ARTHROTEC® Highlights

(misoprostol, diclofenac sodium)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS

See full prescribing information for complete boxed warning.

•
Administration of misoprostol, a component of ARTHROTEC, 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)
•
ARTHROTEC 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)
•
ARTHROTEC 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, 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

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 adult 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 the shortest duration consistent with individual patient treatment goals. (2.1)
•
Osteoarthritis: The recommended dosage for maximal GI protection is one tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) three times daily. A dosage of diclofenac higher than 150 mg/day is not recommended. (2.2)
•
Rheumatoid Arthritis: The recommended dosage for maximal GI protection is one tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) three or four times daily A dosage of diclofenac higher than 200 mg/day is not recommended. (2.3)
•
For dosage modifications due to intolerance, see the full Prescribing Information. (2.2, 2.3)

DOSAGE FORMS AND STRENGTHS

Delayed-release tablets:

•
50 mg diclofenac sodium and 200 mcg misoprostol (3)
•
75 mg diclofenac sodium and 200 mcg misoprostol (3)

CONTRAINDICATIONS

•
Pregnancy (4)
•
In the setting of CABG surgery (4)
•
Active gastrointestinal bleeding (4)
•
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
•
Known hypersensitivity to diclofenac sodium, misoprostol, or any components of the drug product (4)

WARNINGS AND PRECAUTIONS

•
Embryo-Fetal Toxicity with NSAIDs: Use of NSAIDs, including diclofenac in women at about 20 weeks gestation and later in pregnancy may cause oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. (4, 5.1, 8.1)
•
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. (5.4)
•
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. (5.5, 7)
•
Heart Failure and Edema: Avoid in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. (5.6)
•
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. (5.7)
•
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. (5.8)
•
Exacerbation of Asthma Related to Aspirin Sensitivity: Contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). (5.9)
•
Serious Skin Reactions: Discontinue at first appearance of skin rash or other signs of hypersensitivity. (5.10)
•
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically. (5.11)
•
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. (5.12, 7)

ADVERSE REACTIONS

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 Inc.at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

See full prescribing information for a list of clinically important drug interactions. (7)

USE IN SPECIFIC POPULATIONS

•
Reversible Infertility: Consider withdrawal in women who have difficulties conceiving. (8.3)
•
Geriatric Patients: Avoid use in patients with cardiovascular and/or renal risk factors. (8.5)
•
Renal Impairment: Avoid use in patients with advanced renal disease. (8.6)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 12/2022

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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; SERIOUS CARDIOVASCULAR EVENTS; AND SERIOUS GASTROINTESTINAL EVENTS

See full prescribing information for complete boxed warning.

•
Administration of misoprostol, a component of ARTHROTEC, 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)
•
ARTHROTEC 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)
•
ARTHROTEC 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, 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

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 adult 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 the shortest duration consistent with individual patient treatment goals. (2.1)
•
Osteoarthritis: The recommended dosage for maximal GI protection is one tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) three times daily. A dosage of diclofenac higher than 150 mg/day is not recommended. (2.2)
•
Rheumatoid Arthritis: The recommended dosage for maximal GI protection is one tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) three or four times daily A dosage of diclofenac higher than 200 mg/day is not recommended. (2.3)
•
For dosage modifications due to intolerance, see the full Prescribing Information. (2.2, 2.3)

DOSAGE FORMS AND STRENGTHS

Delayed-release tablets:

•
50 mg diclofenac sodium and 200 mcg misoprostol (3)
•
75 mg diclofenac sodium and 200 mcg misoprostol (3)

CONTRAINDICATIONS

•
Pregnancy (4)
•
In the setting of CABG surgery (4)
•
Active gastrointestinal bleeding (4)
•
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
•
Known hypersensitivity to diclofenac sodium, misoprostol, or any components of the drug product (4)

WARNINGS AND PRECAUTIONS

•
Embryo-Fetal Toxicity with NSAIDs: Use of NSAIDs, including diclofenac in women at about 20 weeks gestation and later in pregnancy may cause oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus. (4, 5.1, 8.1)
•
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. (5.4)
•
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. (5.5, 7)
•
Heart Failure and Edema: Avoid in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. (5.6)
•
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. (5.7)
•
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. (5.8)
•
Exacerbation of Asthma Related to Aspirin Sensitivity: Contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). (5.9)
•
Serious Skin Reactions: Discontinue at first appearance of skin rash or other signs of hypersensitivity. (5.10)
•
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically. (5.11)
•
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. (5.12, 7)

ADVERSE REACTIONS

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 Inc.at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

See full prescribing information for a list of clinically important drug interactions. (7)

USE IN SPECIFIC POPULATIONS

•
Reversible Infertility: Consider withdrawal in women who have difficulties conceiving. (8.3)
•
Geriatric Patients: Avoid use in patients with cardiovascular and/or renal risk factors. (8.5)
•
Renal Impairment: Avoid use in patients with advanced renal disease. (8.6)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 12/2022
Medication Guide

Health Professional Information

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