NAPROXEN- naproxen tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)
Available from:
NuCare Pharmaceuticals,Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). NAPROXEN TABLETS ARE INDICATED:    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    NAPROXEN TABLETS ARE ALSO INDICATED:    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
Product summary:
NAPROXEN TABLETS 250 MG : WHITE TO OFF-WHITE, ROUND SHAPED TABLET WITH 138 DEBOSSED ON ONE SIDE AND SCORED ON OTHER SIDE. PACKAGED IN LIGHT-RESISTANT BOTTLES OF 100 AND 500. NDC 68071-4995-2 BOTTLES OF 20 STORE AT 20°-25°C (68°-77°F) EXCURSIONS PERMITTED TO 15°-30°C (59°-86°F) IN WELL-CLOSED CONTAINERS [SEE USP CONTROLLED ROOM TEMPERATURE]. DISPENSE IN LIGHT-RESISTANT CONTAINERS. RX ONLY
Authorization status:
Abbreviated New Drug Application
Authorization number:
68071-4995-2

NAPROXEN- naproxen tablet

NuCare Pharmaceuticals,Inc.

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MED GUIDE FOR NAPROXEN TABLETS USP

250 MG 375 MG 500 MG

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Non-Steroidal Anti-

Inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:

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

Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have

an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to

the stomach), stomach and intestines:

o any time during use

o without warning symptoms

o that may cause death

The risk of getting an ulcer or bleeding increases with:

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 older age

o longer use of NSAIDs o poor health

o smoking o advanced liver disease

o drinking alcohol o bleeding problems

NSAIDs should only be used:

o exactly as prescribed

o at the lowest dose possible for your treatment

o for the shortest time needed

What are NSAIDs?

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.

Who should not take NSAIDs?

Do not take NSAIDs:

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.

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:

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. You should not take NSAIDs after 29 weeks of pregnancy.

are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter

medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other

and cause serious side effects. Do not start taking any new medicine without talking to your healthcare

provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about medicines called Nonsteroidal Anti-

inflammatory Drugs (NSAIDs)"?

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

Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea,

vomiting, and dizziness.

Get emergency help right away if you have any of the following symptoms:

shortness of breath or trouble breathing

chest pain

weakness in one part or side of your body

slurred speech

swelling of the face or throat

Stop taking your NSAID and call your healthcare provider right away if you get any of the following

symptoms:

nausea

more tired or weaker than usual

diarrhea

itching

your skin or eyes look yellow

indigestion or stomach pain

flu-like symptoms

vomit blood

there is blood in your bowel movement or it is black and sticky like tar

unusual weight gain

skin rash or blisters with fever

swelling of the arms and legs, hands and feet

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

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 Marksans at 1-877-376-4271 and/orFDA at 1-800-FDA-1088.

Other information about 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 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.

General information about the safe and effective use of NSAIDs

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.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your

pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

Manufactured for:

Time-Cap Labs, Inc.

7 Michael Avenue,

Farmingdale,

NY 11735, USA

Manufactured by:

Marksans Pharma Ltd.

Plot No. L-82, L-83,

Verna Indl. Estate,

Verna, GOA - 403722, India.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: October 2017

Revised: 7/2019

Document Id: 8e986e51-73c5-f31e-e053-2a95a90a0aac

34391-3

Set id: 8e986e48-d5d2-7554-e053-2995a90ae1d3

Version: 1

Effective Time: 20190726

NuCare Pharmaceuticals,Inc.

NAPROXEN- naproxen tablet

NuCare Pharmaceuticals,Inc.

----------

CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND

OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE

THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH

INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS: GASTROINTESTINAL

BLEEDING, ULCERATION, AND PERFORATION).

NAPROXEN TABLETS ARE INDICATED:

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

NAPROXEN TABLETS ARE ALSO INDICATED:

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 TABLETS

250MG: WHITE TO OFF-WHITE, ROUND SHAPED TABLET WITH 138 DEBOSSED ON ONE

SIDE AND SCORED ON OTHER

SIDE. PACKAGED IN LIGHT-RESISTANT BOTTLES OF 100 AND 500.

NDC 68071-4995-2 BOTTLES OF 20

STORE AT 20°-25°C (68°-77°F) EXCURSIONS PERMITTED TO 15°-30°C (59°-86°F) IN WELL-

CLOSED CONTAINERS

[SEE USP CONTROLLED ROOM TEMPERATURE]. DISPENSE IN LIGHT-RESISTANT

CONTAINERS.

RX ONLY

CARDIOVAS CULAR THROMBOTIC EVENTS

CLINICAL TRIALS OF SEVERAL COX-2 SELECTIVE AND NON-SELECTIVE NSAIDS OF UP

TO THREE YEARS DURATION HAVE SHOWN AN INCREASED RISK OF SERIOUS

CARDIOVASCULAR (CV) THROMBOTIC EVENTS, MYOCARDIAL INFARCTION, AND

STROKE, WHICH CAN BE FATAL. BASED ON AVAILABLE DATA, IT IS UNCLEAR THAT

THE RISK FOR CV THROMBOTIC EVENTS IS SIMILAR FOR ALL NSAIDS. THE RELATIVE

INCREASE IN SERIOUS CV THROMBOTIC EVENTS OVER BASELINE CONFERRED BY

NSAID USE APPEARS TO BE SIMILAR IN THOSE WITH AND WITHOUT KNOWN CV

DISEASE OR RISK FACTORS FOR CV DISEASE. HOWEVER, PATIENTS WITH KNOWN CV

DISEASE OR RISK FACTORS HAD A HIGHER ABSOLUTE INCIDENCE OF EXCESS SERIOUS

CV THROMBOTIC EVENTS, DUE TO THEIR INCREASED BASELINE RATE.

SOMEOBSERVATIONAL STUDIES FOUND THAT THIS INCREASED RISK OF SERIOUS CV

THROMBOTIC EVENTS BEGAN AS EARLY AS THE FIRST WEEKS OF TREATMENT. THE

INCREASE IN CV THROMBOTIC RISK HAS BEEN OBSERVED MOST CONSISTENTLY AT

HIGHER DOSES.

TO MINIMIZE THE POTENTIAL RISK FOR AN ADVERSE CV EVENT IN NSAID-TREATED

PATIENTS, USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION

POSSIBLE. PHYSICIANS AND PATIENTS SHOULD REMAIN ALERT FOR THE

DEVELOPMENT OF SUCH EVENTS, THROUGHOUT THE ENTIRE TREATMENT COURSE,

EVEN IN THE ABSENCE OF PREVIOUS CV SYMPTOMS. PATIENTS SHOULD BE INFORMED

ABOUT THE SYMPTOMS OF SERIOUS CV EVENTS AND THE STEPS TO TAKE IF THEY

OCCUR.

THERE IS NO CONSISTENT EVIDENCE THAT CONCURRENT USE OF ASPIRIN MITIGATES

THE INCREASED RISK OF SERIOUS CV THROMBOTIC EVENTS ASSOCIATED WITH NSAID

USE. THE CONCURRENT USE OF ASPIRIN AND AN NSAID, SUCH AS NAPROXEN,

INCREASES THE RISK OF SERIOUS GASTROINTESTINAL (GI) EVENTS (SEE WARNINGS;

GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION).

STATUS POST CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY

TWO LARGE, CONTROLLED, CLINICAL TRIALS OF A COX-2 SELECTIVE NSAID FOR THE

TREATMENT OF PAIN IN THE FIRST 10-14 DAYS FOLLOWING CABG SURGERY FOUND AN

INCREASED INCIDENCE OF MYOCARDIAL INFARCTION AND STROKE. NSAIDS ARE

CONTRAINDICATED IN THE SETTING OF CABG (SEE CONTRAINDICATIONS).

POST-MI PATIENTS

OBSERVATIONAL STUDIES CONDUCTED IN THE DANISH NATIONAL REGISTRY HAVE

DEMONSTRATED THAT PATIENTS TREATED WITH NSAIDS IN THE POST-MI PERIOD

WERE AT INCREASED RISK OF REINFARCTION, CV-RELATED DEATH, AND ALL CAUSE

MORTALITY BEGINNING IN THE FIRST WEEK OF TREATMENT. IN THIS SAME COHORT,

THE INCIDENCE OF DEATH IN THE FIRST YEAR POST-MI WAS 20 PER 100 PERSON YEARS

IN NSAID-TREATED PATIENTS COMPARED TO 12 PER 100 PERSON YEARS IN NON-NSAID

EXPOSED PATIENTS. ALTHOUGH THE ABSOLUTE RATE OF DEATH DECLINED

SOMEWHAT

AFTER THE FIRST YEAR POST-MI, THE INCREASED RELATIVE RISK OF DEATH IN NSAID

USERS PERSISTED OVER AT LEAST THE NEXT FOUR YEARS OF FOLLOW-UP.

AVOID THE USE OF NAPROXEN IN PATIENTS WITH A RECENT MI UNLESS THE BENEFITS

ARE EXPECTED TO OUTWEIGH THE RISK OF RECURRENT CV THROMBOTIC EVENTS. IF

NAPROXEN IS USED IN PATIENTS WITH A RECENT MI, MONITOR PATIENTS FOR SIGNS

OF CARDIAC ISCHEMIA.

GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION

NSAIDS, INCLUDING NAPROXEN CAUSE SERIOUS GASTROINTESTINAL (GI) ADVERSE

EVENTS INCLUDING INFLAMMATION, BLEEDING, ULCERATION, AND PERFORATION OF

THE ESOPHAGUS, STOMACH, SMALL INTESTINE, OR LARGE INTESTINE, WHICH CAN BE

FATAL. THESE SERIOUS ADVERSE EVENTS CAN OCCUR AT ANY TIME, WITH OR

WITHOUT WARNING SYMPTOMS, IN PATIENTS TREATED WITH NSAIDS. ONLY ONE IN

FIVE PATIENTS WHO DEVELOP A SERIOUS UPPER GI ADVERSE EVENT ON NSAID

THERAPY IS SYMPTOMATIC. UPPER GI ULCERS, GROSS BLEEDING, OR PERFORATION

CAUSED BY NSAIDS OCCURRED IN APPROXIMATELY 1% OF PATIENTS TREATED FOR 3-6

MONTHS, AND IN ABOUT 2%-

4% OF PATIENTS TREATED FOR ONE YEAR. HOWEVER, EVEN SHORT-TERM NSAID

THERAPY IS NOT WITHOUT RISK. RISK FACTORS FOR GI BLEEDING, ULCERATION, AND

PERFORATION PATIENTS WITH A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI

BLEEDING WHO USED NSAIDS HAD A GREATER

THAN 10-FOLD INCREASED RISK FOR DEVELOPING A GI BLEED COMPARED TO

PATIENTS WITHOUT THESE RISK FACTORS. OTHER FACTORS THAT INCREASE THE RISK

OF GI BLEEDING IN PATIENTS TREATED WITH NSAIDS INCLUDE LONGER DURATION OF

NSAID THERAPY; CONCOMITANT USE OF ORAL CORTICOSTEROIDS, ASPIRIN,

ANTICOAGULANTS, OR SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS);

SMOKING; USE OF ALCOHOL; OLDER AGE; AND POOR GENERAL HEALTH STATUS. MOST

POSTMARKETING REPORTS OF FATAL GI EVENTS OCCURRED IN ELDERLY OR

DEBILITATED PATIENTS.

ADDITIONALLY, PATIENTS WITH ADVANCED LIVER DISEASE AND/OR COAGULOPATHY

ARE AT INCREASED RISK FOR GI BLEEDING.

STRATEGIES TO MINIMIZE THE GI RISKS IN NSAID-TREATED PATIENTS:

USE THE LOWEST EFFECTIVE DOSAGE FOR THE SHORTEST POSSIBLE DURATION.

AVOID ADMINISTRATION OF MORE THAN ONE NSAID AT A TIME.

AVOID USE IN PATIENTS AT HIGHER RISK UNLESS BENEFITS ARE EXPECTED TO

OUTWEIGH THE INCREASED RISK OF

BLEEDING. FOR SUCH PATIENTS, AS WELL AS THOSE WITH ACTIVE GI BLEEDING,

CONSIDER ALTERNATE THERAPIES OTHER THAN NSAIDS.

REMAIN ALERT FOR SIGNS AND SYMPTOMS OF GI ULCERATION AND BLEEDING

DURING NSAID THERAPY.

IF A SERIOUS GI ADVERSE EVENT IS SUSPECTED, PROMPTLY INITIATE EVALUATION

AND TREATMENT, AND DISCONTINUE NAPROXEN UNTIL A SERIOUS GI ADVERSE

EVENT IS RULED OUT.

IN THE SETTING OF CONCOMITANT USE OF LOW-DOSE ASPIRIN FOR CARDIAC

PROPHYLAXIS, MONITOR PATIENTS MORE CLOSELY FOR EVIDENCE OF GI BLEEDING

(SEE PRECAUTIONS; DRUG INTERACTIONS).

HEPATOTOXICITY

ELEVATIONS OF ALT OR AST (THREE OR MORE TIMES THE UPPER LIMIT OF NORMAL

[ULN]) HAVE BEEN REPORTED IN APPROXIMATELY 1% OF PATIENTS IN CLINICAL

TRIALS. IN ADDITION, RARE, SOMETIMES FATAL, CASES OF SEVERE HEPATIC INJURY,

INCLUDING FULMINANT HEPATITIS, LIVER NECROSIS AND HEPATIC FAILURE HAVE

BEEN REPORTED.

ELEVATIONS OF ALT OR AST (LESS THAN THREE TIMES ULN) MAY OCCUR IN UP TO 15%

OF PATIENTS TAKING NSAIDS INCLUDING NAPROXEN.

INFORM PATIENTS OF THE WARNING SIGNS AND SYMPTOMS OF HEPATOTOXICITY (E.G.,

NAUSEA, FATIGUE, LETHARGY, DIARRHEA, PRURITUS, JAUNDICE, RIGHT UPPER

QUADRANT TENDERNESS, AND "FLULIKE" SYMPTOMS). IF CLINICAL SIGNS AND

SYMPTOMS CONSISTENT WITH LIVER DISEASE DEVELOP, OR IF SYSTEMIC

MANIFESTATIONS OCCUR (E.G., EOSINOPHILIA, RASH, ETC.), DISCONTINUE NAPROXEN

IMMEDIATELY, AND PERFORM A CLINICAL EVALUATION OF THE PATIENT.

HYPERTENSION

NSAIDS, INCLUDING NAPROXEN, CAN LEAD TO ONSET OF NEW HYPERTENSION OR

WORSENING OF PRE-EXISTING HYPERTENSION, EITHER OF WHICH MAY CONTRIBUTE

TO THE INCREASED INCIDENCE OF CV EVENTS. PATIENTS TAKING ANGIOTENSIN

CONVERTING ENZYME (ACE) INHIBITORS, THIAZIDES OR LOOP DIURETICS MAY HAVE

IMPAIRED RESPONSE TO THESE THERAPIES WHEN TAKING NSAIDS (SEE PRECAUTIONS;

DRUG INTERACTIONS).

MONITOR BLOOD PRESSURE (BP) DURING THE INITIATION OF NSAID TREATMENT AND

THROUGHOUT THE COURSE OF THERAPY.

HEART FAILURE AND EDEMA

THE COXIB AND TRADITIONAL NSAID TRIALISTS’ COLLABORATION META-ANALYSIS

OF RANDOMIZED CONTROLLED TRIALS DEMONSTRATED AN APPROXIMATELY TWO-

FOLD INCREASE IN HOSPITALIZATION FOR HEART FAILURE IN COX-2 SELECTIVE-

TREATED PATIENTS AND NONSELECTIVE NSAID-TREATED PATIENTS COMPARED TO

PLACEBO-TREATED PATIENTS. IN A DANISH NATIONAL REGISTRY STUDY OF PATIENTS

WITH HEART FAILURE, NSAID USE INCREASED THE RISK OF MI, HOSPITALIZATION FOR

HEART FAILURE, AND DEATH. ADDITIONALLY, FLUID RETENTION AND EDEMA HAVE

BEEN OBSERVED IN SOME PATIENTS TREATED WITH NSAIDS. USE OF NAPROXEN MAY

BLUNT THE CV EFFECTS OF SEVERAL THERAPEUTIC AGENTS USED TO TREAT THESE

MEDICAL CONDITIONS (E.G., DIURETICS, ACE INHIBITORS, OR ANGIOTENSIN RECEPTOR

BLOCKERS [ARBS]) (SEE PRECAUTIONS; DRUG INTERACTIONS).

AVOID THE USE OF NAPROXEN IN PATIENTS WITH SEVERE HEART FAILURE UNLESS

THE BENEFITS ARE EXPECTED TO OUTWEIGH THE RISK OF WORSENING HEART

FAILURE. IF NAPROXEN IS USED IN PATIENTS WITH SEVERE HEART FAILURE, MONITOR

PATIENTS FOR SIGNS OF WORSENING HEART FAILURE.

RENAL TOXICITY AND HYPERKALEMIA

RENAL TOXICITY

LONG-TERM ADMINISTRATION OF NSAIDS HAS RESULTED IN RENAL PAPILLARY

NECROSIS AND OTHER RENAL INJURY.

RENAL TOXICITY HAS ALSO BEEN SEEN IN PATIENTS IN WHOM RENAL

PROSTAGLANDINS HAVE A COMPENSATORY ROLE IN THE MAINTENANCE OF RENAL

PERFUSION. IN THESE PATIENTS, ADMINISTRATION OF AN NSAID MAY CAUSE A

DOSEDEPENDENT REDUCTION IN PROSTAGLANDIN FORMATION AND, SECONDARILY,

IN RENAL BLOOD FLOW, WHICH MAY PRECIPITATE OVERT RENAL DECOMPENSATION.

PATIENTS AT GREATEST RISK OF THIS REACTION ARE THOSE WITH IMPAIRED

RENAL FUNCTION, HYPOVOLEMIA, HEART FAILURE, LIVER DYSFUNCTION, SALT

DEPLETION, THOSE TAKING DIURETICS AND ACE INHIBITORS OR ARBS, AND THE

ELDERLY. DISCONTINUATION OF NSAID THERAPY IS USUALLY FOLLOWED BY

RECOVERY TO THE PRETREATMENT STATE. NO INFORMATION IS AVAILABLE FROM

CONTROLLED CLINICAL STUDIES REGARDING THE USE OF NAPROXEN IN PATIENTS

WITH ADVANCED RENAL DISEASE. THE RENAL EFFECTS OF NAPROXEN MAY HASTEN

THE PROGRESSION OF RENAL DYSFUNCTION IN PATIENTS WITH PREEXISTING RENAL

DISEASE.

CORRECT VOLUME STATUS IN DEHYDRATED OR HYPOVOLEMIC PATIENTS PRIOR TO

INITIATING NAPROXEN. MONITOR RENAL FUNCTION IN PATIENTS WITH RENAL OR

HEPATIC IMPAIRMENT, HEART FAILURE, DEHYDRATION, OR HYPOVOLEMIA DURING

USE OF NAPROXEN (SEE PRECAUTIONS; DRUG INTERACTIONS). AVOID THE USE OF

NAPROXEN IN PATIENTS WITH ADVANCED RENAL DISEASE UNLESS THE BENEFITS ARE

EXPECTED TO OUTWEIGH THE RISK OF WORSENING RENAL FUNCTION. IF NAPROXEN IS

USED IN PATIENTS WITH ADVANCED RENAL DISEASE, MONITOR PATIENTS FOR SIGNS

WORSENING RENAL FUNCTION.

HYPERKALEMIA

INCREASES IN SERUM POTASSIUM CONCENTRATION, INCLUDING HYPERKALEMIA,

HAVE BEEN REPORTED WITH USE OF NSAIDS, EVEN IN SOME PATIENTS WITHOUT

RENAL IMPAIRMENT. IN PATIENTS WITH NORMAL RENAL FUNCTION, THESE EFFECTS

HAVE BEEN ATTRIBUTED TO A HYPORENINEMIC HYPOALDOSTERONISM STATE.

ANAPHYLACTOID REACTIONS

NAPROXEN HAS BEEN ASSOCIATED WITH ANAPHYLACTIC REACTIONS IN PATIENTS

WITH AND WITHOUT KNOWN HYPERSENSITIVITY TO NAPROXEN AND IN PATIENTS

WITH ASPIRIN-SENSITIVE ASTHMA (SEE

CONTRAINDICATIONS, WARNINGS; EXACERBATION OF ASTHMA RELATED TO ASPIRIN

SENSITIVITY).

EXACERBATION OF ASTHMA RELATED TO ASPIRIN SENSITIVITY

A SUBPOPULATION OF PATIENTS WITH ASTHMA MAY HAVE ASPIRIN-SENSITIVE

ASTHMA WHICH MAY INCLUDE CHRONIC RHINOSINUSITIS COMPLICATED BY NASAL

POLYPS; SEVERE, POTENTIALLY FATAL BRONCHOSPASM; AND/OR INTOLERANCE TO

ASPIRIN AND OTHER NSAIDS. BECAUSE CROSS-REACTIVITY BETWEEN ASPIRIN AND

OTHER NSAIDS HAS BEEN REPORTED IN SUCH ASPIRIN-SENSITIVE PATIENTS,

NAPROXEN TABLETS ARE CONTRAINDICATED IN PATIENTS WITH THIS FORM OF

ASPIRIN SENSITIVITY (SEE CONTRAINDICATIONS). WHEN NAPROXEN TABLETS ARE

USED IN PATIENTS WITH PREEXISTING ASTHMA (WITHOUT KNOWN ASPIRIN

SENSITIVITY), MONITOR PATIENTS FOR CHANGES IN THE SIGNS AND SYMPTOMS OF

ASTHMA.

SERIOUS SKIN REACTIONS

NSAIDS, INCLUDING NAPROXEN, CAN CAUSE SERIOUS SKIN ADVERSE EVENTS SUCH AS

EXFOLIATIVE DERMATITIS, STEVENS- JOHNSON SYNDROME (SJS), AND TOXIC

EPIDERMAL NECROLYSIS (TEN), WHICH CAN BE FATAL. THESE SERIOUS EVENTS MAY

OCCUR WITHOUT WARNING. PATIENTS SHOULD BE INFORMED ABOUT THE SIGNS AND

SYMPTOMS OF SERIOUS SKIN MANIFESTATIONS AND TO DISCONTINUE THE USE OF

NAPROXEN AT THE FIRST APPEARANCE OF SKIN RASH OR ANY OTHER SIGN OF

HYPERSENSITIVITY. NAPROXEN TABLETS ARE CONTRAINDICATED IN PATIENTS WITH

PREVIOUS

SERIOUS SKIN REACTIONS TO NSAIDS (SEE CONTRAINDICATIONS).

PREMATURE CLOSURE OF FETAL DUCTUS ARTERIOSUS

NAPROXEN MAY CAUSE PREMATURE CLOSURE OF THE FETAL DUCTUS ARTERIOSUS.

AVOID USE OF NSAIDS, INCLUDING NAPROXEN, IN PREGNANT WOMEN STARTING AT 30

WEEKS OF GESTATION (THIRD TRIMESTER) (SEE PRECAUTIONS; PREGNANCY).

HEMATOLOGIC TOXICITY

ANEMIA HAS OCCURRED IN NSAID-TREATED PATIENTS. THIS MAY BE DUE TO OCCULT

OR GROSS BLOOD LOSS, FLUID RETENTION, OR AN INCOMPLETELY DESCRIBED EFFECT

ON ERYTHROPOIESIS. IF A PATIENT TREATED WITH NAPROXEN HAS ANY SIGNS OR

SYMPTOMS OF ANEMIA, MONITOR HEMOGLOBIN OR HEMATOCRIT.

NSAIDS, INCLUDING NAPROXEN, MAY INCREASE THE RISK OF BLEEDING EVENTS. CO-

MORBID CONDITIONS SUCH AS COAGULATION DISORDERS, OR CONCOMITANT USE OF

WARFARIN AND OTHER ANTICOAGULANTS, ANTIPLATELET AGENTS (E.G., ASPIRIN),

SEROTONIN REUPTAKE INHIBITORS (SSRIS) AND SEROTONIN NOREPINEPHRINE

REUPTAKE INHIBITORS (SNRIS) MAY INCREASE THIS RISK. MONITOR THESE PATIENTS

FOR SIGNS OF BLEEDING (SEE PRECAUTIONS; DRUG

INTERACTIONS).

CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND

OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE

THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH

INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS; GASTROINTESTINAL

BLEEDING, ULCERATION, AND PERFORATION).

AFTER OBSERVING THE RESPONSE TO INITIAL THERAPY WITH NAPROXEN TABLETS,

THE DOSE AND FREQUENCY SHOULD BE ADJUSTED TO SUIT AN INDIVIDUAL PATIENT'S

NEEDS.

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.

ALTHOUGH NAPROXEN TABLETS, NAPROXEN SUSPENSION, NAPROXEN DELAYED-

RELEASED TABLETS, AND NAPROXEN SODIUM TABLETS ALL CIRCULATE IN THE

PLASMA AS NAPROXEN, THEY HAVE PHARMACOKINETIC DIFFERENCES THAT MAY

AFFECT ONSET OF ACTION. ONSET OF PAIN RELIEF CAN BEGIN WITHIN 1 HOUR IN

PATIENTS TAKING NAPROXEN. THE RECOMMENDED STRATEGY FOR INITIATING

THERAPY IS TO CHOOSE A FORMULATION AND A STARTING DOSE LIKELY TO BE

EFFECTIVE FOR THE PATIENT AND THEN ADJUST THE DOSAGE BASED ON

OBSERVATION OF BENEFIT AND/OR ADVERSE EVENTS. A LOWER DOSE SHOULD BE

CONSIDERED IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT OR IN ELDERLY

PATIENTS (SEE WARNINGS; HEPATOTOXICITY, AND RENAL TOXICITY AND

HYPERKALEMIA, AND PRECAUTIONS; GERIATRIC USE).

GERIATRIC PATIENTS

STUDIES INDICATE THAT ALTHOUGH TOTAL PLASMA CONCENTRATION OF

NAPROXEN IS UNCHANGED, THE UNBOUND PLASMA FRACTION OF NAPROXEN IS

INCREASED IN THE ELDERLY. CAUTION IS ADVISED WHEN HIGH DOSES ARE REQUIRED

AND SOME ADJUSTMENT OF DOSAGE MAY BE REQUIRED IN ELDERLY PATIENTS. AS

WITH OTHER DRUGS USED IN THE ELDERLY, IT IS PRUDENT TO USE THE LOWEST

EFFECTIVE DOSE.

PATIENTS WITH MODERATE TO SEVERE RENAL IMPAIRMENT

NAPROXEN-CONTAINING PRODUCTS ARE NOT RECOMMENDED FOR USE IN PATIENTS

WITH MODERATE TO SEVERE AND SEVERE RENAL IMPAIRMENT (CREATININE

CLEARANCE < 30 ML/MIN) (SEE WARNINGS: RENAL EFFECTS).

RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS

THE RECOMMENDED DOSE IS 250 MG, 375 MG, OR 500 MG TWICE DAILY. DURING LONG-

TERM ADMINISTRATION, THE DOSE OF NAPROXEN MAY BE ADJUSTED UP OR DOWN

DEPENDING ON THE CLINICAL RESPONSE OF THE PATIENT. A LOWER DAILY DOSE MAY

SUFFICE FOR LONG-TERM ADMINISTRATION. THE MORNING AND EVENING DOSES DO

NOT HAVE TO BE EQUAL IN SIZE AND THE ADMINISTRATION OF THE DRUG MORE

FREQUENTLY THAN TWICE DAILY IS NOT NECESSARY. IN PATIENTS WHO TOLERATE

LOWER DOSES WELL, THE DOSE MAY BE INCREASED TO NAPROXEN 1500 MG/DAY FOR

LIMITED PERIODS OF UP TO 6 MONTHS WHEN A HIGHER LEVEL OF ANTI-

INFLAMMATORY/ANALGESIC ACTIVITY IS REQUIRED. WHEN TREATING SUCH

PATIENTS WITH NAPROXEN 1500 MG/DAY, THE PHYSICIAN SHOULD OBSERVE

SUFFICIENT INCREASED CLINICAL BENEFITS TO OFFSET THE POTENTIAL INCREASED

RISK. THE MORNING AND EVENING DOSES DO NOT HAVE TO BE EQUAL IN SIZE AND

ADMINISTRATION OF THE DRUG MORE FREQUENTLY THAN TWICE DAILY DOES NOT

GENERALLY MAKE A DIFFERENCE IN RESPONSE (SEE CLINICAL PHARMACOLOGY).

JUVENILE ARTHRITIS

NAPROXEN TABLETS MAY NOT ALLOW FOR THE FLEXIBLE DOSE TITRATION NEEDED

IN PEDIATRIC PATIENTS WITH JUVENILE ARTHRITIS. A LIQUID FORMULATION MAY BE

MORE APPROPRIATE. IN PEDIATRIC PATIENTS, DOSES OF 5 MG/KG/DAY PRODUCED

PLASMA LEVELS OF NAPROXEN SIMILAR TO THOSE SEEN IN ADULTS TAKING 500 MG

OF NAPROXEN (SEE CLINICAL PHARMACOLOGY). THE RECOMMENDED TOTAL DAILY

DOSE OF NAPROXEN IS APPROXIMATELY 10 MG/KG GIVEN IN 2 DIVIDED DOSES. ONE-

HALF OF THE 250 MG TABLET WILL BE NEEDED FOR DOSING LOWER-WEIGHT

CHILDREN. DOSING WITH NAPROXEN TABLETS IS NOT APPROPRIATE FOR CHILDREN

WEIGHING LESS THAN 25 KILOGRAMS. THE RECOMMENDED TOTAL DAILY DOSE OF

NAPROXEN IS APPROXIMATELY 10 MG/KG GIVEN IN 2 DIVIDED DOSES (I.E., 5 MG/KG

GIVEN TWICE A DAY). NAPROXEN TABLETS ARE NOT WELL SUITED TO THIS DOSAGE

SO USE OF NAPROXEN ORAL SUSPENSION IS RECOMMENDED FOR THIS INDICATION.

MANAGEMENT OF PAIN, PRIMARY DYSMENORRHEA, AND ACUTE TENDONITIS AND

BURSITIS

BECAUSE THE SODIUM SALT OF NAPROXEN IS MORE RAPIDLY ABSORBED, NAPROXEN

SODIUM IS RECOMMENDED FOR THE MANAGEMENT OF ACUTE PAINFUL CONDITIONS

WHEN PROMPT ONSET OF PAIN RELIEF IS DESIRED. NAPROXEN MAY ALSO BE USED.

THE RECOMMENDED STARTING DOSE OF NAPROXEN IS 500 MG, FOLLOWED BY 500 MG

EVERY 12 HOURS OR 250 MG EVERY 6 TO 8 HOURS AS REQUIRED. THE INITIAL TOTAL

DAILY DOSE SHOULD NOT EXCEED 1250 MG OF NAPROXEN.

ACUTE GOUT

THE RECOMMENDED STARTING DOSE IS 750 MG OF NAPROXEN FOLLOWED BY 250 MG

EVERY 8 HOURS UNTIL THE ATTACK HAS SUBSIDED.

MED GUIDE FOR NAPROXEN TABLETS USP 250 MG 375 MG 500 MG

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Non-Steroidal Anti-

Inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:

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

Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft

(CABG).”

Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may

have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth

to the stomach), stomach and intestines:

o any time during use

o without warning symptoms

o that may cause death

The risk of getting an ulcer or bleeding increases with:

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 older age

o longer use of NSAIDs o poor health

o smoking o advanced liver disease

o drinking alcohol o bleeding problems

NSAIDs should only be used:

o exactly as prescribed

o at the lowest dose possible for your treatment

o for the shortest time needed

What are NSAIDs?

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.

Who should not take NSAIDs?

Do not take NSAIDs:

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.

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if

you:

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. You should not take NSAIDs after 29 weeks of pregnancy.

are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all of the medicines you take, including prescription or over-the-

counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with

each other and cause serious side effects. Do not start taking any new medicine without talking to your

healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about medicines called Nonsteroidal Anti-

inflammatory Drugs (NSAIDs)"?

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

Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea,

vomiting, and dizziness.

Get emergency help right away if you have any of the following symptoms:

shortness of breath or trouble breathing

chest pain

weakness in one part or side of your body

slurred speech

swelling of the face or throat

Stop taking your NSAID and call your healthcare provider right away if you get any of the following

symptoms:

nausea

more tired or weaker than usual

diarrhea

itching

your skin or eyes look yellow

indigestion or stomach pain

flu-like symptoms

vomit blood

there is blood in your bowel movement or it is black and sticky like tar

unusual weight gain

skin rash or blisters with fever

swelling of the arms and legs, hands and feet

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

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 Marksans at 1-877-376-4271 and/orFDA at 1-800-FDA-1088.

Other information about 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 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.

General information about the safe and effective use of NSAIDs

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.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your

pharmacist or healthcare provider for information about NSAIDs that is written for health

professionals.

Manufactured for:

Time-Cap Labs, Inc.

7 Michael Avenue,

Farmingdale,

NY 11735, USA

Manufactured by:

Marksans Pharma Ltd.

Plot No. L-82, L-83,

Verna Indl. Estate,

Verna, GOA - 403722, India.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: October 2017

618R NAPROXEN 500 MG 100 COUNT

NAPROXEN

naproxen tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 8 0 71-49 9 5(NDC:49 48 3-6 19 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

NAPRO XEN (UNII: 57Y76 R9 ATQ) (NAPROXEN - UNII:57Y76 R9 ATQ)

NAPROXEN

250 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

Product Characteristics

Color

white

S core

2 pieces

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 71-49 9 5-2

20 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/26 /20 19

NuCare Pharmaceuticals,Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 1416

0 7/0 6 /20 16

Labeler -

NuCare Pharmaceuticals,Inc. (010632300)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare Pharmaceuticals,Inc.

0 10 6 3230 0

re pa c k(6 8 0 71-49 9 5)

Revised: 7/2019

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