Usual Adult Dose for Osteoarthritis

Famotidine 26.6 mg-Ibuprofen 800 mg (1 tablet) orally 3 times a day

Uses: For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis; and to decrease the risk of developing upper gastrointestinal ulcers, including gastric and/or duodenal ulcer in patients taking ibuprofen for those indications

Usual Adult Dose for Rheumatoid Arthritis

Famotidine 26.6 mg-Ibuprofen 800 mg (1 tablet) orally 3 times a day

Uses: For the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis; and to decrease the risk of developing upper gastrointestinal ulcers, including gastric and/or duodenal ulcer in patients taking ibuprofen for those indications

Renal Dose Adjustments

CrCl less than 50 mL/min: Not recommended.

Liver Dose Adjustments

• Patients who have an abnormal liver test or who develop signs or symptoms of liver dysfunction should be evaluated for hepatic dysfunction.
• If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued.

Dose Adjustments

Elderly: Consider lower doses and close monitoring of renal function in elderly patients due to the increased risk for adverse effects and likelihood of concomitant renal or hepatic insufficiency which can lead to toxicity.

Precautions

US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
• NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.

Dialysis

Data not available

Other Comments

Administration advice:

• Swallow whole; do not break, crush, or chew
• Missed dose: If a dose is missed, take as soon as possible; however, if next scheduled dose is due, do not take the missed dose and instead take the next dose on time; do not take 2 doses at one time.
• Do not substitute with single-ingredient products of famotidine and ibuprofen.

• Prior to initiating treatment, the potential benefits and risks of this drug should be weighed against other treatment options.
• The shortest duration consistent with individual patient treatment goals should be used.
• Clinical trials primarily included patients less than 65 years without prior history of gastrointestinal ulcer.
• There is an increased risk of heart attack, heart failure, and stroke when taking nonsteroidal anti-inflammatory drugs (NSAIDs); these events may occur at any time during treatment and risk increases with long term use, a history of cardiovascular (CV) disease or risk factors for CV disease, and higher doses.

• Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy.
• Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding.
• Hematological: Monitor CBC and chemistry profile periodically in patients receiving long-term therapy.
• Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.

• Patients should seek medical advice for signs and symptoms of gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
• Patients should seek medical attention immediately if signs/symptoms of cardiovascular events occur including, shortness of breath, slurred speech, chest pain, or weakness on one side of the body.
• Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; NSAIDs should not be used at 20 weeks or later in pregnancy unless specifically advised to do so by their health care professional.