RELAFEN Tablet (2020)

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BLUCREST PHARMACEUTICALS LLC

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BOXED WARNING SECTION

Cardiovascular Risk Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which ...

1. Description

Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure: C15H16O2 M.W. 228.3 Nabumetone is a ...

2. Clinical 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 ...

3. Indications and Usage

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 ...

4. Contraindications

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, ...

5. Warnings

Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular ...

6. Precautions

Hepatic Effects Borderline elevations of 1 or more liver function tests may occur in up to 15% of patients taking NSAIDs including nabumetone tablets. These laboratory abnormalities may progress, may remain ...

6.1. General

Nabumetone tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on ...

6.2. Information for Patients

Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID ...

6.3. Laboratory Tests

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs, should ...

6.4. Drug Interactions

ACE-Inhibitors 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. ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis, Mutagenesis In 2 year studies conducted in mice and rats, nabumetone had no statistically significant tumorigenic effect. Nabumetone did not show mutagenic potential in the Ames test and ...

6.7. Pregnancy

0.152 Teratogenic Effects Pregnancy category C. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are ...

6.8. Labor and Delivery

In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of nabumetone ...

6.9. Nursing Mothers

It is not known whether this drug is excreted in human milk, however 6MNA is excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.11. Geriatric Use

As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older). Of the 1,677 patients in U.S. clinical studies who were treated with nabumetone, 411 patients (24%) were 65 ...

7. Adverse Reactions

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 ...

9. Overdosage

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 ...

10. Dosage and Administration

11. How Supplied

RELAFEN Nabumetone tablets USP, 500 mg are white, coated, modified capsule-shaped tablets, debossed with HT on one side and 500 on the other. They are available in bottles of: 30 tablets NDC 73684-100-30. ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).