Naproxen
FULL PRESCRIBING INFORMATION: CONTENTS*
- Cardiovascular Risk
- NAPROXEN DESCRIPTION
- CLINICAL PHARMACOLOGY
- CLINICAL STUDIES
- INDICATIONS & USAGE
- NAPROXEN CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- NAPROXEN ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- Medication Guide
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
NAPROXEN DESCRIPTION
CLINICAL PHARMACOLOGY
PharmacodynamicsPharmacokinetics
PRECAUTIONS, Nursing Mothers).
WARNINGS, Renal Effects).
WARNINGS, Renal Effects).
CLINICAL STUDIES
General InformationGeriatric Patients
INDICATIONS & USAGE
WARNINGS).NAPROXEN CONTRAINDICATIONS
WARNINGS, Anaphylactoid ReactionsandPRECAUTIONS, Preexisting Asthma).
WARNINGS).
WARNINGS
CARDIOVASCULAR EFFECTSGastrointestinal Effects-Risk of Ulceration, Bleeding, and Perforation).
CONTRAINDICATIONS).
Gastrointestinal Effects-Risk of Ulceration, Bleeding, and Perforation
PRECAUTIONS, Drug Interactions). Although these studies focused on upper gastrointestinal bleeding, there is reason to believe that bleeding at other sites may be similarly potentiated.
Renal Effects
WARNINGS, Advanced Renal Disease).
Advanced Renal Disease
Anaphylactoid Reactions
CONTRAINDICATIONSandPRECAUTIONS, Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs. Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.
Skin Reactions
Pregnancy
PRECAUTIONS
GeneralNaproxen-containing products such as naproxen tablets, naproxen delayed-release tablets, naproxen sodium tablets, naproxen suspension, and other naproxen products should not be used concomitantly since they all circulate in the plasma as the naproxen anion.
Hepatic Effects
Hematological Effects
Preexisting Asthma
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 Medication Guide that accompanies each prescription dispensed.
WARNINGS, CARDIOVASCULAR EFFECTS).
WARNINGS, Gastrointestinal EffectsRisk of Ulceration, Bleeding, and Perforation).
WARNINGS).
Laboratory Tests
Drug Interactions
WARNINGS, Renal Effects), as well as to assure diuretic efficacy.
Other Information Concerning Drug Interactions
Drug/Laboratory Test Interactions
Carcinogenesis
Pregnancy
Labor and Delivery
Nursing Mothers
Pediatric Use
DOSAGE AND ADMINISTRATION). There are no adequate effectiveness or dose-response data for other pediatric conditions, but the experience in juvenile arthritis and other use experience have established that single doses of 2.5 to 5 mg/kg (as naproxen suspension, seeDOSAGE AND ADMINISTRATION), with total daily dose not exceeding 15 mg/kg/day, are well tolerated in pediatric patients over 2 years of age.
Geriatric Use
WARNINGS).
WARNINGS, Renal Effects).
NAPROXEN ADVERSE REACTIONS
CLINICAL PHARMACOLOGY).
Gastrointestinal (GI) Experiences, including:heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis
Central Nervous System:headache*, dizziness*, drowsiness*, lightheadedness, vertigo
Dermatologic:pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpura
Special Senses:tinnitus*, visual disturbances, hearing disturbances
Cardiovascular:edema*, palpitations
General:dyspnea*, thirst
Gastrointestinal (GI) Experiences, including:flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting
General:abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes
Body as a Whole:anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)
Cardiovascular:congestive heart failure, vasculitis, hypertension, pulmonary edema
Gastrointestinal:gastrointestinal bleeding and/or perforation, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohndisease), nonpeptic gastrointestinal ulceration, ulcerative stomatitis, esophagitis, peptic ulceration
Hepatobiliary:jaundice, abnormal liver function tests, hepatitis (some cases have been fatal)
Hemic and Lymphatic:eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia
Metabolic and Nutritional:hyperglycemia, hypoglycemia
Nervous System:inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions
Respiratory:eosinophilic pneumonitis, asthma
Dermatologic:alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.
Special Senses:hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema
Urogenital:glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine
Reproduction (female):infertility
Body as a Whole:fever, infection, sepsis, anaphylactic reactions, appetite changes, death
Cardiovascular:hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction
Gastrointestinal:dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation
Hepatobiliary:hepatitis, liver failure
Hemic and Lymphatic:rectal bleeding, lymphadenopathy, pancytopenia
Metabolic and Nutritional:weight changes
Nervous System:anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations
Respiratory:asthma, respiratory depression, pneumonia
Dermatologic:exfoliative dermatitis
Special Senses:blurred vision, conjunctivitis
Urogenital:cystitis, dysuria, oliguria/polyuria, proteinuria
OVERDOSAGE
Symptoms and SignsTreatment
DOSAGE & ADMINISTRATION
WARNINGS).Different dose strengths and formulations (i.e., tablets, suspension) of the drug are not necessarily bioequivalent. This difference should be taken into consideration when changing formulation.
CLINICAL PHARMACOLOGY).
WARNINGSandPRECAUTIONS).
Geriatric Patients
Patients With Moderate to Severe Renal Impairment
WARNINGS, Renal Effects).
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis
CLINICAL PHARMACOLOGY).
Juvenile Arthritis
Management of Pain, Primary Dysmenorrhea, and Acute Tendonitis and Bursitis
CLINICALPHARMACOLOGYandINDICATIONS AND USAGE).
Acute Gout
CLINICAL PHARMACOLOGY).
HOW SUPPLIED
STORAGE AND HANDLING
Medication Guide
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)Rx only
(See the end of this Medication Guide for a list of prescription NSAID medicines.)
What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.This chance increases:
NSAID medicines should never be used right before or after a heart surgery called aartery bypass graft (CABG).
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:
The chance of a person getting an ulcer or bleeding increases with:
NSAID medicines should only be used:
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
Tell your healthcare provider:
Keep a list of your medicines to show to your healthcare provider and pharmacist.
NSAID medicines should not be used by pregnant women late in their pregnancy.
Talk to your doctor.
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
Serious Side effects include:
Other side effects include:
Get emergency help right away if you have any of the following symptoms:
Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
NSAID medicines that need a prescription
Generic Name Tradename
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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!
