Dosing and uses of Duexis (ibuprofen/famotidine)
Adult dosage forms and 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
Pediatric dosage forms and strengths
Safety and efficacy not established
Geriatric dosage forms and strengths
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
Duexis (ibuprofen/famotidine) adverse (side) 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%)
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
Pregnancy and lactation
Pregnancy category: C; D (after 30 weeks gestation)
Avoid during late stages of pregnancy; NSAIDs are known to cause premature closure of the ductus arteriosus in the fetus
The Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls. (CMAJ, September 6, 2011; DOI:10.1503/cmaj.110454)
Lactation: Unknown whether distributed in breast milk; caution advised
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.
Pharmacology of Duexis (ibuprofen/famotidine)
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%
