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Diclofenac

Brand Name: Cataflam, Voltaren-XR, Dyloject, Cambia, Zipsor, Zorvolex

Generic Name: diclofenac

Drug Class: NSAIDs

What Is Diclofenac and How Does It Work?

Diclofenac is indicated for treatment of primary dysmenorrhea, for relief of mild to moderate pain, for relief of the signs and symptoms of osteoarthritis, for relief of the signs and symptoms of rheumatoid arthritis, for relief of symptoms of ankylosing spondylitis and for relief of acute migraine symptoms.

Diclofenac has analgesic, anti-inflammatory, and antipyretic properties.

Diclofenac is available under the following different brand names: Cataflam, Voltaren-XR, Dyloject, Cambia, Zipsor, and Zorvolex.

What Are Dosages of Diclofenac?

Dosages of Diclofenac:

Adult and Pediatric Dosage Forms & Strengths

Tablet as potassium

Tablet delayed-release as sodium

  • 25 mg
  • 50 mg
  • 75 mg

Tablet, extended-release

  • 100 mg

Capsule (Adult Only)

  • 18 mg
  • 25 mg
  • 35 mg

Powder packet for oral solution

  • 50 mg

Solution for IV injection (Adult Only)

  • 37.5mg/mL (Dyloject)

Dosage Considerations – Should be Given as Follows:

Rheumatoid Arthritis

Diclofenac potassium:

  • 50 mg orally every 8-12 hours
  • Diclofenac sodium: 50 mg orally every 8 hours or 75 mg orally every 12 hours
  • Extended-release: 100 mg orally once daily; may be increased to 100 mg orally every 12 hours

Osteoarthritis

  • Diclofenac potassium: 50 mg orally every 8-12 hours
  • Diclofenac sodium: 50 mg orally every 8 hours or 75 mg orally every 12 hours
  • Extended-release: 100 mg orally once daily; may be increased to 100 mg orally every 12 hours
  • Zorvolex: 35 mg orally three times/day

Juvenile Idiopathic arthritis (Off-label)

  • Safety and efficacy not established; the drug has been used safely in a limited number of children aged 3-16 years with juvenile rheumatoid arthritis
  • Children younger than 3 years: Safety and efficacy not established
  • Children 3 years and older: 2-3 mg/kg/day for up to 4 weeks

Ankylosing Spondylitis

  • Diclofenac sodium: 25 mg orally 4 or 5 times daily
  • Diclofenac potassium: 50 mg orally every 12 hours

Dysmenorrhea

  • Immediate-release (Cataflam): 100 mg orally once, then 50 mg orally every 8 hours as needed

Mild-to-Moderate Acute Pain

  • Immediate-release tab (Cataflam): 100 mg orally once, then 50 mg orally every 8 hours as needed
  • Zipsor: 25 mg orally four times/day as needed
  • Zorvolex: 18 mg or 35 mg orally three times/day

Pain (IV Administration)

  • Indicated for management of mild-to-moderate pain and moderate-to-severe pain alone or in combination with opioid analgesics
  • Use for the shortest duration consistent with individual patient treatment goals
  • 37.5 mg intravenous (IV) bolus injection infused over 15 seconds every 6 hours as needed, not to exceed 150 mg/day
  • To reduce the risk of renal adverse reactions, patients must be well hydrated before IV administration

Acute Migraine

  • Oral solution: 50 mg (1 packet) in 30-60 mL of water, mixed well and drunk immediately
  • Not for prophylaxis

Dosing Considerations

  • Diclofenac potassium: Cambia, Cataflam, Zipsor
  • Diclofenac sodium: Voltaren XR

Administration

  • Take with food or 8-12 oz of water to avoid GI adverse effects
  • Zorvolex: Take on an empty stomach; food decreases AUC by 11% and peak concentration by 60%
  • Oral solution: Do not use liquids other than water to reconstitute; foods decrease the effectiveness
  • It May be combined with misoprostol

What Are Side Effects Associated with Using Diclofenac?

Side effects associated with the use of Diclofenac, include the following:

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

What Other Drugs Interact with Diclofenac?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Severe interactions of diclofenac include:

  • None

Serious Interactions of diclofenac include:

Diclofenac has moderate interactions with at least 247 different drugs.

Diclofenac has mild interactions with at least 109 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

What Are Warnings and Precautions for Diclofenac?

Warnings

  • Gastrointestinal risk
    • NSAIDs increase the risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
    • GI adverse events may occur at any time during use and without warning symptoms
    • Elderly patients are at greater risk for serious GI events

This medication contains diclofenac. Do not take Cataflam, Voltaren-XR, Dyloject, Cambia, Zipsor, or Zorvolex if you are allergic to diclofenac or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

  • Absolute: Hypersensitivity to diclofenac, history of aspirin triad, treatment of perioperative pain associated with CABG; active gastrointestinal bleeding
  • IV: Moderate-to-severe renal insufficiency in the perioperative period and patients who are at risk for volume depletion
  • Zipsor capsules are contraindicated in patients with a history of hypersensitivity to bovine protein

Effects of Drug Abuse

  • The agent is a potent diuretic that, if given in excessive amounts, may lead to a profound diuresis with water and electrolyte depletion

Short-Term Effects

  • Increase in transaminase levels reported within 2 months of therapy; may occur at any time; monitor transaminase levels periodically beginning 4-8 weeks after initiation of therapy
  • See "What Are Side Effects Associated with Using Diclofenac?"

Long-Term Effects

  • Long-term administration of NSAIDs may result in renal papillary necrosis and another renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
  • See "What Are Side Effects Associated with Using Diclofenac?"

Cautions

Pregnancy and Lactation

  • Use caution in patients with bronchospasm, cardiac disease, CHF, hepatic porphyria, hypertension, fluid retention, severe renal impairment, smoking, systemic lupus erythematosus
  • Platelet aggregation and adhesion may be decreased; may prolong bleeding time
  • Use caution in blood dyscrasias or bone marrow depression; also with thrombocytopenia, agranulocytosis, and aplastic anemia
  • Long-term administration of NSAIDs may result in renal papillary necrosis and another renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
  • Therapy may increase the risk of hyperkalemia, especially in renal disease, diabetics, the elderly, and concomitant use of agents that may induce hyperkalemia; monitor potassium closely
  • May cause dizziness blurred vision and neurologic effects that may impair physical and mental abilities
  • Risk of serious skin reactions, including Stevens-Johnson syndrome and necrotizing enterocolitis
  • Persistent urinary symptoms, including bladder pain and dysuria, hematuria, or cystitis may occur after initiating therapy; discontinue therapy with symptom onset and evaluate the cause
  • Increase in transaminase levels reported within 2 months of therapy; may occur at any time; monitor transaminase levels periodically beginning 4-8 weeks after initiation of therapy
  • May increase risk of aseptic meningitis (rare), especially in patients with systemic lupus erythematosus, and mixed connective tissue disorders
  • Use caution if the patient is dehydrated before initiating therapy; rehydrate the patient before initiating therapy and monitor renal function closely
  • Injectable dosage form not recommended for long-term use
  • Different formulations are not bioequivalent even if the milligram strength is the same; do not interchange products
  • Withhold for at least 4-6 half-lives before surgical or dental procedures
  • Heart failure risk:
    • Avoid the use of diclofenac in late pregnancy (may cause premature closure of ductus arteriosus). After 30 weeks gestation, use diclofenac only in LIFE-THREATENING emergencies when no safer drug is available. There is positive evidence of human fetal risk
    • Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to non-aspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and approximately 2.6% of controls
    • Diclofenac is excreted in breast milk; it is not recommended for use while breastfeeding