General MedicationsORALBlack Box

Ibuprofen and famotidine

Standard Dose

Carefully consider the potential benefits and risks of ibuprofen and famotidine tablets and other treatment options before deciding to use ibuprofen and famotidine tablets. Use ibuprofen at the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5 )] .

Max Dose

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Primary Use

Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies ( 14 ), Use in Specific Populations ( 8.5 )] .

Summary

The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer.

Structured Monograph

Clinical summary

Indications and usage Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H 2 -receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months [see Clinical Studies ( 14 ), Use in Specific Populations ( 8.5 )] . Standard dosing Carefully consider the potential benefits and risks of ibuprofen and famotidine tablets and other treatment options before deciding to use ibuprofen and famotidine tablets. Use ibuprofen at the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5 )] . The recommended daily dose of ibuprofen and famotidine 800 mg/26.6 mg is a single tablet administered orally three times per day. Ibuprofen and famotidine tablets should be swallowed whole, and should not be cut to supply a lower dose. Do not chew, divide, or crush tablets. Patients should be instructed that if a dose is missed, it should be taken as soon possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose. Do not substitute ibuprofen and famotidine tablet with the single-ingredient products of ibuprofen and famotidine. Contraindications Ibuprofen and famotidine tablet is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ibuprofen or famotidine or any components of the drug product [see Warnings and Precautions ( 5.8 , 5.11 )] . History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.8 , 5.10 )] . In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1 )] . Ibuprofen and famotidine tablet should not be administered to patients with a history of hypersensitivity to other H 2 -receptor antagonists. Cross sensitivity with other H 2 -receptor antagonists has been observed. Key warnings Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 5.4 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.5 , 7 ) Heart Failure and Edema : Avoid use of ibuprofen and famotidine tablets in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. ( 5.6 ) Active Bleeding : Active and clinically significant bleeding from any source can occur; discontinue ibuprofen and famotidine tablet if active bleeding occurs. ( 5.3 ) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ibuprofen and famotidine tablet in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. ( 5.7 ) Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs. ( 5.8 ) Exacerbation of Asthma Related to Aspirin Sensitivity : Ibuprofen and famotidine tablet are contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin-sensitivity). ( 5.10 ) Serious Skin Reactions : Discontinue ibuprofen and famotidine tablet at first appearance of skin rash or other signs of hypersensitivity ( 5.11 ). Drug Reaction with Eosinophilia and Systematic Symptoms (DRESS) : Discontinue and evaluate clinically ( 5.12 ). Fetal Toxicity : Limit use of NSAIDs, including ibuprofen and famotidine tablet, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus ( 5.13 , 8.1 ) Hematologic Toxicity : Monitor hemoglobin or hematocrit in patient with any signs or symptoms of anemia. ( 5.14 ) Drug interactions See Table 3 for clinically significant drug interactions with ibuprofen. Table 3: Clinically Significant Drug Interactions with Ibuprofen and Famotidine Drugs That Interfere with Hemostasis Clinical Impact: Ibuprofen and anticoagulants such

Boxed Warning

Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions ( 5.1 )] . Ibuprofen and famotidine tablet is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ s ee Contraindications (4) and Warnings and Precautions (5.1)]. Gastrointestinal Bleeding, Ulceration, and Perforation 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 greater risk for serious GI events [see Warnings and Precautions ( 5.2 )] .

Monitoring

• Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

Interaction Notes

• See Table 3 for clinically significant drug interactions with ibuprofen.
• Table 3: Clinically Significant Drug Interactions with Ibuprofen and Famotidine Drugs That Interfere with Hemostasis Clinical Impact: Ibuprofen and anticoagulants such as warfarin have a synergistic effect on bleeding.
• The concomitant use of ibuprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
• Serotonin release by platelets plays an important role in hemostasis.