
Prescription Drug Name:
Naproxen Sodium Tablets, USP, Rx only, These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS., NAPROXEN SODIUM tablets, for oral use, Initial U.S. Approval: 1976
ID:
636556f6-2989-984f-e053-2991aa0a201a
Code:
34391-3
BOXED WARNING SECTION
id: 638a4320-9c21-4122-e053-2991aa0af758
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1
GASTROINTESTINAL EVENTS • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)]. • Naproxen sodium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4), Warnings and Precautions (5.1)]. • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2)]. |
1 INDICATIONS AND USAGE
id: 637957d5-3e86-9f7a-e053-2a91aa0a4157
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
the relief of the signs and symptoms of:
• rheumatoid arthritis
• osteoarthritis
• ankylosing spondylitis
• Polyarticular Juvenile Idiopathic Arthritis
the relief of signs and symptoms of:
• tendonitis
• bursitis
• acute gout
• pain
• primary dysmenorrhea
3 DOSAGE FORMS AND STRENGTHS
id: 63737fdd-40ab-c3bc-e053-2991aa0a9ccb
displayName: DOSAGE FORMS & STRENGTHS SECTION
FDA Article Code: 43678-2
4 CONTRAINDICATIONS
id: 637333e4-638c-371d-e053-2a91aa0a707b
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
• In the setting of coronary artery bypass graft (CABG) surgery
6 ADVERSE REACTIONS
id: 63741c04-f5b1-d8ad-e053-2991aa0a2e08
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
• GI Bleeding, Ulceration, and Perforation
• Hepatotoxicity
• Hypertension
• Heart Failure and Edema
• Renal Toxicity and Hyperkalemia
• Anaphylactic Reactions
• Serious Skin Reactions
• Hematologic Toxicity
7 DRUG INTERACTIONS
id: 638a6376-8e2b-7fbc-e053-2a91aa0a20b9
displayName: DRUG INTERACTIONS SECTION
FDA Article Code: 34073-7
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• 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. |
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Monitor patients with concomitant use of naproxen sodium with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding |
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Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone |
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Concomitant use of naproxen sodium and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding naproxen sodium are not substitutes for low dose aspirin for cardiovascular protection. |
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• NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
• In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. |
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• During concomitant use of naproxen sodium and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
• During concomitant use of naproxen sodium and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see Warnings and Precautions (5.6)]. • When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. |
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Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. |
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During concomitant use of naproxen sodium with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects |
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The concomitant use of naproxen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin |
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During concomitant use of naproxen sodium and digoxin, monitor serum digoxin levels. |
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NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. |
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During concomitant use of naproxen sodium and lithium, monitor patients for signs of lithium toxicity. |
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Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). |
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During concomitant use of naproxen sodium and methotrexate, monitor patients for methotrexate toxicity. |
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Concomitant use of naproxen sodium and cyclosporine may increase cyclosporine’s nephrotoxicity. |
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During concomitant use of naproxen sodium and cyclosporine, monitor patients for signs of worsening renal function. |
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Concomitant use of naproxen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy |
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The concomitant use of naproxen with other NSAIDs or salicylates is not recommended. |
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Concomitant use of naproxen sodium and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). |
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During concomitant use of naproxen sodium and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. |
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Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen. |
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Concomitant administration of antacids such as magnesium oxide or aluminum hydroxide, and sucralfate with naproxen sodium is not recommended. |
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Concomitant administration of cholestyramine can delay the absorption of naproxen. |
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Concomitant administration of cholestyramine with naproxen sodium is not recommended. |
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Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly. |
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Patients simultaneously receiving naproxen sodium and probenecid should be observed for adjustment of dose if required. |
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Naproxen is highly bound to plasma albumin; it thus has a theoretical potential for interaction with other albumin-bound drugs such as coumarin -type anticoagulants, sulphonylureas, hydantoins, other NSAIDs, and aspirin. |
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Naproxen may decrease platelet aggregation and prolong bleeding time. |
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This effect should be kept in mind when bleeding times are determined. |
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The administration of naproxen may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-di-nitrobenzene used in this assay. |
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Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that therapy with naproxen be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used. |
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Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA) |
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This effect should be kept in mind when urinary 5-hydroxy indoleacetic acid is determined. |
10 OVERDOSAGE
id: 6374e8ff-23c7-e471-e053-2a91aa0ab50b
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
11 DESCRIPTION
id: 6374e8ff-23d8-e471-e053-2a91aa0ab50b
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
14 CLINICAL STUDIES
id: 637544e2-f0f8-7547-e053-2991aa0a795c
displayName: CLINICAL STUDIES SECTION
FDA Article Code: 34092-7
51Cr blood loss and gastroscopy studies with normal volunteers, daily administration of 1,000 mg of naproxen1,100 mg of naproxen sodium has been demonstrated to cause statistically significantly less gastric bleeding and erosion than 3,250 mg of aspirin.
16 HOW SUPPLIED/STORAGE AND HANDLING
id: 637544e2-f0f9-7547-e053-2991aa0a795c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Bottle of 500 Tablets: NDC 42291-517-50
17 PATIENT COUNSELING INFORMATION
id: 6375306a-66ee-4c08-e053-2991aa0a19f7
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
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
Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop naproxen sodium and seek immediate medical therapy
Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur
Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur
Advise patients to stop naproxen sodium immediately if they develop any type of rash and to contact their healthcare provider as soon as possible
Advise females of reproductive potential who desire pregnancy that NSAIDs, including naproxen sodium, may be associated with a reversible delay in ovulation
Inform pregnant women to avoid use of naproxen sodium and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus
Inform patients that the concomitant use of naproxen sodium with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy
Inform patients not to use low-dose aspirin concomitantly with naproxen sodium until they talk to their healthcare provider
AvKARE, Inc.
Pulaski, TN 38478
AV 09/17 (P)
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
id: 63754cf1-2cf7-801a-e053-2991aa0a3e01
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1
• Increased risk of a heart attack or stroke that can lead to death
. This risk may happen early in treatment and may increase:
o with increasing doses of NSAIDs
o with longer use of NSAIDs
o anytime during use
o without warning symptoms
o that may cause death
o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
o increasing doses of NSAIDs
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems
o exactly as prescribed
o at the lowest dose possible for your treatment
o for the shortest time needed
NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.
• if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
• right before or after heart bypass surgery.
• have liver or kidney problems
• have high blood pressure
• have asthma
• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are
considering taking NSAIDs during pregnancy.
• are breastfeeding or plan to breast feed.
• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions •
• shortness of breath or trouble breathing | • slurred speech |
• chest pain | • swelling of the face or throat |
• weakness in one part or side of your body |
• nausea | • vomit blood |
• more tired or weaker than usual | • there is blood in your bowel movement or it is black and sticky like tar |
• diarrhea | • unusual weight gain |
• itching | • skin rash or blisters with fever |
• your skin or eyes look yellow | • swelling of the arms, legs, hands and feet |
• indigestion or stomach pain | |
• flu-like symptoms |
These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
• Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some NSAIDs are sold in lower doses without a prescription (over-the counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.
AvKARE, Inc.
Pulaski, TN 38478
Mfg. 09/17 (P)