Naproxen description, usages, side effects, indications, overdosage, supplying and lots more!

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Naproxen

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

Cardiovascular Risk
  • ●     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).
  • ●     Naproxen as Naproxen Tablets, USP is contraindicated for the treatment of peri0operative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS).
Gastrointestinal Risk
  • ●     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



Naproxen





CLINICAL PHARMACOLOGY

Pharmacodynamics

Pharmacokinetics

Absorption



PRECAUTIONS: Nursing Mothers



WARNINGS: Renal Effects








WARNINGS: Renal Effects

CLINICAL STUDIES

General Information









Geriatric Patients


INDICATIONS & USAGE

WARNINGS

  • ●     For the relief of the signs and symptoms of rheumatoid arthritis
  • ●     For the relief of the signs and symptoms of osteoarthritis
  • ●     For the relief of the signs and symptoms of ankylosing spondylitis
  • ●     For the relief of the signs and symptoms of juvenile arthritis
  • ●     For relief of the signs and symptoms of tendonitis
  • ●     For relief of the signs and symptoms of bursitis
  • ●     For relief of the signs and symptoms of acute gout
  • ●     For the management of pain
  • ●     For the management of primary dysmenorrhea

NAPROXEN CONTRAINDICATIONS


WARNINGS: Anaphylactoid ReactionsPRECAUTIONS: Preexisting Asthma
WARNINGS

WARNINGS

CARDIOVASCULAR EFFECTS


Gastrointestinal 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
CONTRAINDICATIONSPRECAUTIONS: Preexisting Asthma
Skin Reactions

Pregnancy


PRECAUTIONS

General
Naproxen-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 NSAID Medication Guide that accompanies each prescription dispensed.
WARNINGS: Cardiovascular Effects
WARNINGS: Gastrointestinal Effects- Risk of Ulceration, Bleeding, and Perforation



WARNINGS




LABORATORY TESTS



DRUG INTERACTIONS










WARNINGS: Renal Effects






Other Information Concerning Drug Interactions




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


Gastrointestinal (GI) Experiences, including:
Central Nervous System:
Dermatologic:
Special Senses:
Cardiovascular:
General:

Gastrointestinal (GI) Experiences, including:
General:

Body as a Whole:
Cardiovascular:
Gastrointestinal:
Hepatobiliary:
Hemic and Lymphatic:
Metabolic and Nutritional:
Nervous System:
Respiratory:
Dermatologic:
Special Senses:
Urogenital:
Reproduction (female):

Body as a Whole:
Cardiovascular:
Gastrointestinal:
Hepatobiliary:
Hemic and Lymphatic:
Metabolic and Nutritional:
Nervous System:
Respiratory:
Dermatologic:
Special Senses:
Urogenital:


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.

WARNINGSPRECAUTIONS
Geriatric Patients

Patients With Moderate to Severe Renal Impairment
WARNINGS: Renal Effects
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis

CLINICAL PHARMACOLOGY
Acute Gout


HOW SUPPLIED






STORAGE AND HANDLING




SPL MEDGUIDE

Medication Guide
for
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.
NSAID medicines should never be used right before or after a heart surgery called a
coronary 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)?

  • ●     different types of arthritis
  • ●     menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
  • ●     if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • ●     for pain right before or after heart bypass surgery
Tell your healthcare provider:
  • ●     about all of your medical conditions.
  • ●     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.
  • ●     if you are pregnant.NSAID medicines should not be used by pregnant women late in their pregnancy.
  • ●     if you are breastfeeding.Talk to your doctor.
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
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)
  • ●     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.
  • ●     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.
NSAID medicines that need a prescription



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Naproxen

Naproxen

Naproxen TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:24236-995(NDC:53746-190)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Naproxen NAPROXEN 500 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
povidone
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
white 16 mm IP190;500 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24236-995-20 100 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075927 2012-01-12


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Be sure to consult your doctor before taking any medication!
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