NAPROXEN tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)

Tilgjengelig fra:

NuCare Pharmaceuticals,Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

NAPROXEN- NAPROXEN TABLET
NuCare Pharmaceuticals,Inc.
----------
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 bef

Preparatomtale

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.
SOME