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nabumetone 750 mg tablet

Out of Stock Manufacturer ACTAVIS/TEVA 00591367101
Out of Stock

Uses

Nabumetone is used for anti-inflammatory and analgesic effects in the symptomatic treatment of osteoarthritis and rheumatoid arthritis.

The potential benefits and risks of nabumetone therapy as well as alternative therapies should be considered prior to initiating nabumetone therapy. The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed.

Patients should be advised that nabumetone, like other NSAIAs, is not free of potential adverse effects, including some that can cause discomfort, and that more serious effects (e.g., myocardial infarction, stroke, GI bleeding), which may require hospitalization and may even be fatal, also can occur. NSAIAs, including selective cyclooxygenase-2 (COX-2) inhibitors and prototypical NSAIAs, increase the risk of serious adverse cardiovascular thrombotic events, including myocardial infarction and stroke, in patients with or without cardiovascular disease or risk factors for cardiovascular disease. Available data suggest that the increase in risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use. Use of NSAIAs also is associated with an increased risk of heart failure. The risk of potentially serious adverse GI effects also should be considered in patients receiving nabumetone, particularly in patients receiving chronic therapy with the drug. NSAIAs are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Patients should be advised to read the medication guide for NSAIAs that is provided to the patient each time the drug is dispensed.

Dosage and Administration

Administration

The potential benefits and risks of nabumetone therapy as well as alternative therapies should be considered prior to initiating nabumetone therapy.

Nabumetone is administered orally. Although the rate of GI nabumetone absorption and of subsequent systemic metabolism to 6-methoxy-2-naphthylacetic acid (6-MNA), the active form, may be increased by concomitant administration of the drug with food, the manufacturer states that nabumetone can be administered orally without regard to meals since the extent of 6-MNA formation is not affected.

Dosage

The lowest possible effective dosage and shortest duration of therapy consistent with treatment goals of the patient should be employed. Dosage of nabumetone must be carefully adjusted according to individual requirements and response, using the lowest possible effective dosage.

Nabumetone is recommended for use in adults. The manufacturer states that safety and efficacy in pediatric patients have not been established.

For the symptomatic treatment of osteoarthritis or rheumatoid arthritis, the usual initial adult dosage of nabumetone is 1 g once daily. The usual adult maintenance dosage is 1-2 g daily, given as single or 2 divided doses daily. Patients weighing less than 50 kg are less likely to require a nabumetone dosage that exceeds 1 g daily. The manufacturer states that dosages exceeding 2 g daily have not been studied.

Dosage in Renal Impairment

Modification of nabumetone dosage generally is not necessary in patients with mild renal impairment (creatinine clearance of 50 mL/minute or greater).

For the symptomatic treatment of osteoarthritis or rheumatoid arthritis in patients with moderate renal impairment (creatinine clearance of 30-49 mL/minute), the initial dosage should not exceed 750 mg once daily. After careful monitoring of renal function, dosage may be increased, if needed, to a maximum dosage of 1.5 g daily.

For the symptomatic treatment of osteoarthritis or rheumatoid arthritis in patients with severe renal impairment (creatinine clearance less than 30 mL/minute), the initial dosage should not exceed 500 mg once daily. After careful monitoring of renal function, dosage may be increased, if needed, to a maximum dosage of 1 g daily.

Because formation of the active metabolite depends on biotransformation in the liver, such formation could be decreased in patients with severe hepatic impairment; therefore, the manufacturer states that the drug should be used cautiously in such patients.

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