Boxed Warning (Black Box)
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS 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)] . Ibup...
IBUPROFEN AND FAMOTIDINE
IBUPROFEN AND FAMOTIDINE
Manufacturer: Advanced Rx Pharmacy of Tennessee, LLC
Clinical information
Indications & Usage
1 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)] . Ibuprofen and famotidine tablet, a combination of a nonsteroidal anti-inflammatory drug (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. (1)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. One ibuprofen and famotidine tablet administered orally three times per day. (2) Use ibuprofen at the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (2) Do not substitute ibuprofen and famotidine tablet with the single-ingredient products of ibuprofen and famotidine. (2)
Contraindications
4 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. Known hypersensitivity to ibuprofen or famotidine or any components of the drug product. (4) History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. (4) In the setting of CABG surgery. (4) Known hypersensitivity to other H 2 -receptor antagonists. (4)
Safety
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] GI Bleeding, Ulceration, and Perforation [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.4)] Hypertension [see Warnings and Precautions (5.5)] Heart Failure and Edema [see Warnings and Precautions (5.6)] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.7)] Anaphylactic Reactions [see Warnings and Precautions (5. 8)] Seizures [see Warnings and Precautions (5.9)] Serious Skin Reactions [see Warnings and Precautions (5.11)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.12)] Fetal Toxicity [see Warnings and Precautions (5.13)] Hematologic Toxicity [see Warnings and Precautions (5.14)] Aseptic Meningitis [see Warnings and Precautions (5.18)] Ophthalmological Effects [see Warnings and Precautions (5.19)] Most common adverse reactions (≥1% and greater than ibuprofen alone) are nausea, diarrhea, constipation, upper abdominal pain, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals, Inc., at 1-866-495-8330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ibuprofen and famotidine tablet was evaluated in 1022 patients in controlled clinical studies, including 508 patients treated for at least 6 months and 107 patients treated for approximately 1 year. Patients treated with ibuprofen and famotidine tablet ranged in age from 39 to 80 years (median age 55 years), with 67% female, 79% Caucasian, 18% African-American, and 3% other races. Two randomized, active-controlled clinical studies (Study 301 and Study 303) were conducted for the reduction of the risk of development of ibuprofen-associated, upper gastrointestinal ulcers in patients who required use of ibuprofen, which included 1022 patients on ibuprofen and famotidine tablet and 511 patients on ibuprofen alone. Approximately 15% of patients were on low-dose aspirin. Patients were assigned randomly, in a 2:1 ratio, to treatment with either ibuprofen and famotidine tablet or ibuprofen 800 mg three times a day for 24 consecutive weeks. Three serious cases of acute renal failure were observed in patients treated with ibuprofen and famotidine tablet in the two controlled clinical trials. All three patients recovered to baseline levels after discontinuation of ibuprofen and famotidine tablet. Additionally, increases in serum creatinine were observed in both treatment arms in the two clinical studies. Many of these patients were taking concomitant diuretics and/or angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers. There were patients with a normal baseline serum creatinine level who developed abnormal values in the controlled trials as presented in Table 1. Most Commonly Reported Adverse Reactions The most common adverse reactions (≥2%), from pooled data from the two controlled studies are presented in Table 2. In controlled clinical studies, the discontinuation rate due to adverse events for patients receiving ibuprofen and famotidine tablet and ibuprofen alone were similar. The most common adverse reactions leading to discontinuation from ibuprofen and famotidine tablet therapy were nausea (0.9%) and upper abdominal pain (0.9%). There were no differences in types of related adverse reactions seen during maintenance treatment up to 12 months compared to short-term treatment. table 1 table 2.1 table 2.2 6.2 Postmarketing Experience Ibuprofen The following adverse reactions have been identified during post-approval use of ibuprofen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reports are listed below by body system: Cardiac disorders: myocardial infarction Gastrointestinal disorders: nausea, vomiting, diarrhea, abdominal pain General disorders and administration site conditions: pyrexia, pain, fatigue, asthenia, chest pain, drug ineffective, edema peripheral Musculoskeletal and connective tissue disorders: arthralgia Nervous system disorders: headache, dizziness Psychiatric disorders: depression, anxiety Renal and urinary disorders: renal failure acute Respiratory, thoracic, and mediastinal disorders: dyspnea Vascular disorders: hypertension Famotidine The following adverse reactions have been identified during post-approval use of famotidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reports are listed below by body system: Blood and lymphatic system disorders: anemia, thrombocytopenia Gastrointestinal disorders: nausea, diarrhea, vomiting, abdominal pain General disorders and administration site conditions: pyrexia, condition aggravated, asthenia, drug ineffective, chest pain, fatigue, pain, edema peripheral Hepatobiliary disorders: hepatic function abnormal Infections and infestations: pneumonia, sepsis Investigations: platelet count decreased, aspartate aminotransferase increased, alanine aminotransferase increased, hemoglobin decreased Metabolism and nutrition disorders: decreased appetite Nervous system disorders: dizziness, headache Respiratory, thoracic, and mediastinal disorders: dyspnea Vascular disorders: hypotension To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals, Inc., at 1-866-495-8330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
7 DRUG INTERACTIONS See Table 3 for clinically significant drug interactions with ibuprofen. Table 3: Clinically Significant Drug Interactions with Ibuprofen and Famotidine See full prescribing information for a list of clinically important drug interactions. (7) table 3.1 table 3.2 table 3.3
Additional information
Description
11 DESCRIPTION Ibuprofen and famotidine is supplied as a tablet for oral administration which combines the nonsteroidal anti-inflammatory drug, ibuprofen, and the histamine H 2 -receptor antagonist, famotidine. Ibuprofen is (±)-2-( p- isobutylphenyl)propionic acid. Its chemical formula is C 13 H 18 O 2 and molecular weight is 206.28. Ibuprofen is a white powder that is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. Its structural formula is: Famotidine is N'- (aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. Its chemical formula is C 8 H 15 N 7 O 2 S 3 and molecular weight is 337.43. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol. Its structural formula is: Each ibuprofen and famotidine tablet contains ibuprofen (800 mg) and famotidine, USP (26.6 mg). The inactive ingredients in ibuprofen and famotidine tablet include: microcrystalline cellulose, pregelatinized starch, silicon dioxide, magnesium stearate, Hydroxy Propyl Methyl Cellulose, Glycerin, croscarmellose sodium, FD&C Blue#1, talc, povidone, FD&C Blue#2. Ibu-struct.jpg famotidine-struct.jpg
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 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 an engraved circle on the other side and supplied as: Bottles of 30 NDC: 80425-0384-01 Bottles of 60 NDC: 80425-0384-02 Bottles of 90 NDC: 80425-0384-03 Storage Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F). [See USP Controlled Room Temperature]
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Frequently Asked Questions
What is ibuprofen and famotidine used for?+
Ibuprofen and famotidine is used for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It works by reducing pain, inflammation, and stomach acid production. Consult a doctor for proper diagnosis and treatment.
How long does it take for ibuprofen and famotidine to start working?+
Ibuprofen and famotidine starts working within 1-2 hours after taking the medication, but the full effects may take several days to develop. It's essential to take the medication as directed and not exceed the recommended dose. Consult a doctor for personalized advice on dosage and treatment duration.
Can I take ibuprofen and famotidine with other medications?+
It's crucial to inform your doctor about all medications you're currently taking, as ibuprofen and famotidine may interact with certain drugs, such as blood thinners, diabetes medications, and certain antidepressants. Your doctor will help you manage potential interactions and ensure safe treatment. Consult a doctor before taking any new medications.
What are the common side effects of ibuprofen and famotidine?+
Common side effects of ibuprofen and famotidine include stomach upset, nausea, diarrhea, and dizziness. More severe side effects, such as stomach ulcers and kidney problems, can occur in rare cases. Consult a doctor if you experience any unusual or persistent side effects.
Can I stop taking ibuprofen and famotidine if my symptoms improve?+
It's essential to continue taking ibuprofen and famotidine as directed by your doctor, even if your symptoms improve. Stopping the medication abruptly may lead to a recurrence of symptoms or worsening of your condition. Consult a doctor before making any changes to your treatment plan.
MEDICAL DISCLAIMER
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