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Nabumetone (Nabumetone)

Trade Name : Nabumetone

Impax Generics

TABLET, FILM COATED

Strength 500 mg/1

NABUMETONE Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nabumetone (Nabumetone) which is also known as Nabumetone and Manufactured by Impax Generics. It is available in strength of 500 mg/1 per ml. Read more

Nabumetone (Nabumetone) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Cardiovascular Thrombotic Events
  • Gastrointestinal Risk
  • Nabumetone, USP is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure:
  • CHO M.W. 228.3
  • Nabumetone, USP is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4.
  • Each tablet, for oral administration, contains either 500 mg or 750 mg of nabumetone, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulphate, sodium starch glycolate, talc, and titanium dioxide. The 750 mg tablets also contain black iron oxide, red iron oxide, and yellow iron oxide.
  • 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.
  • 6-methoxy-2-naphthylacetic acid (6MNA)
  • It is acidic and has an n-octanol:phosphate buffer partition coefficient of 0.5 at pH 7.4.
  • No data
  • Carefully consider the potential benefits and risks of Nabumetone Tablets USP and other treatment options before deciding to use Nabumetone Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
  • Nabumetone Tablets USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
  • Nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or product excipients.
  • Nabumetone tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see , and , , ).
  • Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
  • No data
  • No data
  • Adverse reaction information was derived from blinded-controlled and open-labeled clinical trials and from worldwide marketing experience. In the description below, rates of the more common events (greater than 1%) and many of the less common events (less than 1%) represent results of U.S. clinical studies.
  • Of the 1,677 patients who received nabumetone during U.S. clinical trials, 1,524 were treated for at least 1 month, 1,327 for at least 3 months, 929 for at least a year, and 750 for at least 2 years. More than 300 patients have been treated for 5 years or longer.
  • The most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia, and abdominal pain.
  • Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
  • Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 g/kg in children), and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
  • There have been overdoses of up to 25 grams of nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H-blockers, etc.).
  • Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
  • After observing the response to initial therapy with nabumetone tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
  • The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone tablets can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment (see , ). Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patientsu2019 requirements.
  • Nabumetone Tablets USP are available as follows:
  • 500 mg: White, oval-shaped, unscored, film-coated tablet debossed with the numbers u201c93u201d on one face of the tablet and u201c15u201d on the other. They are available in bottles of 100 tablets (NDC 0115-1657-01) and 1000 tablets (NDC 0115-1657-03).
  • 750 mg: Beige, oval-shaped, unscored, film-coated tablet debossed with the numbers u201c93u201d on one face of the tablet and u201c16u201d on the other. They are available in bottles of 100 tablets (NDC 0115-1658-01) and 1000 tablets (NDC 0115-1658-03).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Manufactured In Israel By:n Jerusalem, 9777402, Israel
  • Distributed by:Impax GenericsHayward, CA 94544
  • Rev.u00a0V 6/2016
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Israel By:n n Jerusalem, 9777402, Israel
  • Distributed by:Impax GenericsHayward, CA 94544
  • 1831-01Rev. 06/2016
  • Impax Genericsu00a0
  • NDC n- 1657
  • NABUMETONEn- Tablets USPn- 500 mg
  • PHARMACIST: Dispense the accompanying Medication Guide to each patient.
  • Rx only100 TABLETS
  • Impax Genericsu00a0
  • NDC n- 1658
  • NABUMETONEn- Tablets USPn- 750 mg
  • PHARMACIST: Dispense the accompanying Medication Guide to each patient.
  • Rx only100 TABLETS

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