No

Nonsteroidal Anti-Inflammatory Agent (NSAID)

Acute treatment of mild to moderate pain; acute and chronic treatment of rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis; used for juvenile rheumatoid arthritis, gout, dysmenorrhea; ophthalmic solution for postoperative inflammation after cataract extraction

B (D in 3rd trimester)

Known hypersensitivity to diclofenac, any component, aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs); porphyria

Use with caution in patients with congestive heart failure, dehydration, hypertension, decreased renal or hepatic function, history of GI disease, or those receiving anticoagulants

>10%:

Dermatologic: Rash

Gastrointestinal: Abdominal cramps, heartburn, indigestion, nausea

1% to 10%:

Cardiovascular: Angina pectoris, arrhythmias

Central nervous system: Dizziness, nervousness

Dermatologic: Itching

Gastrointestinal: GI ulceration, vomiting

Genitourinary: Vaginal bleeding

Otic: Tinnitus

<1%: Chest pain, congestive heart failure, hypertension, tachycardia, convulsions, forgetfulness, mental depression, drowsiness, insomnia, urticaria, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, angioedema, stomatitis, cystitis, agranulocytosis, anemia, pancytopenia, leukopenia, thrombocytopenia, hepatitis, peripheral neuropathy, trembling, weakness, blurred vision, change in vision, decreased hearing, interstitial nephritis, nephrotic syndrome, renal impairment, wheezing, laryngeal edema, shortness of breath, epistaxis, anaphylaxis, diaphoresis (increased)

Symptoms of overdose include acute renal failure, vomiting, drowsiness, leukocytosis

Management of a nonsteroidal anti-inflammatory drug (NSAID) intoxication is primarily supportive and symptomatic. Fluid therapy is commonly effective in managing the hypotension that may occur following an acute NSAID overdose, except when this is due to an acute blood loss.

CYP2C8 and 2C9 enzyme substrate; CYP2C9 enzyme inhibitor

Increased toxicity of digoxin, methotrexate, cyclosporine, lithium, insulin, sulfonylureas, potassium-sparing diuretics, aspirin

Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclo-oxygenase, which results in decreased formation of prostaglandin precursors

Onset of action: Cataflam® has a more rapid onset of action than does the sodium salt (Voltaren®), because it is absorbed in the stomach instead of the duodenum

Protein binding: 99%

Metabolism: In the liver to inactive metabolites

Half-life: 2 hours

Time to peak serum concentration: Cataflam®: Within 1 hour; Voltaren®: Within 2 hours

Elimination: Primarily in urine

Adults:

Analgesia: Starting dose: 50 mg 3 times/day

Rheumatoid arthritis: 150-200 mg/day in 2-4 divided doses (100 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: Instill 1 drop into affected eye 4 times/day beginning 24 hours after cataract surgery and continuing for 2 weeks

May be taken with food to decrease GI distress

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

May cause nervousness or dizziness; may rarely cause depression

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

No information available to require special precautions

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®).

Oral: Take this medication exactly as directed; do not increase dose without consulting prescriber. Do not crush or chew tablets. Take with 8 ounces of water, along with food or milk products to reduce GI distress. Maintain adequate fluid intake (2-3 L/day of fluids unless instructed to restrict fluid intake). Avoid excessive alcohol, aspirin and aspirin-containing medication, and all 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 (frequent small meals, frequent mouth care, sucking lozenges, or chewing gum may help); or constipation (increased exercise, fluids, or dietary fruit and 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 difficulty breathing; unusual bruising/bleeding or blood in urine, stool, mouth, or vomitus; unusual fatigue; skin rash or itching; unusual weight gain or swelling of extremities; change in urinary pattern; change in vision or hearing; or ringing in ears. Pregnancy/breast-feeding precautions: Consult prescriber if pregnant or breast-feeding.

Ophthalmic: For ophthalmic use only. Apply prescribed amount as often as directed. Wash hands before using and do not let tip of applicator touch eye or contaminate tip of applicator. Tilt head back and look upward. Gently pull down lower lid and put drop(s) in inner corner of eye. Close eye and roll eyeball in all directions. Do not blink for 1/2 minute. 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 touch tip of applicator to eye or contaminate tip of applicator. 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 disturbances, or other adverse eye response; worsening of condition or lack of improvement. Consult prescriber if pregnant or breast-feeding.

Do not crush tablets

Solution, ophthalmic, as sodium (Voltaren®): 0.1% (2.5 mL, 5 mL)

Tablet, enteric coated, as sodium: 25 mg, 50 mg, 75 mg

Voltaren®: 25 mg, 50 mg, 75 mg

Tablet, delayed release: 25 mg, 50 mg, 75 mg

Tablet, extended release, as sodium (Voltaren®-XR): 100 mg

Tablet, as potassium (Cataflam®): 50 mg

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, Ostick G, "Absence of Abdominal Pain in Elderly Patients With Peptic Ulcer," Age Ageing, 1984, 13:120-3.

Clive DM, Stoff JS, "Renal Syndromes Associated With Nonsteroidal Anti-inflammatory Drugs," N Engl J Med, 1984, 310(9):563-72.

Court H and Volans GN, "Poisoning After Overdose With Nonsteroidal Anti-inflammatory Drugs," Adverse Drug React Acute Poisoning Rev, 1984, 3(1):1-21.

"Drugs for Pain," Med Lett Drugs Ther, 1998, 40(1033):79-84.

George S and Rahi AH, "Thrombocytopenia Associated With Diclofenac Therapy," Am J Health Syst Pharm, 1995, 52(4):420-1.

Graham DY, "Prevention of Gastroduodenal Injury Induced by Chronic Nonsteroidal Anti-inflammatory Drug Therapy," Gastroenterology, 1989, 96(2 Pt 2 Suppl):675-81.

Gurwitz JH, Avorn J, Ross-Degnan D, et al, "Nonsteroidal Anti-Inflammatory Drug-Associated Azotemia in the Very Old," JAMA, 1990, 264(4):471-5.

Haapasaari J, Wuolijoki E, and Ylijoki H, "Treatment of Juvenile Rheumatoid Arthritis With Diclofenac Sodium" Scand J Rheumatol, 1983, 12(4):325-30.

Hawkey CJ, Karrasch JA, Szczepanski L, et al, "Omeprazole Compared With Misoprostrol for Ulcers Associated With Nonsteroidal Anti-inflammatory Drugs," N Engl J Med, 1998, 338(11):727-34.

Helfgott SM, Sandberg-Cook J, Zakim D, et al, "Diclofenac-Associated Hepatotoxicity," JAMA, 1990, 264(20):2660-2.

Hoppmann RA, Peden JG, and Ober SK, "Central Nervous System Side Effects of Nonsteroidal Anti-inflammatory Drugs. Aseptic Meningitis, Psychosis, and Cognitive Dysfunction," Arch Intern Med, 1991, 151(7):1309-13.

Isdale A and Wright V, "Misoprostol/NSAID Fixed Combinations. Help or Hindrance in Clinical Practice?" Drug Saf, 1995, 12(5):291-8.

Kulling EJ, Beckman EA, and Skagius AS, "Renal Impairment After Acute Diclofenac, Naproxen, and Sulindac Overdoses," J Toxicol Clin Toxicol, 1995, 33(2):173-7.

Pillans PI and O'Connor N, "Tissue Necrosis and Necrotizing Fasciitis After Intramuscular Administration of Diclofenac," Ann Pharmacother, 1995, 29(3):264-6.

Pounder R, "Silent Peptic Ulceration: Deadly Silence or Golden Silence?" Gastroenterology, 1989, 96(2 Pt 2 Suppl):626-31.

Robinson MH, Wheatley T, and Leach IH, "Nonsteroidal Anti-inflammatory Drug-Induced Colonic Stricture; an Unusual Cause of Large Bowel Obstruction and Perforation," Dig Dis Sci, 1995, 40(2):315-9.

Robinson PM and Ahmed I, "Diclofenac and Post-tonsillectomy Haemorrhage," Clin Otolaryngol, 1994, 19(4):344-5.

Smolinske SC, Hall AH, Vandenberg SA, et al, "Toxic Effects of Nonsteroid Anti-inflammatory Drugs in Overdose. An Overview of Recent Evidence on Clinical Effects and Dose-Response Relationships," Drug Saf, 1990, 5(4):252-74.

Vale JA and Meredith TJ, "Acute Poisoning Due to Nonsteroidal Anti-inflammatory Drugs," Med Toxicol, 1986, 1(1):12-31.

Verbeeck RK, "Pharmacokinetic Drug Interactions With Nonsteroidal Anti-inflammatory Drugs," Clin Pharmacokinet, 1990, 19(1):44-66.

Willkens RF, "Worldwide Clinical Safety Experience With Diclofenac," Semin Arthritis Rheum, 1985, 15(2 Suppl 1):105-10.

Yeomans ND, Tulassay Z, Juhasz L, et al, "A Comparison of Omeprazole With Ranitidine for Ulcers Associated With Nonsteroidal Anti-inflammatory Drugs," N Engl J Med, 1998, 338(11):719-26.