HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use ARTHROTEC safely and effectively. See full prescribing information for ARTHROTEC. ARTHROTEC® (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 |
Boxed Warning | 7/2020 |
INDICATIONS AND USAGEARTHROTEC 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)
ARTHROTEC 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 ARTHROTEC 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 ARTHROTEC 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: ARTHROTEC is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) (5.8)
- Serious Skin Reactions: Discontinue ARTHROTEC 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 ARTHROTEC 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 ARTHROTEC 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: ARTHROTEC is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) (5.8)
- Serious Skin Reactions: Discontinue ARTHROTEC 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 Pfizer 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 Pfizer 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 ARTHROTEC in women who have difficulties conceiving (8.3)
Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of ARTHROTEC in women who have difficulties conceiving (8.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2020