Label: DICLOFENAC SODIUM- diclofenac sodium topical gel, 1%, gel

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

Drug Label Information

Updated September 26, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL GEL safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

      

    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 Topical Gel, 1% 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 topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. Diclofenac sodium ...
  • 2 DOSAGE AND ADMINISTRATION
    Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. 2.1 Dosing Card [See the patient Instructions ...
  • 3 DOSAGE FORM AND STRENGTH
    Diclofenac sodium topical gel, 1%
  • 4 CONTRAINDICATIONS
    Diclofenac sodium topical gel is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of ...
  • 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 Bleeding, Ulceration ...
  • 7 DRUG INTERACTIONS
    See Table 2 for clinically significant drug interactions with diclofenac. Table 2:  Clinically Significant Drug Interactions with Diclofenac - Drugs That Interfere with Hemostasis ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation  Risk Summary - Use of NSAIDs, including diclofenac sodium topical gel, during the third ...
  • 10 OVERDOSAGE
    Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care ...
  • 11 DESCRIPTION
    Diclofenac sodium topical gel, 1% is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. The chemical name is 2-[(2,6-dichlorophenyl) amino]benzene- acetic acid, monosodium salt ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium topical gel, like that of other NSAIDs, is not ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Carcinogenicity studies in mice and rats administered diclofenac sodium as a dietary constituent for 2 years at doses ...
  • 14 CLINICAL STUDIES
    14.1 Pivotal Studies in Osteoarthritis of the Superficial Joints of the Extremities - Study 1 evaluated the efficacy of diclofenac sodium topical gel for the treatment of osteoarthritis of the ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Product: 50090-7243 - NDC: 50090-7243-0 100 g in a TUBE / 1 in a CARTON
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) that accompanies each prescription dispensed. Patients, families, or their caregivers ...
  • MEDICATION GUIDE
    Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Antiinflammatory Drugs ...
  • Instructions for Use
    Diclofenac sodium topical gel, 1% Important: Use the dosing card that is inside the diclofenac sodium topical gel carton to correctly measure each dose. The dosing card is re-usable. Do not ...
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  • INGREDIENTS AND APPEARANCE
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