Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)
NuCare Pharmaceuticals,Inc.
ORAL
PRESCRIPTION DRUG
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 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
Abbreviated New Drug Application
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 Baca dokumen lengkap
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 Baca dokumen lengkap