Dosing & Uses
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
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

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
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
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.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)
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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Patient Handout
Formulary
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