Ibuprofen and Famotidine 800 mg; 26.6 mg Tablet, 90-count
Other active recalls for Ibuprofen And Famotidine (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Histamine-2 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.714 | $64.24 / 90 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.9336 | $84.02 / 90 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ibuprofen And Famotidine 800 mg/1; 26.6 mg 31722-0315-90 | Camber | 90 tablets | $0.714 | AB | Availability likely | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 49884-0366-09 | Par | 90 tablets | $0.714 | AB | Availability likely | — |
| Ibuprofen and Famotidine 800 mg/1; 26.6 mgthis 72578-0214-16 | Viona | 90 tablets | $0.714 | AB | Availability likely | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 59651-0908-90 | Aurobindo | 90 tablets | — | — | FDA listed | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 63629-8891-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 67877-0626-01 | Ascend | 100 tablets | — | AB | FDA listed | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 68788-8897-09 | Preferred | 90 tablets | — | AB | FDA listed | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 69306-0266-30 | Doc | 30 tablets | — | AB | FDA listed | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 70518-4580-00 | REMEDYREPACK | 60 tablets | — | AB | FDA listed | — |
| Ibuprofen and Famotidine 800 mg/1; 26.6 mg 70771-1924-09 | Zydus | 90 tablets | — | AB | FDA listed | — |
| Ibuprofen Famotidine 800 mg/1; 26.6 mg 72189-0641-90 | Direct_Rx | 90 tablets | — | AB | FDA listed | — |
| Ibuprofen Famotidine 800 mg/1; 26.6 mg 72189-0667-90 | Direct_Rx | 90 tablets | — | AB | FDA listed | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 76420-0891-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Ibuprofen And Famotidine 800 mg/1; 26.6 mg 80425-0384-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 80425-0422-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 80425-0483-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Ibuprofen and Famotidine 800 mg/1; 26.6 mg 80425-0587-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 85509-1010-03 | PHOENIX | 30 tablets | — | AB | FDA listed | — |
| Ibuprofen And Famotidine 800 mg/1; 26.6 mg 85509-1315-03 | PHOENIX | 30 tablets | — | AB | FDA listed | — |
| Ibuprofen and famotidine 800 mg/1; 26.6 mg 85509-1626-03 | PHOENIX | 30 tablets | — | AB | FDA listed | — |
| Ibuprofen And Famotidine 800 mg/1; 26.6 mg 43602-0544-05 | Ascent | 500 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72578-0214-16 You're viewing this | 90 TABLET in 1 BOTTLE (72578-214-16) | 2025-06-01 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
BOXED WARNING 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 )] . Ibuprofen and famotidine tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see 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 )] .
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 tablets are 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 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Ibuprofen and famotidine tablets, 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 tablets, 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 and 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 tablets 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 tablets with the single-ingredient products of ibuprofen and famotidine.
( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ibuprofen and famotidine tablets, 800 mg/26.6 mg are white to off-white colored, modified capsule shaped, film coated beveled edge tablets imprinted with "777" on one side and plain on other side. Ibuprofen and famotidine tablets: 800 mg ibuprofen and 26.6 mg famotidine. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Ibuprofen and famotidine tablets are 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 tablets 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 tablets 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 tablets 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 tablets 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 tablets 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 tablets, between about 20 weeks 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 )
5.1Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDS. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.
However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as ibuprofen, increases the risk of serious gastrointestinal GI events [see Warnings and Precautions ( 5.2 )]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10…
🤒 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 Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 tablets was evaluated in 1,022 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 tablets ranged in age from 39 years 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 1,022 patients on ibuprofen and famotidine tablets 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 tablets 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 tablets in the two controlled clinical trials. All three patients recovered to baseline levels after discontinuation of ibuprofen and famotidine tablets. 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. Table 1 Shift Table of Serum Creatinine, Normal ** to Abnormal *** in Controlled Studies * At any point after baseline level ** serum creatinine normal range is 0.5 mg/dL to 1.4 mg/dL or 44 micromol/L to 124 micromol/L *** serum creatinine > 1.4 mg/dL Study 301 Study 303 Baseline Post-Baseline * Ibuprofen and Famotidine Tablets N=414 % (n) Ibuprofen N=207 % (n) Ibuprofen and Famotidine Tablets N=598 % (n) Ibuprofen N=296 % (n) Normal ** Abnormal *** 4% (17) 2% (4) 2% (15) 4% (12) Most Commonly Reported Adverse Reactions The most common adverse reactions (≥ 2%), from pooled data from the two controlled studies are presented in Table 2.
Table 2 Incidence of Adverse Reactions in Controlled Studies Ibuprofen and Famotidine Tablets N=1,022 Ibuprofen…
🔄 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 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. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of ibuprofen and famotidine tablets with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions ( 5.16 )].
Aspirin Clinical Impact: Pharmacodynamic (PD) studies have demonstrated interference with the antiplatelet activity of aspirin when ibuprofen 400 mg, given three times daily, is administered with enteric-coated low-dose aspirin. The interaction exists even following a once-daily regimen of ibuprofen 400 mg, particularly when ibuprofen is dosed prior to aspirin. The interaction is alleviated if immediate-release low-dose aspirin is dosed at least 2 hours prior to a once-daily regimen of ibuprofen; however, this finding cannot be extended to enteric-coated low-dose aspirin [see Clinical Pharmacology ( 12.2 )].
Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see Warnings and Precautions ( 5.2 )]. Intervention: Because there may be an increased risk of cardiovascular events due to the interference of ibuprofen with the antiplatelet effect of aspirin, for patients taking low-dose aspirin for cardioprotection who require analgesics, consider use of an NSAID that does not interfere with the antiplatelet effect of aspirin or non-NSAID analgesics, where appropriate.
Concomitant use of ibuprofen and famotidine tablets and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions ( 5.3 )]. Ibuprofen and famotidine tablets are not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers and Beta-blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) or beta-blockers (including propranolol).
In patients who are elderly, volume-depleted (including those on diuretic therapy) or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Intervention: During concomitant use of ibuprofen and famotidine tablets and ACE-inhibitors, ARBs or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
During concomitant use of ibuprofen and famotidine tablets and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted or have impaired renal function, monitor for signs of worsening renal function [see Warnings and Precautions ( 5.7 )] . Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibitio…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation. ( 5.13 , 8.1 ) Females and Males of Reproductive Potential: NSAIDs are associated with reversible infertility. Consider withdrawal of ibuprofen and famotidine tablets in women who have difficulties conceiving. ( 8.3 )
8.1Pregnancy Risk Summary Use of NSAIDs, including ibuprofen and famotidine tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of ibuprofen and famotidine tablets use between about 20 weeks and 30 weeks of gestation and avoid ibuprofen and famotidine tablets use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data).
Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including ibuprofen and famotidine tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios and in some cases, neonatal renal impairment. There are no available data with ibuprofen and famotidine tablets use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; however, there are published studies with each individual component of ibuprofen and famotidine tablets.
Ibuprofen Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, there were no clear developmental effects at doses up to 0.4-times the maximum recommended human dose (MRHD) in the rabbit and 0.5-times in the MRHD rat when dosed throughout gestation. In contrast, an increase in membranous ventricular septal defects was reported in rats treated on Gestation Days 9 & 10 with 0.8-times the MRHD.
Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre-and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development.
In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. Famotidine Limited published data do not report an increased risk of congenital malformations or other adverse pregnancy effects with use of H 2 -receptor antagonists, including ibuprofen and famotidine tablets, during pregnancy; however, these data are insufficient to adequately determine a drug-associated risk. Reproductive studies with famotidine have been performed in rats and rabbits at oral doses of up to 2,000 mg/kg/day and 500 mg/kg/day (approximately 243 times and 122 times the recommended human dose, respectively, based on body surface area) and in both species at intravenous (I.V.) doses of up to 200 mg/kg/day and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the general U.S. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Art…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Use of NSAIDs, including ibuprofen and famotidine tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of ibuprofen and famotidine tablets use between about 20 weeks and 30 weeks of gestation and avoid ibuprofen and famotidine tablets use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data).
Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including ibuprofen and famotidine tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios and in some cases, neonatal renal impairment. There are no available data with ibuprofen and famotidine tablets use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; however, there are published studies with each individual component of ibuprofen and famotidine tablets.
Ibuprofen Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies, there were no clear developmental effects at doses up to 0.4-times the maximum recommended human dose (MRHD) in the rabbit and 0.5-times in the MRHD rat when dosed throughout gestation. In contrast, an increase in membranous ventricular septal defects was reported in rats treated on Gestation Days 9 & 10 with 0.8-times the MRHD.
Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre-and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development.
In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. Famotidine Limited published data do not report an increased risk of congenital malformations or other adverse pregnancy effects with use of H 2 -receptor antagonists, including ibuprofen and famotidine tablets, during pregnancy; however, these data are insufficient to adequately determine a drug-associated risk. Reproductive studies with famotidine have been performed in rats and rabbits at oral doses of up to 2,000 mg/kg/day and 500 mg/kg/day (approximately 243 times and 122 times the recommended human dose, respectively, based on body surface area) and in both species at intravenous (I.V.) doses of up to 200 mg/kg/day and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the general U.S. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including ibuprofen and famotidine tablets, can cause premature closure of the fetal ductus arteriosus (see Data). Oligohydramnios/Neonatal Renal Impairment If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If ibuprofen and famotidine tablets treat…
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of ibuprofen and famotidine tablets in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range and monitor patients for adverse effects [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 , 5.7 , 5.16 )]. The clinical trials primarily enrolled patients less than 65 years of age.
Of the 1,022 patients in clinical studies of ibuprofen and famotidine tablets, 18% (249 patients) were 65 years of age or older. Efficacy results in patients who are greater than or equal to 65 years of age are summarized in the CLINICAL STUDIES section [see Clinical Studies ( 14 )]. Famotidine is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and adjusting dose interval and it may be useful to monitor renal function [see Warnings and Precautions ( 5.7 )].
🆘 Overdosage ▾
10 OVERDOSAGE Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare [see Warnings and Precautions ( 5.1 , 5.2 , 5.5 , 5.7 , 5.9 )].
No data are available with regard to overdose of ibuprofen and famotidine tablets. Findings related to the individual active substances are listed below. Ibuprofen Approximately 1 1/2 hours after the reported ingestion of from 7 to 10 ibuprofen tablets (400 mg), a 19-month-old child weighing 12 kg was seen in the hospital emergency room, apneic and cyanotic, responding only to painful stimuli.
This type of stimulus, however, was sufficient to induce respiration. Oxygen and parenteral fluids were given; a greenish-yellow fluid was aspirated from the stomach with no evidence to indicate the presence of ibuprofen. Two hours after ingestion the child's condition seemed stable; she still responded only to painful stimuli and continued to have periods of apnea lasting from 5 seconds to 10 seconds.
She was admitted to intensive care and sodium bicarbonate was administered as well as infusions of dextrose and normal saline. By 4 hours post-ingestion she could be aroused easily, sit by herself and respond to spoken commands. Blood level of ibuprofen was 102.9 mcg/mL approximately 8.5 hours after accidental ingestion.
At 12 hours she appeared to be completely recovered. In two other reported cases where children (each weighing approximately 10 kg) accidentally, acutely ingested approximately 120 mg/kg, there were no signs of acute intoxication or late sequelae. Blood level in one child 90 minutes after ingestion was 700 mcg/mL — about 10 times the peak levels seen in absorption-excretion studies.
A 19-year-old male who had taken 8,000 mg of ibuprofen over a period of a few hours complained of dizziness and nystagmus was noted. After hospitalization, parenteral hydration and 3 days bed rest, he recovered with no reported sequelae. Famotidine The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience.
Oral doses of up to 640 mg/day have been given to adult patients with pathological hypersecretory conditions with no serious adverse effects. Manage patients with symptomatic and supportive care following an NSAID overdosage, including ibuprofen and famotidine tablet overdose. There are no specific antidotes.
Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 grams per kg to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 times to 10 times the recommended dose). Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding. If over-exposure occurs, call your poison control center at 1-800-222-1222 for current information on the management of poisoning or over-exposure.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Ibuprofen and famotidine tablet are a fixed-combination tablet of ibuprofen and famotidine. The ibuprofen component has analgesic, anti-inflammatory and antipyretic properties. The mechanism of action of the ibuprofen component of ibuprofen and famotidine tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Ibuprofen is a potent inhibitor of prostaglandin synthesis in vitro . Ibuprofen concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models.
Prostaglandins are mediators of inflammation. Because ibuprofen is an inhibitor of prostaglandin synthesis, its mode of action may be due to an increase of prostaglandins in peripheral tissues. Famotidine is a competitive inhibitor of histamine H 2 -receptors.
The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output. Systemic effects of famotidine in the CNS, cardiovascular, respiratory or endocrine systems were not noted in clinical pharmacology studies.
Also, no antiandrogenic effects were noted. Serum hormone levels, including prolactin, cortisol, thyroxine (T 4 ) and testosterone, were not altered after treatment with famotidine.
12.2Pharmacodynamics In a healthy volunteer study, ibuprofen 400 mg given once daily, administered 2 hours prior to immediate-release aspirin (81 mg) for 6 days, showed an interaction with the antiplatelet activity of aspirin as measured by % serum thromboxane B2 (TxB2) inhibition at 24 hours following the day-6 aspirin dose [53%]. An interaction was still observed, but minimized, when ibuprofen 400 mg given once-daily was administered as early as 8 hours prior to the immediate-release aspirin dose [90.7%]. However, there was no interaction with the antiplatelet activity of aspirin when ibuprofen 400 mg, given once daily, was administered 2 hours after (but not concomitantly, 15 min or 30 min after) the immediate-release aspirin dose [99.2%].
In another study, where immediate-release aspirin 81 mg was administered once daily with ibuprofen 400 mg given three times daily (1, 7 and 13 hours post-aspirin dose) for 10 consecutive days, the mean % serum thromboxane B2 (TxB2) inhibition suggested no interaction with the antiplatelet activity of aspirin [98.3%]. However, there were individual subjects with serum TxB2 inhibition below 95%, with the lowest being 90.2%. When a similarly designed study was conducted with enteric-coated aspirin, where healthy subjects were administered enteric-coated aspirin 81 mg once daily for 6 days and ibuprofen 400 mg three times daily (2, 7 and 12 h post-aspirin dose) for 6 days, there was an interaction with the antiplatelet activity at 24 hours following the day-6 aspirin dose [67%] [see Drug Interactions ( 7 )].
12.3Pharmacokinetics Absorption Ibuprofen and famotidine are rapidly absorbed after a single dose administration of ibuprofen and famotidine tablets. Mean C max values for ibuprofen are 45 mcg/mL and are reached approximately 1.9 hours after oral administration of ibuprofen and famotidine tablets. The C max and AUC 0-24hours values for the 800 mg of ibuprofen contained in a ibuprofen and famotidine tablet are bioequivalent to the values for 800 mg of ibuprofen administered alone.
C max values for famotidine were 61 ng/mL and are reached at approximately 2 hours after oral administration of ibuprofen and famotidine tablets. A high-fat meal reduced famotidine C max and AUC by approximately by 15% and 11%, respectively and reduced ibuprofen AUC by approximately 14% but did not change C max . Food delayed famotidine T max and ibuprofen T max by approximately 1 hour and 0.2 h…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Ibuprofen and famotidine tablet are a fixed-combination tablet of ibuprofen and famotidine. The ibuprofen component has analgesic, anti-inflammatory and antipyretic properties. The mechanism of action of the ibuprofen component of ibuprofen and famotidine tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Ibuprofen is a potent inhibitor of prostaglandin synthesis in vitro . Ibuprofen concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models.
Prostaglandins are mediators of inflammation. Because ibuprofen is an inhibitor of prostaglandin synthesis, its mode of action may be due to an increase of prostaglandins in peripheral tissues. Famotidine is a competitive inhibitor of histamine H 2 -receptors.
The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output. Systemic effects of famotidine in the CNS, cardiovascular, respiratory or endocrine systems were not noted in clinical pharmacology studies.
Also, no antiandrogenic effects were noted. Serum hormone levels, including prolactin, cortisol, thyroxine (T 4 ) and testosterone, were not altered after treatment with famotidine.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Ibuprofen and famotidine tablets,800 mg and 26.6 mg are white to off-white colored, modified capsule shaped, film-coated beveled edge tablets imprinted with "777" on one side and plain on other side and are supplied as follows: NDC 72578-214-16 in bottle of 90 tablets with child-resistant closure Storage Store at 20°C to 25°C (68ºF to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
📋 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, USP is (±)-2-( p -isobutylphenyl) propionic acid. Its molecular formula is C 13 H 18 O 2 and molecular weight is 206.28.
Ibuprofen, USP is a white to off-white crystalline powder that is practically insoluble in water and very soluble in alcohol, in methanol, in acetone and in chloroform; slightly soluble in ethyl acetate. Its structural formula is: Famotidine, USP is N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. Its molecular formula is C 8 H 15 N 7 O 2 S 3 and molecular weight is 337.45.
Famotidine, USP is a white to pale yellowish white crystalline powder 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 tablets contain 800 mg of ibuprofen, USP and 26.6 mg of famotidine, USP which contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, glyceryl monocaprylocaprate type 1, hypromellose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-partially hydrolyzed, sodium lauryl sulfate, talc and titanium dioxide.
The tablet is imprinted with black ink and contains the following inactive ingredients: black iron oxide, propylene glycol and shellac. Image Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients, families or caregivers of the following before initiating therapy with ibuprofen and famotidine tablets and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness or slurring of speech and to report any of these symptoms to their health care provider immediately [see Warnings and Precautions ( 5.1 )].
Gastrointestinal Bleeding, Ulceration and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions ( 5.2 )]. Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness and "flu-like" symptoms).
If these occur, instruct patients to stop ibuprofen and famotidine tablets and seek immediate medical therapy [see Warnings and Precautions ( 5.4 )]. Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain or edema and to contact their health care provider if such symptoms occur [see Warnings and Precautions ( 5.6 )]. Anaphylactic Reactions Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat).
Instruct patients to seek immediate emergency help if these occur [see Contraindications ( 4 ), Warnings and Precautions ( 5.8 )]. Serious Skin Reactions, including DRESS Advise patients to stop taking ibuprofen and famotidine tablets immediately if they develop any type of rash or fever and contact their health care provider as soon as possible [see Warnings and Precautions ( 5.11 , 5.12 )]. Infertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including ibuprofen and famotidine tablets, may be associated with a reversible delay in ovulation [see Use in Specific Populations ( 8.3 )].
Fetal Toxicity Inform pregnant women to avoid use of ibuprofen and famotidine tablets and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closure of the fetal ductus arteriosus. If treatment with ibuprofen and famotidine tablets is needed for a pregnant woman between about 20 weeks to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios [see Warnings and Precautions ( 5.13 ) and Use in Specific Populations ( 8.1 )]. Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of ibuprofen and famotidine tablets with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity and little or no increase in efficacy [see Warnings and Precautions ( 5.2 , 5.17 ), Drug Interactions ( 7 )].
Alert patients that NSAIDs may be present in the "over the counter" medications for treatment of colds, fever or insomnia. Use of NSAIDs and Low-Dose Aspirin Inform patients not to use low-dose aspirin concomitantly with ibuprofen and famotidine tablets until they talk to their health care provider [see Drug Interactions ( 7 )]. Nephrotoxicity Patients should be monitored for development of nephrotoxicity (e.g., azotemia, hypertension and/or proteinuria).
If these patients should be instructed to stop therapy and seek immediate medical therapy. Creatinine Clearance Ibuprofen and famotidine tablets are not recommended in patients with creatinine clearance < 50 mL/min because of seizures, delirium, coma and other CNS effect. Taking Ibuprofen and Famotidine Table…
💬 Medication Guide ▾
Medication Guide Ibuprofen (eye″ bue proe′ fen) and Famotidine (fa moe′ ti deen) Tablets, for oral use What is the most important information I should know about Ibuprofen and famotidine tablets? Ibuprofen and famotidine tablets 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: o with increasing doses of medicine containing NSAIDs o with longer use of medicine containing NSAIDs Do not take Ibuprofen and famotidine tablets right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking Ibuprofen and famotidine tablets 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 tablets 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: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers or stomach or intestinal bleeding with the use of NSAIDs smoking taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" drinking alcohol increasing doses of NSAIDs older age longer use of NSAIDs poor health advanced liver disease bleeding problems You should take Ibuprofen and famotidine tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed.
Ibuprofen and famotidine tablets contain a non-steroidal anti-inflammatory drug NSAID (ibuprofen). Do not use ibuprofen and famotidine tablets 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 tablets may help your acid-related symptoms, but you could still have serious stomach problems.
Talk with your healthcare provider. Ibuprofen and famotidine tablets contain ibuprofen, an NSAID and famotidine, a histamine H 2 -receptor blocker medicine. What are ibuprofen and famotidine tablets?
Ibuprofen and famotidine tablets are a prescription medicine used to: relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis. decrease the risk of developing ulcers of the stomach and upper intestines (upper gastrointestinal ulcers) in people taking ibuprofen for rheumatoid arthritis and osteoarthritis. It is not known if ibuprofen and famotidine tablets are safe and effective in children. Do not take ibuprofen and famotidine tablets: if you are allergic to ibuprofen, famotidine, any other histamine H 2 -receptor blocker or any of the ingredients in ibuprofen and famotidine tablets.
See the end of this Medication Guide for a complete list of ingredients. if you have had an asthma attack, hives or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery. Before taking ibuprofen and famotidine tablets, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems. have high blood pressure. have heart problems. have asthma. have bleeding problems. are pregnant or plan to become pregnant. Taking ibuprofen and famotidine tablets at about 20 weeks of pregnancy or later may harm your unborn baby.
If you need to take ibuprofen and famotidine tablets when you are between 20 weeks and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take ibuprofen and famotidine tablets after about 30 weeks of pregnancy. are breastfeeding or plan to breast feed. Ibuprofen and famotidine can pass into your breast milk.
Talk to your healthcare provider about the best way to feed your baby if you take ibuprofen and famotidine tablets. Tell your healthcare provi…