Clinical Pharmacology Details


Diclofenac Sodium


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Indications & Dose:

Adult


Osteoarthritis:



PO 100-150 mg/day in divided doses (50 mg bid-tid or 75 mg bid)


Rheumatoid arthritis:



PO 150 200 mg/day in divided doses (50 mg tid-qid or 75 mg bid)


Ankylosing spondylitis: 



PO 100 125 mg/day; give 25 mg qid and 25 mg hs if needed



Pain, dysmenorrhea:



PO 50 mg immediate-release tid; loading dose (100 mg) useful in some patients


SR:tabs 100 mg once daily. DS: tabs 100 mg once daily in severe cases two tablets a day.


Dispersable:tabs 100-150mg daily in two divided doses, dispersed in a glass of water, max; treatment period 3 months



75-150 mg daily in divided doses.



75 mg once daily (or twice in severe cases) for max. of 2 days, treatment should not exceed 2 days, continue if necessary tablet or suppositories


Postoperative pain:



75mg by i.v infusion ovrt 30 minutes to 2 hours, repeat if necessary 4-6 hour, max; 150mg in 24 hours


Prevention of postoperative pain:



25-50mg by iv infusion ovrt 15minutes to 1 hour than continue iv infusion of 5mg/hr, max; 150mg in24 hour.


Prevention of post-operative pain,


initially after surgery 25-50mg over 15-60 minutes than 5mg/hour for maximum 2 days.


Children



1-12 years , juvenile artheritis, by mouth/by rectum 1-3mg/kg daily in divided doses (25mg cc tablets 12.5mg and 25mg suppositories only) 

Contraindications:

 Bronchospasm, nasal polyps, angioedema precipitated by aspirin or other NSAIDs

Side Effects:

CNS: Anxiety, confusion, depression, dizziness, drowsiness, fatigue, insomnia, muscle weakness, nervousness, paresthesia, tremors


CV: CHF, dysrhythmias, fluid retention, hypertension, hypotension, palpitations, peripheral edema, tachycardia


EENT: Blurred vision; hearing loss, tinnitus; Ophth: anterior chamber reaction, burning, elevated intraocular pressure, irritation, keratitis, ocular allergy


GI: Anorexia, cholestatic hepatitis, constipation, cramps, diarrhea, dry mouth, flatulance, GI bleeding, jaundice, nausea, peptic ulcer, vomiting


GU: Azotemia, cystitis, dysuria, hematuria, nephrotoxicity, oliguria, UTI


HEME: Blood dyscrasias, bruising, epistaxis


RESP: Bronchospasm, dyspnea, hemoptysis, laryngeal edema, pharyngitis, rhinitis, shortness of breath


SKIN: Alopecia, erythema, petechiae, photosensitivity, pruritus, purpura, rash, sweating

Cautions:

Precautions:

: History of GI ulceration, bleeding, or perforation; renal dysfunction, hypertension or cardiac conditions aggravated by fluid retention and edema, history of liver dysfunction, history of coagulation 

Interaction:

Aminoglycosides: Reduced clearance with elevated aminoglycoside levels and potential for toxicity (especially indomethacin in premature infants; other NSAIDs probably)


Anticoagulants: Excessive hypoprothrornbinemia, decreased platelet aggregation with increased risk of GI bleeding


Antihypertensives (alpha blockers, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, beta blockers, diuretics: Inhibition of antihypertensive and other favorable hemodynamic effects


Corticosteroids: Increased risk of GI ulceration


Cyclosporine: Increased nephrotoxicity risk


Lithium: Decreased clearance of lithium (mediated via prostaglandins) resulting in elevated serum lithium levels and risk of toxicity


Methotrexate: Decreased renal secretion of methotrexate resulting in elevated methotrexate levels and risk of toxicity


Phenylpropanolamine: Possible acute hypertensive reaction


Potassium-sparing diuretics: Additive hyperkalemia potential


Triamterene: Acute renal failuge reported with addition of indomethacin; caution with other NSAIDs

Warnings:

Adverse Effects:

Lactations:

Excreted in breast milk 

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: