Na Diklo

AHFS DI® Essentials™ Page 1 of 35
Diclofenac (Systemic, Local)
Introductory Information
Prototypical NSAIA;1, 2, 3, 4, 5, 6, 7, 8, 9, 189, 302, 303, 317, 318 phenylacetic acid derivative;1, 2, 3, 4, 5, 6, 7,
8, 9, 189, 262 structurally related to meclofenamate sodium and mefenamic acid.203
Class: 28:08.04.92 Other Nonsteroidal Anti-inflammatory Agents
Brands*: Arthrotec® (combination), Cataflam®, Flector®, Voltaren®
*also available generically
Generic Name: Diclofenac Potassium

CAS Number: 15307-81-0
Chemical Name: 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt
Molecular Formula: C14H11C12NO2•K
Investigational Drug Number: CGP 45840B
Synonym: Diclophenac Potassium
Generic Name: Diclofenac Sodium

CAS Number: 15307-79-6
Chemical Name: 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt
Molecular Formula: C14H11C12NO2.Na
Investigational Drug Number: GP 45840
Synonym: Diclophenac Sodium
Generic Name: Diclofenac Epolamine

CAS Number: 119623-66-4
Chemical Name: 2-[(2,6-Dichlorophenyl)amino]-benzeneacetic acid, 2-(pyrrolidin-1-yl) ethanol salt
Molecular Formula: C20H24Cl2N2O3
Boxed Warning
Cardiovascular Risk
• Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI,
stroke).1, 302, 303, 317, 318 Risk may increase with duration of use.1, 302, 303, 317, 318 Individuals with
cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.1, 302, 303,
317, 318 (See Cardiovascular Effects under Cautions.)
• Contraindicated for the treatment of pain in the setting of CABG surgery.1, 302, 303, 317, 318
GI Risk
• Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the
stomach or intestine).1, 302, 303, 317, 318 Serious GI events can occur at any time and may not be
preceded by warning signs and symptoms.1, 302, 303, 317, 318 Geriatric individuals are at greater risk
for serious GI events.1, 302, 303, 317, 318 (See GI Effects under Cautions.)
REMS:
mk:@MSITStore:D:\KULIAH\SEM%206\Pr.%20Farkin\Dafpus\AHFS%202011.chm::/84... 3/17/2023
FDA approved a REMS for diclofenac to ensure that the benefits of a drug outweigh the risks. However,
FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS
Resource Center ([Web]).
Uses
Inflammatory Diseases
Orally for symptomatic treatment of osteoarthritis,1, 81, 82, 83, 84, 85, 86, 89, 90, 107, 108, 109, 110, 111, 112,
113, 114, 121, 125, 126, 133, 274, 302, 303 rheumatoid arthritis,1, 74, 75, 76, 77, 78, 79, 80, 87, 88, 107, 115, 116, 117,
118, 119, 121, 125, 126, 129, 254, 302, 303 and ankylosing spondylitis.1, 91, 120, 121, 125, 127, 274
Orally in fixed combination with misoprostol for the symptomatic treatment of osteoarthritis and
rheumatoid arthritis in patients at high risk for developing NSAIA-induced gastric or duodenal ulcers and
in patients at high risk for developing complications from these ulcers.284
Topically (as gel) for the symptomatic treatment of osteoarthritis-related joint pain.318, 321 Used for
joints amenable to topical therapy (e.g., hands, knees); has not been evaluated on joints of the spine, hip,
or shoulder.318
Orally for management of juvenile rheumatoid arthritis .3, 128, 210
Orally for symptomatic relief of acute gouty arthritis .121, 130, 131, 132
Orally or topically for symptomatic treatment of infusion-related superficial thrombophlebitis .310, 311
Pain
Orally for relief of pain, including postoperative (e.g., orthopedic, gynecologic, oral) pain, in adults.276,
277, 278, 279, 303
Transdermally for relief of acute pain due to minor strains, sprains, and contusions.317, 319
Dysmenorrhea
Orally for symptomatic management of primary dysmenorrhea.303
Dosage and Administration
General
• Consider potential benefits and risks of diclofenac therapy as well as alternative therapies before
initiating therapy with the drug.1, 302, 303, 317
Administration
Oral Administration
Diclofenac sodium delayed-release (enteric-coated) and extended-release tablets are not recommended
for relief of acute pain3, 248 or primary dysmenorrhea1 because of slow onset of action.53, 54, 56, 57, 60, 61
Topical Administration
Diclofenac Sodium 1% Gel
Apply gel 4 times daily to the affected joint.318 Use the dosing card from the manufacturer to measure
the appropriate dose.318 Apply the gel within the oblong area of the dosing card up to the appropriate (2-
or 4-g of gel) line; then use the dosing card to apply the gel.318 Gently massage the gel into the skin;
ensure gel is applied to the entire affected joint (e.g., foot [including sole, top of foot, and toes], knee,
ankle, hand [including palm, back of hand, and fingers], elbow, wrist).318
Allow application site to dry for 10 minutes before covering treated area with clothing; wait at least 60
minutes before bathing or showering.318 Wash hands after application unless the treated joint is in the
hand.318
Do not apply to open wounds, infected or inflamed areas of skin, or areas affected with exfoliative
dermatitis; avoid contact with eyes and mucous membranes.318
Do not expose treated joint to external heat or to natural or artificial sunlight; do not use occlusive
dressings.318
Avoid application of sunscreens, cosmetics, lotions, moisturizers, insect repellents, or other topical agents
to the same site; concomitant use with other topical agents not studied.318
Diclofenac Epolamine Transdermal System

Apply transdermal system to the most painful area twice daily.317 Apply to intact skin; do not apply to
damaged skin (e.g., wounds, burns, infected areas of skin, areas affected with eczema or exudative
dermatitis).317
Wash hands after handling the system.317
Avoid contact with eyes and mucous membranes.317
Do not wear the transdermal system while bathing or showering.317
If a system should begin to peel off during the period of use, the edges of the system may be taped to the
skin.317
Dosage
Available as diclofenac potassium, diclofenac sodium, or diclofenac epolamine; dosage expressed in

terms of the salt.1, 302, 303, 317, 318
To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage
and shortest duration of therapy consistent with the patient's treatment goals.1, 302, 303, 317 Adjust dosage
based on individual requirements and response; attempt to titrate to the lowest effective dosage.1, 302, 303,
317
Commercially available diclofenac sodium enteric-coated tablets (Voltaren®), diclofenac sodium

extended-release tablets (Voltaren®-XR), and diclofenac potassium immediate-release tablets
(Cataflam®) are not necessarily bioequivalent on a mg-per-mg basis.1, 302, 303
Adults
>Osteoarthritis
Oral:
Preparation Dosage
Diclofenac potassium conventional tablets 100-150 mg daily, given as 50 mg 2 or 3 times daily303
100-150 mg daily, given as 50 mg 2 or 3 times daily or
Diclofenac sodium delayed-release tablets
75 mg twice daily1
Diclofenac sodium extended-release tablets 100 mg once daily302
Diclofenac sodium (in fixed combination with
misoprostol) 50 mg 3 times daily284a
aMay change dosage to 50 or 75 mg twice daily in patients who do not tolerate usual dosage; however,
these dosages may be less effective in preventing NSAIA-induced ulcers.284
Topical (gel): For lower extremity (i.e., knees, ankles, feet) joint pain, massage 4 g of diclofenac sodium
1% gel into the affected joint 4 times daily.318
For upper extremity (i.e., elbows, wrists, hands) joint pain, massage 2 g of diclofenac sodium 1% gel into
the affected joint 4 times daily.318
If multiple joints are treated, total daily dose applied to all joints should be ≤32 g of gel daily.318
>Rheumatoid Arthritis
Oral:
Preparation Dosage
Diclofenac potassium conventional tablets 150-200 mg daily, given as 50 mg 3 or 4 times daily303
150-200 mg daily, given as 50 mg 3 or 4 times daily or
Diclofenac sodium delayed-release tablets
75 mg twice daily1
100 mg once daily; may increase to 100 mg twice daily
Diclofenac sodium extended-release tablets 302
Diclofenac sodium (in fixed combination with

misoprostol) 50 mg 3 or 4 times daily284b
bMay change dosage to 50 or 75 mg twice daily in patients who do not tolerate usual dosage; however,
these dosages may be less effective in preventing NSAIA-induced ulcers.284
>Ankylosing Spondylitis
Oral: 100-125 mg daily (as diclofenac sodium delayed-release tablets); administer as 25 mg 4 times
daily, with 5th dose at bedtime as needed.1, 91, 125
Pain
Oral: 50 mg 3 times daily (as diclofenac potassium conventional tablets).303 Some patients may benefit
from initial dose of 100 mg (followed by 50-mg doses).303
>Topical (transdermal system)

Apply 1 transdermal system (diclofenac epolamine 1.3%) twice daily.317
Dysmenorrhea
Oral: 50 mg 3 times daily (as diclofenac potassium conventional tablets).303 Some patients may benefit
from initial dose of 100 mg (followed by 50-mg doses).303
Prescribing Limits
Adults
>Osteoarthritis
Topical (gel): Maximum total daily dose applied to all affected joints: 32 g of diclofenac sodium 1%
gel.318 Maximum 16 g of gel applied daily to any single lower extremity joint and 8 g applied daily to
any single upper extremity joint.318
Special Populations
Renal Impairment
Dosage adjustment not required.1, 3, 72, 247, 248, 302, 303
Hepatic Impairment
Reduction of oral dosage may be necessary.1, 302, 303
Cautions
Contraindications
• Known hypersensitivity to diclofenac or any ingredient in the formulation.1, 302, 303, 317, 318
• History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.1, 141,
144, 145, 146, 147, 168, 225, 302, 303, 317, 318
• Treatment of perioperative pain in the setting of CABG surgery.1, 302, 303, 317, 318
• Diclofenac sodium in fixed combination with misoprostol is contraindicated in pregnant women.284
Warnings/Precautions
Warnings
Consider potential benefits and risks of diclofenac therapy as well as alternative therapies before
initiating therapy with the drug.1, 302, 303, 317 Use lowest effective dosage and shortest duration of
therapy consistent with the patient's treatment goals.1, 302, 303, 317, 318
Cardiovascular Effects
Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI,
stroke) in certain situations.305 Several prototypical NSAIAs also have been associated with increased
risk of cardiovascular events.312, 313, 314 Current evidence suggests that use of diclofenac is associated
with increased cardiovascular risk.312, 313, 314, 316
Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular
events), and at the lowest effective dosage for the shortest duration necessary.1, 302, 303, 317, 318
Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with
increased risk of serious cardiovascular events (except immediately following CABG surgery).305
No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious
adverse cardiovascular events associated with NSAIAs.1, 302, 303, 317, 318 (See Specific Drugs under
Interactions.)
Hypertension and worsening of preexisting hypertension reported; either event may contribute to the
increased incidence of cardiovascular events.1, 302, 303, 317, 318 Use with caution in patients with
hypertension; monitor BP.1, 302, 303, 317, 318 Impaired response to certain diuretics may occur.1, 302, 303,
317, 318 (See Specific Drugs under Interactions.)
Fluid retention and edema reported.1, 302, 303, 317, 318 Caution in patients with fluid retention or heart
failure.1, 302, 303, 317, 318
GI Effects
Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms;
increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with
alcohol dependence, and those in poor general health.1, 167, 181, 187, 256, 259, 260, 267, 268, 282, 292, 300,
302, 303, 317, 318
For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding,
perforation), consider concomitant use of misoprostol;249, 254, 284, 292, 293 alternatively, consider
concomitant use of a proton-pump inhibitor (e.g., omeprazole)249, 254, 292 or use of an NSAIA that is a
selective inhibitor of COX-2 (e.g., celecoxib).249
Renal Effects
Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA
therapy.1, 302, 303, 317, 318
Potential for overt renal decompensation.1, 171, 302, 303, 317, 318 Increased risk of renal toxicity in patients
with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion,
and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.1, 160, 174, 185, 191,
284, 302, 303, 306, 315, 317, 318 (See Renal Impairment under Cautions.)
Sensitivity Reactions
Hypersensitivity Reactions
Anaphylactoid reactions (e.g., anaphylaxis, angioedema) reported.1, 302, 303, 317, 318
Immediate medical intervention and discontinuance for anaphylaxis.1, 302, 303, 317, 318
Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with
asthma.1, 302, 303, 317, 318
Dermatologic Reactions
Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal
necrolysis) reported; can occur without warning.1, 302, 303, 317, 318 Discontinue at first appearance of rash
or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).1, 302, 303, 317, 318
General Precautions
Do not use multiple diclofenac-containing preparations concomitantly.1, 302, 303 Concomitant use of
diclofenac sodium 1% gel and oral NSAIAs may increase risk of adverse effects.318
Observe the usual cautions, precautions, and contraindications associated with misoprostol therapy when
diclofenac is used in fixed combination with misoprostol.284
Hepatic Effects
Severe, sometimes fatal, reactions including jaundice, fulminant hepatitis, liver necrosis, and hepatic
failure reported rarely with diclofenac.1, 302, 303, 317, 318, 323
Elevations of serum ALT or AST reported.1, 302, 303, 317, 318, 323
Monitor for symptoms and/or signs suggesting liver dysfunction.1, 302, 303, 317, 318, 323 Obtain serum
transaminase values 4-8 weeks after initiating therapy; monitor periodically during long-term therapy.317,
318, 323 ALT (SGPT) is the recommended hepatic function marker for monitoring liver injury.317, 318, 323
Discontinue if abnormal liver function test results persist or worsen, if clinical signs and symptoms
consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash).1, 164,
255, 302, 303, 317, 318, 323
Hematologic Effects
Anemia reported rarely.1, 302, 303, 317, 318 Determine hemoglobin concentration or hematocrit in patients
receiving long-term therapy if signs or symptoms of anemia occur.1, 248, 302, 303, 317, 318
May inhibit platelet aggregation and prolong bleeding time.3, 40, 41, 42, 43, 165, 166
Precautions Specific to Diclofenac Sodium 1% Gel

Minimize or avoid exposure of treated areas to natural or artificial sunlight.318 Topical application of
diclofenac gel formulations has resulted in early onset of ultraviolet (UV) light-related skin tumors in
animal studies.318, 321 The potential effects of topical diclofenac gel on skin response to UV damage in
humans are not known.318
Application to nonintact skin may alter absorption and tolerability; apply only to intact skin.318
Avoid contact with the eyes and mucous membranes.318 If contact with the eyes occurs, thoroughly rinse
the eyes with water or saline.318 If ocular irritation persists for >1 hour, consult a clinician.318
Precautions Specific to Diclofenac Epolamine Transdermal System

Avoid contact with eyes and mucous membranes.317 If contact with the eyes occurs, thoroughly rinse the
eyes with water or saline.317 If ocular irritation persists for >1 hour, consult a clinician.317
Do not apply to nonintact or damaged skin.317
Patient should bathe or shower after removing one transdermal system and before applying a new system;
the transdermal system should not be worn during bathing or showering.317
Store and discard transdermal systems in a manner that avoids accidental exposure or ingestion by
children or pets.317
Other Precautions
Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.1, 248,
302, 303, 317, 318
May mask certain signs of infection.1, 302, 303, 317, 318
Obtain CBC and chemistry profile periodically during long-term use.1, 302, 303, 317, 318
Specific Populations
Pregnancy
Category C.1, 302, 303, 317, 318 Avoid use in third trimester because of possible premature closure of the
ductus arteriosus.1, 302, 303, 317, 318
Category X (in fixed combination with misoprostol).284 Misoprostol exhibits abortifacient activity and
can cause serious fetal harm.284
Lactation
Distributed into milk; 3 discontinue nursing or the drug.1, 302, 303, 317, 318
Pediatric Use
Safety and efficacy not established in children.1, 302, 303, 317, 318
Good results with oral diclofenac obtained in a limited number of children 3-16 years of age for the
management of juvenile rheumatoid arthritis .3, 128, 210
Geriatric Use
Oral diclofenac: Caution advised.1, 302, 303 Fatal adverse GI effects reported more frequently in geriatric
patients than younger adults.1, 302, 303, 317, 318
Diclofenac sodium 1% gel: No substantial difference in safety and efficacy in individuals ≥65 years of
age compared with younger individuals; possibility of greater sensitivity to the drug in some geriatric
individuals.318
Diclofenac epolamine transdermal system: Insufficient experience in individuals ≥65 years of age to
determine whether geriatric patients respond differently than younger individuals.317
Use diclofenac with caution because of age-related decreases in renal function.317, 318 May be useful to
monitor renal function.317, 318
Hepatic Impairment
Reduction of oral dosage may be necessary.1, 302, 303
Renal Impairment
Metabolites eliminated principally via the kidney.1, 302, 303
Use with caution in patients with renal disease.1, 302, 303, 317, 318 Use not recommended in patients with
advanced renal disease; close monitoring of renal function advised if used.1, 248, 302, 303, 304, 317, 318
Common Adverse Effects
Oral diclofenac: Abdominal pain or cramps,1, 75, 86, 93, 107, 113, 136, 302, 303 constipation,1, 75, 113, 132,
134, 136, 302 303 diarrhea,1, 84, 86, 87, 93, 95, 125, 134, 302, 303 flatulence,1, 302, 303 GI bleeding,1, 302, 303 GI
perforation, 1, 302, 303 peptic ulcer,1, 302, 303 vomiting, 1, 302, 303 dyspepsia,1, 302, 303 nausea,1, 76, 78, 84,
85, 93, 95, 96, 97, 98, 99, 109, 111, 113, 126, 129, 134, 165, 302, 303 dizziness,1, 102, 107, 113, 125, 129, 165, 302, 303
headache,1, 89, 90, 91, 93, 95, 107, 110, 113, 118, 125, 127, 129, 132, 165, 302, 303 liver function test
abnormalities,1, 116, 125, 165, 189, 209, 223, 255, 302, 303 renal function abnormalities,1, 302, 303 anemia,1,
302, 303 prolonged bleeding time,1, 302, 303 pruritus,1, 302, 303 rash,1, 302, 303 tinnitus,1, 302, 303 edema.1,
109, 125, 132, 159, 165, 302, 303
Diclofenac sodium 1% gel: Application site reactions (e.g., dermatitis).318
Diclofenac epolamine transdermal system: Application site reactions (e.g., pruritus, dermatitis), nausea,
altered taste.317
Interactions
Protein-bound Drugs
Only minimally displaces other highly protein-bound drugs from binding sites; however, may be
displaced from binding sites by other highly protein-bound drugs.51, 52, 59, 61
Specific Drugs
Drug Interaction Comments

Reduced BP response to ACE inhibitor1, 248, 302,
303, 317, 318 Monitor BP1, 248, 302, 303,
ACE inhibitors 317, 318
Possible deterioration of renal function in
individuals with renal impairment315
Reduced BP response to angiotensin II receptor
Angiotensin II antagonist315
receptor antagonists Possible deterioration of renal function in
individuals with renal impairment315
Antacids Delayed diclofenac absorption3, 189, 238

(magnesium- or
aluminum-containing)
Anticoagulants
(warfarin) Possible bleeding complications1, 302, 303, 317, 318 Caution advised1, 302, 303
Decreased peak plasma concentration and AUC of
diclofenac;22, 61, 184, 202, 302, 303 limited data
indicate that diclofenac does not inhibit antiplatelet
effect of aspirin262 Manufacturer states that
Increased risk of GI ulceration and other concomitant use not
Aspirin
complications1, 302, 303, 317, 318 recommended1, 302, 303, 317,
No consistent evidence that low-dose aspirin 318
mitigates the increased risk of serious
cardiovascular events associated with NSAIAs305,
317, 318
Possible increase in nephrotoxic effects of Caution advised1, 302, 303,

Cyclosporine
cyclosporine1, 302, 303, 318 318
Monitor for diuretic efficacy

Diuretics (furosemide, Reduced natriuretic effects1, 22, 179, 302, 303, 317,
and renal failure1, 302, 303,
thiazides) 318
317, 318
Increased plasma lithium concentrations1, 176, 188, Monitor for lithium toxicity1,
Lithium 265, 302, 303, 317, 318 302, 303, 317, 318
Severe, sometimes fatal toxicity associated with

Caution advised1, 302, 303,
Methotrexate increased plasma methotrexate concentrations175, 317, 318
307
Quinolones
(ciprofloxacin) Possible increased risk of seizures183, 197, 198
Pharmacokinetics
Absorption
Bioavailability
Well absorbed following oral administration.1, 3, 51, 52, 53, 57, 68, 189, 302, 303 Undergoes first-pass
metabolism; only 50-60% of a dose reaches systemic circulation as unchanged drug.1, 52, 53, 73, 284, 302,
303
Peak plasma concentration usually attained within about 1 hour (diclofenac potassium conventional
tablets), 2 hours (diclofenac sodium delayed-release tablets), or 5.25 hours (diclofenac sodium extended-
release tablets).1, 3, 51, 52, 302, 303, 307
Absorbed into systemic circulation following topical administration as gel or transdermal system; plasma
concentrations generally very low compared with oral administration.3, 227, 317, 318
Following application of a single diclofenac epolamine transdermal system to intact skin on the upper
arm, peak plasma concentrations occur in 10-20 hours.317
Following topical application of diclofenac sodium 1% gel, peak plasma concentrations occur in about
10-14 hours.318
Moderate exercise does not alter systemic absorption of topically applied diclofenac (transdermal system
or 1% gel).317, 318
Application of a heat patch for 15 minutes before application of the 1% gel did not affect systemic
absorption.318 Not established whether application of heat following gel application affects systemic
absorption.318
Onset
Single 50- or 100-mg doses of diclofenac potassium provide pain relief within 30 minutes.307
Duration
Pain relief lasts up to 8 hours following administration of single 50- or 100-mg doses of diclofenac
potassium.307
Food
Food delays time to reach peak plasma concentration but does not affect extent of absorption following
administration as conventional, delayed-release, or extended-release tablets.1, 302, 303
Distribution
Extent
Widely distributed in animals.3, 51, 52
Following oral administration, concentrations in synovial fluid may exceed those in plasma.1, 3, 62, 63, 64,
65, 66, 67, 68, 69, 302, 303
Plasma Protein Binding

>99%.1, 3, 51, 52, 58, 59, 66, 302, 303, 317
Elimination
Metabolism
Metabolized in the liver via hydroxylation and conjugation.1, 3, 51, 52, 68, 70, 302, 303 Some metabolites
may exhibit anti-inflammatory activity.1, 3, 22, 302, 303
Elimination Route
Excreted in urine (65%) and in feces via biliary elimination (35%) as metabolites.1, 3, 51, 55, 56, 70, 71, 302,
303
Half-life
Oral preparations: 1-2 hours.2, 53, 57, 60, 302, 303
Diclofenac epolamine transdermal system: Approximately 12 hours.317
Special Populations
In geriatric patients, pharmacokinetic profile similar to that in younger adults.307
In patients with renal impairment, plasma clearance not substantially altered,1, 3, 208, 302, 303 although
clearance of metabolites may be decreased.3, 72
Stability
Storage
Oral
Tablets
Tight containers at ≤30°C.1, 302, 303
Topical
Gel
25°C (may be exposed to 15-30°C).318 Do not freeze.318
Transdermal System
25°C (may be exposed to 15-30°C).317
Actions
• Inhibits cyclooxygenase-1 (COX-1) and COX-2.285, 286, 287, 288, 289, 290
• Pharmacologic actions similar to those of other prototypical NSAIAs;1, 3, 20, 21, 22, 23, 24, 25, 26, 189,
302, 303, 317, 318 exhibits anti-inflammatory, analgesic, and antipyretic activity.1, 3, 21, 22, 23, 189, 302,
303, 317, 318
Advice to Patients
• Importance of reading the medication guide for NSAIAs that is provided each time the drug is
dispensed.1, 302, 303, 317, 318
• Risk of serious cardiovascular events with long-term use.1, 302, 303, 317, 318
• Risk of GI bleeding and ulceration.1, 167, 181, 302, 303, 317, 318
• Risk of serious skin reactions.1, 302, 303, 317, 318 Risk of anaphylactoid and other sensitivity reactions.1,
302, 303, 317, 318
• Risk of hepatotoxicity.1, 302, 303, 317, 318

• Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea,
weakness, slurred speech) occur.1, 302, 303, 317, 318
• Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained
weight gain, or edema develops.1, 302, 303, 317, 318
• Importance of discontinuing diclofenac and contacting clinician if rash or other signs of hypersensitivity
(blisters, fever, pruritus) develop.1, 302, 303, 317, 318 Importance of seeking immediate medical
attention if an anaphylactic reaction occurs.1, 302, 303, 317, 318
• Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of
hepatotoxicity (nausea, anorexia, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness,
flu-like symptoms) occur.1, 302, 303, 317, 318
• Importance of warning patients to keep diclofenac transdermal system out of the reach of children and
pets and to safely dispose of used units.317 Importance of properly disposing of dosing cards used to
apply diclofenac gel.318

• Importance of adhering to instructions for administration of topical gel or transdermal system.317, 318
• Importance of avoiding or limiting exposure of skin treated with diclofenac gel to natural or artificial
sunlight.318
• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-
feed.1, 302, 303, 317, 318 Importance of avoiding diclofenac in late pregnancy (third trimester).1, 302, 303,
317, 318
• Importance of informing clinicians of existing or contemplated concomitant therapy, including
prescription and OTC drugs.1, 302, 303, 317, 318
• Importance of informing patients of other important precautionary information.1, 302, 303, 317, 318 (See
Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some
individuals; consult specific product labeling for details.
Diclofenac Epolamine
Routes Dosage Forms Strengths Brand Names Manufacturer
Topical Transdermal System 1.3% Flector® King
Diclofenac Potassium
Oral Tablets 50 mg* Cataflam® Novartis
Diclofenac Potassium Tablets
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary)
name
Diclofenac Sodium
Tablets, delayed-release (enteric- Diclofenac Sodium Delayed-release
Oral 25 mg*
coated) Tablets
Diclofenac Sodium Delayed-release
50 mg*
Tablets
Diclofenac Sodium Delayed-release
75 mg*
Tablets
Voltaren® Novartis
Diclofenac Sodium Extended Release
Tablets, extended-release 100 mg*
Tablets
Voltaren®-XR Novartis
Topical Gel 1% Voltaren® Novartis
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary)
name
Diclofenac Sodium Combinations
Brand
Routes Dosage Forms Strengths Manufacturer
Names
Tablets, delayed-release 50 mg diclofenac sodium enteric-coated
Oral (enteric-coated core), film- core, with 200 mcg of misoprostol outer Arthrotec® Searle
coated layer
75 mg diclofenac sodium enteric-coated
core, with 200 mcg of misoprostol outer Arthrotec® Searle
layer
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing
information was updated 10/2011. For the most current and up-to-date pricing information, please visit
www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-
order locations and health insurance copays.
Arthrotec 50 50-200MG-MCG Tablets (PFIZER U.S.): 60/$199.98 or 180/$579.96
Arthrotec 75 75-200MG-MCG Tablets (PFIZER U.S.): 60/$203.98 or 180/$579.96
Cataflam 50MG Tablets (NOVARTIS): 100/$401.99 or 300/$1,183.94
Diclofenac Potassium 50MG Tablets (SANDOZ): 60/$39.99 or 180/$99.98
Diclofenac Sodium 25MG Enteric-coated Tablets (SANDOZ): 60/$75.99 or 180/$209.96
Diclofenac Sodium 50MG Enteric-coated Tablets (MYLAN): 90/$45.99 or 180/$83.00
Diclofenac Sodium 75MG Enteric-coated Tablets (WATSON LABS): 60/$47.99 or 180/$112.98
Diclofenac Sodium CR 100MG 24-hr Tablets (WATSON LABS): 30/$75.99 or 90/$209.97
Pennsaid 1.5% Solution (MALLINCKRODT BRAND PHARMA): 150/$180.00 or 450/$499.95
Solaraze 3% Gel (PHARMADERM): 100/$559.97 or 300/$1,649.99
Voltaren 1% Gel (ENDO PHARMACEUTICALS): 100/$40.99 or 300/$105.97
Voltaren-XR 100MG 24-hr Tablets (NOVARTIS): 30/$229.99 or 90/$689.98
Zipsor 25MG Capsules (XANODYNE PHARMACEUTICALS): 30/$81.99 or 90/$229.96
Use is not currently included in the labeling approved by the US Food and Drug Administration.
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AHFS DI® Essentials™ Page 1 of 35

Diclofenac (Systemic, Local)

Class: 28:08.04.92 Other Nonsteroidal Anti-inflammatory Agents

Brands*: Arthrotec® (combination), Cataflam®, Flector®, Voltaren®

*also available generically

Generic Name: Diclofenac Potassium

Generic Name: Diclofenac Sodium

Generic Name: Diclofenac Epolamine

Orally for management of juvenile rheumatoid arthritis .3, 128, 210

Orally for symptomatic management of primary dysmenorrhea.303

Dosage and Administration

Diclofenac Epolamine Transdermal System

Wash hands after handling the system.317

Avoid contact with eyes and mucous membranes.317

Do not wear the transdermal system while bathing or showering.317

Available as diclofenac potassium, diclofenac sodium, or diclofenac epolamine; dosage expressed in

Commercially available diclofenac sodium enteric-coated tablets (Voltaren®), diclofenac sodium

these dosages may be less effective in preventing NSAIA-induced ulcers.284

Diclofenac sodium (in fixed combination with

these dosages may be less effective in preventing NSAIA-induced ulcers.284

from initial dose of 100 mg (followed by 50-mg doses).303

>Topical (transdermal system)

Precautions Specific to Diclofenac Sodium 1% Gel

Precautions Specific to Diclofenac Epolamine Transdermal System

Do not apply to nonintact or damaged skin.317

May mask certain signs of infection.1, 302, 303, 317, 318

Common Adverse Effects

Diclofenac sodium 1% gel: Application site reactions (e.g., dermatitis).318

Drug Interaction Comments

Antacids Delayed diclofenac absorption3, 189, 238

Possible increase in nephrotoxic effects of Caution advised1, 302, 303,

Monitor for diuretic efficacy

Severe, sometimes fatal toxicity associated with

Plasma Protein Binding

Diclofenac epolamine transdermal system: Approximately 12 hours.317

• Risk of hepatotoxicity.1, 302, 303, 317, 318

apply diclofenac gel.318

Diclofenac Sodium Combinations

Arthrotec 50 50-200MG-MCG Tablets (PFIZER U.S.): 60/$199.98 or 180/$579.96

Arthrotec 75 75-200MG-MCG Tablets (PFIZER U.S.): 60/$203.98 or 180/$579.96

Cataflam 50MG Tablets (NOVARTIS): 100/$401.99 or 300/$1,183.94

Diclofenac Potassium 50MG Tablets (SANDOZ): 60/$39.99 or 180/$99.98

Diclofenac Sodium 25MG Enteric-coated Tablets (SANDOZ): 60/$75.99 or 180/$209.96

Diclofenac Sodium 50MG Enteric-coated Tablets (MYLAN): 90/$45.99 or 180/$83.00

Diclofenac Sodium 75MG Enteric-coated Tablets (WATSON LABS): 60/$47.99 or 180/$112.98

Diclofenac Sodium CR 100MG 24-hr Tablets (WATSON LABS): 30/$75.99 or 90/$209.97

Pennsaid 1.5% Solution (MALLINCKRODT BRAND PHARMA): 150/$180.00 or 450/$499.95

Solaraze 3% Gel (PHARMADERM): 100/$559.97 or 300/$1,649.99

Voltaren 1% Gel (ENDO PHARMACEUTICALS): 100/$40.99 or 300/$105.97

Voltaren-XR 100MG 24-hr Tablets (NOVARTIS): 30/$229.99 or 90/$689.98

Zipsor 25MG Capsules (XANODYNE PHARMACEUTICALS): 30/$81.99 or 90/$229.96

1. Novartis. Voltaren® (diclofenac sodium enteric-coated tablets) prescribing information. East

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137. Keinanen-Kiukaanniemi S, Simila S, Kapyla H. Antipyretic therapy: evaluation of diclofenac