f diuretics. Observe patient closely.
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Nursing or drug should be discontinued (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 02/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNING: AVOID USE IN PREGNANCY
1 INDICATIONS AND USAGE
2DOSAGE AND ADMINISTRATION
2.1General Considerations
2.2Add-On Therapy
2.3Replacement Therapy
2.4Initial Therapy
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Fetal/Neonatal Morbidity and Mortality
5.2 Hypotension in Volume- and/or Salt-Depleted Patients
5.3Impaired Hepatic Function
5.4 Hypersensitivity Reaction
5.5 Systemic Lupus Erythematosus
5.6 Lithium Interaction
5.7 Serum Electrolytes
5.8 Impaired Renal Function
5.9 Acute Myopia and Secondary Angle-Closure Glaucoma
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.3 Clinical Laboratory Test Findings
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4Pediatric Use
8.5 Geriatric Use
10OVERDOSAGE
11DESCRIPTION
12CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.3Developmental Toxicity Studies14CLINICAL STUDIES
14.1 Hypertension
14.2 Initial Therapy-Hypertension
16HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
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FULL PRESCRIBING INFORMATION
WARNING: AVOID USE IN PREGNANCY
When pregnancy is detected, discontinue DiovanHCT® as soon as possible. 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
DiovanHCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension.
DiovanHCT may be used in patients whose blood pressure is not adequately controlled on monotherapy.
DiovanHCT may be used as initial therapy inpatients who are likely to need multiple drugs to achieve blood pressure goals.
The choice of DiovanHCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
Patients with stage 2 hypertension are at a 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 should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.
Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with DiovanHCT compared to valsart |
