Diclofenac

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ALERT: U.S. Boxed Warning

The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a
concise summary of this information. For verbatim wording of the boxed warning, consult the
product labeling or www.fda.gov.

Medication Safety Issues

Sound-alike/look-alike issues:

Diclofenac may be confused with Diflucan, Duphalac

Cataflam may be confused with Catapres

Voltaren may be confused with traMADol, Ultram, Verelan

Pronunciation

(dye KLOE fen ak)

U.S. Brand Names

Cataflam; Flector; Solaraze; Voltaren Ophthalmic; Voltaren; Voltaren Gel;

Voltaren-XR

Canadian Brand Names

Apo-Diclo Rapide; Apo-Diclo SR; Apo-Diclo; Cataflam; Dom-Diclofenac; Dom-

Diclofenac SR; Novo-Difenac; Novo-Difenac K; Novo-Difenac-SR; Nu-Diclo; Nu-Diclo-SR;
Pennsaid; PMS-Diclofenac; PMS-Diclofenac SR; Pro-Diclo-Rapide; Riva-Diclofenac; Riva-
Diclofenac-K; Sab-Diclofenac; Sandoz-Diclofenac; Voltaren Ophtha; Voltaren Rapide;
Voltaren
 Pharmacologic Category

Nonsteroidal Anti-inflammatory Drug (NSAID); Nonsteroidal Anti-inflammatory Drug

(NSAID), Ophthalmic; Nonsteroidal Anti-inflammatory Drug (NSAID), Oral; Nonsteroidal
Anti-inflammatory Drug (NSAID), Topical

Use: Labeled Indications

Immediate release tablet: Ankylosing spondylitis; primary dysmenorrhea; acute and chronic
treatment of rheumatoid arthritis, osteoarthritis

Delayed-release tablet: Acute and chronic treatment of rheumatoid arthritis, osteoarthritis,

ankylosing spondylitis

Extended-release tablet: Chronic treatment of osteoarthritis, rheumatoid arthritis

Ophthalmic solution: Postoperative inflammation following cataract extraction; temporary relief

of pain and photophobia in patients undergoing corneal refractive surgery

Topical gel 1%: Relief of osteoarthritis pain in joints amenable to topical therapy (eg, ankle,
elbow, foot, hand, knee, wrist)

Topical gel 3%: Actinic keratosis (AK) in conjunction with sun avoidance

Topical patch: Acute pain due to minor strains, sprains, and contusions

Use: Unlabeled/Investigational

Juvenile rheumatoid arthritis

Use: Dental

Immediate-release tablets: Acute treatment of mild to moderate pain

Dosing: Adults

Analgesia/primary dysmenorrhea: Oral: Starting dose: 50 mg 3 times/day; maximum dose:

150 mg/day

Rheumatoid arthritis: Oral: 150-200 mg/day in 2-4 divided doses (100 mg/day of sustained
release product)
Osteoarthritis:

Oral: 100-150 mg/day in 2-3 divided doses (100-200 mg/day of sustained release product)

Topical (Voltaren Gel): Note: Maximum total body dose of 1% gel should not exceed
32 g per day

Lower extremities: Apply 4 g of 1% gel to affected area 4 times daily (maximum: 16 g

per joint per day)

Upper extremities: Apply 2 g of 1% gel to affected area 4 times daily (maximum: 8 g

per joint per day)

Ankylosing spondylitis: Oral: 100-125 mg/day in 4-5 divided doses

Cataract surgery: Ophthalmic: Instill 1 drop into affected eye 4 times/day beginning 24 hours
after cataract surgery and continuing for 2 weeks

Corneal refractive surgery: Ophthalmic: Instill 1-2 drops into affected eye within the hour
prior to surgery, within 15 minutes following surgery, and then continue for 4 times/day, up
to 3 days

Actinic keratosis (AK): Topical (Solaraze Gel): Apply 3% gel to lesion area twice daily for
60-90 days

Acute pain (strains, sprains, contusions): Topical (patch): Apply 1 patch twice daily to most
painful area of skin

Dosing: Elderly

Refer to adult dosing. No specific dosing recommendations; elderly may demonstrate adverse
effects at lower doses than younger adults, and >60% may develop asymptomatic peptic
ulceration with or without hemorrhage; monitor renal function.

Dosing: Renal Impairment

Not recommended in patients with advanced renal disease or significant renal impairment.

Dosing: Hepatic Impairment

No adjustment necessary.
 Administration: Oral

Do not crush tablets. Administer with food or milk to avoid gastric distress. Take with full glass
of water to enhance absorption.

Administration: Topical

Topical gel:

1% formulation: Apply gel to affected joint and rub into skin gently, making sure to apply
to entire joint. Do not cover area with occlusive dressings or apply sunscreens,
cosmetics, or other medications to affected area. Do not wash area for one hour
following application. Wash hands immediately after application (unless hands are
treated joint).

3% formulation: Apply to lesion with gel and smooth into skin gently. Do not cover lesion
with occlusive dressings or apply sunscreens, cosmetics, or other medications to
affected area.

Topical patch: Apply to intact, nondamaged skin. Remove transparent liner prior to applying to
skin. Wash hands after applying as well as after removal of patch. May tape down edges of
patch, if peeling occurs. Should not be worn while bathing or showering. Fold used patches
so the adhesive side sticks to itself; dispose of used patches out of reach of children and
pets.

Administration: Other

Ophthalmic: Wait at least 5 minutes before administering other types of eye drops.

Dietary Considerations

Oral formulations may be taken with food to decrease GI distress.

Diclofenac potassium = Cataflam; potassium content: 5.8 mg (0.15 mEq) per 50 mg tablet

Storage

Ophthalmic solution: Store at 15C to 25C (59F to 77F).

Tablet: Store below 30C (86F). Protect from moisture; store in tight container.
Topical gel: Store at controlled room temperature of 20C to 25C (68F to 77F); do not
freeze.

Topical patch: Store at controlled room temperature 25C (77F); excursions permitted to
15C to 30C (59F to 86F). Keep envelope sealed when not being used.

Restrictions

An FDA-approved medication guide must be distributed when dispensing an oral outpatient

prescription (new or refill) where this medication is to be used without direct supervision of a
healthcare provider. Medication guides are available at
http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.

Contraindications

Hypersensitivity to diclofenac, aspirin, other NSAIDs, or any component of the formulation;

perioperative pain in the setting of coronary artery bypass graft (CABG) surgery

Topical patch: Do not apply to nonintact or damaged skin (eg, exudative dermatitis, eczema,
infected lesions, burns or wounds)

Allergy Considerations

Nonsteroidal Anti-inflammatory Drug (NSAID) Allergy

Warnings/Precautions

Boxed warnings:

Cardiovascular events: See Concerns related to adverse effects below.

Coronary artery bypass graft surgery: See Disease-related concerns below.

Gastrointestinal events: See Concerns related to adverse effects below.

Concerns related to adverse effects:

Anaphylactoid reactions: Even in patients without prior exposure anaphylactoid

reactions may occur; patients with "aspirin triad" (bronchial asthma, aspirin
intolerance, rhinitis) may be at increased risk. Do not use in patients who experience
bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy.
 Bleeding/hemostasis: Platelet adhesion and aggregation may be decreased; may prolong
bleeding time; patients with coagulation disorders or who are receiving anticoagulants
should be monitored closely. Anemia may occur; patients on long-term NSAID
therapy should be monitored for anemia.

Cardiovascular events: [U.S. Boxed Warning]: NSAIDs are associated with an

increased risk of adverse cardiovascular thrombotic events, including MI, stroke,
and new onset or worsening of pre-existing hypertension. Risk may be increased
with duration of use or pre-existing cardiovascular risk factors or disease. Carefully
evaluate individual cardiovascular risk profiles prior to prescribing. Use caution with
fluid retention, HF, or hypertension. Concurrent administration of ibuprofen, and
potentially other nonselective NSAIDs, may interfere with aspirins
cardioprotective effect. Use the lowest effective dose for the shortest duration of time,
consistent with individual patient goals, to reduce risk of cardiovascular events;
alternate therapies should be considered for patients at high risk.

Gastrointestinal events: [U.S. Boxed Warning]: NSAIDs may increase risk of

gastrointestinal irritation, inflammation, ulceration, bleeding, and perforation.
These events may occur at any time during therapy and without warning. Use caution
with a history of GI disease (bleeding or ulcers), concurrent therapy with aspirin,
anticoagulants and/or corticosteroids, smoking, use of alcohol, the elderly or
debilitated patients. Use the lowest effective dose for the shortest duration of time,
consistent with individual patient goals, to reduce risk of GI adverse events; alternate
therapies should be considered for patients at high risk.

Skin reactions: NSAIDs may cause serious skin adverse events including exfoliative
dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN);
discontinue use at first sign of skin rash or hypersensitivity.

Disease-related concerns:

Asthma: Do not administer to patients with aspirin-sensitive asthma; severe

bronchospasm may occur. Use caution in patients with other forms of asthma.

Coronary artery bypass graft surgery (CABG): [U.S. Boxed Warning]: Use is
contraindicated for treatment of perioperative pain in the setting of coronary
artery bypass graft (CABG) surgery. Risk of MI and stroke may be increased with
use following CABG surgery.

Hepatic impairment: Use with caution in patients with decreased hepatic function.
Closely monitor patients with any abnormal LFT. Rarely, severe hepatic reactions (eg,
fulminant hepatitis, liver failure) have occurred with NSAID use; discontinue all
formulations if signs or symptoms of liver disease develop, or if systemic
manifestations occur.
 Renal impairment: NSAID use may compromise existing renal function; dose-
dependent decreases in prostaglandin synthesis may result from NSAID use, reducing
renal blood flow which may cause renal decompensation. Patients with impaired renal
function, dehydration, heart failure, liver dysfunction, those taking diuretics and ACEI,
and the elderly are at greater risk of renal toxicity. Rehydrate patient before starting
therapy; monitor renal function closely. Not recommended for use in patients with
advanced renal disease. Long-term NSAID use may result in renal papillary necrosis.

Special populations:

Elderly: The elderly are at increased risk for adverse effects (especially peptic
ulceration, CNS effects, and renal toxicity) from NSAIDs even at low doses.

Pediatrics: Safety and efficacy have not been established in children.

Dosage form specific issues:

Ophthalmic drops: Monitor patients for 1 year following application of ophthalmic

drops for corneal refractive procedures. Patients using ophthalmic drops should not
wear soft contact lenses. Ophthalmic drops may slow/delay healing or prolong
bleeding time following surgery.

Topical gel: Do not apply topical gel to the eyes, mucous membranes, open wounds,
infected areas, or to exfoliative dermatitis. Avoid use of occlusive dressings. Should
not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect
repellents, or other topical medication on the same skin sites. Avoid sunlight exposure
to treated areas.

Topical patch: Do not apply topical patch to the eyes, mucous membranes, open
wounds, infected areas, or to exudative dermatitis. Patch should not be worn during
bathing or showering.

Other warnings/precautions:

Surgical/dental procedures: Withhold for at least 4-6 half-lives prior to surgical or

dental procedures.

Geriatric Considerations

Elderly are a high-risk population for adverse effects from nonsteroidal anti-inflammatory
agents. As much as 60% of the elderly can develop peptic ulceration and/or hemorrhage
asymptomatically. The concomitant use of H2 blockers and sucralfate is not effective as
prophylaxis with the exception of NSAID-induced duodenal ulcers which may be prevented by
the use of ranitidine. Misoprostol and proton pump inhibitors are the only agents proven to help
prevent the development of NSAID-induced ulcers. Also, concomitant disease and drug use
contribute to the risk for GI adverse effects. Use lowest effective dose for shortest period
possible. Consider renal function decline with age. Use of NSAIDs can compromise existing
renal function especially when Clcr is 30 mL/minute. CNS adverse effects such as
confusion, agitation, and hallucination are generally seen in overdose or high dose situations, but
elderly may demonstrate these adverse effects at lower doses than younger adults.

Pregnancy Risk Factor

B (topical gel 3%); C (oral, topical gel 1%, topical patch); D (3rd trimester)

Pregnancy Considerations

Safety and efficacy in pregnant women have not been established. Exposure late in pregnancy
may lead to premature closure of the ductus arteriosus and may inhibit uterine contractions.
Avoid use of diclofenac (all forms) in late pregnancy.

Lactation

Excretion in breast milk unknown/not recommended

Adverse Reactions

Ophthalmic solution (drops):

>10%: Ocular: Lacrimation (30%), keratitis (28%), intraocular pressure increased (15%),
transient burning/stinging (15%)

1% to 10%:

Cardiovascular: Facial edema (3%)

Central nervous system: 3%: Dizziness, fever, headache, insomnia, pain

Gastrointestinal: 3%: Abdominal pain, nausea, vomiting

Neuromuscular & skeletal: 3%: Pain, weakness

Ocular: 5%: Abnormal vision, blurred vision, conjunctivitis, corneal deposits, corneal
edema, corneal lesions, corneal opacity, discharge, eyelid swelling, injection, iritis,
irritation, itching, lacrimation disorder, ocular allergy

Respiratory: Rhinitis (3%)

 Miscellaneous: Viral infection (3%)

<1%, postmarketing, and/or case reports: Corneal erosion, corneal infiltrates, corneal perforation,
corneal thinning, corneal ulceration, epithelial breakdown, superficial punctuate keratitis

Oral:

1% to 10%:

Cardiovascular: Edema

Central nervous system: Dizziness, headache

Dermatologic: Pruritus, rash

Endocrine & metabolic: Fluid retention

Gastrointestinal: Abdominal distension, abdominal pain, constipation, diarrhea, dyspepsia,

flatulence, GI perforation, heartburn, nausea, peptic ulcer/GI bleed, vomiting

Hematologic: Anemia, bleeding time increased

Hepatic: Liver enzyme abnormalities

Otic: Tinnitus

Renal: Renal function abnormal

<1%, postmarketing, and/or case reports: Abnormal coordination, agranulocytosis, alopecia,

amblyopia, anaphylactoid reactions, anaphylaxis, anxiety, angioedema, aphthous stomatitis,
aplastic anemia, appetite changes, arrhythmia, aseptic meningitis, asthma, azotemia, blurred
vision, bruising, chest pain, cirrhosis, CHF, colitis, confusion, coma, cystitis, depression,
dermatitis, diaphoresis, diplopia, disorientation, drowsiness, dyspnea, epistaxis, eructation,
erythema multiforme, esophageal lesions, exfoliative dermatitis, dysuria, flushing,
hallucination, hearing impairment, hearing loss, hematuria, hemoglobin decreased,
hemolytic anemia, hepatitis, hepatic failure, hepatic necrosis, hyper-/hypotension, hyper-
/hypoglycemia, hyperventilation, impotence, infection, interstitial nephritis, intestinal
perforation, jaundice, laryngeal edema, leukopenia, lymphadenopathy, malaise, melena,
memory disturbance, meningitis, MI, nervousness, night blindness, nocturia, oliguria,
palpitation, pancreatitis, pancytopenia, paresthesia, pharynx edema, photosensitivity,
pneumonia, polyuria, purpura, psychotic reactions, PVCs, rectal bleeding, renal failure,
respiratory depression, scotoma, seizure, sepsis, somnolence, Stevens-Johnson syndrome,
swelling of lips and tongue, stomatitis, syncope, tachycardia, taste disorder,
thrombocytopenia, tic, toxic epidermal necrolysis, tremor, urinary frequency, urticaria,
vaginal bleeding, vertigo, vitreous floaters, weight change, weakness, vasculitis, xerostomia
Topical gel:

>10%: Local: Application site reactions (incidence increased with 3% gel): Pruritus (52%),
rash (35% to 46%), contact dermatitis (4% to 33%), dry skin (27%), pain (15% to
26%), exfoliation (3% gel; 6% to 24%), paresthesia (20%)

1% to 10% (reported for 3% gel):

Cardiovascular: Chest pain, hypertension

Central nervous system: Headache, pain

Dermatologic: Pruritus, rash, skin ulcer

Endocrine & metabolic: Hypercholesterolemia, hyperglycemia

Gastrointestinal: Abdominal pain, diarrhea, dyspepsia

Genitourinary: Hematuria

Hepatic: Liver enzymes increased

Local: Alopecia, edema, photosensitivity

Neuromuscular and skeletal: Arthralgia, arthrosis, back pain, CPK increased, hypokinesia,
myalgia, neck pain, weakness

Ocular: Conjunctivitis

Respiratory: Asthma, dyspnea, pneumonia, sinusitis

Miscellaneous: Flu-like syndrome

Topical patch:

1% to 10%:

Central nervous system: Dizziness, hypaesthesia

Dermatologic: Dermatitis (2%), dermal allergic reaction

Gastrointestinal: Nausea (3%), dysgeusia (2%), abdominal pain, constipation, diarrhea,

gastritis, vomiting, xerostomia
 Local: Application site dryness, irritation, erythema, atrophy, discoloration, hyperhidrosis,
and vesicles, edema, itching

Neuromuscular & skeletal: Hyperkinesia

Metabolism/Transport Effects

Substrate (minor) of CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A4; Inhibits CYP1A2 (moderate),
2C9 (weak), 2E1 (weak), 3A4 (weak)

Drug Interactions

ACE Inhibitors: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive

effect of ACE Inhibitors. Risk C: Monitor therapy

Aminoglycosides: Nonsteroidal Anti-Inflammatory Agents may decrease the excretion of

Aminoglycosides. Data only in premature infants. Risk C: Monitor therapy

Angiotensin II Receptor Blockers: Nonsteroidal Anti-Inflammatory Agents may diminish the

therapeutic effect of Angiotensin II Receptor Blockers. The combination of these two
agents may also significantly decrease glomerular filtration and renal function. Risk C:
Monitor therapy

Anticoagulants: Nonsteroidal Anti-Inflammatory Agents may enhance the anticoagulant effect of

Anticoagulants. Risk C: Monitor therapy

Antidepressants (Serotonin/Norepinephrine Reuptake Inhibitor): May enhance the antiplatelet

effect of NSAID (Nonselective). Risk C: Monitor therapy

Antidepressants (Tricyclic, Tertiary Amine): May enhance the antiplatelet effect of NSAID
(Nonselective). Risk C: Monitor therapy

Antiplatelet Agents: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic

effect of Antiplatelet Agents. An increased risk of bleeding may occur. Nonsteroidal Anti-
Inflammatory Agents may diminish the cardioprotective effect of Antiplatelet Agents. This
interaction is likely specific to aspirin, and not to other antiplatelet agents. Risk C: Monitor
therapy

Beta-Blockers: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect

of Beta-Blockers. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy

Bile Acid Sequestrants: May decrease the absorption of Nonsteroidal Anti-Inflammatory Agents.
Risk D: Consider therapy modification
Bisphosphonate Derivatives: Nonsteroidal Anti-Inflammatory Agents may enhance the
adverse/toxic effect of Bisphosphonate Derivatives. Both an increased risk of
gastrointestinal ulceration and an increased risk of nephrotoxicity are of concern. Risk C:
Monitor therapy

Corticosteroids (Systemic): May enhance the adverse/toxic effect of NSAID (Nonselective). Risk
C: Monitor therapy

CycloSPORINE: Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of

CycloSPORINE. Nonsteroidal Anti-Inflammatory Agents may increase the serum
concentration of CycloSPORINE. Risk D: Consider therapy modification

CYP1A2 Substrates: CYP1A2 Inhibitors (Moderate) may decrease the metabolism of CYP1A2
Substrates. Risk C: Monitor therapy

Desmopressin: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of

Desmopressin. Risk C: Monitor therapy

Eplerenone: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of

Eplerenone. Risk C: Monitor therapy

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the
adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Bleeding may occur. Risk
D: Consider therapy modification

HydrALAZINE: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive

effect of HydrALAZINE. Risk C: Monitor therapy

Ketorolac: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.

Risk X: Avoid combination

Latanoprost: NSAID (Ophthalmic) may diminish the therapeutic effect of Latanoprost. Risk C:
Monitor therapy

Lithium: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of

Lithium. Risk D: Consider therapy modification

Loop Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the diuretic effect of
Loop Diuretics. Risk C: Monitor therapy

Methotrexate: Nonsteroidal Anti-Inflammatory Agents may decrease the excretion of

Methotrexate. Risk D: Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of other

Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy
Pemetrexed: NSAID (Nonselective) may decrease the excretion of Pemetrexed. Risk D:
Consider therapy modification

Probenecid: May increase the serum concentration of Nonsteroidal Anti-Inflammatory Agents.

Risk C: Monitor therapy

Quinolone Antibiotics: Nonsteroidal Anti-Inflammatory Agents may enhance the

neuroexcitatory and/or seizure-potentiating effect of Quinolone Antibiotics. Risk C:
Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the antiplatelet effect of NSAID
(Nonselective). Risk D: Consider therapy modification

Thiazide Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect
of Thiazide Diuretics. Risk C: Monitor therapy

Thrombolytic Agents: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic

effect of Thrombolytic Agents. An increased risk of bleeding may occur. Risk C: Monitor
therapy

Treprostinil: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents.

Bleeding may occur. Risk C: Monitor therapy

Vancomycin: Nonsteroidal Anti-Inflammatory Agents may decrease the excretion of

Vancomycin. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): NSAID (Nonselective) may enhance the anticoagulant
effect of Vitamin K Antagonists. Risk D: Consider therapy modification

Voriconazole: May increase the serum concentration of Diclofenac. Risk D: Consider therapy
modification

Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may enhance gastric mucosal irritation).

Herb/Nutraceutical: Avoid alfalfa, anise, bilberry, bladderwrack, bromelain, cat's claw, celery,
chamomile, coleus, cordyceps, dong quai, evening primrose, fenugreek, feverfew, garlic,
ginger, ginkgo biloba, grapeseed, green tea, ginseng (Siberian), guggul, horse chestnut,
horseradish, licorice, prickly ash, red clover, reishi, SAMe (s-adenosylmethionine), sweet
clover, turmeric, white willow (all have additional antiplatelet activity).

Monitoring Parameters
Monitor CBC, liver enzymes; monitor urine output and BUN/serum creatinine; occult blood loss,
hemoglobin, hematocrit

Nursing: Physical Assessment/Monitoring

Evaluate cardiac risk and potential for GI bleeding prior to prescribing this medication. Assess
other medications patient may be taking for effectiveness and interactions. Monitor blood
pressure at the beginning of therapy and periodically during use. Assess results of laboratory
tests, therapeutic effectiveness, and adverse reactions (systemic or ophthalmic) at beginning of
therapy and periodically throughout therapy. Schedule ophthalmic evaluations for patients who
develop eye complaints during long-term NSAID therapy. Assess knowledge/teach patient
appropriate use (oral, ophthalmic, gel), interventions to reduce side effects, and adverse
symptoms to report.

Monitoring: Lab Tests

CBC, liver enzymes, urine output and BUN/serum creatinine in patients receiving diuretics,
occult blood loss

Patient Education

Oral: Take this medication exactly as directed; do not increase dose without consulting
prescriber. Do not crush or chew tablets. Take with 8 oz of water, along with food or milk
products to reduce GI distress. Maintain adequate hydration (2-3 L/day of fluids) unless
instructed to restrict fluid intake. Avoid alcohol, aspirin and aspirin-containing medication, or
any other anti-inflammatory medications unless consulting prescriber. You may experience
dizziness, nervousness, or headache (use caution when driving or engaging in tasks requiring
alertness until response to drug is known); nausea, vomiting, dry mouth, or heartburn (small
frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); or
constipation (increased exercise, fluids, fruit, or fiber may help). GI bleeding, ulceration, or
perforation can occur with or without pain; discontinue medication and contact prescriber if
persistent abdominal pain or cramping, or blood in stool occurs. Report chest pain or
palpitations; breathlessness or respiratory difficulty; unusual bruising/bleeding or blood in urine,
stool, mouth, or vomitus; unusual fatigue; skin rash or itching; jaundice, unusual weight gain, or
swelling of extremities; change in urinary pattern; change in vision or hearing (ringing in ears).
Pregnancy/breast-feeding precautions: Consult prescriber if you are pregnant. This drug
should not be used in the 3rd trimester of pregnancy. Consult prescriber if you are breast-
feeding.

Ophthalmic: For ophthalmic use only. Apply prescribed amount as often as directed. Wash hands
before using. Tilt head back and look upward. Gently pull down lower lid and put drop(s) in
inner corner of eye. Do not let tip of applicator touch eye; do not contaminate tip of applicator
(may cause eye infection, eye damage, or vision loss). Close eye and roll eyeball in all directions.
Do not blink for 1/2minute. Apply gentle pressure to inner corner of eye for 30 seconds. Wipe
away excess from skin around eye. Do not use any other eye preparation for at least 10 minutes.
Do not share medication with anyone else. May cause sensitivity to bright light (dark glasses
may help); temporary stinging or blurred vision may occur. Inform prescriber if you experience
eye pain, redness, burning, watering, dryness, double vision, puffiness around eye, vision
changes, other adverse eye response, worsening of condition, or lack of improvement.

Gel: This preparation is for topical use only. Treatment may take up to 3 months. Do not use
more often than recommended; use at regular intervals. Wash hands before and after use. Follow
directions on prescription label. Gently apply enough of the gel to cover the lesion. Advise
prescriber if you are using any other skin preparations. Avoid direct sunlight and sunlamps while
using this medication. You may experience dry skin, itching, peeling, swelling, or tingling at site
of application. If severe skin reaction develops, stop applications and notify your prescriber at
once.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult
specific product labeling. [DSC] = Discontinued product

Gel, as sodium:

Solaraze: 3% (50 g, 100 g)

Voltaren Gel: 1% (100 g)

Solution, ophthalmic, as sodium [drops]: 0.1% (2.5 mL, 5 mL)

Voltaren Ophthalmic: 0.1% (2.5 mL, 5 mL)

Tablet, as potassium: 50 mg

Cataflam: 50 mg

Tablet, delayed release, enteric coated, as sodium: 50 mg, 75 mg

Voltaren: 25 mg [DSC], 50 mg [DSC], 75 mg

Tablet, extended release, as sodium: 100 mg

Voltaren-XR: 100 mg

Transdermal system, topical, as epolamine:

Flector: 1.3% (30s) [180 mg]

 Generic Available

Yes: Excludes gel, patch

Pricing: U.S. (www.drugstore.com)

Gel (Solaraze)

3% (50): $205.80

3% (100): $350.74

Gel (Voltaren)

1% (100): $32.99

Patch (Flector)

1.3% (30): $155.99

Solution (Voltaren)

0.1% (2.5): $49.11

0.1% (5): $76.99

Tablet, 24-hour (Diclofenac Sodium CR)

100 mg (30): $74.92

Tablet, 24-hour (Voltaren-XR)

100 mg (30): $175.43

Tablet, EC (Diclofenac Sodium)

25 mg (60): $42.38

50 mg (90): $35.99

75 mg (60): $26.99

Tablet, EC (Voltaren)
 25 mg (60): $58.09

75 mg (60): $174.97

Tablets (Cataflam)

50 mg (100): $328.51

Tablets (Diclofenac Potassium)

50 mg (60): $39.99

Mechanism of Action

Reversibly inhibits cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, which result in decreased
formation of prostaglandin precursors; has antipyretic, analgesic, and anti-inflammatory
properties

Pharmacodynamics/Kinetics

Onset of action: Cataflam is more rapid than sodium salt (Voltaren) because it dissolves
in the stomach instead of the duodenum

Absorption: Topical gel: 6% to 10%

Protein binding: 99% to albumin

Metabolism: Hepatic to several metabolites

Half-life elimination: 2 hours; Patch: ~12 hours

Time to peak, serum: Cataflam: ~1 hour; Flector: 10-20 hours; Solaraze Gel: ~5
hours; Voltaren: ~2 hours; Voltaren Gel: 10-14 hours

Excretion: Urine (65%); feces (35%)

Related Information

Nonsteroidal Anti-inflammatory Agents

Dental Health: Effects on Dental Treatment

NSAID formulations are known to reversibly decrease platelet aggregation via mechanisms
different than observed with aspirin. The dentist should be aware of the potential of abnormal
coagulation. Caution should also be exercised in the use of NSAIDs in patients already on
anticoagulant therapy with drugs such as warfarin (Coumadin).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause nervousness or dizziness; may rarely cause depression

Mental Health: Effects on Psychiatric Treatment

May rarely cause agranulocytosis; use caution with clozapine and carbamazepine; may decrease
the clearance of lithium resulting in elevated serum levels and potential toxicity; monitor serum
lithium levels

Cardiovascular Considerations

Blood Pressure: In short-term use, NSAIDs vary considerably in their effect on blood pressure.
A meta-analysis (Pope, 1993) showed that indomethacin and naproxen had the largest effect on
blood pressure. Other NSAIDs, including piroxicam, ibuprofen, and sulindac had less of an
effect. Ibuprofen combined with captopril or losartan may attenuate the antihypertensive effects
of ACE inhibition or receptor blockade on sitting or 24-hour ambulatory diastolic blood pressure.
When NSAIDs are used in patients with hypertension, appropriate monitoring of blood pressure
responses should be completed and the duration of therapy, when possible, kept short.

Heart Failure: The use of NSAIDs in the treatment of patients with congestive heart failure may
be associated with an increased risk for fluid accumulation and edema. One study showed that
NSAID use in elderly patients had an increased risk of hospitalization for heart failure. This
study gives compelling reasons to avoid or limit the use of NSAIDs in patients with congestive
heart failure, particularly in the elderly population. The ACC/AHA 2005 chronic heart failure
guidelines suggest that NSAIDs be avoided or withdrawn whenever possible in patients with
current or prior symptoms of heart failure and reduced LVEF.

Risk of Cardiovascular Events: Patients at increased risk of cardiovascular adverse events

include patients immediately postoperative (10-14 days) from CABG surgery, and those with
existing CAD, CVD, or history of TIA. Prescribers are encouraged to use the lowest effective
dose for the shortest duration of time based on individual patient treatment goals. Available
evidence reviewed by the FDA does not suggest an increased risk of serious CV events when
NSAIDs are given short term and in the lower doses used OTC.

Anesthesia and Critical Care Concerns/Other Considerations

The 2002 ACCM/SCCM guidelines for analgesia (critically-ill adult) suggest that NSAIDs may
be used in combination with opioids in select patients for pain management. Concern about
adverse events (increased risk of renal dysfunction, altered platelet function and gastrointestinal
irritation) limits its use in patients who have other underlying risks for these events.

In short-term use, NSAIDs vary considerably in their effect on blood pressure. When NSAIDs
are used in patients with hypertension, appropriate monitoring of blood pressure responses
should be completed and the duration of therapy, when possible, kept short. The use of NSAIDs
in the treatment of patients with congestive heart failure may be associated with an increased risk
for fluid accumulation and edema; may precipitate renal failure in dehydrated patients.

Index Terms

Diclofenac Epolamine; Diclofenac Potassium; Diclofenac Sodium

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