HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS |
Boxed Warning | 7/2020 |
INDICATIONS AND USAGEDiclofenac 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 patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications (1)
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 patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications (1)
DOSAGE AND ADMINISTRATION- Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals (2)
- Osteoarthritis: 100 mg to 150 mg diclofenac and 400 mcg to 600 mcg misoprostol per day, divided for administration two or three times a day. Dose of diclofenac higher than 150 mg/day is not recommended (2)
- Rheumatoid Arthritis: 100 mg to 200 mg diclofenac and 400 mcg to 800 mcg misoprostol per day, divided for administration two, three or four times a day. Dose of diclofenac higher than 225 mg/day is not recommended (2)
- Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals (2)
- Osteoarthritis: 100 mg to 150 mg diclofenac and 400 mcg to 600 mcg misoprostol per day, divided for administration two or three times a day. Dose of diclofenac higher than 150 mg/day is not recommended (2)
- Rheumatoid Arthritis: 100 mg to 200 mg diclofenac and 400 mcg to 800 mcg misoprostol per day, divided for administration two, three or four times a day. Dose of diclofenac higher than 225 mg/day is not recommended (2)
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS- Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop (5.3)
- Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (5.4, 7)
- Heart Failure and Edema: Avoid use of diclofenac sodium/misoprostol in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5)
- Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of diclofenac sodium/misoprostol in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function (5.6)
- Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs (5.7)
- Exacerbation of Asthma Related to Aspirin Sensitivity: Diclofenac sodium/misoprostol is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) (5.8)
- Serious Skin Reactions: Discontinue diclofenac sodium/misoprostol at first appearance of skin rash or other signs of hypersensitivity (5.9)
- Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnancy. Diclofenac may cause premature closure of the fetal ductus arteriosus (5.10, 8.1)
- Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia (5.11, 7)
- Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop (5.3)
- Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (5.4, 7)
- Heart Failure and Edema: Avoid use of diclofenac sodium/misoprostol in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5)
- Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of diclofenac sodium/misoprostol in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function (5.6)
- Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs (5.7)
- Exacerbation of Asthma Related to Aspirin Sensitivity: Diclofenac sodium/misoprostol is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) (5.8)
- Serious Skin Reactions: Discontinue diclofenac sodium/misoprostol at first appearance of skin rash or other signs of hypersensitivity (5.9)
- Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnancy. Diclofenac may cause premature closure of the fetal ductus arteriosus (5.10, 8.1)
- Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia (5.11, 7)
ADVERSE REACTIONSMost common adverse reactions (> 2%) are: abdominal pain, diarrhea, dyspepsia, nausea, flatulence, gastritis, vomiting, constipation, headache, dizziness, alanine aminotransferase increased, hematocrit decreased (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Most common adverse reactions (> 2%) are: abdominal pain, diarrhea, dyspepsia, nausea, flatulence, gastritis, vomiting, constipation, headache, dizziness, alanine aminotransferase increased, hematocrit decreased (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONSSee full prescribing information for a list of clinically important drug interactions (7)
See full prescribing information for a list of clinically important drug interactions (7)
USE IN SPECIFIC POPULATIONSInfertility: NSAIDs are associated with reversible infertility. Consider withdrawal of diclofenac sodium/misoprostol in women who have difficulties conceiving (8.3)
Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of diclofenac sodium/misoprostol in women who have difficulties conceiving (8.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 9/2020