Drug Notebook

FDA Alerts

    Cardiovascular Risk
  • Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke). Risk may increase with duration of use. Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk. (See Cardiovascular Effects under Cautions.)
  • Contraindicated for the treatment of pain in the setting of CABG surgery.

    GI Risk
  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine). Serious GI events can occur at any time and may not be preceded by warning signs and symptoms. Geriatric individuals are at greater risk for serious GI events. (See GI Effects under Cautions.)

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diclofenac
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(dye KLOE fen ak)

Uses

Consider potential benefits and risks of diclofenac therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.

Inflammatory Diseases

Symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

Used in fixed combination with misoprostol for the symptomatic treatment of osteoarthritis and rheumatoid arthritis in patients at high risk for developing NSAIA-induced gastric or duodenal ulcers and in patients at high risk for developing complications from these ulcers.

Management of juvenile rheumatoid arthritis†.

Symptomatic relief of acute gouty arthritis†.

Symptomatic treatment of infusion-related superficial thrombophlebitis†.

Pain

Relief of pain, including postoperative (e.g., orthopedic, gynecologic, oral) pain, in adults.

Dysmenorrhea

Symptomatic management of primary dysmenorrhea.

Dosage and Administration

General

  • Consider potential benefits and risks of diclofenac therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Oral Administration

Diclofenac sodium delayed-release (enteric-coated) and extended-release tablets are not recommended for relief of acute pain or primary dysmenorrhea because of slow onset of action.

Dosage

Available as diclofenac potassium or diclofenac sodium; dosage expressed in terms of the salt.

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.

Commercially available diclofenac sodium enteric-coated tablets (Voltaren®), diclofenac sodium extended-release tablets (Voltaren®-XR), and diclofenac potassium immediate-release tablets (Cataflam®) are not necessarily bioequivalent on a mg-per-mg basis.

Adults

Inflammatory Diseases

Osteoarthritis
Oral
Preparation Dosage
Diclofenac potassium conventional tablets 100–150 mg daily, given as 50 mg 2 or 3 times daily
Diclofenac sodium delayed-release tablets 100–150 mg daily, given as 50 mg 2 or 3 times daily or 75 mg twice daily
Diclofenac sodium extended-release tablets 100 mg once daily
Diclofenac sodium (in fixed combination with misoprostol) 50 mg 3 times daily
May change dosage to 50 or 75 mg twice daily in patients who do not tolerate usual dosage; however, these dosages may be less effective in preventing NSAIA-induced ulcers.
Rheumatoid Arthritis
Oral
Preparation Dosage
Diclofenac potassium conventional tablets 150–200 mg daily, given as 50 mg 3 or 4 times daily
Diclofenac sodium delayed-release tablets 150–200 mg daily, given as 50 mg 3 or 4 times daily or 75 mg twice daily
Diclofenac sodium extended-release tablets 100 mg once daily; may increase to 100 mg twice daily
Diclofenac sodium (in fixed combination with misoprostol) 50 mg 3 or 4 times daily
May change dosage to 50 or 75 mg twice daily in patients who do not tolerate usual dosage; however, these dosages may be less effective in preventing NSAIA-induced ulcers.
Ankylosing Spondylitis
Oral

100–125 mg daily (as diclofenac sodium delayed-release tablets); administer as 25 mg 4 times daily, with 5th dose at bedtime as needed.

Pain

Oral

50 mg 3 times daily (as diclofenac potassium conventional tablets). Some patients may benefit from initial dose of 100 mg (followed by 50-mg doses).

Dysmenorrhea

Oral

50 mg 3 times daily (as diclofenac potassium conventional tablets). Some patients may benefit from initial dose of 100 mg (followed by 50-mg doses).

Special Populations

Dosage in Renal Impairment

Dosage adjustment not required.

Hepatic Impairment

Dosage reductions may be necessary.

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