Nabuflex 500 mg

INDICATIONS

Nabumetone is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. Carefully consider the potential benefits and risks of Nabumetone and other treatment options before deciding to use Nabumetone. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

PHARMACOLOGY

Nabumetone is a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic properties in pharmacologic studies. As with other non-steroidal 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

DOSAGE & ADMINISTRATION

Nabumetone 500 mg & 750 mg Tablet: Oral Nabumetone 1000 mg Tablet: Mix 1 tablet thoroughly in a glass (250 ml) of pure water and drink it completely.Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 1000 mg taken as a single dose with or without food, Some patients may obtain more symptomatic relief from 1500 mg to 2000 mg per day. Nabumetone can be given in either a single or twice-daily dose. Dosages greater than 2000 mg per day have not been studied The lowest effective dose should be used for chronic treatment. Moderate or severe renal insufficiency: Caution should be taken in prescribing Nabumetone to patients with moderate or severe 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 1500 mg and 1000 mg, respectively.Use in pediatric patients: Safety and effectiveness in pediatric patients have not been established.

INTERACTION

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

SIDE EFFECTS

Gastrointestinal: Diarrhea, dyspepsia, abdominal pain, constipation, flatulence, nausea, positive stool guaiac, dry mouth, gastritis, stomatitis, vomiting.Central Nervous System: Dizziness, headache, fatigue, increased sweating, insomnia, nervousness, somnolence.Dermatologic: Pruritus, rashSpecial Senses: TinnitusMiscellaneous: Edema

PREGNANCY & LACTATION

Pregnancy Category C. There are no adequate, well-controlled studies in pregnant women. This drug should be used during pregnancy only if dearly needed Because of the known effect of prostaglandin-synthesis-inhibiting drugs on the human fetal cardiovascular system (closure of ductus arteriosus), use of Nabumetone during the third trimester of pregnancy is not recommended Lactation: Nabumetone is not recommended for use in nursing mothers because of the possible adverse effects of prostaglandin-synthesis-inhibiting drugs on neonates

PRECAUTIONS & WARNINGS

As a class, NSAIDs have been associated with renal papillary necrosis and other abnormal renal pathology during long-term administration to animals. The second form of renal toxicity often associated with NSAIDs is seen in patients with conditions leading to a reduction in renal blood flow or blood volume, where renal prostaglandins have a supportive role in the maintenance of renal perfusion in these patients, administration of an NSAID results in a dose-dependent decrease in prostaglandin synthesis and, secondarily, in a reduction of renal blood flow, which may precipitate overt renal decompensation Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, and the elderly Discontinuation of NSAID therapy is typically followed by recovery to the pretreatment state

THERAPEUTIC CLASS

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis

STORAGE CONDITIONS

Store in a cool and dry place, away from light & moisture. Keep all medicines out of reach of children.