Rheumatol Rehabil. Akt Rheumatol. 1985; 37:259-68. Siraux P. Diclofenac (Voltaren) for the treatment of osteo-arthrosis: a double-blind comparison with naproxen. Hart FD, Huskisson EC, Answell BM. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 120. 121. JAMA. Dysmenorrhoea and prostaglandins: pharmacological and therapeutic considerations. Biochem Pharmacol. 1986; 80(Suppl 4B):53-7. http://www.ncbi.nlm.nih.gov/pubmed/3518434?dopt=AbstractPlus, 82. Br Med J. For over-the-counter (OTC) NSAIDs intended for use in adults, FDA will also update the Drug Facts labels, available at: [Web]. Anon. Voltaren (diclofenac sodium enteric-coated tablets) prescribing information. 1986; 80(Suppl 4B):29-33. http://www.ncbi.nlm.nih.gov/pubmed/3085489?dopt=AbstractPlus, 10. Settipane GA. Effects of diclofenac on synovial eicosanoid product formation in arthritis patients. Menassé R, Hedwall PR, Kraetz J et al. 3. BMJ. In: Hansten PD, Horn JR. Drug interactions and updates. Am J Med. Germain BF. J Int Med Res. A guideline for the treatment and prevention of NSAID-induced ulcers. A new metabolite of diclofenac sodium in human plasma. Am J Med. Am J Med. Use of diclofenac in analgesia. Increased mortality and cardiovascular morbidity associated with use of nonsteroidal anti-inflammatory drugs in chronic heart failure. ), 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, 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, 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, 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, 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, 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, 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, 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, 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, Distributed into milk; 3 discontinue nursing or the drug.1 302 303 317 318, 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, 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, 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, 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, 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, Reduced BP response to ACE inhibitor1 248 302 303 317 318, Possible deterioration of renal function in individuals with renal impairment315, Reduced BP response to angiotensin II receptor antagonist315, Antacids (magnesium- or aluminum-containing), Possible bleeding complications1 302 303 317 318, 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, Increased risk of GI ulceration and other complications1 302 303 317 318, No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs305 317 318 502 508, Manufacturer states that concomitant use not recommended1 302 303 317 318, Possible increase in nephrotoxic effects of cyclosporine1 302 303 318, Reduced natriuretic effects1 22 179 302 303 317 318, Monitor for diuretic efficacy and renal failure1 302 303 317 318, Increased plasma lithium concentrations1 176 188 265 302 303 317 318, Monitor for lithium toxicity1 302 303 317 318, Severe, sometimes fatal toxicity associated with increased plasma methotrexate concentrations175 307, Possible increased risk of seizures183 197 198, 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, Single 50- or 100-mg doses of diclofenac potassium provide pain relief within 30 minutes.307, Pain relief lasts up to 8 hours following administration of single 50- or 100-mg doses of diclofenac potassium.307, 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, Following oral administration, concentrations in synovial fluid may exceed those in plasma.1 3 62 63 64 65 66 67 68 69 302 303, 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, Excreted in urine (65%) and in feces via biliary elimination (35%) as metabolites.1 3 51 55 56 70 71 302 303, Oral preparations: 1–2 hours.2 53 57 60 302 303, Diclofenac epolamine transdermal system: Approximately 12 hours.317, 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, 25°C (may be exposed to 15–30°C).318 Do not freeze.318, 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, 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 (e.g., MI, stroke).1 302 303 317 318 500 508, 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, Importance of seeking immediate medical attention if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.1 302 303 317 318 500 508, 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, Risk of heart failure or edema; importance of reporting dyspnea, unexplained weight gain, or edema.508, 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.).
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