NAPROXEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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 375 MG : WHITE TO OFF-WHITE, OVAL SHAPED TABLET WITH “139” DEBOSSED ON ONE SIDE AND PLAIN ON OTHER SIDE. NDC 68071-3345-5 Bottles of 15 NDC 68071-3345-2 Bottles of 20 NDC 68071-3345-3 Bottles of 30 NDC 68071-3345-4 Bottles of 40 NDC 68071-3345-6 Bottles of 60 NDC 68071-3345-9 Bottles of 90 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

Patient Information leaflet

NAPROXEN- NAPROXEN TABLET
NuCare Pharmaceuticals,Inc.
----------
WARNINGS
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. N

Summary of Product characteristics

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
375MG: WHITE TO OFF-WHITE, OVAL SHAPED TABLET WITH “139” DEBOSSED
ON ONE
SIDE AND PLAIN ON OTHER SIDE.
NDC 68071-3345-5 Bottles of 15
NDC 68071-3345-2 Bottles of 20
NDC 68071-3345-3 Bottles of 30
NDC 68071-3345-4 Bottles of 40
NDC 68071-3345-6 Bottles of 60
NDC 68071-3345-9 Bottles of 90
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
WARNINGS
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 FACTO