1982; 21:238-42. http://www.ncbi.nlm.nih.gov/pubmed/7134745?dopt=AbstractPlus. Clin Rheumatol. 1984; 73:431-3. http://www.ncbi.nlm.nih.gov/pubmed/6423718?dopt=AbstractPlus, 145. Machtey I. Diclofenac in the treatment of painful joints and traumatic tendinitis (including strains and sprains): a brief review. are a class of medicines available by prescription and OTC. Kalamazoo, MI; 1985 Jul. Biotransformation of diclofenac sodium (Voltaren) in animals and in man. Am J Med. Am J Health-Sys Pharm. Eur J Clin Pharmacol. NSAIDs for renal and biliary colic: intramuscular diclofenac. Hépatite aigue mortelle au cours d’un traitement par le diclofenac (Voltarène). Buller HR, Agnelli G, Hull RD et al. Bonfiglioli D, Sommariva D, Zanaboni L et al. BMJ. Xenobiotica. 1987; 295:556. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1247465&blobtype=pdf, 216. Does the drug diclofenac have narcotics in it? Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. Friman C, Johnston C, Chew C et al. Peripheral antialgesics: a review. J Int Med Res. Treatment of biliary pain by prostaglandin synthetase inhibition with diclofenac sodium. Forensic Sci Int. 1977; 7:573-7. http://www.ncbi.nlm.nih.gov/pubmed/602882?dopt=AbstractPlus, 38. Vale JA, Meredith TJ. 13. Lithium-ibuprofen; lithium-indomethacin; lithium-naproxen; lithium-piroxicam. 125. Bettini R, Grossi E, Rapazzini P et al. Lascar G, Grippon P, Lévy VG. CAS Number: 15307-81-0 1986; 80(Suppl 4B):34-8. http://www.ncbi.nlm.nih.gov/pubmed/3085490?dopt=AbstractPlus. Pharm Int. J Am Geriatr Soc. 102. Treatment of ureteral colic by prostaglandin synthetase inhibition with diclofenac sodium. Rheumatic disorders. Hart FD. Diclofenac hepatitis. Ann Intern Med. Ibuprofen-induced meningitis in systemic lupus erythematosus. AUDIENCE: Consumer, Patient, Health Professional, Pharmacy. JAMA. 2011; 123:2226-35. http://www.ncbi.nlm.nih.gov/pubmed/21555710?dopt=AbstractPlus, 506. 19. Am J Med. 1985; 15:73-9. http://www.ncbi.nlm.nih.gov/pubmed/4081794?dopt=AbstractPlus, 127. 99. The First Aid directions on the label are incorrect. Gabrielsen TO, Staerfelt F, Thune PO. 2rd ed. Ann Intern Med. Discontinue the NSAID if oligohydramnios occurs and follow up according to clinical practice. 1983; 23:545-56. http://www.ncbi.nlm.nih.gov/pubmed/6363465?dopt=AbstractPlus, 193. Haapasaari J, Wuolijoki E, Ylijoki H. Treatment of juvenile rheumatoid arthritis with diclofenac sodium. Erythema multiforme major following use of diclofenac. N Engl J Med. Proceedings of ICAAC New York 1987. of Rogor L 30 were applied to 3 plots of 10 ha. Martinez-Elizondo P. Un estudio controlado de diclofenac sodico en reumatologia. Voltaren in co-medication. Xenobiotica. Widener HL, Littman BH. Ultrastructural and functional studies on human platelets incubated with diclofenac sodium (Voltaren). COX-2 inhibitors, other NSAIDs, and cardiovascular risk; the seduction of common sense. All rights reserved. Acta Haematol. 166. In: Huff BB, ed. Diclofenac sodium, a negative chemokinetic factor for neutrophil locomotion. Increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).1 302 303 317 318 500 502 508 Risk may occur early in treatment and may increase with duration of use.500 502 505 506 508 (See Cardiovascular Thrombotic Effects under Cautions. McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. Am J Med. 1985; 40:784-6. Settipane GA. A comparative study of diclofenac and sulindac in ankylosing spondylitis. Ciccolunghi SN, Chaudri HA, Schubiger BI et al. Clin Ther. New York, NY; 2006 Mar. Renal papillary necrosis associated with diclofenac sodium. BMJ. Khalil H, Molinary E, Stoller JK. Bateman DN. Breen EG, McNicholl J, Cosgrove E et al. Diclophenac sodium (Voltaren) in rheumatoid arthritis: a double-blind comparison with indomethacin and placebo. Acute intrinsic renal failure induced by indomethacin: role of prostaglandin synthetase inhibition. http://www.ncbi.nlm.nih.gov/pubmed/21980265?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=3181230&blobtype=pdf, 507. J Int Med Res. Weinberger M. Analgesic sensitivity in children with asthma. Introduction. 1986; 80(Suppl 1A):62-70. http://www.ncbi.nlm.nih.gov/pubmed/3511686?dopt=AbstractPlus. Adverse reactions to aspirin and related drugs. FDA is warning that use of NSAIDs around 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Fowler PD, Dawes PT, John VA et al. Changing the class of NSAID in cases of hepatotoxicity. Mandell B, Shen HS, Hepburn B. 512. 308. Willis JV, Jack DB, Kendall MJ et al. 1988; 35:244-85. http://www.ncbi.nlm.nih.gov/pubmed/3286213?dopt=AbstractPlus, 4. Crook PR, Fowler PD, Hothersall TE et al. J Int Med Res. In: Gilman AG, Goodman LS, Rall TW et al, eds. Chan KKH, Vyas KH, Brandt KD. Willis JV, Kendall MJ, Flinn RM et al. 1989; 19:3-4. A quantity of cans were filled with a herbicide containing Tryclophyr. Evaluations of drug interactions. Wilson DE. Report on a long-term tolerability study of up to two years with diclofenac sodium (voltaren). Dunk AA, Walt RP, Jenkins WJ et al. Can NSAIDs be used to treat a COVID-19 fever? Diclofenac sodium: a reappraisal of its pharmacodynamic and pharmacokinetic properties, therapeutic efficacy. Gayatri Pesticides Private Limited - Offering GPPL Gp Rogor Dimethoate 30% EC, 1 Litre, for Agriculture at Rs 320/liter in Indore, Madhya Pradesh. Anon. 1985; 15(Suppl 1):36-41. http://www.ncbi.nlm.nih.gov/pubmed/3936178?dopt=AbstractPlus, 21. Altman R. International experiences with diclofenac in osteoarthritis. Diovan (valsartan) capsules prescribing information (dated 1997 Apr). 64. Thanks for taking out time to give the review. Drug class: Nonsteroidal anti-inflammatory drugs, Diclofenac Extended Release Tablets 100mg. Reynolds JEF, ed. 184. S Afr Med J. 1986; 62:63-5. http://www.ncbi.nlm.nih.gov/pubmed/3797366?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=2418538&blobtype=pdf, 224. Cheminova Insecticide Rogor. 1986; 15:41-6. http://www.ncbi.nlm.nih.gov/pubmed/3008321?dopt=AbstractPlus, 29. 1987; 4:241-7. 2004; 126(Suppl):401S-28S. Hirsch U. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. Postgrad Med. Rheumatol Rehabil. Be the first to write the review | Write review. Drug interaction facts. Drug safety communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes. Morris BAP, Remtulla SS. Risks of agranulocytosis and aplastic anemia: a first report of their relation to drug use with special reference to analgesics. Gaz Med Fr. 1990; 18:104-11. http://www.ncbi.nlm.nih.gov/pubmed/2111251?dopt=AbstractPlus, 280. 1999; 26(Suppl 56):18-24. Weisman MH. 1987; 25:85-6. http://www.ncbi.nlm.nih.gov/pubmed/3315540?dopt=AbstractPlus. Eur J Clin Pharmacol. BMJ. Chest. 88. It can be applied by mixing 1-2 ml with a litre of water and spraying over the concerned plants. Reviewers’ comments (personal observations); 1989 Jul. Dysmenorrhoea and prostaglandins: pharmacological and therapeutic considerations. Drug-drug and drug-disease interactions with nonsteroidal anti-inflammatory drugs. Lancet. Smith Kline & French. 1989 Jan. 251. 1975; 24:641-3. http://www.ncbi.nlm.nih.gov/pubmed/804905?dopt=AbstractPlus, 27. 197. New York: Elsevier; 1988:66-72. 1995; 5:325-43. Morris BAP, Remtulla SS. Hawkey CJ. Ku EC, Wasvary JM, Cash WD. 1987; 2:1204-5. http://www.ncbi.nlm.nih.gov/pubmed/2890822?dopt=AbstractPlus, 158. Samuelson CO Jr, Williams HJ. South African multicentre trial with Voltaren in osteo- arthritis of the knee. In: Hansten PD, Horn JR. Drug interactions and updates. Topical … From European Medicines Agency website. J Pharm Sci. Small bowel perforation associated with an excessive dose of slow release diclofenac sodium. 1982; 57:289-96. http://www.ncbi.nlm.nih.gov/pubmed/6952058?dopt=AbstractPlus, 253. If NSAID treatment is deemed necessary between 20 to 30 weeks of pregnancy, limit use to the lowest effective dose and shortest duration possible. Leak AM, Richter MR, Clemens LE et al. 283. 104. Huskisson EC, Bryans R. Diclofenac sodium in the treatment of painful stiff shoulder. Effect of diclofenac and naproxen on gastroduodenal mucosa. Scand J Rheumatol. Kearney PM, Baigent C, Godwin J et al. Semin Arthritis Rheum. Ottobratica) from an Agusta Bell 47 G 2 fitted with a Vapo 54 spraying system … Polman HA, Huijbers WAR, Augusteijn R. The use of diclofenac sodium (Voltaren) suppositories as an antipyretic in children with fever due to acute infections: a double-blind, between-patient, placebo- controlled study. ), Apply 1 transdermal system (diclofenac epolamine 1.3%) twice daily.317, Some authorities (e.g., Health Canada) state that a total dose of 200 mg may be administered on the first day of treatment for dysmenorrhea but subsequent dosage should not exceed 100 mg daily.520 (See Cardiovascular Thrombotic Effects under Cautions. Harima Y, Maekawa T, Miyauchi Y et al. Giorn Chir. Am J Med. 1993; 19:5991. 1986; 7:1613-8. 1983; 9:21-3. http://www.ncbi.nlm.nih.gov/pubmed/6833624?dopt=AbstractPlus. Rheumatol Rehabil. 119. 254. FDA briefing document: Joint meeting of the arthritis advisory committee and the drug safety and risk management advisory committee, February 10-11, 2014. Nonsteroidal anti-inflammatory drug interactions: lithium-diclofenac. Diclofenac, a nonsteroidal anti-inflammatory drug, decreases proteinuria in some glomerular diseases: a controlled study. The United States Pharmacopeial Convention, Inc. Diclofenac sodium delayed-release tablets. 1996; 384:644-8. http://www.ncbi.nlm.nih.gov/pubmed/8967954?dopt=AbstractPlus, 287. 227. 156. Bahamonde LA, Saavedra H. Comparison of the analgesic and anti-inflammatory effects of diclofenac potassium versus piroxicam versus placebo in ankle sprain patients. 201. 508. J Allergy Clin Immunol. Vandenburg MJ, Currie WJC, Mann SG et al. 50 mg 3 times daily (as diclofenac potassium conventional tablets). Clin Exp Pharmacol Physiol. 1975; 3:139-44. http://www.ncbi.nlm.nih.gov/pubmed/162669?dopt=AbstractPlus. 1978; 22(Suppl):5-16. 315. Scand J Haematol. Novartis. Rahway, NJ: Merck & Co, Inc; 1983:447-8. 30. Clin Pharmacokinet. ), Commercially available diclofenac sodium enteric-coated tablets (e.g., Voltaren), diclofenac sodium extended-release tablets (e.g., Voltaren-XR), and diclofenac potassium immediate-release tablets are not necessarily bioequivalent on a mg-per-mg basis.1 302 303, Some authorities (e.g., Health Canada) recommend that systemic diclofenac dosage for inflammatory diseases not exceed 100 mg daily.520 (See Cardiovascular Thrombotic Effects under Cautions. George S, Rahi AHS. Accessed 2005 Oct 12. http://www.rheumatology.org, 309. 1984; 36:1203-09. 260. Am J Med. 1980; 87:2036-40. 1977; 2:231-2. http://www.ncbi.nlm.nih.gov/pubmed/406961?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1631372&blobtype=pdf, 169. each in an olive grove (var. Pharmacokinetics and metabolism of the anti- inflammatory agent Voltaren. Oradell, NJ: Medical Economics Company, Inc; 1989:2051-2. 265. Fatal hepatitis associated with diclofenac. Use of diclofenac in analgesia. 152. Jpn Med Gaz. 132. Can J Physiol Pharmacol. Salicylates: molecular mechanism of therapeutic action. Carson J, Notis WM, Orris ES. 1999; 340:1888-99. http://www.ncbi.nlm.nih.gov/pubmed/10369853?dopt=AbstractPlus, 293. Pleskow WW, Stevenson DD, Mathison DA et al. Montvale, NJ: Medical Economics Company Inc; 2002:2315-19. AMA drug evaluations. Children aged 5 to 12 years should be given one 5ml spoonful three to four times a day, 20 minutes to one hour after meals and at bedtime, as needed to relieve symptoms. A study on enhanced epileptogenicity of new quinolones in the presence of anti-inflammatory drugs. Diclofenac sodium in the treatment of primary nocturnal enuresis: double-blind crossover study. Am J Med. Kendall MJ, Thornhill DP, Willis JV. 274. A long-term study of diclophenac sodium in the treatment of rheumatoid arthritis and osteo-arthrosis. BMJ. 22. 1991; 19:165-70. http://www.ncbi.nlm.nih.gov/pubmed/1864453?dopt=AbstractPlus, 277. Mefenamic acid and diclofenac sodium in osteoarthritis of the weight bearing joints: a double blind comparison. 1991; 114:307-19. http://www.ncbi.nlm.nih.gov/pubmed/1987878?dopt=AbstractPlus. 155. 122. Ward JR. Efficacy of diclofenac in osteoarthritis. Zur Beziehung von in-vitro- und in-vivo-Untersuchungen beim Menschen am Beispiel von Diclofenac-Suppositorien. Perianin A, Gougerot-Pocidalo MA, Giroud JP et al. Harmful effects of NSAIDs among patients with hypertension and coronary artery disease. 1987; 31:553-7. http://www.ncbi.nlm.nih.gov/pubmed/3549320?dopt=AbstractPlus, 174. Broggini M, Corbetta E, Grossi E et al. 1981; 29:183-92. Semin Arthritis Rheum. Schumacher A, Faust-Tinnefeldt G, Geissler H et al. 59. 1988; 18:535-43. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 96. 151. 1985; 37:435-6. Philadelphia: Lea & Febiger; 1985:402,408. Richgro Garden Products—Rogor Insecticide. Pharmacology of diclofenac sodium. Variation in response to naproxen and diclofenac in patients with osteoarthritis. Biotransformation of diclofenac sodium (Voltaren) in animals and in man: I. Crop Protection Products. Car A, Jajic I, Krampac I et al. 206. Biochem Pharmacol. Drugs. 87. Nephron. 41. N Engl J Med. Lehtola J, Sipponen P. A gastroscopic and histological double-blind study of the effects of diclofenac sodium and naproxen on the human gastric mucosa. Crook PR, Willis JV, Kendall MJ et al. Mazeika PK, Ford MJ. Dapas F (Geigy, Ardsley, NY): Personal communication; 1989 Jul. Materials and methods Pesticide used The organophosphorous pesticide Rogor (O,O-dimethyl-S-N-methyl carbamoyl methyl- 30 TABLE 1 DOSE, CONCENTRATION AND MODE OF ADMINIS- TRATION OF ROGOR AND VITAMIN C IN DIFFER- ENT TEST SYSTEMS Test Dose/ Mode of concentration administration Onion root-tip cells Rogor 0.01% (30 ppm) Vitamin C 0.005% Mice Rogor … 1983; 10:32-9. Some of our popular products are fungicides such as Contaf, Contaf Plus, Master and Fujione, weedicides such as Fateh, Tata Metri, Tata Panida and … 1985; 39:276-281. http://www.ncbi.nlm.nih.gov/pubmed/3896286?dopt=AbstractPlus. Willis JV, Kendall MJ, Jack DB. You can also choose from liquid, powder rogor pesticide There are 41 suppliers who sells rogor pesticide on … Flector (diclofenac epolamine) topical patch prescribing information. Kanaya T, Kanda A, Saeki T et al. ), 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, Dosage adjustment not required.1 3 72 247 248 302 303, Reduction of oral dosage may be necessary.1 302 303, 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, Diclofenac sodium in fixed combination with misoprostol is contraindicated in pregnant women.284, 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, NSAIAs (selective COX-2 inhibitors, prototypical NSAIAs) increase the risk of serious adverse cardiovascular thrombotic events (e.g., MI, stroke) in patients with or without cardiovascular disease or risk factors for cardiovascular disease.500 502 508, Findings of FDA review of observational studies, meta-analysis of randomized controlled trials, and other published information500 501 502 indicate that NSAIAs may increase the risk of such events by 10–50% or more, depending on the drugs and dosages studied.500, Relative increase in risk appears to be similar in patients with or without known underlying cardiovascular disease or risk factors for cardiovascular disease, but the absolute incidence of serious NSAIA-associated cardiovascular thrombotic events is higher in those with cardiovascular disease or risk factors for cardiovascular disease because of their elevated baseline risk.500 502 506 508, Increased risk may occur early (within the first weeks) following initiation of therapy and may increase with higher dosages and longer durations of use.500 502 505 506 508, In controlled studies, increased risk of MI and stroke observed in patients receiving a selective COX-2 inhibitor for analgesia in first 10–14 days following CABG surgery.508, In patients receiving NSAIAs following MI, increased risk of reinfarction and death observed beginning in the first week of treatment.505 508, Increased 1-year mortality rate observed in patients receiving NSAIAs following MI;500 508 511 absolute mortality rate declined somewhat after the first post-MI year, but the increased relative risk of death persisted over at least the next 4 years.508 511, Some systematic reviews of controlled observational studies and meta-analyses of randomized studies suggest naproxen may be associated with lower risk of cardiovascular thrombotic events compared with other NSAIAs.312 313 314 316 500 501 502 503 506 FDA states that limitations of these studies and indirect comparisons preclude definitive conclusions regarding relative risks of NSAIAs.500, Findings from some meta-analyses and systematic reviews also suggest that cardiovascular risk of diclofenac, particularly at higher dosages (e.g., ≥150 mg daily), is similar to that observed with selective COX-2 inhibitors.312 313 501 503 506 520 521 Some authorities (e.g., Health Canada) now recommend that systemic diclofenac dosage not exceed 100 mg daily (except for first day of treatment for dysmenorrhea).520 (See Dosage under Dosage and Administration. The long-term efficacy and tolerability of Voltaren (diclofenac sodium) and indomethacin in rheumatoid arthritis. 196. Schubiger BI, Ciccolunghi SN, Tanner K. Once daily dose treatment with a non-steroidal anti- rheumatic drug (diclofenac) in osteoarthrosis. In: Avery GS, ed. 289. From the FDA web site. Woodhouse KW, Wynne H. The pharmacokinetics of non-steroidal anti-inflammatory drugs in the elderly. Impiego di un F.A.N.S. 1984; 3:1-21. J Int Med Res. Palmer JF. Diclofenac-induced hepatotoxicity. Arthritis Rheum. A guideline for the treatment and prevention of NSAID-induced ulcers. Granulomatous interstitial nephritis after nonsteroidal anti-inflammatory drugs. Drugs for rheumatoid arthritis. J Int Med Res. In: Hart FD, ed. Zimmerer J, Tittor W, Degen P. Rheuma-therapie bei Leberkranken. Do nonsteroidal antiinflammatory drugs reduce the risk of Alzheimer’s disease? Lancet. For over-the-counter (OTC) NSAIDs intended for use in adults, FDA will also update the Drug Facts labels, available at: [Web]. Different pharmacological approaches to the treatment of acute biliary colic. From Health Canada website. 1996; 47:425-32. http://www.ncbi.nlm.nih.gov/pubmed/8757015?dopt=AbstractPlus, 297. Voltaren (diclofenac sodium enteric-coated tablets) prescribing information. Piper JM, Ray WA, Daugherty JR et al. 1979; 18(Suppl 2):60-8. Seishin Igaku. 1987; 76:105-8. http://www.ncbi.nlm.nih.gov/pubmed/3572745?dopt=AbstractPlus, 67. Rogor is a contact & systemic organophosphate insecticide providing quick knockdown used to manage insect pests such as bug, stem borer, shoot fly, aphids, thrips, beetles etc. 15. Pharmacokinetics of diclofenac sodium after intramuscular administration in combination with triamcinolone acetate. 1977; 84:3547- 54. 1994; 343:769-72. http://www.ncbi.nlm.nih.gov/pubmed/7907735?dopt=AbstractPlus, 268. 1988; 47:791. http://www.ncbi.nlm.nih.gov/pubmed/3178321?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1003601&blobtype=pdf, 210. Riess W, Stierlin H, Degen P et al. Becherucci A, Bagilet D, Marenghini J et al. Merck Sharp & Dohme. 296. It acts … 1982; 27:624-35. http://www.ncbi.nlm.nih.gov/pubmed/6953009?dopt=AbstractPlus, 36. Chou R, Helfand M, Peterson K et al. Effective postoperative pain control by preoperative injection of diclofenac. 27 Feb 2003. JAMA. 1986; 40:876- 82. 5th ed. 1984; 8:881- 2. http://www.ncbi.nlm.nih.gov/pubmed/6526249?dopt=AbstractPlus, 215. 1987; 7:198-202. http://www.ncbi.nlm.nih.gov/pubmed/3307414?dopt=AbstractPlus, 34. 1986; 36:118-20. http://www.ncbi.nlm.nih.gov/pubmed/3952461?dopt=AbstractPlus, 226. Court H, Volans GN. Corticosteroid interactions: nonsteroidal anti-inflammatory drugs (NSAIDs). 1980; 28:359-66. Ann Intern Med. 1986; 31:363-5. http://www.ncbi.nlm.nih.gov/pubmed/3792436?dopt=AbstractPlus, 179. Kantor TG. The effects of diclofenac sodium on arachidonic acid metabolism. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Increased mortality and cardiovascular morbidity associated with use of nonsteroidal anti-inflammatory drugs in chronic heart failure. VanArsdel PP Jr. Aspirin idiosyncracy and tolerance. Scand J Rheumatol. 284. Eur J Clin Pharmacol. Bernheim HA, Block LH, Atkins E. Fever: pathogenesis, pathophysiology, and purpose. Passage du diclofénac sodium dans le liquide synovial. ), 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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