INDICATIONS
AVAPRO (irbesartan) is indicated for the treatment of hypertension. It may be used
alone or in combination with other antihypertensive agents.
AVAPRO is also indicated for the treatment of diabetic nephropathy with an elevated
serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes
and hypertension. In this population, AVAPRO reduces the rate of progression of
nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage
renal disease (need for dialysis or renal transplantation).
AVALIDE (irbesartan-hydrochlorothiazide) is indicated for the treatment of hypertension.
AVALIDE may be used in patients whose blood pressure is not adequately controlled
on monotherapy.
AVALIDE may also be used as initial therapy in patients who are likely to need multiple
drugs to achieve their blood pressure goals.
The choice of AVALIDE as initial therapy for hypertension should be based on an
assessment of potential benefits and risks and this decision should be shaped by
considerations such as baseline blood pressure, target goal, and likelihood of achieving
goal compared to monotherapy. (Please see Indications and Usage section of
full Prescribing Information.)
IMPORTANT SAFETY INFORMATION
WARNING: USE IN PREGNANCY
When pregnancy is detected, discontinue AVAPRO or AVALIDE as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. [See
Warnings and Precautions: Fetal/Neonatal Morbidity and Mortality in the
full Prescribing Information.]
- Because of the hydrochlorothiazide component, AVALIDE is contraindicated in patients
with anuria or hypersensitivity to sulfonamide-derived drugs
- In patients with volume or sodium depletion (eg, patients vigorously treated with
diuretics or on dialysis), such depletion should be corrected prior to administration
of AVAPRO or AVALIDE, or a lower initial dose of AVAPRO (75 mg) should be used,
to avoid possible symptomatic hypotension
- Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or
without a history of allergy or bronchial asthma, but are more likely in patients
with such a history
- Thiazide diuretics have been reported to cause exacerbation or activation of systemic
lupus erythematosus
- Lithium generally should not be given with thiazides
- Thiazides should be used with caution in patients with severe renal disease and
in patients with impaired hepatic function or progressive liver disease, since minor
alterations of fluid and electrolyte balance may precipitate hepatic coma
- In placebo-controlled hypertension studies, there were no significant differences
in adverse events (AEs) between AVAPRO and placebo. Adverse events that occurred
in at least 1% of patients treated with AVAPRO and at a higher incidence vs placebo
included diarrhea (3% vs 2%), dyspepsia/heartburn (2% vs 1%) and fatigue (4% vs
3%)
- Additionally, in a study of hypertensive type 2 diabetic patients with renal disease
(proteinuria ≥900 mg/day), the reported AEs for AVAPRO were similar to those
seen in hypertension studies, with the exception of an increased incidence of orthostatic
symptoms; AVAPRO compared to placebo (both groups received adjunctive antihypertensives):
dizziness (10.2% vs 6.0%), orthostatic dizziness (5.4% vs 2.7%) and orthostatic
hypotension (5.4% vs 3.2%), respectively. In patients with proteinuria, monitor
serum potassium
- In placebo-controlled hypertension studies, the most common adverse experiences
reported with AVALIDE that occurred in ≥1% of patients and at a higher incidence
vs placebo included fatigue (7% vs 3%), musculoskeletal pain (7% vs 5%), dizziness
(8% vs 4%), and nausea/vomiting (3% vs 0%). In a study with AVALIDE used as initial
therapy in moderate hypertension, the most common incidences of pre-specified adverse
experiences reported that occurred in ≥1% of patients were: dizziness (3.0%,
3.8% and 1.0%), headache (5.5%, 3.8% and 4.8%) and hyperkalemia (1.2%, 0% and 1.0%)
in AVALIDE, AVAPRO and HCTZ, respectively. In a study with AVALIDE used as initial
therapy in severe hypertension, the most common incidences of pre-specified adverse
experiences reported that occurred in ≥1% were:
dizziness (3.6% and 4.0%) and headache (4.3% and 6.6%) in AVALIDE and AVAPRO, respectively
- In patients who are elderly, volume-depleted (e.g. on diuretics), or renally compromised, coadministration of AVAPRO or AVALIDE and NSAIDs, including COX-2 inhibitors, may result in impaired renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in these patients. The antihypertensive effect of AVAPRO or AVALIDE may be attenuated by NSAIDs including COX-2 inhibitors
Please see
full Prescribing Information.
