Label: DICLOFENAC SODIUM solution

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

Drug Label Information

Updated January 10, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION ...
  • 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 solution 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 solution is indicated for the treatment of the pain of osteoarthritis of the knee(s).
  • 2. DOSAGE AND ADMINISTRATION
    2.1 General Dosing Instructions - Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.2)]. For relief ...
  • 3. DOSAGE FORMS AND STRENGTHS
    Diclofenac sodium topical solution, USP: 2% w/w
  • 4. CONTRAINDICATIONS
    Diclofenac sodium topical solution is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components ...
  • 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 (CV ...
  • 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 ...
  • 7. DRUG INTERACTIONS
    See Table 3 for clinically significant drug interactions with diclofenac. Table 3: Clinically Significant Drug Interactions with Diclofenac - Drugs That Interfere with Hemostasis ...
  • 8. USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Use of NSAIDs, including diclofenac sodium topical solution, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to ...
  • 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 2% topical solution, contains diclofenac sodium, a benzeneacetic acid derivative that is a nonsteroidal anti-inflammatory drug, and is available as a clear, colorless to faintly ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium topical solution, like that of other NSAIDs, is ...
  • 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 ...
  • 14 CLINICAL STUDIES
    14.1 Study in Osteoarthritis of the Knee - Diclofenac Sodium Topical Solution - The use of diclofenac sodium topical solution for the treatment of pain of osteoarthritis of the knee was ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Diclofenac Sodium Topical Solution, USP 2% w/w, is supplied as a clear, colorless to faintly pink or orange solution containing 20 mg of diclofenac sodium per gram of solution, in a white ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following ...
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    Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs ...
  • Instructions for Use
    Diclofenac Sodium (dye kloe' fen ak soe' dee um) Topical Solution, USP 2% Read the Medication Guide that comes with diclofenac sodium topical solution first. Be sure that you read, understand ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2% w/w Container Label (112 grams Bottle)
    Rx only - NDC  72603-207-01 - Diclofenac Sodium - Topical Solution, USP - 2% w/w - FOR EXTERNAL USE ONLY - Alcohol Content (31.07% v/v) Usual dosage: Apply two pump - activations to affected ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2% w/w Container Carton Label (112 grams Bottle)
    Rx only - NDC 72603-207-01 - Diclofenac Sodium - Topical Solution, USP - 2% w/w - FOR EXTERNAL USE ONLY - Alcohol Content (31.07% v/v) Usual dosage: Apply two pump activations - to ...
  • INGREDIENTS AND APPEARANCE
    Product Information