TGP Diclofenac Sodium

Relief of painful & inflammatory conditions due to RA, tendinitis, OA, bursitis, & other articular or periarthritic disorders.

Adult 1 tab once daily.

Should be taken with food: Take after meals. Should not be fragmented nor chewed.

Hypersensitivity. Peptic ulcer. Asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs.

Possibility of hypersensitivity reactions to Na disulphite particularly in patients w/ asthma. Caution in patients w/ symptoms/history of GI disease, impaired hepatic, cardiac or renal function, porphyria & patients taking diuretics, anticoagulant, or antidiabetics. Periodically monitor liver function & blood counts during prolonged treatment. May impair female fertility & is not recommended in women attempting to conceive. Prostaglandin synthesis inhibition may adversely affect pregnancy &/or embryo/fetal development.

GI disorders, headache, dizziness or vertigo, rash, elevation of SGOT/SGPT, rare peptic ulcer, GI bleeding, hepatitis, hypersensitivity reactions.

May raise plasma conc of lithium or digoxin. Decreased antihypertensive effect of diuretics or antihypertensive agents (eg, β-blockers, ACE inhibitors). Increased risk of nephrotoxicity w/ diuretics & ACE inhibitors; ciclosporin; tacrolimus. Increased serum K levels w/ K-sparing diuretics, ciclosporin, tacrolimus or trimethoprim. Increased risk of bleeding w/ anticoagulants & anti-platelet agents. Increased risk of GI bleeding or ulceration w/ other systemic NSAIDs or corticosteroids; SSRIs. Isolated reports of hypoglycemic & hyperglycemic effects necessitating changes in the dosage of antidiabetic agents during treatment w/ diclofenac. Increased blood conc & toxicity of MTX. Convulsions may occur w/ quinolones. Increased exposure to phenytoin. Delayed or decreased absorption w/ colestipol & cholestyramine. Concomitant use of cardiac glycosides may exacerbate cardiac failure, reduce GFR & increase plasma glycoside levels. Reduced effect of mifepristone. Increased peak plasma conc & exposure w/ potent CYP2C9 inhibitors (eg, voriconazole).

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

Rx