Naproxen

Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout the management of: • pain • primary dysmenorrhea Naproxen tablets and naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • polyarticular juvenile idiopathic arthritis Naproxen tablets and naproxen sodium t …

• Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals
• Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Naproxen tablets 250 mg (one-half tablet) 500 mg twice daily Naproxen sodium tablets 275 mg (one-half tablet) 550 mg twice daily The dose may be adjusted up or down depending on the clinical response of the patient
• In patients who tolerate lower doses well, the dose may be increased to naproxen 1500 mg/ day for up to 6 months
• Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets may not allow for the flexible dose titration needed
• In pediatric patients with polyarticular juvenile idiopathic arthritis
• A liquid formulation may be more appropriate
• Recommended total daily dose of naproxen is approximately 10 mg/kg given in 2 divided doses
• Dosing with naproxen tablets is not appropriate for children weighing less than 50 kilograms
• Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis Recommended starting dose 550 mg of naproxen sodium as naproxen sodium tablets followed by 550 mg every 12 hours or 275 mg every 6 to 8 hours as required
• The initial total daily dose should not exceed 1375 mg of naproxen sodium
• Thereafter, the total daily dose should not exceed 1100 mg of naproxen sodium
• Naproxen sodium tablets are recommended for the management of acute painful conditions when prompt onset of pain relief is desired
• Acute Gout Recommended starting dose 750 mg of naproxen tablets followed by 250 mg every 8 hours until the attack has subsided. …

Naproxen Tablets, USP 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. Naproxen Tablets, USP 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G32’ on one side and ‘375’ on the other side. …

• Safety and effectiveness
• In pediatric patients below the age of 2 years have not been established
• Pediatric dosing recommendations for polyarticular juvenile idiopathic arthritis are based on well-controlled studies [ see Dosage and Administration ]
• There are no adequate effectiveness or dose-response data for other pediatric conditions, but the experience in polyarticular juvenile idiopathic arthritis and other use experience have established that single doses of 2.5 to 5 mg/kg as naproxen suspension, with total daily dose not exceeding 15 mg/kg/day, are well tolerated
• In pediatric pa …

The hepatic and renal tolerability of long-term naproxen administration was studied in two double-blind clinical trials involving 586 patients. Of the patients studied, 98 patients were age 65 and older and 10 of the 98 patients were age 75 and older. NAPROXEN was administered at doses of 375 mg twice daily or 750 mg twice daily for up to 6 months. …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed
• Inform patients, families, or their caregivers of the following information before initiating therapy with naproxen tablets or naproxen sodium tablets and periodically during the course of ongoing therapy
• Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [ see Warnings and Precautions ]. …

Naproxen tablets and naproxen sodium tablets are contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [ see Warnings and Precautions ( 5.7 , 5.9 ) ] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. …

See Table 1 for clinically significant drug interactions with naproxen. Table 1: Clinically Significant Drug Interactions with naproxen Drugs That Interfere with Hemostasis Clinical Impact: • Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. …

Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 5.3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.4 , 7 ) Heart Failure and Edema: Avoid use of naproxen tablets and naproxen sodium tablets in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. …

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] • GI Bleeding, Ulceration, and Perforation [ see Warnings and Precautions ( 5.2 ) ] • Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] • Hypertension [ see Warnings and Precautions ( 5.4 ) ] • Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] • Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] • Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] • Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] • Hematologic Toxicity [ see Warnings and Precautions …

8.1 Pregnancy Risk Summary Use of NSAIDs, including naproxen tablets and naproxen sodium tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. …

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [ see Warnings and Precautions ( 5.1 , 5.2 ) ].Because naproxen sodium may be rapidly absorbed, high and early blood levels should be anticipated. A few patients have experienced convulsions, but it is not clear whether or not these were drug-related. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.