Adult Dosing
Treatment of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers
Notes:- Tablets should be swallowed whole; do not chew, cut, or crush tablets
- Use the shortest effective treatment duration consistent with individual patient treatment goals
- If a dose is missed, it should be taken as soon possible. However, if the next scheduled dose is due, do not take the missed dose
- Do not take 2 doses at one time to make up for a missed dose
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <50 mL/min: Use not recommended
Hepatic Dose Adjustment
- Hepatic Impairment: Dose adjustments not defined; caution advised
- NSAIDs may increase the risk of serious and potentially fatal cardiovascular thrombotic events, MI, and stroke. This risk further increases with the duration of use and with the presence of cardiovascular disease/risk factors for CV disease. These therapy is contraindicated for the treatment of peri-operative pain in the setting of CABG surgery [US Black Box Warning]
- Inform patients about the signs/symptoms of serious CV events and the steps to take if they occur. Use the lowest effective dose for the shortest duration possible to minimize the potential risk for an adverse CV event
- NSAIDs may increase the risk of serious GI events such as bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Such events may occur at any time during use and without warning symptoms. The risk for serious GI events is higher in elderly patients [US Black Box Warning]
- Factors that increase the risk for GI bleeding in patients receiving NSAID therapy include concomitant use of oral corticosteroids, antiplatelet or anticoagulant drugs, longer duration of NSAID therapy, smoking, alcohol use, older age, and poor general health status
- If a serious GI adverse event is suspected, discontinue therapy and promptly institute an alternative therapy
- Therapy may cause onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events; use with caution in hypertensive patients
- Patients taking thiazides or loop diuretics may have impaired response of these agents during therapy with NSAIDs. Closely monitor BP during therapy
- Cautiously administer therapy in patients with congestive heart failure or fluid retention, as it may cause fluid retention and edema
- Seizures, delirium, and coma have been reported with famotidine in patients with moderate and severe renal insufficiency. Therapy not recommended in patients with CrCl <50 mL/min
- Suspend therapy if active and clinically significant bleeding from any source occurs during therapy
- Long-term administration of NSAIDs may cause renal papillary necrosis and other renal injury. Use with caution in patients at greatest risk for this reaction such as the elderly, those with renal impairment, heart failure, liver dysfunction, and those taking diuretics or ACE inhibitors
- Discontinue therapy if clinical signs (azotemia, hypertension, and proteinuria) and symptoms consistent with renal disease develop
- Ibuprofen component of this combination drug may cause aseptic meningitis with fever and coma, particularly in patients with systemic lupus erythematosus (SLE) and related connective tissue diseases
- As with other NSAIDs, anaphylaxis may occur in patients without known prior exposure to ibuprofen; contraindicated in patients with aspirin triad, which typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit potentially fatal bronchospasm after taking aspirin or other NSAIDs
- Starting at 30 weeks gestation, avoid therapy in pregnant women as it may cause premature closure of the ductus arteriosus
- Evaluation of hemoglobin and hematocrit values at regular intervals in patients on long-term treatment with NSAIDs is recommended as therapy may cause anemia, possibly due to fluid retention, occult or gross GI blood loss
- NSAIDs inhibit platelet aggregation and prolong bleeding time in certain patients; closely monitor patients with coagulation disorders or those receiving anticoagulants
- Serious and potentially fatal skin reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis may occur during therapy; discontinue therapy at the first appearance of skin rash or other sign of hypersensitivity
- Rare cases of severe hepatic reactions including jaundice, fulminant hepatitis, liver necrosis, and hepatic failure have been reported during therapy; periodically perform liver function tests. Discontinue therapy immediately if abnormal liver tests persist or worsen, if clinical signs and symptoms of liver disease develop, or if systemic manifestations occur
- Administer cautiously in patients with preexisting asthma or aspirin-sensitive asthma as it may cause severe bronchospasm, which can be fatal
- The pharmacological activity of this drug in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, noninflammatory painful conditions
- Suspend therapy if patients develop blurred and/or diminished vision, scotomata, and/or changes in color vision; and perform ophthalmologic examination, which includes central visual fields and color vision testing
- Famotidine/ibuprofen cannot be used to treat corticosteroid insufficiency or as a substitute for corticosteroids
Cautions: Use cautiously in
Pregnancy Category:C
Breastfeeding: Famotidine has been used in newborn infants in higher dosages than are transmitted in breastmilk. It would not be expected to cause any adverse effects in breastfed infants. Due to its extremely low levels in breastmilk, short half-life and use in infants in doses much higher than those excreted in breastmilk, ibuprofen is a preferred choice as an analgesic or anti-inflammatory agent in nursing mothers. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 2 August 2011). Manufacturer recommends discontinuation of breastfeeding or postponing of treatment, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
Duexis (famotidine/ibuprofen)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]