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NABUMETONE is a brand name for Nabumetone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 05/2022 1 INDICATIONS, 1.1 Pediatrics 05/2022 1 INDICATIONS, 1.2 Geriatrics 05/2022
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Use of NABUMETONE should be limited to the lowest effective dose for the shortest possible duration of treatment (see 1 INDICATIONS). 2 Recommended Dose and Dosage Adjustment). 2 Recommended Dose and Dosage Adjustment Osteoarthritis and Rheumatoid Arthritis Adults The starting and usual dose is 1000 mg daily taken as a single dose.
The dosage may be increased to 1500 mg or 2000 mg per day given either as a single dose or in two divided doses. 3 Pharmacokinetics, Table 4). For this reason, dosage adjustments during therapy should not be made more frequ ently than at one-week intervals, except in the case of side effects.
3 Pediatrics). 4 Geriatrics).
Renal impairment:
In patients with impaired renal function, lower doses should be considered, patients should be closely monitored, and dosage level adjustments should be made on an individual basis. 4 Drug-Drug Interactions). 5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored) (see 2 CONTRAINDICATIONS).
Hepatic impairment:
Patients with impaired hepatic function should be carefully monitored and kept at the minimal effective daily dosage. 4 Drug-Drug Interactions). NABUMETONE is contraindicated in patients with severe hepatic impairment or active liver disease (see 2 CONTRAINDICATIONS).
4 Administration NABUMETONE should be taken immediately after a meal or with food or milk. Tablets should be swallowed whole, not crushed or chewed. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember.
If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule. The patient should be instructed not to take 2 doses at the same time.
1 Adverse Reaction Overview The most common adverse reactions encountered with NSAIDs are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred particularly in the elderly (see Gastrointestinal).
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Adverse reaction information was derived from blinded controlled and open -labelled clinical trials and from worldwide marketing experience.
Over 6,000 patients have been treated with nabumetone in clinical trials, and over 49,000 patients included in post-marketing surveillance studies and NABUMETONE (Nabumetone tablets) Page 24 of 53 nabumetone has been prescribed extensively in those countries where the drug has received registration clearance.
In large scale post-marketing studies the adverse event profile was highly consistent with the profile seen in clinical trials of nabumetone. The pattern of adverse events remained similar in patients treated with nabumetone for several years, similar in patients taking 1 to 2 g doses, and was similar in patients aged <65 or ≥65 years.
Information on adverse experiences observed in US clinical studies is presented below. Of the 1,677 patients who received nabumetone during US clinical trials, 1,524 were treated for at least one month, 1,327 for at least three months, 929 for at least a year, and 750 for at least two years.
Over 300 patients have been treated for five years or longer. The most frequently reported adverse reactions were related to the gastrointestinal tract. They were diarrhea, dyspepsia, and abdominal pain. 1 % (abdominal pain) during the double blind phase of the US clinical trials involving 930 patients treated with nabumetone for up to 6 months.
4 Geriatrics 05/2022 NABUMETONE (Nabumetone tablets) Page 4 of 53 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ......................................................................................................
2 TABLE OF CONTENTS ........................................................................................................................ 4 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................
6 1 INDICATIONS............................................................................................................................. 1 Pediatrics............................................................................................................................
2 Geriatrics ............................................................................................................................ 6 2 CONTRAINDICATIONS ...............................................................................................................
7 3 SERIOUS WARNINGS AND PRECAUTIONS BOX........................................................................... 8 4 DOSAGE AND ADMINISTRATION ...............................................................................................
1 Dosing Considerations......................................................................................................... 2 Recommended Dose and Dosage Adjustment ......................................................................
4 Administration.................................................................................................................. 5 Missed Dose .....................................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8% at two years. The following table displays adverse events reported in long-term clinical trial follow-up involving treatment for up to 8 years. Where available, percentages are based upon the total number of observations, thus patients reporting multiple incidents of an adverse event have been recorded for each occurrence.
Causal relationship to nabumetone has not necessarily been established for all of the events listed below. 3 Less Common Clinical Trial Adverse Reactions Less Common Clinical Trial Adverse Drug Reactions (<1%): The following adverse events were reported in long-term clinical trial follow-up involving treatment for up to 8 years.
01% are based on spontaneous reports from worldwide marketing experience. Where available, percentages are based upon the total number of observations, thus patients reporting multiple incidents of an adverse event have been recorded for each occurrence.
Causal relationship to nabumetone has not necessarily been established for all of the events listed below. 01). 1%). 2%). 2%). 01%). 01%). 01). 1%). 1%). 01%). 1%), […]
10 5 OVERDOSAGE.......................................................................................................................... 10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................................
10 7 WARNINGS AND PRECAUTIONS .............................................................................................. 1 Special Populations ...........................................................................................................
1 Pregnant Women ........................................................................................................... 2 Breast-feeding ................................................................................................................
3 Pediatrics ....................................................................................................................... 4 Geriatrics........................................................................................................................
23 8 ADVERSE REACTIONS .............................................................................................................. 1 Adverse Reaction Overview ...............................................................................................
2 Clinical Trial Adverse Reactions ......................................................................................... 3 Less Common Clinical Trial Adverse Reactions ...................................................................
5 Post-Market Adverse Reactions ......................................................................................... 27 9 DRUG INTERACTIONS ..............................................................................................................
3 Drug-Behavioural Interactions ........................................................................................... 4 Drug-Drug Interactions......................................................................................................
5 Drug-Food Interactions ..................................................................................................... 6 Drug-Herb Interactions......................................................................................................
7 Drug-Laboratory Test Interactions ..................................................................................... 34 10 CLINICAL PHARMACOLOGY .....................................................................................................
1 Mechanism of Action ........................................................................................................ 2 Pharmacodynamics ...........................................................................................................
3 […]