Tolmetin Dosage

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Osteoarthritis

200 to 400 mg orally 3 times a day.
Doses generally range from 600 to 1800 mg/day in 3 divided doses.

Usual Adult Dose for Rheumatoid Arthritis

200 to 400 mg orally 3 times a day.
Doses generally range from 600 to 1800 mg/day in 3 divided doses.

Usual Adult Dose for Acute Gout

600 mg orally one time, followed by 400 mg every 6 to 8 hours until the gouty attack has resolved, usually 2 to 3 days.

Usual Adult Dose for Pain

200 to 400 mg orally every 6 to 8 hours.

Usual Pediatric Dose for Pain

Greater than 2 years:
5 to 7 mg/kg/dose every 6 to 8 hours.

Usual Pediatric Dose for Anti-inflammatory

Greater than 2 years:
Initial dose: 20 mg/kg/day in 3 to 4 divided doses.
Maintenance dose: 15 to 30 mg/kg/day in 3 divided doses.
Doses greater than 30 mg/kg/day are not recommended.

Renal Dose Adjustments

Lower doses should be used in patients with impaired renal function, and renal function should be closely monitored.

Liver Dose Adjustments

Data not available

Dose Adjustments

Doses larger than 1800 mg/day have not been studied and are not recommended. If no improvement is seen in 2 to 4 weeks of therapy, an alternative NSAID should be considered.

Precautions

An increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal, have been reported during clinical trials of several COX-2 selective and nonselective NSAIDs of up to 3 years. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. 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. Two large controlled trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

Serious gastrointestinal (GI) toxicity, such as bleeding, ulceration, and perforation can occur at any time with or without warning symptoms, in patients receiving NSAID therapy chronically. It has been shown that the incidence of upper GI ulcers, gross bleeding, or perforation, caused by NSAIDs, increases with duration of use. However, even short-term therapy is not without risk. Only 1 in 5 patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Caution should be exercised when using NSAIDs in the elderly and debilitated, because most of the spontaneous reports of fatal GI adverse events are in this population. To minimize the risk of an adverse GI event, the lowest effective dose should be used for the shortest duration possible. Patients with a prior history of peptic ulcer disease and/or GI bleeding and who use NSAIDs have a greater than 10-fold risk of developing a GI bleeding than patients with neither of these risk factors. In addition, comorbid conditions may increase the risk of GI bleeding, such as treatment with longer duration of NSAID therapy, smoking, alcoholism, older age, and poor general health status. All patients on chronic NSAID therapy should be closely monitored for ulceration and bleeding even in the absence of previous GI problems. NSAIDs should be administered with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.

Nabumetone is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Patients with the "triad" of asthma, nasal polyps, and aspirin or other nonsteroidal anti-inflammatory agent hypersensitivity (i.e., angioedema, bronchospasm, urticaria, rhinitis) may be cross-sensitive to nabumetone. The use of nabumetone is considered contraindicated in these patients.

NSAIDs, including nabumetone, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including nabumetone, should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Fluid retention and edema have been observed in some patients taking NSAIDs. Nabumetone should be used with caution in patients with fluid retention or congestive heart failure.

Renal papillary necrosis and other renal injury has been observed following long-term use of NSAIDs. 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, the use of an NSAID results in a dose-dependent decrease in prostaglandin synthesis and, secondarily, in a reduction of renal blood flow, which may precipitate over renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, and the elderly. Discontinuation of NSAID therapy is typically followed by recovery to pretreatment state. No information is available from controlled clinical studies regarding the use of nabumetone in patients with advanced renal disease. Therefore, treatment with nabumetone is not recommended in these patients with advanced renal disease. If nabumetone therapy must be initiated, close monitoring of the patient's renal function is advisable. Renal function may be further compromised by the use of nabumetone in patients with renal dysfunction, heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Baseline laboratory tests should be conducted at initiation of therapy and repeated within weeks. If the impairment worsens, discontinuation of nabumetone may be warranted.

NSAIDs, including nabumetone, can cause serious skin adverse effects such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. The drug should be discontinued at the first appearance of skin rash or another sign of hypersensitivity.

Borderline elevations of one or more liver function tests have been reported in patients taking NSAIDs, including nabumetone. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Elevations of ALT or AST (approximately 3 or more times the upper limit of normal) have been reported in patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some with fatal outcomes, have been reported. If signs and/or symptoms suggesting liver dysfunction, or an abnormal liver function test occur, the patient should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with nabumetone. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, nabumetone should be discontinued.

Nabumetone should be used with caution in patients with preexisting asthma.

Based on ultraviolet light photosensitivity testing, nabumetone may be associated with more reactions to sun exposure than might be expected based on skin tanning types.

Anemia has been reported in patients receiving NSAIDs, including nabumetone. This may be due to fluid retention, GI blood loss, or an effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including nabumetone, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and there are reports of prolonged bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients taking nabumetone who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.

Dialysis

Data not available

Other Comments

If gastrointestinal symptoms occur, tolmetin can be administered with antacids other than sodium bicarbonate.

Hide
(web5)