NAPROXEN tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

NuCare Pharmaceuticals,Inc.

INN (International Name):

NAPROXEN

Sammensætning:

NAPROXEN 500 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 oversigt:

NAPROXEN TABLETS 500 MG : WHITE TO OFF-WHITE, CAPSULE-SHAPED TABLETS WITH “140” DEBOSSED ON ONE SIDE AND SCORED ON OTHER SIDE. NDC 68071-4006-1 Bottles of 10 NDC 68071-4006-7 Bottles of 14 NDC 68071-4006-5 Bottles of 15 NDC 68071-4006-2 Bottles of 20 NDC 68071-4006-3 Bottles of 30 NDC 68071-4006-4 Bottles of 40 NDC 68071-4006-6 Bottles of 60 NDC 68071-4006-9 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

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

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).
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

Produktets egenskaber

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
500 MG: WHITE TO OFF-WHITE, CAPSULE-SHAPED TABLETS WITH “140”
DEBOSSED ON
ONE SIDE AND SCORED ON
OTHER SIDE.
NDC 68071-4006-1 Bottles of 10
NDC 68071-4006-7 Bottles of 14
NDC 68071-4006-5 Bottles of 15
NDC 68071-4006-2 Bottles of 20
NDC 68071-4006-3 Bottles of 30
NDC 68071-4006-4 Bottles of 40
NDC 68071-4006-6 Bottles of 60
NDC 68071-4006-9 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
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 DIS