Diclofenac Epolamine

DEA Class; Rx

Diclofenac (potassium/sodium)

Common Brand Names; Cataflam, Voltaren-XR, Dyloject, Cambia, Zipsor, Zorvolex

Diclofenac topical (Rx, OTC)

NSAIDs

NSAID available in intravenous, oral, topical, and ophthalmic formulations

Analgesic and antipyretic properties

Increases risk of serious GI events and may increase risk of serious CV events; use lowest dose for shortest time

Rheumatoid Arthritis,  Osteoarthritis, Ankylosing Spondylitis, Dysmenorrhea 

Acute Pain

Indicated for treatment of mild to moderate acute pain in adults

Acute Migraine

Indicated for acute treatment of migraine attacks with or without aura, Not for prophylaxis. Use lowest effective dose for shortest duration consistent with individual patient treatment goals

Indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions

Hypersensitivity (eg, anaphylaxis, serious skin reactions) to diclofenac or any components of the product

History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

In the setting of coronary artery bypass graft (CABG) surgery

Zipsor capsules are contraindicated in patients with history of hypersensitivity to bovine protein

>10%

Zorvolex

Edema (33%)

Nausea (27%)

Headache (13%)

Zipsor

Nausea (16.5%)

Headache (12.5%)

1-10%

Cambia

Nausea (3%)

Dizziness (1%)

Diclofenac potassium tablets

Abdominal pain

Constipation

Diarrhea

Dyspepsia

Flatulence

Gross bleeding/perforation

Heartburn

Nausea

GI ulcers (gastric/duodenal)

Vomiting

Abnormal renal function

Anemia

Dizziness

Ophthalmic Solution (Voltaren Ophthalmic)

Mild ocular stinging, irritation

May slow corneal wound healing

Lacrimation

Increased IOP

Keratitis

Dizziness

Insomnia

Pain

Fever

Chills

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 other 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

Increase risk of hyperkalemia may occur, especially in renal disease, diabetics, the elderly, and concomitant use of agents that may induce hyperkalemia; monitor potassium closely

Pregnancy; There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive

Lactation; The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition

Adults

Rheumatoid Arthritis

Diclofenac potassium: 50 mg PO q8-12hr

Diclofenac sodium: 50 mg PO q8hr or 75 mg PO q12hr

Extended release: 100 mg PO once daily; may be increased to 100 mg PO q12hr

Osteoarthritis

Diclofenac potassium: 50 mg PO q8-12hr

Diclofenac sodium: 50 mg PO q8hr or 75 mg PO q12hr

Extended release: 100 mg PO once daily; may be increased to 100 mg PO q12hr

Zorvolex: 35 mg PO TID

Ankylosing Spondylitis

Diclofenac sodium: 25 mg PO 4 or 5 times daily

Diclofenac potassium: 50 mg PO q12hr

Dysmenorrhea

Immediate-release: 100 mg PO once, then 50 mg PO q8hr PRN

Acute Pain

Indicated for treatment of mild to moderate acute pain in adults

Immediate-release tablets: 100 mg PO once, then 50 mg PO q8hr PRN

Extended-release tablets

Zipsor: 25 mg PO QID PRN

Zorvolex: 18 mg or 35 mg PO TID

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goal

Acute Migraine

Indicated for acute treatment of migraine attacks with or without aura

Cambia: 50 mg (1 packet) in 30-60 mL of water, mixed well and drunk immediately

Not for prophylaxis

Use lowest effective dose for shortest duration consistent with individual patient treatment goals

Pediatric 

Acute Pain

Zipsor only

Indicated for relief of mild-to-moderate pain in adult and pediatric patients aged ≥12 years

<12 years: Safety and efficacy not established

≥12 years: 25 mg PO QID PRN

Diclofenac potassium

Packet

• 50mg/single-dose packet (generic, Cambia)
• Delivers 50-mg dose when mixed in water

Tablet

• 50mg (generic)
• capsule
• 25mg (Zipsor)

Diclofenac sodium

Tablet, delayed release

• 25mg (generic)
• 50mg (generic)
• 75mg (generic)

Tablet, extended-release

• 100mg (generic)

Capsule

• 18mg (Zorvolex)
• 35mg (Zorvolex)

Ophthalmic solution

• 0.1%

Topical Diclofenac

Gel

• diclofenac sodium
• 1% (Voltaren Gel, Voltaren Arthritis Pain [OTC])
• 3% (Solaraze Gel)

Patch

• diclofenac epolamine
• 1.3% (180mg) (Flector)

Topical solution (Pennsaid)

• diclofenac sodium
• 1.5% (16.05mg/mL; dropper bottle)
• 2% (20mg/pump actuation)

Topical system

• diclofenac epolamine
• 1.3% (Licart)