Label: CAPSINAC- diclofenac sodium and capsaicin kit

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

Drug Label Information

Updated August 26, 2020

If you are a consumer or patient please visit this version.

  • 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?)
    Cardiovascular Risk - Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal ...

    WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK

    Cardiovascular Risk

    • Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions (5.1)].
    • Diclofenac sodium topical solution is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4)].

    Gastrointestinal Risk

    • NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.2)].
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  • 1. INDICATIONS AND USAGE
    Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).
  • 2. DOSAGE AND ADMINISTRATION
    2.1 General Instructions - For the relief of the signs and symptoms of osteoarthritis of the knee(s), the recommended dose is 40 drops per knee, 4 times a day. Apply diclofenac sodium topical ...
  • 3. DOSAGE FORMS AND STRENGTHS
    1.5% w/w topical solution
  • 4. CONTRAINDICATIONS
    Diclofenac sodium topical solution is contraindicated in patients with a known hypersensitivity to diclofenac sodium or any other component of diclofenac sodium topical solution. Diclofenac sodium ...
  • 5. WARNINGS AND PRECAUTIONS
    5.1 Cardiovascular Thrombotic Events - Clinical trials of several oral COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular ...
  • 6. ADVERSE REACTIONS
    6.1 Clinical Studies Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of another drug cannot be directly ...
  • 7. DRUG INTERACTIONS
    Drug interactions with the use of diclofenac sodium topical solution have not been studied. The following drug interactions [sections 7.1 to 7.7] are noted for oral diclofenac sodium. 7.1 ...
  • 8. USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation. Teratogenic Effects: There are no adequate and well-controlled studies of diclofenac ...
  • 10. OVERDOSAGE
    There have been no known experiences of overdose with diclofenac sodium topical solution. Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and ...
  • 11. DESCRIPTION
    Diclofenac sodium topical solution is a clear, colorless to faintly pink-orange solution for topical application. Diclofenac sodium topical solution contains 1.5% w/w diclofenac sodium, a ...
  • 12. CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of diclofenac is similar to that of other nonsteroidal anti-inflammatory drugs. Diclofenac inhibits the enzyme, cyclooxygenase (COX), an early ...
  • 13. NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity studies in mice and rats administered diclofenac sodium, as a dietary constituent for 2 years resulted in no ...
  • 14. CLINICAL STUDIES
    14.1 Pivotal Studies in Osteoarthritis of the Knee - The use of diclofenac sodium topical solution for the treatment of the signs and symptoms of osteoarthritis of the knee was evaluated in two ...
  • 16. HOW SUPPLIED/STORAGE AND HANDLING
    Diclofenac Sodium Topical Solution is supplied as a clear, colorless to faintly pink-orange solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white high density ...
  • 17. PATIENT COUNSELING INFORMATION
    See FDA-Approved Patient Labeling (Medication Guide and Instructions for Use). 17.1 Patient/Caregiver Instructions - Inform patients of the following information before initiating therapy with ...
  • Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
    (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory ...
  • INSTRUCTIONS FOR USE
    17.11 Patient Instructions for Use - Diclofenac Sodium Topical Solution - Read the Medication Guide that comes with diclofenac sodium topical solution first. Be sure that you read, understand, and ...
  • SPL UNCLASSIFIED SECTION
    Capsaicin Cream - (Capsaicin 0.025%)
  • Active ingredient
    Capsicum Oleoresin 0.0625% (containing capsaicin 0.025%)
  • Purpose
    Topical Analgesic
  • Uses
    For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, and sprains.
  • Warnings
    For external use only - This is not a face cream. Do not apply to the face. Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. Do not apply to wounds or damaged ...
  • Directions
    Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock. Before using on children under 18 years of age, consult a physician. Apply sparingly to affected area not more than 4 ...
  • Other information
    WARNING: FLAMMABLE PRODUCT - Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.
  • Inactive ingredients
    Aloe Barbadensis Leaf Extract, Bisabolol, Carbomer, Caprylyl Glycol, Cetearyl Alcohol, Ceteareth-20, Green Tea (Camellia Sinensis) Leaf Extract, Glycerin, Methylisothiazolinone, PEG-8 ...
  • Questions or comments ?
    Call toll-free1-888-452-9975 or visit us at www.sirclelabs.com - Manufactured for: Sircle Laboratories, LLC, Madison, MS 39110
  • CAPSINAC Therapy Kit (NDC 73247-201-01)
    How Supplied: 1 unit (pack); NDC 73247-201-01 - Each kit contains: 1 - Diclofenac Sodium 1.5% Topical Solution (150ml bottle) 1 - Capsaicin 0.025% Cream (237ml bottle) *See individual products ...
  • PRINCIPAL DISPLAY PANEL - Kit Carton
    Rx Only - NDC 73247-201-01 - CAPSINAC - Therapy Kit - Diclofenac Sodium Topical Solution - (1.5% w/w, 5 fl oz/150mL) Capsaicin Cream - (Capsaicin 0.025%, 8 fl oz/237mL) TOPICAL ONLY - BODYSPHERE + MADE IN ...
  • INGREDIENTS AND APPEARANCE
    Product Information