Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1), MISOPROSTOL (UNII: 0E43V0BB57) (MISOPROSTOL - UNII:0E43V0BB57)
Greenstone LLC
DICLOFENAC SODIUM
DICLOFENAC SODIUM 50 mg
ORAL
PRESCRIPTION DRUG
Diclofenac sodium/misoprostol is 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/misoprostol is contraindicated in the following patients: Risk Summary Diclofenac sodium/misoprostol is contraindicated in pregnant women [see Contraindications (4)] . If a woman becomes pregnant while taking diclofenac sodium/misoprostol, discontinue the drug and advise the woman of the potential risks to her and to a fetus. There are no adequate and well-controlled studies of diclofenac sodium/misoprostol in pregnant women; however, there is information available about the active drug components of diclofenac sodium/misoprostol, diclofenac sodium and misoprostol. Administration of misoprostol to pregnan
Diclofenac sodium and misoprostol delayed-release tablets are supplied as: The dosage strengths are supplied in: Diclofenac sodium/misoprostol 50 50 mg diclofenac sodium and 200 mcg misoprostol 59762-0028-1 bottle of 60 59762-0028-2 bottle of 90 Diclofenac sodium/misoprostol 75 75 mg diclofenac sodium and 200 mcg misoprostol 59762-0029-1 bottle of 60 Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
New Drug Application Authorized Generic
Greenstone LLC ---------- MEDICATION GUIDE MEDICATION GUIDE FOR DICLOFENAC SODIUM/MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS) FOR ORAL USE What is the most important information I should know about diclofenac sodium/misoprostol? Diclofenac sodium/misoprostol contains 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/misoprostol if you are pregnant. • Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with diclofenac sodium/misoprostol. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with diclofenac sodium/misoprostol. Females who are able to become pregnant should use an effective form of birth control (contraception) during treatment with diclofenac sodium/misoprostol. 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: o with increasing doses of NSAIDs o 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. • Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: o anytime during use MEDICA read_full_document
DICLOFENAC SODIUM AND MISOPROSTOL- DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED GREENSTONE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DICLOFENAC SODIUM/MISOPROSTOL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DICLOFENAC SODIUM/MISOPROSTOL. DICLOFENAC SODIUM/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._ • • • • • INDICATIONS AND USAGE Diclofenac sodium/misoprostol is a combination of diclofenac sodium, a non‑steroidal anti‑inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for the treatment of 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. (1) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Delayed-release tablets: • • CONTRAINDICATIONS ADMINISTRATION OF MISOPROSTOL, A COMPONENT OF DICLOFENAC SODIUM/MISOPROSTOL, 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/MISOPROSTOL IS CONTRAINDICATED IN PREGNANCY AND IS 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/MISOPROSTOL IS 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, A read_full_document