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DICLOFENAC Sodium AND MISOPROSTOL Tablets (GREENSTONE LLC) Highlights

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; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

See full prescribing information for complete boxed warning.

DICLOFENAC SODIUM/MISOPROSTOL CONTAINS DICLOFENAC SODIUM AND MISOPROSTOL. ADMINISTRATION OF MISOPROSTOL TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, BIRTH DEFECTS, OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION. THE RISK OF UTERINE RUPTURE INCREASES WITH ADVANCING GESTATIONAL AGES AND WITH PRIOR UTERINE SURGERY, INCLUDING CESAREAN DELIVERY. DICLOFENAC SODIUM/MISOPROSTOL SHOULD NOT BE TAKEN BY PREGNANT WOMEN (4, 5.11, 8.1).

PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. Diclofenac sodium/misoprostol should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID. In such patients, diclofenac sodium/misoprostol may be prescribed if the patient:

  • has had a negative serum pregnancy test within 2 weeks prior to beginning therapy (8.3).
  • is capable of complying with effective contraceptive measures.
  • has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
  • will begin diclofenac sodium/misoprostol only on the second or third day of the next normal menstrual period.

Cardiovascular Thrombotic Events Risk

  • NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (5.1).
  • Diclofenac sodium/misoprostol is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (4, 5.1).

Gastrointestinal Bleeding, Ulceration, and Perforation Risk

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (5.2).

RECENT MAJOR CHANGES

Warnings and Precautions, Gastrointestinal Bleeding, Ulceration, and Perforation (5.2)8/2021
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (5.10)4/2021
Warnings and Precautions, Fetal Toxicity (5.11)4/2021

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 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: One tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) two or three times daily; or one tablet (containing 75 mg of diclofenac and 200 mcg of misoprostol) two times daily. A dosage of diclofenac higher than 150 mg/day is not recommended (2)
  • Rheumatoid Arthritis: One tablet (containing 50 mg of diclofenac and 200 mcg of misoprostol) two to four times daily; or one tablet (containing 75 mg of diclofenac and 200 mcg of misoprostol) two times daily. A dosage of diclofenac higher than 200 mg/day is not recommended (2)

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

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

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)
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue and evaluate clinically (5.10)
  • Fetal Toxicity: Use of NSAIDs, including diclofenac in women at about 30 weeks gestation and later in pregnancy may cause oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus (4, 5.11, 8.1)
  • 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 Greenstone LLC 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

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: 8/2021

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