diclofenac topical (Rx, OTC)

Brand and Other Names:Flector Transdermal Patch, Voltaren Gel, more...Pennsaid topical solution, Solaraze Gel, Licart, Voltaren Arthritis Pain
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

gel

  • diclofenac sodium
  • 1% (Voltaren Gel, Voltaren Arthritis Pain [OTC])
  • 3% (Solaraze Gel)

patch

  • diclofenac epolamine
  • 1.3% (180mg) (Flector)

topical solution (Pennsaid)

  • diclofenac sodium
  • 1.5% (16.05mg/mL; dropper bottle)
  • 2% (20mg/pump actuation)

topical system

  • diclofenac epolamine
  • 1.3% (Licart)

Actinic Keratosis

Solaraze gel: Apply thin layer to affected skin q12hr x60-90 days

Osteoarthritis

Voltaren gel

  • Apply 2 g (upper extremities)/4 g (lower extremities) q6hr
  • Not to exceed 8 g/day to any single joint of (upper) extremities; 16 g/day to any single joint of (lower extremities)
  • Administration: Use supplied dosing card to determine amount

Pennsaid topical solution

  • Indicated for osteoarthritis of the knee
  • 1.5%: Apply 40 gtt on each painful knee QID; dispense 10 gtts at a time either directly onto knee or first into hand and then spread evenly to front, sides, and back of knee; repeat procedure until 40 gtt have been applied
  • 2%: Apply 40 mg (2 pump actuations) on each painful knee BID; dispense 40 mg at a time directly into palm of hand and then apply evenly to front, sides, and back of knee

Acute Pain

Indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions

Flector patch: 1 patch q12hr applied on most painful area

Licart topical system

  • Use lowest effective dosage for shortest duration consistent with individual patient treatment goals
  • Apply 1 topical system to the most painful area qDay

Arthritis Pain

Voltaren Arthritis Pain gel

  • Indicated for temporary relief of arthritis pain only in upper body (ie, hand, wrist, elbow) or upper body (ie, foot, ankle, knee)
  • Not for immediate pain relief
  • Dose
    • Apply to affected area(s) QID
    • Do not apply to more than 2 body areas at once
    • Measure gel using enclosed dosing card
    • Upper body area dose: 2.25-inches for each upper body area
    • Lower body area dose: 4.5-inches for each lower body area
    • May take up to 7 days to work for arthritis pain; if pain unrelieved in 7 days, discontinue
    • May use for up to 21 days unless directed by physician

Dosage Forms & Strengths

transdermal patch

  • diclofenac epolamine
  • 1.3% (180mg) (Flector)

Acute Pain

Indicated for topical treatment of acute pain due to minor strains, sprains, and contusions

<6 years

  • Safety and efficacy not established

≥6 years

  • Flector patch: 1 patch q12hr applied on most painful area
  • Use lowest effective dosage for the shortest duration consistent with individual patient treatment goals

Elderly patients are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions

Consider the benefits and potential risk of treatment

Start dose at the lower dosing range, and monitor for adverse effects

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Interactions

Interaction Checker

and diclofenac topical

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (3)

              • aminolevulinic acid oral

                aminolevulinic acid oral, diclofenac topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid administering other phototoxic drugs with aminolevulinic acid oral for 24 hr during perioperative period.

              • aminolevulinic acid topical

                diclofenac topical, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.

              • methyl aminolevulinate

                diclofenac topical, methyl aminolevulinate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.

              Monitor Closely (9)

              • axitinib

                diclofenac topical increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • deferasirox

                deferasirox, diclofenac topical. Other (see comment). Use Caution/Monitor. Comment: Combination may increase GI bleeding, ulceration and irritation. Use with caution.

              • finerenone

                diclofenac topical will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

              • ivacaftor

                diclofenac topical increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .

              • lomitapide

                diclofenac topical increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

              • midazolam intranasal

                diclofenac topical will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

              • mifepristone

                mifepristone will increase the level or effect of diclofenac topical by Other (see comment). Use Caution/Monitor. Inhibits CYP2C8/2C9; use smallest recommended doses for substrates and monitor

              • tazemetostat

                diclofenac topical will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tinidazole

                diclofenac topical will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              Minor (24)

              • aspirin

                diclofenac topical, aspirin. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • aspirin/citric acid/sodium bicarbonate

                diclofenac topical, aspirin/citric acid/sodium bicarbonate. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • celecoxib

                diclofenac topical, celecoxib. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • choline magnesium trisalicylate

                diclofenac topical, choline magnesium trisalicylate. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • diclofenac

                diclofenac topical, diclofenac. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • diflunisal

                diclofenac topical, diflunisal. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • etodolac

                diclofenac topical, etodolac. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • fenoprofen

                diclofenac topical, fenoprofen. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • ibuprofen

                diclofenac topical, ibuprofen. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • ibuprofen IV

                diclofenac topical, ibuprofen IV. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • indomethacin

                diclofenac topical, indomethacin. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • ketoprofen

                diclofenac topical, ketoprofen. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • ketorolac

                diclofenac topical, ketorolac. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • ketorolac intranasal

                diclofenac topical, ketorolac intranasal. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • meclofenamate

                diclofenac topical, meclofenamate. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • mefenamic acid

                diclofenac topical, mefenamic acid. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • meloxicam

                diclofenac topical, meloxicam. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • nabumetone

                diclofenac topical, nabumetone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • naproxen

                diclofenac topical, naproxen. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • oxaprozin

                diclofenac topical, oxaprozin. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • piroxicam

                diclofenac topical, piroxicam. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • salsalate

                diclofenac topical, salsalate. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • sulindac

                diclofenac topical, sulindac. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

              • tolmetin

                diclofenac topical, tolmetin. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Although low, there is systemic exposure to diclofenac topical; theoretically, concomitant administration with systemic NSAIDS or aspirin may result in increased NSAID adverse effects.

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              Adverse Effects

              >10%

              Dry skin (25-27%)

              Rash (20-35%)

              Contact dermatitis (19-33%)

              Pain (15-26%)

              Paresthesia (≤ 20%)

              Pruritus (≤ 52%)

              Exfoliation (6-24%)

              1-10%

              Hypertension

              Chest pain

              Skin ulcer

              Diarrhea

              Dyspepsia

              Alepesia

              Photosensitivity

              Edema

              Conjunctivitis

              Hematuria

              Asthma

              Pneumonia

              <1%

              Application site pruritus

              Other application site reactions

              Postmarketing Reports

              Dermal allergic reactions

              Photoallergic reactions

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              Warnings

              Black Box Warnings

              Cardiovascular Risk

              • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), & stroke, which can be fatal
              • Risk may increase with duration of use
              • Patients with risk factors for or existing cardiovascular disease may be at greater risk
              • NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)
              • Transdermal patch is contraindicated for use on non intact or damaged skin

              Gastrointestinal Risk

              • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
              • GI adverse events may occur at any time during use & without warning symptoms
              • Elderly patients are at greater risk for serious GI events

              Contraindications

              Hypersensitivity to diclofenac, aspirin other NSAIDs or any ingredient

              CABG perioperative period

              History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

              Flector patch: Use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds

              Cautions

              Long-term administration of NSAIDs resulted in renal papillary necrosis and other renal injury; renal toxicity also seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion

              Risks of: cardiovascular thrombotic events; GI bleeding & ulceration; hepatotoxicity (with Na-salt)

              Anemia has occurred in NSAID-treated patients

              Diclofenac associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma

              May lead to new onset or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events; coadministration with angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs

              Randomized controlled trials demonstrated an ~2-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients

              Increases in serum potassium concentration reported with use of NSAIDs, even in some patients without renal impairment; patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state

              Diclofenac may cause premature closure of the fetal ductus arteriosus; avoid use of NSAIDs in pregnant women starting at 30 weeks of gestation (third trimester) (see Pregnancy)

              Pharmacological activity of diclofenac in reducing inflammation, and possibly fever, may diminish the utility of these diagnostic signs in detecting infections

              Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically

              Even a used diclofenac contains a large amount of diclofenac epolamine (as much as 170 mg); potential therefore exists for a small child or pet to suffer serious adverse effects from chewing or ingesting a new or used drug; store and keep out of the reach of children and pets

              Avoid contact of diclofenac with eyes and mucosa

              Concomitant use of oral and topical NSAIDs may result in a higher rate of hemorrhage, more frequent abnormal creatinine, urea and hemoglobin

              NSAIDs can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and may occur without warning

              Drug reaction with eosinophilia and systemic symptoms (DRESS)

              • Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
              • Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
              • Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
              • Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately
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              Pregnancy & Lactation

              Pregnancy

              Use of NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment

              Because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy

              Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases risk of premature closure of fetal ductus arteriosus

              Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment

              Data from observational studies regarding other potential embryofetal risks of NSAID use in women in first or second trimesters of pregnancy are inconclusive

              In animal reproduction studies, drug administered orally to pregnant rats and rabbits during period of organogenesis produced embryotoxicity at approximately 3 and 7 times, respectively, the topical exposure from maximum recommended human dose (MRHD)

              In rats, increased incidences of skeletal anomalies and maternal toxicity were also observed at this dose; drug administered orally to both male and female rats prior to mating and throughout mating period, and during gestation and lactation in females produced embryotoxicity at doses approximately 3 and 7 times, respectively, the topical exposure from the MRHD (

              Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization

              In animal studies, administration of prostaglandin synthesis inhibitors resulted in increased pre-and post-implantation loss; prostaglandins also have been shown to have an important role in fetal kidney development

              In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses

              Reproductive potential

              • Based on mechanism of action, the use of prostaglandin-mediated NSAIDs may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some
              • Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin- mediated follicular rupture required for ovulation
              • Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation; consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility

              Lactation

              Data from published literature reports with oral preparations of diclofenac indicate presence of small amounts of diclofenac in human milk

              There are no data on effects on breastfed infant, or effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from the drug or from underlying maternal condition

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Decreases formation of prostaglandin by inhibiting cyclooxygenase enzymes 1 and 2; may have anti-inflammatory effects by inhibiting chemotaxis, inhibiting neutrophil aggregation/activation, and decreasing proinflammatory cytokine levels

              Absorption

              Absorption: 10% in epidermis (Solaraze gel); 6% systemic (Voltaren gel); 2-3% (topical solution)

              Peak plasma time: 4.5 hr (Solaraze); 10-14 hr (Voltaren gel); 10-20 hr (Flector Patch); 6 hr (Licart)

              Peak plasma concentration: 1.01 (Licart); 2.2-8.1 ng/mL (Flector Patch; while resting), and 2.7-7.2 ng/mL (Flector Patch; during exercise)

              AUC: 18.58 ng·hr/mL (Licart)

              Distribution

              Protein bound: >99%

              Metabolism

              Metabolites: 4'- hydroxy- (very weak pharmacological activity), 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy diclofenac

              Primarily mediated by CPY2C9 Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion

              Acylglucuronidation mediated by UGT2B7 and oxidation mediated by CPY2C8

              CY3A4 is responsible for the formation of minor metabolites, 5-hydroxy and 3’-hydroxy- diclofenac.

              Excretion

              Half-Life: 12 hr (patch)

              Excretion: Urine (~65%); bile (~35%, conjugates of unchanged diclofenac)

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              Administration

              Topical Administration

              Wash your hands after applying, handling, or removing

              Do not apply external heat and/or occlusive dressings to treated joints

              Do not apply to open wounds

              Avoid contact with eyes and mucous membranes

              Avoid exposure of the treated joint(s) to natural or artificial sunlight

              Avoid use on treated skin site with other topical products, including sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications

              Concomitant use with oral NSAIDs not evaluated, and may increase adverse NSAIDs effects

              Gel

              • Avoid showering/bathing for at least 1 hr after application; wash hands after use, unless hands are the treated joint
              • If applied to hand(s) for treatment; inform patient not to wash the treated hand(s) for at least 1 hr after the application
              • Avoid wearing of clothing or gloves for at least 10 minutes after applying gel

              Topical system or transdermal patch

              • If patch begins to peel-off, tape down edges of the topical system
              • If problems with adhesion persist, overlay topical system with a mesh netting sleeve, where appropriate (eg, to secure topical systems applied to ankles, knees, or elbows)
              • Do not apply to non-intact or damaged skin resulting from any etiology (eg, exudative dermatitis, eczema, infected lesion, burns, wounds)
              • Do not wear when bathing or showering

              Storage

              Gel: Store at 20-25°C (68-77°F)

              Transdermal patch: Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)

              Topical system

              • Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)
              • Once envelope is opened, stable up to 6 months, if stored at room temperature in the re-sealed envelope
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              diclofenac epolamine transdermal
              -
              1.3 % transdermal system
              diclofenac epolamine transdermal
              -
              1.3 % transdermal system
              diclofenac epolamine transdermal
              -
              1.3 % transdermal system
              diclofenac epolamine transdermal
              -
              1.3 % transdermal system
              Licart transdermal
              -
              1.3 % transdermal system
              Licart transdermal
              -
              1.3 % transdermal system
              Flector transdermal
              -
              1.3 % transdermal system

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              diclofenac epolamine transdermal

              DICLOFENAC - TRANSDERMAL

              (dye-KLOE-fen-ack)

              COMMON BRAND NAME(S): Flector, Licart

              WARNING: Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while using this drug but is more likely if you use it for a long time. The risk may be greater in older adults or if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not use this drug right before or after heart bypass surgery (CABG).Also, this drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while using this drug. Older adults may be at higher risk for this effect.Stop using diclofenac and get medical help right away if you notice any of these rare but serious side effects: stomach/abdominal pain that doesn't go away, black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes.

              USES: Diclofenac patches are used to relieve pain from various conditions (e.g., sprained ankle). This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

              HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using diclofenac and each time you get a refill. If you have any questions, consult your doctor or pharmacist.The patch comes in a resealable envelope. When opening the envelope for the first time, cut it open as instructed. Remove a patch from the envelope and reseal the envelope. It is important to reseal the envelope after each opening, or the remaining patches will not stick correctly.Before applying the patch, remove the clear liner. Apply the patch to the skin to cover the most painful area. Do not apply the patch on burns, cuts, or irritated skin (e.g., eczema). Use the patch as directed by your doctor. Depending on your product, the patch is usually changed every 12 or 24 hours. Follow the directions carefully. Fold the used patch in half with the sticky sides together, and discard out of reach of children and pets.If the patch begins to peel off, you may tape the edges to the skin.Do not wear the patch during bathing or showering. Take baths/showers at times that you normally change the patch.To avoid getting the medication in your eyes, nose, mouth, or vaginal area, wash your hands after handling the patch. If the medication or patch does come in contact with those areas, flush with plenty of water. Contact your doctor right away if irritation persists.Dosage is based on your medical condition and response to treatment. To reduce side effect risks (e.g., stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or use it more often than prescribed. Discuss the risks and benefits with your doctor or pharmacist.If you are using this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medicine may not work as well.Tell your doctor if your pain persists or worsens.

              SIDE EFFECTS: See also Warning section.Itching, burning, irritation, redness, or dry skin may occur at the application site. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).This drug may rarely cause serious (possibly fatal) liver problems. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin; or to other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), stomach/intestine problems (e.g., bleeding, ulcers), liver disease, poorly controlled diabetes, heart disease (e.g., history of heart attack), high blood pressure, stroke, swelling (edema, water retention), blood disorders (e.g., anemia, bleeding/clotting problems), growths in the nose (nasal polyps).Kidney problems can sometimes occur with the use of NSAID medications, including diclofenac. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.Before having surgery, tell your doctor or dentist that you are using this medication.If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Older adults may be at greater risk for stomach/intestinal bleeding, kidney problems, heart attack, and stroke while using this drug.Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.Based on information from related drugs, this medication may pass into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), cidofovir, corticosteroids (e.g., prednisone), lithium, methotrexate, "water pills" (diuretics such as furosemide).This medication may increase the risk of bleeding when used with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or ketorolac). These drugs are similar to diclofenac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

              OVERDOSE: This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as blood pressure, complete blood count, liver and kidney function tests) should be performed periodically to check for side effects. Consult your doctor for more details. Keep all doctor appointments and lab visits so your therapy can be monitored closely.

              MISSED DOSE: If you are prescribed this drug on a regular schedule (not just "as needed") and you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store patches in the envelope at room temperature. Always reseal envelope after opening. The patches expire after a certain amount of time after the envelope is first opened. Check the product packaging for more details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.