Ibuprofen and Famotidine (Page 4 of 8)
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
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: |
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Intervention: | Monitor patients with concomitant use of ibuprofen and famotidine tablet 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 tablet 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 tablet is not a substitute for low dose aspirin for cardiovascular protection. | |
ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-blockers | ||
Clinical Impact: |
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Intervention: |
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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 inhibition of renal prostaglandin synthesis. | |
Intervention: | During concomitant use of ibuprofen and famotidine tablet with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see Warnings and Precautions (5.7)]. | |
Digoxin | ||
Clinical Impact: | The concomitant use of ibuprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. | |
Intervention: | During concomitant use of ibuprofen and famotidine tablet and digoxin, monitor serum digoxin levels. | |
Lithium | ||
Clinical Impact: | NSAIDs have produced elevations of plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. | |
Intervention: | During concomitant use of ibuprofen and famotidine tablet and lithium, monitor patients for signs of lithium toxicity. | |
Methotrexate | ||
Clinical Impact: | Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). | |
Intervention: | During concomitant use of ibuprofen and famotidine tablet and methotrexate, monitor patients for methotrexate toxicity. | |
Cyclosporine | ||
Clinical Impact: | Concomitant use of ibuprofen and cyclosporine may increase cyclosporine’s nephrotoxicity. | |
Intervention: | During concomitant use of ibuprofen and famotidine tablet and cyclosporine, monitor patients for signs of worsening renal function. | |
NSAIDs and Salicylates | ||
Clinical Impact: | Concomitant use of ibuprofen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see Warnings and Precautions (5.2)]. | |
Intervention: | The concomitant use of ibuprofen and famotidine tablet with other NSAIDs or salicylates is not recommended. | |
Pemetrexed | ||
Clinical Impact: | Concomitant use of ibuprofen and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). | |
Intervention: | During concomitant use of ibuprofen and famotidine tablet and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.In the absence of data regarding potential interaction between permetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. | |
Drugs Dependent on Gastric pH for Absorption | ||
Clinical Impact | Because famotidine lowers intra-gastric acidity, this may result in reduced absorption and loss of efficacy of concomitant drugs. | |
Intervention | Concomitant administration of ibuprofen and famotidine tablet is not recommended with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir.For administration instructions of other drugs whose absorption is dependent on gastric pH, refer to their prescribing information (e.g., atazanavir, erlotinib, ketoconazole, itraconazole, nilotinib, ledipasvir/sofosbuvir, and rilpivirine). | |
Tizanidine (CYP1A2 Substrate) | ||
Clinical Impact | Famotidine is considered a weak CYP1A2 inhibitor and may lead to substantial increases in blood concentrations of tizanidine, a CYP1A2 substrate. | |
Intervention | Avoid concomitant use with ibuprofen and famotidine tablet.If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness.Refer to the full prescribing information for tizanidine. |
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