Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1), Misoprostol (UNII: 0E43V0BB57) (Misoprostol - UNII:0E43V0BB57)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2)] . Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in the following patients: Risk Summary Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in pregnant women [see Contraindications (4)] . There are no adequate and well-controlled studies of diclofenac sodium and misoprostol delayed-release tablets in pregnant women; however, there is information available about the active drug components of diclofenac sodium and misoprostol delayed-release tablets, diclofenac sodium and misoprostol. Administration of misoprostol to pregnant women can cause abort
Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied as: The dosage strengths are supplied in: 50 mg diclofenac sodium and 200 mcg misoprostol 71205-865-30 71205-865-60 71205-865-90 71205-865-00 71205-865-72 71205-865-64 71205-865-55 30 60 90 100 120 240 500 75 mg diclofenac sodium and 200 mcg misoprostol 71205-866-30 71205-866-60 71205-866-90 71205-866-00 71205-866-72 71205-866-64 71205-866-55 30 60 90 100 120 240 500 Store in a dry area at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
Proficient Rx LP ---------- Medication Guide for Diclofenac Sodium and Misoprostol Delayed-Release Tablets A combination of diclofenac a Nonsteroidal Anti-inflammatory Drug (NSAID) and misoprostol a GI mucosal protective prostaglandin E1 analog What is the most important information I should know about diclofenac sodium and misoprostol delayed- release tablets? Diclofenac sodium and misoprostol delayed-release tablets contain diclofenac (a nonsteroidal anti- inflammatory drug (NSAID)) and misoprostol, and can cause abortion, premature birth, birth defects, and the uterus to tear (uterine rupture). The risk of uterine rupture increases as your pregnancy advances, if you have given birth to 5 or more children, and if you have had surgery on the uterus, such as a cesarean delivery. Do not take diclofenac sodium and misoprostol delayed-release tablets if you are pregnant. What is the most important information I should know about medicines containing 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 NSAID containing medicines right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAID containing medicines 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 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", or "SNRIs" • increasing doses of NSAIDs • longer use of NSAIDs • smoking • • older age • poor health • advanced liver disease • drinking alcohol bleeding problems NSAID containing medicines shou Belgenin tamamını okuyun
DICLOFENAC SODIUM MISOPROSTOL- DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS. DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL:1997 WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS CONTAIN DICLOFENAC SODIUM AND MISOPROSTOL. ADMINISTRATION OF MISOPROSTOL TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, BIRTH DEFECTS, OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN DELIVERY. DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS SHOULD NOT BE TAKEN BY PREGNANT WOMEN (4, 5.11, 8.1). PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS SHOULD NOT BE USED IN WOMEN OF CHILDBEARING POTENTIAL UNLESS THE PATIENT REQUIRES NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) THERAPY AND IS AT HIGH RISK OF DEVELOPING GASTRIC OR DUODENAL ULCERATION OR FOR DEVELOPING COMPLICATIONS FROM GASTRIC OR DUODENAL ULCERS ASSOCIATED WITH THE USE OF THE NSAID. IN SUCH PATIENTS, DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS MAY BE PRESCRIBED IF THE PATIENT: • • • • CARDIOVASCULAR THROMBOTIC EVENTS RISK • • GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION RISK • RECENT MAJOR CHANGES HAS HAD A NEGATIVE SERUM PREGNANCY TEST WITHI Belgenin tamamını okuyun