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Synjardy
empagliflozin/ metformin
Black Box Warnings .
Lactic Acidosis
post-marketing cases of hypothermia, hypotension, resistant bradyarrhythmias, and death; onset may be subtle w/ nonspecific sx incl. malaise, myalgias, resp. distress, somnolence, abdominal pain; lab findings incl. lactate >5 mmol/L, anion gap acidosis (w/o evidence of ketonuria or ketonemia), incr. lactate/pyruvate ratio, metformin level >5 mcg/mL; risk factors may incl. renal impairment, concomitant meds, pts 65 yo and older, radiocontrast study, any surgery, hypoxemia, excessive acute or chronic alcohol intake, or hepatic insufficiency; D/C metformin immed. if lactic acidosis suspected, hospitalize pt and institute general supportive care, prompt HD recommended
Adult Dosing .
Dosage forms: TAB: 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, 12.5 mg/1000 mg
diabetes mellitus, type 2
- [conversion from metformin]
- Dose: 1-2 tabs PO bid; Start: empagliflozin 5 mg PO bid plus current daily metformin dose PO divided bid; Max: 25 mg/2000 mg/day; Info: give w/ meals; hold tx at least 3 days before surgery/procedure if prolonged fasting; D/C for iodinated contrast study if eGFR <60, hepatic dz hx, alcoholism hx, heart failure hx, or receiving contrast intra-arterially; restart after 48h if stable renal fxn; see empagliflozin for cardiovascular event risk reduction use, heart failure risk reduction use, or kidney dz progression and cardiovascular-associated risk reduction use
- [conversion from empagliflozin]
- Dose: 1-2 tabs PO bid; Start: metformin 500 mg PO bid plus current daily empagliflozin dose PO divided bid; Max: 25 mg/2000 mg/day; Info: give w/ meals; hold tx at least 3 days before surgery/procedure if prolonged fasting; D/C for iodinated contrast study if eGFR <60, hepatic dz hx, alcoholism hx, heart failure hx, or receiving contrast intra-arterially; restart after 48h if stable renal fxn; see empagliflozin for cardiovascular event risk reduction use, heart failure risk reduction use, or kidney dz progression and cardiovascular-associated risk reduction use
- [conversion from empagliflozin plus metformin]
- Dose: 1-2 tabs PO bid; Start: equivalent total daily dose of each component in current regimen PO divided bid; Max: 25 mg/2000 mg/day; Info: give w/ meals; hold tx at least 3 days before surgery/procedure if prolonged fasting; D/C for iodinated contrast study if eGFR <60, hepatic dz hx, alcoholism hx, heart failure hx, or receiving contrast intra-arterially; restart after 48h if stable renal fxn; see empagliflozin for cardiovascular event risk reduction use, heart failure risk reduction use, or kidney dz progression and cardiovascular-associated risk reduction use
renal dosing
- [see below]
- eGFR 30-44: avoid tx initiation; eGFR <30: contraindicated; Info: weigh risk/benefit if eGFR 30-44 during tx
- HD/PD: avoid use
hepatic dosing
- [see below]
- hepatic impairment: avoid use
Peds Dosing .
- Dosage forms: TAB: 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, 12.5 mg/1000 mg
diabetes mellitus, type 2
- [10 yo and older, conversion from metformin]
- Dose: 1-2 tabs PO bid; Start: empagliflozin 5 mg PO bid plus current daily metformin dose PO divided bid; Max: 25 mg/2000 mg/day; Info: give w/ meals; hold tx at least 3 days before surgery/procedure if prolonged fasting; D/C for iodinated contrast study if eGFR <60, hepatic dz hx, alcoholism hx, heart failure hx, or receiving contrast intra-arterially; restart after 48h if stable renal fxn
- [10 yo and older, conversion from empagliflozin]
- Dose: 1-2 tabs PO bid; Start: metformin 500 mg PO bid plus current daily empagliflozin dose PO divided bid; Max: 25 mg/2000 mg/day; Info: give w/ meals; hold tx at least 3 days before surgery/procedure if prolonged fasting; D/C for iodinated contrast study if eGFR <60, hepatic dz hx, alcoholism hx, heart failure hx, or receiving contrast intra-arterially; restart after 48h if stable renal fxn
- [10 yo and older, conversion from empagliflozin plus metformin]
- Dose: 1-2 tabs PO bid; Start: equivalent total daily dose of each component in current regimen PO divided bid; Max: 25 mg/2000 mg/day; Info: give w/ meals; hold tx at least 3 days before surgery/procedure if prolonged fasting; D/C for iodinated contrast study if eGFR <60, hepatic dz hx, alcoholism hx, heart failure hx, or receiving contrast intra-arterially; restart after 48h if stable renal fxn
renal dosing
- [see below]
- renal impairment: not defined, consider adult renal dosing for guidance
- HD/PD: avoid use
hepatic dosing
- [see below]
- hepatic impairment: avoid use