Hypersensitivity reactions (anaphylactic reactions & angioedema) in patients w/ & w/o history of allergic-type reactions to sulfonamides. Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; if there is erythema multiforme or flu-like symptom after use; if SJS symptoms occur eg, fever, erythema multiforme, vesicle, skin & other mucous membrane lesions, conjunctivitis. Not to be administered other than IV or IM (eg, IA, intrathecal). Not to be used for non-severe pain; in acute traumatic pain patients w/ unstable hemodynamic condition. Increased risk of CV & thrombotic adverse events w/ prolonged use. Severe hypotension; new onset HTN or worsening of pre-existing HTN. Upper GI perforations, ulcers or bleeds; TEN, DRESS; fluid retention & edema; acute renal failure. Patients w/ compromised cardiac function, pre-existing edema or other conditions predisposed to or worsened by fluid retention, or at risk of hypovolemia; dehydration; risk factors for developing CHD eg, HTN, hyperlipidemia, diabetes, smoking. History of or active GI disease eg, ulceration, bleeding or inflammatory conditions; sulfonamide allergy. Monitor BP closely during initiation & throughout course of therapy; patient w/ symptoms &/or signs of liver dysfunction or in whom abnormal LFT has occurred, for evidence of development of more severe hepatic reaction while on therapy. Rehydrate patients prior to & at initiation of therapy. Avoid use w/ non-specific NSAIDs. Increased risk of bleeding w/ oral anticoagulants eg, warfarin/coumarin-type & novel oral anticoagulants (eg, apixaban, dabigatran & rivaroxaban). Concomitant use w/ aspirin. Closely monitor renal function in patients w/ severe renal impairment (CrCl <30 mL/min) or those who may be predisposed to fluid retention & initiate treatment at lowest recommended dose; in patients w/ advanced renal disease. Initiate at lowest recommended dose in moderate hepatic impairment (Child-Pugh class B). Not recommended in severe hepatic impairment (Child-Pugh class C). Consider w/drawal of treatment in patients having difficulties conceiving or undergoing investigation of infertility. Avoid during 3rd trimester of pregnancy. Pregnancy (1st & 2nd trimester). Decision should be made whether to discontinue nursing or treatment. Childn <18 yr. Elderly.
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