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Diclofenac Sodium

    Brands

    DEA Class; Rx, 

    Diclofenac (potassium/sodium)

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

     

    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

    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%