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Special Alerts
Voltaren® Gel: Product Availability - January, 2008
This product was approved by the Food and Drug Administration (FDA) in October, 2007. Product launch is expected to be in the first quarter of 2008.
ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section and/or refer to product labeling for additional detail.
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
Index Terms
Generic Available
Yes: Excludes gel, ophthalmic solution, patch
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
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: Dental
Immediate-release tablets: Acute treatment of mild to moderate pain
Use: Unlabeled/Investigational
Juvenile rheumatoid arthritis
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.
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
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)
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 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 aspirin's 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.
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 golmerular 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. 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
Coumarin Derivatives: NSAID (Nonselective) may enhance the anticoagulant effect of Coumarin Derivatives. Risk D: Consider therapy modification
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
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
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
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).
Storage
Ophthalmic solution: Store at 15°C to 25°C (59°F to 77°F).
Tablet: Store below 30°C (86°F). Protect from moisture; store in tight container.
Topical gel: Store at controlled room temperature of 20°C to 25°C (68°F to 77°F); do not freeze.
Topical patch: Store at controlled room temperature 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Keep envelope sealed when not being used.
Mechanism of Action
Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors. Mechanism of action for the treatment of AK has not been established.
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%)
Dosage
Adults:
Oral:
Analgesia/primary dysmenorrhea: Starting dose: 50 mg 3 times/day; maximum dose: 150 mg/day
Rheumatoid arthritis: 150-200 mg/day in 2-4 divided doses (100-200 mg/day of sustained release product)
Osteoarthritis: 100-150 mg/day in 2-3 divided doses (100-200 mg/day of sustained release product)
Ankylosing spondylitis: 100-125 mg/day in 4-5 divided doses
Ophthalmic:
Cataract surgery: Instill 1 drop into affected eye 4 times/day beginning 24 hours after cataract surgery and continuing for 2 weeks
Corneal refractive surgery: 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
Topical gel:
Actinic keratoses (Solaraze® Gel): Apply 3% gel to lesion area twice daily for 60-90 days
Osteoarthritis (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)
Topical patch: Acute pain (strains, sprains, contusions): Apply 1 patch twice daily to most painful area of skin
Dosage adjustment in renal impairment: Not recommended in patients with advanced renal disease or significant renal impairment
Dosage adjustment in hepatic impairment: No specific dosing recommendations
Elderly: 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
Dental Usual Dosing
Pain: Adults: Oral: Starting dose: 50 mg 3 times/day; maximum dose: 150 mg/day
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.
Monitoring Parameters
Monitor CBC, liver enzymes; monitor urine output and BUN/serum creatinine; occult blood loss, hemoglobin, hematocrit
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
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.
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.
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.
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.
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
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.
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]:
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]
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): $34.48
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
References
Arnold MM and McKenna F, “A Double Blind Comparison of the Endoscopic and Clinical Effects of Tenoxicam and Diclofenac in Rheumatoid Arthritis,” Br J Rheumatol, 1995, 34(Suppl 1):95.
Brogden RN, Heel RC, Pakes GE, et al, “Diclofenac Sodium: A Review of Its Pharmacological Properties and Therapeutic Use in Rheumatic Diseases and Pain of Varying Origin,” Drugs, 1980, 20(1):24-48.
Brooks PM and Day RO, “Nonsteroidal Anti-inflammatory Drugs - Differences and Similarities,” N Engl J Med, 1991, 324(24):1716-25.
Clinch D, Banerjee AK, and Ostick G, “Absence of Abdominal Pain in Elderly Patients With Peptic Ulcer,” Age Ageing, 1984, 13(2):120-3.
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Last full review/revision August 2008
Content last modified August 2008
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