablets, oral ibuprofen 800 mg/famotidine 26.6 mg

Pharmacology

Ibuprofen has analgesic and antipyretic properties, probably through inhibition of prostaglandin synthetase. Famotidine inhibits gastric secretion by inhibiting histamine H 2 receptors.

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Indications and Usage

Relief of signs and symptoms of osteoarthritis and rheumatoid arthritis, and to decrease the risk of developing upper GI ulcers in patients who are taking ibuprofen for these indications.

Contraindications

History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery; late stages of pregnancy; hypersensitivity to any component of the product or to other H 2 receptor antagonists.

Dosage and Administration

Osteoarthritis and rheumatoid arthritis
Adults

PO 1 tablet 3 times per day. Use the shortest duration consistent with individual treatment goals.

Renal Function Impairment
CrCl less than 50 mL/min

Use is not recommended.

General Advice

  • Tablets should be swallowed whole and not cut, chewed, crushed, or divided.

Storage/Stability

Store between 59° and 86°F.

Drug Interactions

The following interactions are based on drug interactions involving each component of the ibuprofen/famotidine combination.

Famotidine Azole antifungal agents (ie, itraconazole, ketoconazole)

Famotidine may decrease itraconazole and ketoconazole absorption, reducing plasma concentrations. Administering itraconazole with an acid solution (cola beverage) or staggering the administration times may improve itraconazole bioavailability. Ketoconazole administration at least 2 h before famotidine may minimize the interaction. (See Ibuprofen/Azole Antifungal Agents.)

Dasatinib

Dasatinib plasma concentrations and pharmacologic effects may be decreased by coadministration of famotidine. Coadministration is not recommended.

Erlotinib

Famotidine may decrease the absorption of erlotinib. Administer erlotinib at least 10 h after taking famotidine and at least 2 h before the next famotidine dose. (See Ibuprofen/Erlotinib.)

Ibuprofen ACE inhibitors (eg, captopril)

The hypotensive effects of ACE inhibitors may be diminished by ibuprofen. Also, the risk of nephrotoxicity associated with ACE inhibitors or ibuprofen may be increased. Closely monitor BP. If BP control deteriorates, consider stopping ibuprofen. Periodic measurement of renal function may be necessary.

Alcohol, antiplatelet drugs (eg, clopidogrel, low-dose aspirin, prasugrel), oral corticosteroids (eg, prednisone), smoking

Administration of ibuprofen with these agents may increase the risk of GI bleeding. If coadministration cannot be avoided, use with caution and closely monitor the patient. Instruct patients to report any signs or symptoms of bleeding.

Aminoglycosides (eg, amikacin, gentamicin)

Coadministration of ibuprofen and aminoglycosides may increase the risk of acute renal failure. Avoid coadministration.

Anticoagulants (eg, warfarin)

The effects of ibuprofen and warfarin on GI bleeding are synergistic, increasing the risk of serious GI bleeding. Coadministration may prolong prothrombin time. Bleeding has been reported in patients on concomitant therapy with anticoagulants and ibuprofen. If coadministration cannot be avoided, use with extreme caution. Closely monitor anticoagulant activity and the patient. Instruct patients to report any signs or symptoms of bleeding.

Aspirin and salicylates

Cardioprotective effect of low-dose, uncoated aspirin may be reduced by ibuprofen. Coadministration of ibuprofen with aspirin reduces the protein binding of ibuprofen. The clinical importance is not known. Concomitant use with ibuprofen may increase the risk of GI toxicity. Avoid concurrent use because of the potential for increased adverse reactions.

Azole antifungal agents (ie, fluconazole, voriconazole)

Ibuprofen plasma concentrations may be elevated because of inhibition of metabolism by certain azole antifungal agents. The pharmacologic effects of ibuprofen and risk of adverse reactions may be increased. Monitor the clinical response and adjust the ibuprofen dose as needed. (See Famotidine/Azole Antifungal Agents.)

Beta-blockers (eg, propranolol)

The antihypertensive effect of the beta-blocker may be reduced by ibuprofen. Closely monitor BP and adjust the beta-blocker dose as needed.

Bisphosphonates (eg, alendronate)

Synergistic action between ibuprofen and bisphosphonates may increase the risk of GI adverse effects (eg, gastric ulceration). Use with caution. Closely monitor for possible GI adverse reactions, especially gastric ulceration. Instruct patients to report signs of GI irritation (heartburn, epigastric pain, nausea/vomiting, and sensation of fullness) to their health care provider.

Cholestyramine

Absorption of ibuprofen may be delayed. Monitor the clinical response and adjust treatment as needed.

Cyclosporine, tacrolimus

The nephrotoxicity of ibuprofen and cyclosporine or tacrolimus may be increased. Closely monitor renal function and cyclosporine concentrations. If an interaction is suspected, consider decreasing the cyclosporine or tacrolimus dose or stopping ibuprofen.

Erlotinib

Coadministration of ibuprofen and erlotinib may increase the risk of GI ulceration and GI perforation. If coadministration cannot be avoided, close clinical monitoring for signs of GI bleeding is warranted. Instruct patients to report any signs or symptoms of bleeding. (See Famotidine/Erlotinib.)

Heparin

The risk of heparin-induced bleeding may be increased by ibuprofen. If coadministration cannot be avoided, close clinical and laboratory monitoring is warranted.

Lithium

Lithium concentrations may be elevated by ibuprofen administration, increasing the pharmacologic effects and risk of adverse reactions. Monitor lithium plasma concentrations and the clinical response as well as for signs of lithium toxicity. Adjust the lithium dose as needed.

Loop diuretics (eg, furosemide), thiazide diuretics (eg, hydrochlorothiazide)

The diuretic effects may be reduced by ibuprofen administration. In addition, renal toxicity has been reported. Closely observe patients for diuretic efficacy and signs of renal failure.

Methotrexate

Ibuprofen may decrease the tubular secretion of methotrexate and delay methotrexate clearance. The risk of methotrexate toxicity may be increased. Use with caution. Consider longer leucovorin rescue when giving NSAIDs and methotrexate at antineoplastic doses. Monitor for renal function impairment and methotrexate levels if indicated.

Probenecid

Pharmacologic and toxic effects of ibuprofen may be increased. Closely monitor for signs of ibuprofen toxicity. Adjust the ibuprofen dose as needed.

Quinolones (eg, ciprofloxacin)

Ibuprofen may reduce the renal elimination of quinolones. The risk of CNS stimulation and seizures from quinolones may be increased. In addition, quinolone plasma concentrations may be increased. Use with caution.

Serotonin reuptake inhibitors (eg, fluoxetine, venlafaxine)

Coadministration of ibuprofen and serotonin reuptake inhibitors may increase the risk of upper GI bleeding. If coadministration cannot be avoided, close clinical monitoring for signs of GI bleeding is warranted. Instruct patients to report any signs or symptoms of bleeding.

Triamterene

Ibuprofen may increase the risk of triamterene-induced nephrotoxicity. If coadministration cannot be avoided, closely monitor renal function. If renal function decreases, consider stopping one or both drugs.

Adverse Reactions

Cardiovascular

Hypertension (3%); hypotension, MI (postmarketing).

CNS

Headache (3%); depression (postmarketing).

GI

Nausea (6%); diarrhea, dyspepsia (5%); constipation (4%); upper abdominal pain (3%); abdominal pain, gastroesophageal reflux disease, stomach discomfort, vomiting (2%).

Genitourinary

UTI (2%).

Hematologic

Anemia (2%); thrombocytopenia (postmarketing).

Hepatic

Abnormal hepatic function (postmarketing).

Metabolic

Peripheral edema (2%).

Musculoskeletal

Back pain (2%); arthralgia (1%).

Renal

Increased serum creatinine (4%); acute renal failure.

Respiratory

Upper respiratory tract infection (4%); bronchitis, cough, nasopharyngitis, pharyngolaryngeal pain, sinusitis (2%); dyspnea (postmarketing).

Miscellaneous

Influenza (2%).

Precautions

Warnings

CV risk

NSAIDs may cause an increased risk of serious CV thrombotic events, MI, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk. NSAIDs, including ibuprofen/famotidine, are contraindicated for treatment of perioperative pain in the setting of CABG surgery.

GI risk

NSAIDs cause an increased risk of serious GI adverse reactions, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These reactions can occur any time during use and without warning symptoms. Elderly patients are at greater risk of serious GI events.


Monitor

Monitor for signs and symptoms of GI ulcerations and bleeding. Closely monitor BP. Periodically check CBC and chemistry profile during prolonged therapy. If used in patients with advanced renal disease, monitor renal function.


Pregnancy

Category C . Contraindicated in late stages of pregnancy.

Lactation

Excreted (famotidine); undetermined (ibuprofen). The American Academy of Pediatrics classifies ibuprofen as compatible with breast-feeding.

Children

Safety and efficacy not established.

Elderly

Increased risk of adverse reactions. Most reports of fatal GI events are in elderly patients; use with caution.

Hypersensitivity

May occur. Do not give NSAIDs to patients with the aspirin triad. Cross-sensitivity to famotidine in patients allergic to other H 2 -receptor antagonists has occurred.

Renal Function

Not recommended in patients with CrCl less than 50 mL/min.

Special Risk Patients

Use with caution in patients with a history of inflammatory bowel disease.

Aseptic meningitis

Has been reported rarely with ibuprofen use and is probably more likely to occur in patients with SLE and related connective tissue diseases.

Asthma

Do not use in patients with aspirin-sensitive asthma. Use with caution in patients with preexisting asthma.

Bleeding

Withdraw treatment when active and clinically significant bleeding from any source occurs.

CNS effects

Seizures, delirium, and coma have been reported with famotidine use in patients with moderate and severe renal impairment.

Fluid retention

Fluid retention and edema may occur. Use with caution in patients with fluid retention or heart failure.

Hematologic effects

Anemia and prolonged bleeding time have occurred with NSAIDs.

Hepatic effects

Borderline elevations of 1 or more liver tests may occur in up to 15% of NSAID users. Rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis, and hepatic failure, have occurred. Discontinue therapy if clinical signs or symptoms of liver disease develop or if systemic manifestations occur (eg, eosinophilia, rash).

Hypertension

May develop or worsen.

Masking fever and inflammation

Antipyretic and anti-inflammatory activity may diminish utility of diagnostic signs in detecting complications of presumed noninfectious, noninflammatory painful conditions.

Ophthalmic effects

Blurred and/or diminished vision, scotomata, and/or changes in color vision have been reported.

Renal effects

Renal papillary necrosis and other renal injury have occurred with long-term administration of NSAIDs.

Skin reactions

NSAIDs can cause serious skin adverse reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, and TEN, which can be fatal.

Overdosage

Symptoms

Apnea, cyanosis, dizziness, nystagmus.

Patient Information

  • Advise patients to read the NSAID Medication Guide before starting therapy and with each refill.
  • Advise patients that ibuprofen/famotidine may cause serious CV adverse reactions, such as MI or stroke, which may result in hospitalization and even death.
  • Advise patients that ibuprofen/famotidine can cause GI discomfort and, rarely, serious GI adverse reactions, such as ulcers and bleeding, which may result in hospitalization and even death.
  • Advise patients that ibuprofen/famotidine can cause serious skin adverse reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, and TEN, which may result in hospitalization, and even death. Advise patients to stop therapy immediately and contact their health care provider as soon as possible if they develop any type of rash.
  • Advise patients that they should be monitored for the development of nephrotoxicity.
  • Advise patients to promptly report any signs of unexplained weight gain to their health care provider.
  • Inform patients of the warning signs and symptoms of hepatotoxicity (eg, nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, flu-like symptoms). Instruct patients to seek immediate medical therapy if any of these occur.
  • Inform patients of the signs and symptoms of anaphylaxis (eg, difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if any of these occur.
  • Inform women of childbearing potential or breast-feeding women to consult their health care provider before using ibuprofen/famotidine.
  • Advise patients to swallow tablets whole; they should not be cut, chewed, crushed, or divided.
  • Instruct patients to take a missed dose as soon as possible. If the next scheduled dose is due, instruct patients not to take the missed dose, but to take the next scheduled dose. Inform patients that they should not take 2 doses at once to make up for a missed dose.

Copyright © 2009 Wolters Kluwer Health.

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