Irbesartan
Brand names: AVAPRO, Avapro, Irbesartan, IRBESARTAN
Boxed warning
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue irbesartan tablets as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue irbesartan tablets as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 , 8.1 )
Warnings
BOXED WARNING: FETAL TOXICITY - "Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus." The label instructs to "discontinue irbesartan as soon as possible" once pregnancy is detected. Other key warnings: hypotension in volume- or salt-depleted patients (correct depletion before starting); monitor renal function and serum potassium, as impaired renal function and hyperkalemia can occur; avoid combining with aliskiren in diabetic patients; contraindicated with known hypersensitivity to any component.
Contraindications
4 CONTRAINDICATIONS Irbesartan tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not coadminister aliskiren with irbesartan tablets in patients with diabetes. Hypersensitivity to any component of this product. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )
Overdose
10 OVERDOSAGE No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well-tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodialysis. Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25-fold and 50-fold the MRHD (300 mg) based on body surface area, respectively.
Drug interactions
Uses
Indicated for "treatment of hypertension, to lower blood pressure," noting that "lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events," and for "treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria."
Dosage forms & strengths
2 DOSAGE AND ADMINISTRATION Indication Dose Hypertension ( 2.2 ) 150 to 300 mg once daily Diabetic Nephropathy ( 2.3 ) 300 mg once daily 2.1 General Considerations Irbesartan tablets may be administered with other antihypertensive agents and with or without food. 2.2 Hypertension The recommended initial dose of irbesartan tablets is 150 mg once daily. The dosage can be increased to a maximum dose of 300 mg once daily as needed to control blood pressure [see Clinical Studies (14.1) ]. 2.3 Nephropathy in Type 2 Diabetic Patients The recommended dose is 300 mg once daily [see Clinical Studies (14.2) ]. 2.4 Dose Adjustment in Volume and Salt-Depleted Patients The recommended initial dose is 75 mg once daily in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) [see Warnings and Precautions (5.2) ].
All identified pills
SG 161
WHITE OVAL · Irbesartan
4 manufacturers
SG 162
WHITE OVAL · Irbesartan
4 manufacturers
SG 160
WHITE OVAL · Irbesartan
4 manufacturers
T31
WHITE OVAL · Irbesartan
2 manufacturers
T32
WHITE OVAL · Irbesartan
4 manufacturers
T33
WHITE OVAL · Irbesartan
2 manufacturers
TEVA 7465
WHITE OVAL · Irbesartan
5 manufacturers
TEVA 7466
WHITE OVAL · Irbesartan
2 manufacturers
TEVA 7464
WHITE OVAL · Irbesartan
U 14
WHITE OVAL · Irbesartan
U 17
WHITE OVAL · Irbesartan
U 11
WHITE OVAL · Irbesartan
ZE53
WHITE CAPSULE · Irbesartan
2 manufacturers
ZE54
WHITE CAPSULE · Irbesartan
2 manufacturers
ZE55
WHITE CAPSULE · Irbesartan
2 manufacturers
Side effects
In hypertension trials, commonly reported reactions included diarrhea (3% vs 2% placebo), dyspepsia/heartburn (2% vs 1%), and fatigue (4% vs 3%). In diabetic nephropathy patients, notable effects included hyperkalemia, dizziness, orthostatic dizziness, and orthostatic hypotension.