Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1), MISOPROSTOL (UNII: 0E43V0BB57) (MISOPROSTOL - UNII:0E43V0BB57)
Actavis Pharma, Inc.
DICLOFENAC SODIUM
DICLOFENAC SODIUM 50 mg
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 adult 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 (5.3) ]. Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in the following patients: - Pregnancy. Use of misoprostol, a component of diclofenac sodium and misoprostol delayed-release tablets, during pregnancy can result in maternal and fetal harm, including uterine rupture, abortion, premature birth, or birth defects [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] - In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.2) ] - Active gastrointestinal bleeding [see Warnings and Precautions (5.3)] - History
Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied as: The dosage strengths are supplied in: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
Actavis Pharma, Inc. ---------- MEDICATION GUIDE Diclofenac Sodium (dye kloe' fen ak soe' dee um) and Misoprostol (mye'' soe pros' tol) Delayed-Release Tablets for oral use 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 uterus to tear (uterine rupture), abortion, premature birth, or birth defects. 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. • Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with diclofenac sodium and misoprostol delayed-release tablets. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with diclofenac sodium and misoprostol delayed-release tablets. Females who are able to become pregnant should use an effective form of birth control (contraception) during treatment with diclofenac sodium and misoprostol delayed-release tablets. 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. Lesen Sie das vollständige Dokument
DICLOFENAC SODIUM AND MISOPROSTOL- DICLOFENAC SODIUM AND MISOPROSTOL TABLET, DELAYED RELEASE ACTAVIS PHARMA, INC. ---------- 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; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ ADMINISTRATION OF MISOPROSTOL, A COMPONENT OF DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS, TO PREGNANT WOMEN CAN CAUSE UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS OCCURRED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR AN ABORTION. (4, 5.1, 8.1) DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS ARE CONTRAINDICATED IN PREGNANCY AND ARE NOT RECOMMENDED IN WOMEN OF CHILDBEARING POTENTIAL. PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. (5.1, 8.3) INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND STROKE, WHICH CAN BE FATAL. (5.2) DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS ARE CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. (4, 5.2) INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI) ADVERSE EVENTS INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF THE STOMACH OR INTESTINES, WHICH CAN BE FATAL AND CAN OCCUR AT ANY TIME AND WITHOUT WARNING SYMPTOMS. ELDERLY PATIENTS AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI BLEEDING ARE AT GREATER RISK. (5.3) INDICATIONS AND USAGE Diclofenac sodium and misoprostol delayed-release tablets are a combination of diclofenac sodium, a non-steroidal Lesen Sie das vollständige Dokument