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ACTOplus met
pioglitazone/ metformin
Black Box Warnings .
Congestive Heart Failure
thiazolidinediones cause or exacerbate CHF; observe pts closely after tx initiation or dose incr. for s/sx incl. excessive, rapid wt gain, dyspnea, and/or edema; manage CHF based on current care standards if s/sx develop and consider D/C or dose reduction; contraindicated in pts w/ NYHA Class III-IV CHF and not recommended in pts w/ symptomatic CHF
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: 15 mg/850 mg
diabetes mellitus, type 2
- [tx-naive pts]
- Dose: 1 tab PO qd-tid; Start: 1 tab PO qd; Max: 45 mg/2550 mg/day; Info: start 1 tab PO qd in pts w/ NYHA Class I or II CHF; give w/ meals; 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 pioglitazone and metformin]
- Dose: 1 tab PO qd-tid; Start: equivalent total daily dose of each component in current regimen PO divided qd-tid; Max: 45 mg/2550 mg/day; Info: start 1 tab PO qd in pts w/ NYHA Class I or II CHF; give w/ meals; 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 pioglitazone]
- Dose: 1 tab PO qd-tid; Start: 1 tab PO qd; Max: 45 mg/2550 mg/day; Info: start 1 tab PO qd in pts w/ NYHA Class I or II CHF; give w/ meals; 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 tab PO qd-tid; Start: pioglitazone 15 mg PO qd-bid plus current daily metformin dose PO divided qd-bid; Max: 45 mg/2550 mg/day; Info: start 1 tab PO qd in pts w/ NYHA Class I or II CHF; give w/ meals; 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 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.