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Diclofenac sodium DR

Class
Nonsteroidal anti-inflammatory drugs
Subclass
Acetates
Substance name
Diclofenac sodium DR
Common formulations
Tablet
See also
Diclofenac sodium (Zorvolex®, Voltaren®)
Diclofenac sodium ER
Diclofenac potassium (Cambia®, Zipsor®)
Diclofenac epolamine (Licart®, Flector®)
Dosage and administration
Adults patients
Symptomatic relief
Osteoarthritis
100-150 mg PO daily, in 2-3 divided doses
Treatment
Treatment of goutAcute flareOff-label
100-150 mg PO daily, in 2-4 divided doses
Indications for use
Labeled indications
Adults
Symptomatic relief of axial spondyloarthritis
Symptomatic relief of osteoarthritis
Symptomatic relief of rheumatoid arthritis
Off-label indications
Adults
Treatment of gout (acute flare)
Safety risks
Boxed warnings
Cardiovascular thrombotic events
Use extreme caution as increased risk for myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
Gastrointestinal bleeding, peptic ulcer disease, gastric perforation
Use extreme caution in elderly patients, prior history of peptic ulcer disease and/or GI bleeding, longer duration of NSAID therapy, concomitant use of oral corticosteroids, aspirin, anticoagulants, or SSRIs (SSRIs): smoking, use of alcohol, poor general health status, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.
Contraindications
Hypersensitivity to diclofenac or any of its components
In patients undergoing CABG surgery
Salicylate hypersensitivity or NSAID hypersensitivity
Warnings and precautions
Aseptic meningitis
Use caution in all patients, especially with connective tissue diseases.
Exacerbation of edema, HF
Use caution in patients with pre-existing HF.
Exacerbation of hypertension
Use caution in patients taking antihypertensive medications.
Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, fulminant hepatic failure
Maintain a high level of suspicion, as diclofenac has been associated with an increased risk for these adverse events.
Increased liver enzymes
Maintain a high level of suspicion, as diclofenac has been associated with an increased risk for these adverse events.
Renal papillary necrosis, AKI
Use caution in elderly patients or patients with impaired renal function, HF, liver dysfunction, or taking diuretics or ACEis.
Specific populations
Renal impairment
eGFR > 60 mL/min/1.73 m²
Use acceptable. No dose adjustment required. Monitor renal function. Because renal elimination is not a significant pathway of elimination for unchanged diclofenac, dosing adjustment in patients with mild to moderate renal dysfunction is not necessary.
eGFR 30-60 mL/min/1.73 m²
Use acceptable. No dose adjustment required. Monitor renal function. Use with extreme caution.
eGFR < 30 mL/min/1.73 m²
Avoid use. Monitor renal function.
Renal replacement therapy
Continuous renal replacement
Avoid use.
Intermittent hemodialysis
Use acceptable. No dose adjustment required. Avoid use in patients with residual kidney function.
Peritoneal dialysis
Use acceptable. No dose adjustment required. Avoid use in patients with residual kidney function.
Hepatic impairment
Any severity
Use with caution. Monitor serum aminotransferases. Monitor for toxicity. Use with caution to avoid adverse effects and discontinue if hepatic function worsens.
Pregnancy and breastfeeding
Pregnancy
> 30 weeks of gestation
Avoid use. NSAIDs, including Diclofenac, can cause premature closure of the fetal ductus arteriosus in women at about 30 weeks gestation and later in pregnancy.
20-30 weeks of gestation
Use only if benefits outweigh potential risks. Monitor for oligohydramnios. Use to the lowest effective dose and shortest duration possible. If oligohydramnios occurs, discontinue NSAID. Consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours. Use of NSAIDs around 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.
< 20 weeks of gestation
Use only if benefits outweigh potential risks.
Breastfeeding
Use with caution during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
Edema, nausea
Common 1-10%
Anemia, contact dermatitis, diaphoresis, ecchymosis, fluid retention, gastrointestinal bleeding, hypercholesterolemia, hyperesthesia, hypertension, ↑ blood glucose, ↑ liver enzymes, maculopapular rash, peptic ulcer disease, peripheral vasodilation, pharyngitis, photosensitivity of skin, ↑bleeding time, abdominal pain, arthralgia, back pain, chills, constipation, cough, diarrhea, dizziness, dysgeusia, dyspepsia, dyspnea, flatulence, hair loss, hematuria, myalgia, pyrosis, vomiting, skin discoloration, skin erythema, skin ulceration
Uncommon < 1%
Aseptic meningitis, gastritis, itching, skin rash
Unknown frequency
Acute generalized exanthematous pustulosis, agranulocytosis, angioedema, aplastic anemia, DRESS syndrome, ↓ WBC count, ↓ platelet count, ↓ serum sodium, ↓ urine output, exacerbation of arrhythmia, exfoliative dermatitis, HF, hemolytic anemia, hyperhidrosis, ↑ BUN, ↑ blood eosinophil count, ↑ serum potassium, ↑ urine protein, interstitial nephritis, jaundice, laryngeal edema, laryngitis, liver cirrhosis, liver necrosis, lymphadenopathy, myocardial infarction, nephrotic syndrome, oral ulcers, pancreatitis, pancytopenia, platelet dysfunction, premature ventricular contractions, purpura, renal failure, renal papillary necrosis, chest pain, diplopia, dry mouth, dysuria, fever, gait disturbance, hearing loss, hematemesis, hyperventilation, impotence, melena, muscle cramps, nocturia, nosebleed, palpitations, polyuria, skin flushing, syncope, tinnitus, urinary frequency, vaginal bleeding, weight gain, weight loss, respiratory depression, sinus tachycardia, Stevens-Johnson syndrome, stomatitis, stroke, toxic epidermal necrolysis, vasculitis
Interactions
Drug(s)
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