Classes
DEA Class; Rx
Common Brand Names; Duexis
Nsaids
Description
Nonsteroidal anti-inflammatory drug and histamine H2-receptor antagonist combination
For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis; famotidine is added to decrease the risk of developing upper gastrointestinal ulcers
Indications
For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and for NSAID-induced ulcer prophylaxis.
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
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%)
Warnings
Therapy can lead to new onset of hypertension or worsening of pre-existing hypertension, either of which may contribute to increased incidence of CV events; patients taking angiotensin-converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs; monitor blood pressure (BP) during initiation of NSAID treatment and throughout course of therapy
Fluid retention and edema can occur with NSAID treatment; use with caution in patients with fluid retention or heart failure; ibuprofen may blunt CV effects of several therapeutic agents used to treat medical conditions associated with fluid retention and edema (eg, diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]); avoid use in patients with severe heart failure unless benefits expected to outweigh risk of worsening heart failure; if drug is used in patients with severe heart failure, monitor patients for signs and symptoms of worsening heart failure
Pregnancy and Lactation
Ibuprofen
There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
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
Lactation
Ibuprofen No lactation studies have been conducted.
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
Maximum Dosage
Dosage limits reflect use of the drug in this combination product.
2,400 mg/day PO ibuprofen and 79.8 mg/day PO famotidine.
2,400 mg/day PO ibuprofen and 79.8 mg/day PO famotidine.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
ibuprofen/famotidine
Tablet
- 800mg/26.6mg