NAPROXEN
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- NAPROXEN DESCRIPTION
- CLINICAL PHARMACOLOGY
- CLINICAL STUDIES
- INDICATIONS & USAGE
- NAPROXEN CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- NAPROXEN ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
NAPROXEN DESCRIPTION
CLINICAL PHARMACOLOGY
PharmacodynamicsPharmacokinetics
Absorption
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
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.
Skin Reactions
Pregnancy
PRECAUTIONS
GeneralNaproxen-containing products such as Naproxen Tablets, USP, 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 NSAIDMedication Guide that accompanies each prescription dispensed.
WARNINGS: Cardiovascular Effects).
WARNINGS: Gastrointestinal Effects- Risk of Ulceration, Bleeding, and Perforation).
WARNINGS).
WARNINGS: Renal Effects), as well as to assure diuretic efficacy.
WARNINGS).
WARNINGS: Renal Effects).
NAPROXEN ADVERSE REACTIONS
CLINICAL PHARMACOLOGY).
Gastrointestinal (GI) Experiences, including:heartburn1, abdominal pain1, nausea1, constipation1, diarrhea, dyspepsia, and stomatitis
Central Nervous System:headache1, dizziness1, drowsiness1, lightheadedness, vertigo
Dermatologic:pruritus (itching)1, skin eruptions1, ecchymoses1, sweating, purpura
Special Senses: tinnitus1, visual disturbances, hearing disturbances
Cardiovascular: edema1, palpitations.
General:dyspnea1, 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, nonpeptic gastrointestinal ulceration, ulcerative stomatitis, 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, erythemia multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematosus, 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
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.
WARNINGSandPRECAUTIONS).
Geriatric Patients
Patients With Moderate to Severe Renal Impairment
WARNINGS: Renal Effects).
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis
CLINICAL PHARMACOLOGY).
Acute Gout
HOW SUPPLIED
Naproxen Tablets, USP:250 mg:white, round, biconvex, debossed with "IP 188" on obverse and "250" on the reverse. Packaged in bottles of 100, 500 and 1000.
375 mg:white, capsule-shaped, biconvex, debossed with "IP 189" on obverse and "375" on the reverse. Packaged in bottles of 100, 500 and 1000.
500 mg:white, capsule-shaped, biconvex, debossed with "IP 190" on obverse and "500" on the reverse. Packaged in bottles of 100, 500 and 1000.
STORAGE AND HANDLING
MEDGUIDE
Medication Guidefor
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
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 a
artery 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:
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
NSAID medicines that need a prescription
Generic Name Tradename
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!
