Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
OXAPROZIN (UNII: MHJ80W9LRB) (OXAPROZIN - UNII:MHJ80W9LRB)
PD-Rx Pharmaceuticals, Inc.
OXAPROZIN
OXAPROZIN 600 mg
ORAL
PRESCRIPTION DRUG
DAYPRO is indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis - For relief of the signs and symptoms of juvenile rheumatoid arthritis DAYPRO is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin or any components of the drug product [ see Warnings and Precautions (5.7, 5.9) ] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions (5.7, 5.8) ] - In the setting of CABG surgery [ see Warnings and Precautions (5.1) ] Risk Summary Use of NSAIDs, including DAYPRO, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfun
DAYPRO (oxaprozin) 600 mg caplets are white, capsule-shaped, scored, film-coated, with DAYPRO debossed on one side and 1381 on the other side, supplied as: Storage Keep bottles tightly closed. Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Protect the unit dose from light.
New Drug Application
PD-Rx Pharmaceuticals, Inc. ---------- Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: April 2021 What is the most important information I should know about medicines called Nonsteroidal 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: • with increasing doses of NSAIDs • 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: • anytime during use • without warning symptoms • that may cause death • The risk of getting an ulcer or bleeding increases with: • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs • taking medicines called "corticosteroids", "antiplatelet drugs", "anticoagulants", "SSRIs", "SNRIs" • increasing doses of NSAIDs • longer use of NSAIDs • smoking • drinking alcohol • older age • poor health • advanced liver disease • bleeding problems • NSAIDs should only be used: • exactly as prescribed • at the lowest dose possible for your treatment • 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: Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) • if you have had an asthma attack, hives, or oth Lees het volledige document
DAYPRO- OXAPROZIN TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DAYPRO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DAYPRO. DAYPRO (OXAPROZIN) CAPLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1992 WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND STROKE, WHICH CAN BE FATAL. THIS RISK MAY OCCUR EARLY IN TREATMENT AND MAY INCREASE WITH DURATION OF USE ( 5.1) DAYPRO IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY ( 4, 5.1) NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI) ADVERSE EVENTS INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF THE STOMACH OR INTESTINES, WHICH CAN BE FATAL. THESE EVENTS CAN OCCUR AT ANY TIME DURING USE AND WITHOUT WARNING SYMPTOMS. ELDERLY PATIENTS AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS ( 5.2) RECENT MAJOR CHANGES Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) ( 5.10) 4/2021 Warnings and Precautions, Fetal Toxicity ( 5.11) 4/2021 INDICATIONS AND USAGE DAYPRO is a non-steroidal anti-inflammatory drug indicated for: Relief of signs and symptoms of Osteoarthritis (OA) ( 1) Relief of signs and symptoms of Rheumatoid Arthritis (RA) ( 1) Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) ( 1) DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals ( 2.1) OA: 1200 mg (two 600 mg caplets) given orally once a day ( 2.2, 2.5, 14.1) RA: 1200 mg (two 600 mg caplets) given orally once a day ( 2.3, 2.5, 14.2) JRA: 600 mg once daily in patients 22–31 kg. 900 mg once daily in patients 32–54 kg Lees het volledige document