Diclofenac Sodium/Misoprostol Diclofenac-Sodium-Misoprostol Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
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)] .
What should I know before taking it?
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 of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe,.
What important warnings are listed?
Uterine Rupture, Abortion, Premature Birth, and Birth Defects 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 . Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in pregnancy and not recommended in women of childbearing potential. Patients must be advised of the abortifacient property and warned not to give the drug to others . If diclofenac sodium and misoprostol delayed-release tablets are prescribed,.
How is this medication usually taken?
Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied as a uncoated tablets in dosage strengths of either 50 mg diclofenac sodium/200 mcg misoprostol or 75 mg diclofenac sodium/200 mcg misoprostol. 75 mg/200 mcg dosage strength is a white to off-white, round, biconvex uncoated tablet, debossed with “D 75 M” on one side and plain on other side.
What side effects are listed?
The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions ( 5.2)] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions ( 5.3)] Hepatotoxicity [see Warnings and Precautions ( 5.4)] Hypertension [see Warnings and Precautions ( 5.5)] Heart Failure and Edema [see Warnings and Precautions ( 5.6)] Renal Toxicity and Hyperkalemia [see Warnings and Precautions ( 5.7)] Anaphylactic Reactions [see Warnings and Precautions ( 5.8)] Serious Skin Reactions [see Warnings and Precautions ( 5.10)] Hematologic Toxicity [see Warnings and Precautions ( 5.12)]
What interactions are listed?
See Table 1 for clinically significant drug interactions with diclofenac and misoprostol. Table 1: Clinically Significant Drug Interactions with Diclofenac and Misoprostol Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d6509a1-7af8-473b-8951-c19439274379
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.