There is no evidence of drug accumulation or enzyme induction. The administration of ibuprofen tablets either under fasting conditions or immediately before meals yields quite similar serum ibuprofen concentration-time profiles.
When ibuprofen tablets are administered immediately after a meal, there is a reduction in the rate of absorption but no appreciable decrease in the extent of absorption. The bioavailability of the drug is minimally altered by the presence of food. A bioavailability study has shown that there was no interference with the absorption of ibuprofen when ibuprofen tablets were given in conjunction with an antacid containing both aluminum hydroxide and magnesium hydroxide.
Ibuprofen is rapidly metabolized and eliminated in the urine. The excretion of ibuprofen is virtually complete 24 hours after the last dose. The serum half-life is 1.
Indications and Usage for Ibuprofen mg Carefully consider the potential benefits and risks of ibuprofen and other treatment options before deciding to use ibuprofen tablets. In Adults ibuprofen is indicated: Contraindications Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.
Hypertension NSAIDs, including ibuprofen, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ibuprofen, should be used with caution in patients with hypertension. Ibuprofen should be used with caution in patients with fluid retention or heart failure.
Risk of Ulceration, Bleeding, and Perforation NSAIDs, including ibuprofen, can cause serious gastrointestinal GI adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy.
However, even short-term therapy is not without risk. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. The condition is extremely rare and further study could not replicate the increased risk, so there is some debate about the connection. Studies have also associated ibuprofen intake in early pregnancy to possible increased risk of heart defects , though some experts are skeptical about the association because information about why the ibuprofen was being taken is not known in all cases.
There are studies proving birth defects associated with ibuprofen intake in the third trimester of pregnancy. Associated birth defects include increased risk of ductus arteriosus, pulmonary hypertension and olgiohydramnios.
When under the care of a physician, the maximum dose of ibuprofen is 3. Otherwise, the maximum dose is 1. Individuals should not use ibuprofen for more than 10 days for the treatment of pain or more than 3 days for the treatment of a fever unless directed by a physician.
Ibuprofen should be taken with meals to prevent stomach upset. Which drugs or supplements interact with ibuprofen? My doctor prescribed me an antidepressant. Do I have to stop breastfeeding my baby? In most cases, a woman can continue breastfeeding while taking her antidepressant. Some antidepressants have been better studied and are preferred over others for women who are breastfeeding.
Call the Pregnancy Riskline for information about the safety of your medication s while breastfeeding. Can I drink caffeinated beverages while breastfeeding? Aspirin When ibuprofen is administered with aspirin, its protein binding is reduced, although the clearance of free ibuprofen is not altered.
The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential of increased adverse effects. Furosemide Clinical studies, as well as post marketing observations, have shown that ibuprofen can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.
H-2 Antagonists In studies with human volunteers, coadministration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations. Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. Thus, when NSAIDs and lithium are administered concurrently, patients should be observed carefully for signs of lithium toxicity.
Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Warfarin The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. Pregnancy Teratogenic Effects Pregnancy Category C Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities.
However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Nonteratogenic Effects Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system closure of ductus arteriosus , use during pregnancy particularly late pregnancy should be avoided. Labor and Delivery In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred.
The effects of ibuprofen on labor and delivery in pregnant women are unknown. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human-milk and because of the potential for serious adverse reactions in nursing infants from ibuprofen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use Safety and effectiveness in pediatric patients have not been established. In controlled studies when ibuprofen tablets were compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin- or indomethacin-treated patients.
Those reactions listed in Column one encompass observations in approximately 3, patients. More than of these patients were treated for periods of at least 54 weeks. Still other reactions occurring less frequently than 1 in were reported in controlled clinical trials and from marketing experience.
These reactions have been divided into two categories:
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