Naproxen
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- NAPROXEN DESCRIPTION
- CLINICAL PHARMACOLOGY
- CLINICAL STUDIES
- INDICATIONS & USAGE
- NAPROXEN CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- DRUG & OR LABORATORY TEST INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- LABOR & DELIVERY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- NAPROXEN ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
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● NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fate. This risk may increase with duration of use. Patient with cardiovascular disease or risk factor for cardiovascular disease may be at great risk (seeWARNINGS).
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● Naproxen as Naproxen Tablets, USP is contraindicated for the treatment of peri0operative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS).
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● NSAIDs cause increased risk of serious gastrointestinal adverse event including, 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 are at greater risk for serious gastrointestinal events (seeWARNINGS).
NAPROXEN DESCRIPTION
CLINICAL PHARMACOLOGY
PRECAUTIONS: Nursing Mothers
WARNINGS: Renal Effects
WARNINGS: Renal Effects
CLINICAL STUDIES
INDICATIONS & USAGE
WARNINGS-
● For the relief of the signs and symptoms of rheumatoid arthritis
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● For the relief of the signs and symptoms of osteoarthritis
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● For the relief of the signs and symptoms of ankylosing spondylitis
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● For the relief of the signs and symptoms of juvenile arthritis
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● For relief of the signs and symptoms of tendonitis
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● For relief of the signs and symptoms of bursitis
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● For relief of the signs and symptoms of acute gout
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● For the management of pain
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● For the management of primary dysmenorrhea
NAPROXEN CONTRAINDICATIONS
WARNINGS: Anaphylactoid ReactionsPRECAUTIONS: Preexisting Asthma
WARNINGS
WARNINGS
Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
CONTRAINDICATIONS
WARNINGS: Advanced Renal Disease
CONTRAINDICATIONSPRECAUTIONS: Preexisting Asthma
PRECAUTIONS
INFORMATION FOR PATIENTS
WARNINGS: Cardiovascular Effects
WARNINGS: Gastrointestinal Effects- Risk of Ulceration, Bleeding, and Perforation
WARNINGS
LABORATORY TESTS
DRUG INTERACTIONS
WARNINGS: Renal Effects
DRUG & OR LABORATORY TEST INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
LABOR & DELIVERY
NURSING MOTHERS
PEDIATRIC USE
GERIATRIC USE
WARNINGS
WARNINGS: Renal Effects
NAPROXEN ADVERSE REACTIONS
CLINICAL PHARMACOLOGY
OVERDOSAGE
DOSAGE & ADMINISTRATION
WARNINGSWARNINGSPRECAUTIONS
WARNINGS: Renal Effects
CLINICAL PHARMACOLOGY
HOW SUPPLIED
SPL MEDGUIDE
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● different types of arthritis
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● menstrual cramps and other types of short-term pain
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● if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
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● for pain right before or after heart bypass surgery
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● about all of your medical conditions.
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● about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
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● if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
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● if you are breastfeeding. Talk to your doctor.
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● Aspirin is an NSAID medicine 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.
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● Some of these NSAID medicines are sold in lower doses without a prescription (overthe-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
NaproxenNaproxen TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
