Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Oxaprozin (UNII: MHJ80W9LRB) (oxaprozin - UNII:MHJ80W9LRB)
Dr. Reddy's Laboratories Limited
Oxaprozin
Oxaprozin 600 mg
ORAL
PRESCRIPTION DRUG
Oxaprozin tablets are 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 Oxaprozin 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 coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)] Risk Summary Use of NSAIDs, including oxaprozin, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because
Oxaprozin tablets USP, 600 mg are yellow, oval shaped, scored, film-coated tablets debossed “C” on one side and “01|70” on the other side supplied in bottles of 100 and 500. Bottles of 100 NDC 55111-170-01 Bottles of 500 NDC 55111-170-05 Storage Keep bottles tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.
Abbreviated New Drug Application
Dr. Reddy's Laboratories Limited ---------- Medication Guide 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: • 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: • if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. • right before or after heart bypass surgery. Before taking NSAIDs, tell your heal Prečítajte si celý dokument
OXAPROZIN- OXAPROZIN TABLET, FILM COATED DR. REDDY'S LABORATORIES LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OXAPROZIN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXAPROZIN TABLETS. OXAPROZIN TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1992 _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) OXAPROZIN 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 Oxaprozin 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 tablets) given orally once a day (2.2, 2.5, 14.1) RA: 1200 mg (two 600 mg tablets) given orally once a day (2.3, 2.5, 14.2) JRA: 600 mg once daily in patients 22 to 31 kg. 900 mg once daily in patients 32 to 54 kg. 1200 mg once daily in patients ≥ 55 kg (2.4, 2 Prečítajte si celý dokument