Usual Adult Dose for Osteoarthritis

Diclofenac free acid capsules: 35 mg orally 3 times a day
Diclofenac potassium immediate-release tablets: 50 mg orally 2 or 3 times a day
Diclofenac sodium enteric-coated tablets: 50 mg orally 2 or 3 times a day or 75 mg orally 2 times a day
Maximum dose: 150 mg daily

Diclofenac sodium extended-release tablets: 100 mg orally once a day

Use: For the relief of signs and symptoms of osteoarthritis.

Usual Adult Dose for Ankylosing Spondylitis

Diclofenac sodium enteric-coated and delayed-release tablets: 25 mg orally 4 times a day. An additional 25 mg dose may be administered at bedtime, if necessary
Maximum dose: 125 mg per day

Use: For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.

Usual Adult Dose for Dysmenorrhea

Diclofenac potassium immediate-release tablets: 50 mg orally 3 times a day

Comments: An initial dose of 100 mg orally followed by 50 mg oral doses may provide better relief for some patients; initiate treatment upon appearance of the first symptoms and continue for a few days.

Use: For the relief of signs and symptoms of primary dysmenorrhea.

Usual Adult Dose for Rheumatoid Arthritis

Diclofenac potassium immediate-release tablets: 50 mg orally 3 or 4 times a day
Diclofenac sodium enteric-coated and delayed-release tablets: 50 mg orally 3 to 4 times a day or 75 mg orally twice a day
Maximum dose: 225 mg daily

Diclofenac sodium extended-release tablets: 100 mg orally once a day
Maximum dose: 100 mg orally 2 times a day; this would be for the rare patient in whom the benefits outweigh the clinical risks.

For the relief of signs and symptoms of rheumatoid arthritis

Usual Adult Dose for Migraine

Diclofenac potassium for oral solution packets: 50 mg (1 packet) orally once

Comments: This drug is not indicated for the prophylactic therapy of migraine or for use in cluster headaches; the safety and efficacy of a second dose has not been established.

Use: For acute treatment of migraine with or without aura.

Usual Adult Dose for Pain

Oral:
Diclofenac potassium liquid-filled capsules: 25 mg orally 4 times a day
Diclofenac free acid capsules: 18 mg or 35 mg orally 3 times a day
Diclofenac potassium immediate-release tablets: 50 mg orally 3 times a day; an initial dose of 100 mg orally followed by 50 mg oral doses may provide better relief in some patients.

Comment: Neither the diclofenac potassium liquid filled capsules nor the diclofenac free acid capsules are interchangeable with each other or with other diclofenac products containing the sodium or potassium salt.

Parenteral:
37.5 mg IV bolus over 15 seconds every 6 hours as needed for pain
Maximum Dose: 150 mg per day

Comment: Patients should be well hydrated prior to IV administration of this drug in order to reduce the risk of adverse renal reactions.

Uses: For the management of mild to moderate acute pain (oral, IV) and moderate to severe pain alone or in combination with opioid analgesics (IV).

Usual Pediatric Dose for Pain

Diclofenac potassium liquid-filled capsules:
12 years and older: 25 mg orally four times a day

Comments:

• Use the lowest effective dose for the shortest duration consistent with treatment goals.

Use: Mild to moderate acute pain

Renal Dose Adjustments

Oral:
Use with caution in patients with advanced renal disease; if treatment is initiated, close monitoring of renal function is recommended.

Parenteral:
Moderate to severe renal insufficiency in the perioperative period and at risk for volume depletion: Use is contraindicated
Moderate to severe renal impairment: Use is not recommended

Liver Dose Adjustments

Oral:
Use with caution; patients with hepatic disease may require reduced doses; start at the lowest dose, if efficacy is not achieved, consider drug discontinuation.

Parenteral:
Mild hepatic impairment: No dosage adjustment recommended
Moderate to severe hepatic impairment: Use is not recommended

Dose Adjustments

• Use the lowest effective dose for the shortest possible duration.
• No dose adjustments are recommended based on body weight.

Precautions

US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
• NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.

CONTRAINDICATIONS:

• Known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions ) to the active component or to any of the ingredients
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
• Use the setting of coronary artery bypass graft (CABG) surgery

Additional AU and UK Contraindications:

• Active, gastric or duodenal ulcer, gastrointestinal (GI) bleeding or perforation or history of GI bleeding or perforation, related to previous NSAID therapy
• Active, or history of recurrent peptic ulcer/hemorrhage (2 or more distinct episodes)
• Last trimester of pregnancy
• Severe hepatic, renal, or cardiac failure
• Established congestive heart failure (NYHA II to IV), ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease

Product specific Contraindications:
PARENTERAL USE:

• Moderate or severe renal impairment (serum creatinine greater than 160 micromole/L)
• Patients at risk for volume depletion, hypovolemia or dehydration from any cause

Additional UK Contraindications

• Concomitant NSAID or anticoagulant use (including low dose heparin)
• History of hemorrhagic diathesis, a history of confirmed or suspected cerebrovascular bleeding
• Operations associated with a high risk of hemorrhage

SUPPOSITORY:

• Ulcerative or acute inflammatory conditions of the anus, rectum (proctitis), and sigmoid colon

Safety and efficacy have not been established in patients younger than 12 years (oral liquid filled capsules) to 18 years (other formulations).

Consult WARNINGS section for additional precautions.

Dialysis

Diclofenac is not expected to be removed by dialysis due to its high degree of protein binding.

Other Comments

Administration advice:
Oral:

• Enteric coated: Swallow whole with liquid, preferably before meals
• Immediate-release, extended or modified-release tablets: Swallow whole with liquid preferably with or after meals
• Liquid-filled capsules and Powder for Oral Solution: Take on empty stomach;
• Powder for Oral Solution: Empty contents of a single 50 mg packet into 1 to 2 ounces of water, mix well and drink immediately; taking with food may reduce efficacy.

Parenteral:

• For IV administration only; give by IV bolus over 15 seconds
• Patients should be well hydrated prior to administration

Storage:
Injection for IV use: Protect from light; Do not freeze; Store at controlled room temperature 20C to 25C (68F to 77F)

General:

• Formulations of diclofenac are not bioequivalent or interchangeable.
• This drug is not indicated for the prophylactic therapy of migraine or for use in cluster headaches.
• Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Monitoring:

• Blood pressure should be monitored closely during initiation and throughout course of therapy.
• Monitor for signs/symptoms of gastrointestinal bleeding.
• Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.
• Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy.

Patient advice:

• Patients should seek medical advice for signs and symptoms of cardiovascular events, gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
• Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; NSAIDs should not be used at 20 weeks or later in pregnancy unless specifically advised to do so by their health care professional.
• Patients should talk to their health care provider before they use over the counter analgesics.

Frequently asked questions

• Which painkiller should you use?
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• Why is diclofenac prescription only but ibuprofen is OTC?
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• Does the drug diclofenac have narcotics in it?