Ibuprofen/famotidine

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders

Ibuprofen/famotidine Generic Name & Formulations

General Description

Ibuprofen, famotidine 800mg/26.6mg; tabs.

Pharmacological Class

NSAID + H2 blocker.

How Supplied

Contact supplier

Mechanism of Action

Ibuprofen has analgesic, antiinflammatory, and antipyretic properties. The mechanism of action of the ibuprofen, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Famotidine is a competitive inhibitor of histamine H2-receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.

Ibuprofen/famotidine Indications

Indications

Relief of signs/symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper GI ulcers (eg, gastric and/or duodenal ulcer), in patients who are taking ibuprofen for those indications.

Ibuprofen/famotidine Dosage and Administration

Adult

Do not substitute with single-ingredient ibuprofen and famotidine products. Use lowest effective dose for shortest duration. Swallow whole. 1 tab three times daily.

Children

Not established.

Ibuprofen/famotidine Contraindications

Contraindications

Aspirin allergy. Coronary artery bypass graft surgery.

Ibuprofen/famotidine Boxed Warnings

Boxed Warning

Risk of serious cardiovascular and gastrointestinal events.

Ibuprofen/famotidine Warnings/Precautions

Warnings/Precautions

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure, advanced renal disease; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Inflammatory bowel disease (eg, ulcerative colitis, Crohn’s disease). Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Seizures. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Discontinue and perform eye exam if ophthalmological effects develop (eg, blurred and/or diminished vision, scotomata, and/or changes in color vision). Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.

Ibuprofen/famotidine Pharmacokinetics

Absorption

Ibuprofen: mean Cmax values are 45 µg/mL; and reached ~1.9 hours after oral administration. Famotidine: Cmax values are 61 ng/mL; and reached at ~2 hours after oral administration.

Distribution

Plasma protein bound: extensively (ibuprofen); 15–20% (famotidine).

Elimination

Ibuprofen: Renal (45–79%). Famotidine: Renal (65–70%). Half-life: 2 hours (ibuprofen); 4 hours (famotidine).

Ibuprofen/famotidine Interactions

Interactions

Concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs: not recommended. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine, tizanidine (avoid); monitor for toxicity. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. May antagonize pH-dependent drugs (see full labeling). Avoid dasatinib, delavirdine, cefditoren, fosamprenavir. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.

Ibuprofen/famotidine Adverse Reactions

Adverse Reactions

Nausea, diarrhea, constipation, upper abdominal pain, headache; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, hypersensitivity reactions, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), edema, anemia, active bleeding (discontinue if occurs), ophthalmological effects; rare: aseptic meningitis.

Ibuprofen/famotidine Clinical Trials

See Literature

Ibuprofen/famotidine Note

Notes

Formerly known under the brand name Duexis.

Ibuprofen/famotidine Patient Counseling

See Literature