Label: DICLOFENAC SODIUM AND MISOPROSTOL tablet, delayed release

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 2, 2022

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    Diclofenac Sodium and Misoprostol Delayed-Release Tablets, USP - These highlights do not include all the information needed to use DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS safely ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH
    DEFECTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

    DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS CONTAIN DICLOFENAC SODIUM AND MISOPROSTOL. ADMINISTRATION OF MISOPROSTOL TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY. DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS SHOULD NOT BE TAKEN BY PREGNANT WOMEN [see Contraindications (4), Warnings and Precautions (5.10), and Use in Specific Populations (8.1)].  

    PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. Diclofenac sodium and misoprostol delayed-release tablets 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 and misoprostol delayed-release tablets may be prescribed if the patient:
    ● has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
    ● 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 and misoprostol delayed-release tablets only on the second or third day of the next normal menstrual period [see Use in Specific Populations (8.3)].  

    Cardiovascular Thrombotic Events
    ● Nonsteroidal anti-inflammatory drugs (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 [see Warnings and Precautions (5.1)].
    ● Diclofenac sodium and misoprostol is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4), and Warnings and Precautions (5.1)].  

    Gastrointestinal Bleeding, Ulceration, and Perforation
    ● 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 [see Warnings and Precautions (5.2)].

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  • 1 INDICATIONS AND USAGE
    Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing ...
  • 2 DOSAGE AND ADMINISTRATION
    Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Diclofenac sodium and misoprostol delayed-release tablets, USP: 50 mg/0.2 mg tablet is white to off white, round, biconvex tablets, plain on one side and debossed with “ 0397” on the ...
  • 4 CONTRAINDICATIONS
    Diclofenac sodium and misoprostol is contraindicated in the following patients: ● Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Cardiovascular Thrombotic Events - Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events - [see Warnings and Precautions (5.1)] GI ...
  • 7 DRUG INTERACTIONS
    See Table 1 for clinically significant drug interactions with diclofenac/misoprostol. Table 1: Clinically Significant Drug Interactions with Diclofenac/Misoprostol ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Diclofenac sodium and misoprostol is contraindicated in pregnant women - [see Contraindications (4)]. There are no adequate and well-controlled ...
  • 10 OVERDOSAGE
    The toxic dose of diclofenac sodium and misoprostol has not been determined. However, signs of overdosage from the components of the product have been described. Diclofenac - Symptoms following ...
  • 11 DESCRIPTION
    Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Diclofenac/misoprostol is a combination product containing diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Long-term animal studies to evaluate the potential for carcinogenesis and animal studies to evaluate the effects on ...
  • 14 CLINICAL STUDIES
    Osteoarthritis - Diclofenac sodium, as a single ingredient or in combination with misoprostol, has been shown to be effective in the management of the signs and symptoms of ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied in dosage strengths of either 50 mg diclofenac sodium/0.2 mg misoprostol or 75 mg diclofenac sodium/0.2 mg misoprostol ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling ( Medication Guide). Inform patients, families, or their caregivers of the following information before initiating therapy ...
  • MEDICATION GUIDE
    Medication Guide for - Diclofenac Sodium (dye kloe’ fen ak soe’ dee um) and Misoprostol (mye’ soe pros’ tol) Delayed-Release Tablets - A combination of diclofenac a Nonsteroidal ...
  • PRINCIPAL DISPLAY PANEL
    AVKARE - NDC 42291-232-90 - Diclofenac Sodium - and Misoprostol - Delayed-Release Tablets, USP - 50 mg/0.2 mg ...
  • PRINCIPAL DISPLAY PANEL
    AVKARE - NDC 42291-233-60 - Diclofenac Sodium - and Misoprostol - Delayed-Release Tablets, USP - 75 mg/0.2 mg - 60 Tablets ...
  • INGREDIENTS AND APPEARANCE
    Product Information