diclofenac topical (Rx)

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

AdultPediatricGeriatric

Dosage Forms & Strengths

gel

  • diclofenac sodium
  • 1% (Voltaren)
  • 3% (Solaraze)

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

Also see Administration

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

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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

            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

            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

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            Pregnancy & Lactation

            Pregnancy

            Published literature reports that use of NSAIDs after 30 weeks’ gestation increases the risk of premature closure of the fetal ductus arteriosus

            Data from observational studies regarding potential embryofetal risks of NSAID use, including diclofenac, in women in the first or second trimester of pregnancy are inconclusive

            Clinical considerations

            • Avoid use of NSAIDs in pregnant women after 30 weeks’ gestation because NSAIDs can cause premature closure of the fetal ductus arteriosus

            Lactation

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

            There are no data on the effects on the breastfed infant or the effects on milk production

            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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            Formulary

            FormularyPatient Discounts

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            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.
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            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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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.