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Clinical trials of several COX-2 selective and nonselective NSAIDsof up to three years duration have shown an increased risk of seriouscardiovascular (CV) thrombotic events, myocardial infarction, andstroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective,may have a similar risk. Patients with known CV disease orrisk factors for CV disease may be at greater risk. To minimize thepotential risk for an adverse CV event in patients treated with anNSAID, the lowest effective dose should be used for the shortestduration possible. Physicians and patients should remain alert for thedevelopment of such events, even in the absence of previous CVsymptoms. Patients should be informed about the signs and/orsymptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigatesthe increased risk of serious CV thrombotic events associatedwith NSAID use. The concurrent use of aspirin and an NSAID doesincrease the risk of serious GI events (see GI WARNINGS).
Two large, controlled clinical trials of a COX-2 selective NSAID forthe treatment of pain in the first 10-14 days following CABG surgeryfound an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
NSAIDs including IBU tablets, can lead to onset of new hypertensionor worsening of preexisting hypertension, either of which maycontribute to the increased incidence of CV events. Patients takingthiazides or loop diuretics may have impaired response to these therapieswhen taking NSAIDs. NSAIDs, including IBU tablets, should beused with caution in patients with hypertension. Blood pressure (BP)should be monitored closely during the initiation of NSAID treatmentand throughout the course of therapy.
Fluid retention and edema have been observed in some patients taking NSAIDs. IBU tablets should be used with caution in patients with fluid retention or heart failure.
NSAIDs, including IBU tablets, 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. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patientstreated for 3-6 months, and in about 2-4% of patients treated for oneyear. 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 thosewith a prior history of ulcer disease or gastrointestinal bleeding.Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients treatedwith neither of these risk factors. Other factors that increase the riskof GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GIulcerations and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI event is suspected.This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest riskof this reaction are those with impaired renal function, heart failure,liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
No information is available from controlled clinical studies regarding the use of Ibuprofen tablets in patients with advanced renal disease.Therefore, treatment with IBU tablets is not recommended in these patients with advanced renal disease. If IBU tablet therapy must be initiated, close monitoring of the patients renal function is advisable.
As with other NSAIDs, anaphylactoid reactions may occur inpatients without known prior exposure to IBU tablets. IBU tablets should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS, Preexisting Asthma).Emergency help should be sought in cases where an anaphylactoidreaction occurs.
NSAIDs, including IBU tablets, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome(SJS), and toxic epidermal necrolysis (TEN), which can be fatal.These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
In late pregnancy, as with other NSAIDs, IBU tablets should beavoided because it may cause premature closure of the ductus arteriosus.
There is currently no manufacturer warning information available for this drug.
Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS).
IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
IBU tablets are indicated for relief of mild to moderate pain.
IBU tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.
IBU tablets contain the active ingredient ibuprofen, which is (±) -2 – ( p – isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:
IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.
