diclofenac (Rx)

Brand and Other Names:Cataflam, Voltaren-XR, more...Dyloject, Cambia, Zipsor, Zorvolex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet as potassium

  • 50mg

tablet delayed release as sodium

  • 25mg
  • 50mg (Cataflam)
  • 75mg

tablet, extended-release

  • 100mg (Voltaren XR)

capsule

  • 18mg (Zorvolex)
  • 25mg (Zipsor)
  • 35mg (Zorvolex)

powder packet for oral solution

  • 50mg packet (Cambia)

solution for IV injection

  • 37.5mg/mL (Dyloject)
more...

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 (Cataflam): 100 mg PO once, then 50 mg PO q8hr PRN

Mild-to-Moderate Acute Pain

Immediate-release tab (Cataflam): 100 mg PO once, then 50 mg PO q8hr PRN

Zipsor: 25 mg PO QID PRN

Zorvolex: 18 mg or 35 mg PO TID

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 IV bolus injection infused over 15 seconds q6hr as needed, not to exceed 150 mg/day

To reduce the risk of renal adverse reactions, patients must be well hydrated prior to 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 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 effectiveness

May be combined with misoprostol

Dosage Forms & Strengths

tablet as potassium

  • 50mg

tablet delayed release as sodium

  • 25mg
  • 50mg (Cataflam)
  • 75mg

tablet, extended-release

  • 100mg (Voltaren XR)

powder packet for oral solution

  • 50mg packet (Cambia)
more...

Juvenile Idiopathic arthritis (Off-label)

Safety and efficacy not established; drug has been used safely in limited number of children aged 3-16 years with juvenile rheumatoid arthritis

<3 years: Safety and efficacy not established

≥3 years: 2-3 mg/kg/day for up to 4 weeks

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Interactions

Interaction Checker

and diclofenac

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Abdominal distention and flatulence

            Abdominal pain or cramps

            Constipation

            Diarrhea

            Dizziness

            Dyspepsia

            Edema

            Fluid retention

            Headache

            Nausea

            Peptic ulcer or GI bleeding

            Pruritus

            Rash

            Tinnitus

            Acute hepatitis

            Agranulocytosis

            Asthma

            Aplastic anemia

            Asymptomatic hepatitis

            Blood urea nitrogen (BUN) >40 mg/dL (>14.3 mmol/L)

            Cholestasis

            Chronic active hepatitis

            Congestive heart failure (CHF)

            Decreased hemoglobin

            Epistaxis

            Fatal fulminant hepatitis

            Hemolytic anemia (may be autoimmune)

            Hepatocellular necrosis

            Hypertension

            Jaundice

            Leukopenia

            Nephrotoxicity

            Purpura

            Serum creatinine >2 mg/dL (>177 μmol/L)

            Thrombocytopenia

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            Warnings

            Black Box Warnings

            Cardiovascular risk

            • Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery

            Gastrointestinal risk

            • NSAIDs increase 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

            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 history of hypersensitivity to bovine protein

            Cautions

            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

            Therapy may increase 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 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 erythrmatosus, and mixed connective tissue disorders

            Use caution if patient dehydrated before initiating therapy; rehydrate patient before initiating therapy and monitor renal function closely

            Injectable dosage form not recommended for long-term use

            Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, nonsteroidal anti-inflammatory drugs or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache); may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks; detoxification of patients, including withdrawal of overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary

            Different formulations not bioequivalent even if milligram strength the same; do not interchange products

            Withhold for at least 4-6 half-lives prior to surgical or dental procedures

            Heart failure risk

            • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
            • NSAIDS should be avoided or withdrawn whenever possible
            • AHA/ACC Heart Failure Guidelines; Circulation. 2016;134
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            Pregnancy & Lactation

            Pregnancy category: C; avoid use in late pregnancy (may cause premature closure of ductus arteriosus); category D if >30 weeks after gestation

            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 nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and approximately 2.6% of controls

            Lactation: Excreted in breast milk; not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits cyclooxygenase (COX)-1 and COX-2, thereby inhibiting prostaglandin synthesis

            May also inhibit neutrophil aggregation/activation, inhibit chemotaxis, decrease proinflammatory cytokine level, and alter lymphocyte activity

            Absorption

            ~100% absorbed

            Bioavailability: 50-60%

            Peak plasma time: Oral solution, 10-30 min; prompt-release tablet/capsule, 1 hr; extended-release tablet, 2-3 hr

            Peak plasma concentration (50 mg dose): 1-1.5 mcg/mL

            Onset of action: potassium salt faster acting than sodium salt (dissolves in stomach instead of duodenum)

            Distribution

            Protein bound: 99-99.8%

            Vd: 1.3-1.4 L/kg

            Metabolism

            Metabolized in liver by hydroxylation and conjugation with glucuronic acid, taurine amide, sulfuric acid, and other biogenic ligands, as well as conjugation of unchanged drug

            Metabolites: 3'-hydroxydiclofenac, 4'-hydroxydiclofenac (3'-hydroxy-4'-methoxydiclofenac), 5-hydroxydiclofenac, 4',5-dihydroxydiclofenac

            Enzymes inhibited: COX-1, COX-2

            Elimination

            Half-life: 1.2-2 hr

            Clearance: 263-350 mL/min

            Excretion: Urine (50-70%), feces (30-35%)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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