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Janumet XR
sitagliptin/ 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: 50 mg IR/500 mg ER, 50 mg IR/1000 mg ER, 100 mg IR/1000 mg ER
diabetes mellitus, type 2
- [conversion from sitagliptin plus metformin]
- Dose: 1-2 tabs PO qd; Start: equivalent total daily dose of each component in current regimen PO qd; if on metformin 850 mg PO bid, start 100 mg/2000 mg PO qd; Max: 100 mg/2000 mg/day; Info: give w/ meal; do not cut/crush/chew tab; hold tx for surgery if restricting food/fluid; D/C for iodinated contrast study if eGFR 30-60, hepatic dz hx, alcoholism hx, heart failure hx, or receiving contrast intra-arterially; restart after 48h if stable renal fxn
- [conversion from sitagliptin]
- Dose: 1-2 tabs PO qd; Start: 100 mg/1000 mg PO qd; Max: 100 mg/2000 mg/day; Info: give w/ meal; do not cut/crush/chew tab; hold tx for surgery if restricting food/fluid; D/C for iodinated contrast study if eGFR 30-60, hepatic dz hx, alcoholism hx, heart failure hx, or receiving contrast intra-arterially; restart after 48h if stable renal fxn
- [conversion from metformin]
- Dose: 1-2 tabs PO qd; Start: sitagliptin 100 mg PO qd plus current total daily metformin dose PO qd; if on metformin 850 mg PO bid, start 100 mg/2000 mg PO qd; Max: 100 mg/2000 mg/day; Info: give w/ meal; do not cut/crush/chew tab; hold tx for surgery if restricting food/fluid; D/C for iodinated contrast study if eGFR 30-60, hepatic dz hx, alcoholism hx, heart failure hx, or receiving contrast intra-arterially; restart after 48h if stable renal fxn
renal dosing
- [see below]
- eGFR 30-44: avoid tx initiation; eGFR <30: contraindicated; Info: weigh risk/benefit, max sitagliptin dose 50 mg/day if eGFR 30-44 during tx
- HD/PD: avoid use
hepatic dosing
- [see below]
- hepatic impairment: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.