Irbesartan

AVAPRO

What it isAngiotensin II receptor blocker; hypertension and diabetic nephropathy.

Why this oneRenal outcome data in type 2 diabetic nephropathy, and a long duration suited to once-daily dosing.

What limits itHyperkalemia and the hemodynamic creatinine rise. Contraindicated in pregnancy.

FDA-approved for

BOXED WARNING Fetal toxicity — drugs acting on the renin-angiotensin system can cause fetal injury/death; discontinue when pregnancy is detected.

FDA dosing	Population	Start	Max
Hypertension	Adults	150 mg QD	300 mg QD
Hypertension, volume/salt-depleted	Adults (e.g., high-dose diuretics, hemodialysis)	75 mg QD
Diabetic nephropathy (type 2)	Adults	300 mg QD

Renal Undefined

Hepatic Undefined

May be taken with or without food
May be given with other antihypertensive agents
Correct volume/salt depletion before starting, or use the lower 75 mg starting dose

Fetal toxicity — discontinue when pregnancy detected
Symptomatic hypotension in volume/salt-depleted patients — correct depletion first
Impaired renal function/acute renal failure in RAS-dependent patients — monitor renal function
Hyperkalemia (especially in diabetic nephropathy)

Pregnancy Can cause fetal harm (reduced renal function, oligohydramnios, skull hypoplasia, death); discontinue as soon as pregnancy is detected.

Lactation No human data; not recommended in breastfeeding women due to potential adverse effects on the infant.

⚠ BOXED WARNING

Principal riskHyperkalemia and acute kidney injury

Cost, est. cash$5–$150/month

Generic entry2012

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk4 / 4

Legacy pregnancy categoryD

Defining liabilityHyperkalemia, kidney injury, fetal toxicity and increased lithium exposure.

Box: minimal PK interactions