País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1)
Preferred Pharmaceuticals Inc.
Diclofenac Sodium
Diclofenac Sodium 16.05 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium topical solution is contraindicated in the following patients: Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation. Risk Summary Use of NSAIDs, including diclofenac, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including diclofenac, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of diclofenac sodium topical solution in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregna
Diclofenac sodium topical solution 1.5% w/w is supplied as a clear, colorless to yellow solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white opaque low density polyethylene bottle with a white linear low density polyethylene valve seal dispensing cap. NDC Number & Size 150 mL bottle NDC # 60505-0399-5 Storage Store at room temperature 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature]. Keep product stored upright at all times.
Abbreviated New Drug Application
DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION Preferred Pharmaceuticals Inc. ---------- Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: 1. Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: 1. with increasing doses of NSAIDs 2. 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. 1. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: 1. anytime during use 2. without warning symptoms 3. that may cause death The risk of getting an ulcer or bleeding increases with: 1. past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs 2. taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" 3. increasing doses of NSAIDs 4. longer use of NSAIDs 5. smoking 6. drinking alcohol 7. older age 8. poor health 9. advanced liver disease 10. bleeding problems NSAIDs should only be used: 1. exactly as prescribed 2. at the lowest dose possible for your treatment 3. 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: 1. if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. 2. right before or after heart bypass surgery. Before taking NSAIDS, tell your healthcare provider about all of Leer el documento completo
DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION PREFERRED PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DICLOFENAC SODIUM TOPICAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM TOPICAL SOLUTION 1.5% W/W, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1988 WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _ 4. 5. 6. RECENT MAJOR CHANGES Boxed Warning 5/2016 Warnings and Precautions, Cardiovascular Thrombotic Events (5.1) 5/2016 Warnings and Precautions, Heart Failure and Edema (5.5) 5/2016 INDICATIONS AND USAGE Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). (1) DOSAGE AND ADMINISTRATION 9. 10. 11. 12. 13. 14. 15. 16. DOSAGE FORMS AND STRENGTHS • Diclofenac sodium topical solution 1.5% w/w (3) CONTRAINDICATIONS • Known hypersensitivity to diclofenac or any components of the drug product. (4) • History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. (4) • In the setting of CABG surgery (4) WARNINGS AND PRECAUTIONS 13. 14. 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) DICLOFENAC SODIUM TOPICAL SOLUTION 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 Leer el documento completo