diuretics.
NSAIDs: Can reduce diuretic, natriuretic, and antihypertensive effects of diuretics. Observe patient closely.
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Potential for adverse effects in infant (8.3).
See 17 for PATIENT COUNSELING INFORMATION
Revised: 11/2008
--------------------------------------------------------------------------------
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNING: USE IN PREGNANCY
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Considerations
2.2 Add-On Therapy
2.3 Replacement Therapy
2.4 Initial Therapy
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Fetal/Neonatal Morbidity and Mortality
5.2 Hypotension in Volume- or Salt-Depleted Patients
5.3 Hypersensitivity Reaction
5.4 Systemic Lupus Erythematosus
5.5 Lithium Interaction
5.6 Electrolyte and Metabolic Imbalances
5.7 Hepatic Impairment
5.8 Impaired Renal Function
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
6.3 Laboratory Abnormalities
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Irbesartan Monotherapy
14.2 Irbesartan-Hydrochlorothiazide
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage
17 PATIENT COUNSELING INFORMATION
17.1 Pregnancy
17.2 Symptomatic Hypotension
--------------------------------------------------------------------------------
FULL PRESCRIBING INFORMATION
WARNING: USE IN PREGNANCY
When pregnancy is detected, discontinue 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 (5.1).]
1 INDICATIONS AND USAGE
AVALIDE® (irbesartan-hydrochlorothiazide) Tablets 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.
Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy.
Data from Studies V and VI [see Clinical Studies(14.2)] provide estimates of the probability of reac |
