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diclofenac sodium
generic
Black Box Warnings .
Cardiovascular Thrombotic Event
NSAIDs incr. risk of serious and potentially fatal cardiovascular thrombotic events, incl. MI and stroke; risk may occur early in tx and may incr. w/ duration of use; contraindicated for CABG periop pain
GI Bleeding, Ulceration, and Perforation
NSAIDs incr. risk of serious and potentially fatal GI adverse events incl. bleeding, ulcer, and stomach or intestine perforation; GI events may occur at any time during use and w/o warning sx; elderly pts and pts w/ hx of PUD or GI bleeding at greater risk for serious GI events
Adult Dosing .
Dosage forms: DR TAB: 25 mg, 50 mg, 75 mg; ER TAB: 100 mg
Special Note
- [formulation clarification]
- Info: diclofenac sodium products may not be interchangeable w/ other diclofenac potassium or diclofenac products; reassess dose if switching between products
osteoarthritis
- [delayed-release form]
- Dose: 50 mg PO bid-tid; Max: 150 mg/day; Alt: 75 mg PO bid; Info: use lowest effective dose, shortest effective tx duration; give w/ food if GI upset occurs; D/C if abnormal liver or renal tests persist or worsen
- [extended-release form]
- Dose: 100 mg ER PO qd; Max: 100 mg/day ER; Info: use lowest effective dose, shortest effective tx duration; give w/ food if GI upset occurs; do not cut/crush/chew ER tab; D/C if abnormal liver or renal tests persist or worsen
rheumatoid arthritis
- [delayed-release form]
- Dose: 50 mg PO tid-qid; Max: 200 mg/day; Alt: 75 mg PO bid; Info: use lowest effective dose, shortest effective tx duration; give w/ food if GI upset occurs; D/C if abnormal liver or renal tests persist or worsen
- [extended-release form]
- Dose: 100 mg ER PO qd; Max: 200 mg/day ER; Info: may incr. to 100 mg ER bid; use lowest effective dose, shortest effective tx duration; give w/ food if GI upset occurs; do not cut/crush/chew ER tab; D/C if abnormal liver or renal tests persist or worsen
ankylosing spondylitis
- [delayed-release form]
- Dose: 25 mg PO qid; Info: may give additional 25 mg PO qhs; use lowest effective dose, shortest effective tx duration; give w/ food if GI upset occurs; D/C if abnormal liver or renal tests persist or worsen
renal dosing
- [see below]
- CrCl <30: avoid use; advanced renal dz: avoid use
- HD/PD: avoid use
hepatic dosing
- [adjust dose amount]
- hepatic impairment: decr. usual dose, amount not defined
Peds Dosing .
- Dosage forms: DR TAB: 25 mg, 50 mg, 75 mg
Special Note
- [formulation clarification]
- Info: diclofenac sodium products may not be interchangeable w/ other diclofenac potassium or diclofenac products; reassess dose if switching between products
juvenile idiopathic arthritis (off-label)
- [delayed-release form, 3 yo and older]
- Dose: 2-3 mg/kg/day PO divided bid-qid; Max: 150 mg/day; Info: use lowest effective dose, shortest effective tx duration; give w/ food if GI upset occurs; D/C if abnormal liver or renal tests persist or worsen
pain, post-op (off-label)
- [delayed-release form, 3 yo and older]
- Dose: 1 mg/kg/day PO divided bid-tid; Max: 150 mg/day; Info: use lowest effective dose, shortest effective tx duration; give w/ food if GI upset occurs; D/C if abnormal liver or renal tests persist or worsen
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance