Country: United States
Language: English
Source: NLM (National Library of Medicine)
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM), FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)
Ascent Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Ibuprofen and famotidine tablet, a combination of the NSAID ibuprofen and the histamine H2 -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)] . 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 ot
Ibuprofen and famotidine tablets, 800 mg/26.6 mg, are Blue/Light blue coated modified oval shaped tablets debossed with “T396” on one side and plain on the other side and supplied as: NDC Number 43602-544-30 Bottle of 30 tablets 43602-544-90 Bottle of 90 tablets 43602-544-05 Bottle of 500 tablets Storage Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F). [See USP Controlled Room Temperature]
Abbreviated New Drug Application
Ascent Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Medication Guide IBUPROFEN and FAMOTIDINE (eye-BYOO-proe-fen and fa-MOE-ti-deen) tablets, for oral use What is the most important information I should know about ibuprofen and famotidine tablet? Ibuprofen and famotidine tablet can cause serious side effects including: • Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: • with increasing doses of medicine containing NSAIDs • with longer use of medicine containing NSAIDs Do not take ibuprofen and famotidine tablet right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking ibuprofen and famotidine tablet after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take ibuprofen and famotidine tablet after a recent heart attack. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: You should take ibuprofen and famotidine tablet exactly as prescribed, at the lowest dose possible and for the shortest time needed. Ibuprofen and famotidine tablet contains a non-steroidal anti-inflammatory drug NSAID (ibuprofen). Do not use ibuprofen and famotidine tablet with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your healthcare provider first, because they may contain an NSAID also. Ibuprofen and famotidine tablet may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your healthcare provider. Ibuprofen and famotidine tablet contains ibuprofen, an NSAID and famotidine, a histamine H2-receptor blocker medicine. What is ibuprofen and famotidine tablet? Ibuprofen and famotidine tablet is a prescription medicine used to: • relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis. • decrease the risk of Read the complete document
IBUPROFEN AND FAMOTIDINE- IBUPROFEN AND FAMOTIDINE TABLET ASCENT PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE IBUPROFEN AND FAMOTIDINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IBUPROFEN AND FAMOTIDINE TABLETS. IBUPROFEN AND FAMOTIDINE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2011 WARNING:RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. 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 (5.1) IBUPROFEN AND FAMOTIDINE TABLET IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY (4, 5.1) 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 (5.2) RECENT MAJOR CHANGES Warnings and Precautions, Drug Reaction with 4/2021 Eosinophilia and Systemic Symptoms (DRESS) (5.12) Warnings and Precautions, Fetal Toxicity (5.13) 4/2021 INDICATIONS AND USAGE Ibuprofen and famotidine tablet, a combination of a nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the histamine H -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 w Read the complete document