Rosiglitazone

FDA label

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Titration May increase to 8 mg/day after 8-12 weeks if inadequate FPG response

Renal No adjustment as monotherapy; combination with metformin contraindicated in renal impairment

Hepatic Do not initiate with clinical evidence of active liver disease or ALT >2.5x ULN; check LFTs before starting and periodically

Pediatric data insufficient to recommend use

Instructions

• May take with or without food
• Start at lowest recommended dose; monitor for fluid retention with any dose increase
• If hypoglycemia on combination therapy, reduce the sulfonylurea dose

Contraindications

• Initiation in established NYHA Class III or IV heart failure

Cautions

• Fluid retention and CHF (boxed) — observe for weight gain, dyspnea, edema; not recommended with symptomatic heart failure
• Increased cardiovascular events in NYHA I/II CHF patients
• Myocardial ischemia (boxed) — risk greater when added to insulin or with nitrates; initiation not recommended during acute coronary events
• Hepatic: measure liver enzymes before initiation and periodically; do not start if ALT >2.5x ULN
• Dose-related edema and anemia
• Hypoglycemia when combined with sulfonylurea or insulin
• Increased fractures in women (upper arm, hand, foot; ADOPT trial)

Adverse reactions

• Upper respiratory tract infection
• Headache
• Back pain
• Hyperglycemia
• Fatigue
• Sinusitis
• Edema
• Anemia
• Hypoglycemia (combination therapy)
• Fractures in women

Pregnancy Category C; crosses human placenta; should not be used during pregnancy — most experts recommend insulin monotherapy

Lactation Unknown if excreted in human milk (detected in rat milk); should not be administered to a nursing woman