Nabumax 500 Tablet: Each film coated tablet contains 500 mg Nabumetone USP.
Nabumax 750 Tablet: Each film coated tablet contains 750 mg Nabumetone USP.
Nabumax 1000 Tablet: Each dispersible tablet contains 1000 mg Nabumetone USP.
Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic properties in pharmacologic studies. As with other nonsteroidal anti-inflammatory agents, its mode of action is not known; however, the ability to inhibit prostaglandin synthesis may be involved in the anti-inflammatory effect. The parent compound is a prodrug, which undergoes hepatic biotransformation to the active component, 6-methoxy-2-naphthylacetic acid (6MNA), that is a potent inhibitor of prostaglandin synthesis.
Nabumetone is indicated for acute and chronic relief of the signs and symptoms of Rheumatoid arthritis and Osteoarthritis.
The starting and usual adult dose is 1000 mg daily taken as a single dose with or without food. The dosage may be increased to 1500 mg or 2000 mg per day given either as a single dose or in two divided doses. Renal Impaired Patients: No adjustment of the dosage of Nabumetone is generally necessary in patients with mild renal insufficiency. The maximum starting doses of Nabumetone in patients with moderate or severe renal insufficiency should not exceed 750 mg or 500 mg, respectively once daily. Following careful monitoring of renal function in patients with moderate or severe renal insufficiency, daily doses may be increased to a maximum of 1,500 mg and 1,000 mg, respectively.
*Prescription only*
Because of its affinity for protein, the active metabolite of Nabumetone may displace other protein-bound drugs such as Sulfonylureas, Tolbutamide, Chlorpropamide and Warfarin, from their binding site. Concomitant use of NSAIDs and anticoagulants increase the risk of GI adverse events such as ulceration and bleeding. Digoxin levels should be monitored, and if necessary, a dosage adjustment made when administered concomitantly with Nabumetone. Numerous studies have shown that the concomitant use of NSAIDs and oral glucocorticoids increases the risk of GI side effects such as ulceration and bleeding. This is especially the case in older (>65 years of age) individuals. No specific drug interaction studies have been conducted with Nabumetone and Antihypertensives, Oral Contraceptives, Diuretics, Cyclosporine, Probenecid, Aminoglycosides, Cholestyramine, Oral Hypoglycemic Agents or Alcohol.
There is no clinical trial experience with the use of Nabumetone during human pregnancy.
Use of Nabumetone during the first two trimesters of pregnancy should be restricted to situations where the potential benefit to the mother justifies the potential risk to the fetus or nursing infant.
There is no clinical trial experience with the use of Nabumetone during human lactation. As the safety and efficacy of Nabumetone in human lactation have not been established, its use is therefore not recommended.
Overdosage with Nabumetone have been rarely reported. There is no specific antidote and the active metabolite 6-MNA is not dialysable. If acute overdosage occurs, it is recommended that the stomach be emptied by vomiting or lavage and institution of general supportive measures as necessary. In addition, the use of activated charcoal, up to 60 g, may effectively reduce Nabumetone absorption. Co-administration of Nabumetone with activated charcoal orally in man has resulted in an 80% decrease in maximum plasma concentrations of the active metabolite.
Fluid retention and edema have been observed in patients treated with Nabumetone. It should be used with caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention, serious gastrointestinal toxicity such as ulceration, bleeding, and perforation with NSAID therapy. Nabumetone should be used with caution in patients with severe hepatic impairment. Nabumetone is not recommended for use in children because the safety and efficacy in children have not been established.
Store at below 30°C in a dry place protected from light. Keep out of reach of children.