Label: VALSARTAN tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 16, 2024

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use VALSARTAN TABLETS safely and effectively. See full prescribing information for VALSARTAN TABLETS. VALSARTAN tablets, for ORAL ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: FETAL TOXICITY

    When pregnancy is detected, discontinue valsartan as soon as possible. (5.1)
    Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
    Close
  • 1  INDICATIONS AND USAGE
    1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older. Lowering blood ...
  • 2  DOSAGE AND ADMINISTRATION
    2.1 Important Dosage and Preparation Information - Valsartan tablets and oral suspension are not substitutable on a milligram-per-milligram basis. Do not combine two dosage forms to achieve the ...
  • 3  DOSAGE FORMS AND STRENGTHS
    40 mg are scored yellow, capsule-shaped, biconvex, film-coated tablets debossed with “341” and bisect between 3 and 41 on one side, and “HH” on the other side. 80 mg are brown, capsule-shaped ...
  • 4  CONTRAINDICATIONS
    Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan in patients with diabetes [see Drug Interactions (7.3)].
  • 5  WARNINGS AND PRECAUTIONS
    5.1 Fetal Toxicity Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of ...
  • 6  ADVERSE REACTIONS
    6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly ...
  • 7  DRUG INTERACTIONS
    7.1 Agents Increasing Serum Potassium Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene ...
  • 8  USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy Risk Summary - Valsartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third ...
  • 10  OVERDOSAGE
    Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal ...
  • 11  DESCRIPTION
    Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as ...
  • 12  CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent ...
  • 13  NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility There was no evidence of carcinogenicity when valsartan was administered in the diet to mice and rats for up to 2 years at doses up ...
  • 14  CLINICAL STUDIES
    14.1 Hypertension Adult Hypertension - The antihypertensive effects of valsartan were demonstrated principally in 7 placebo-controlled, 4- to 12-week trials (1 in patients over 65 years) of ...
  • 16  HOW SUPPLIED/STORAGE AND HANDLING
    Product: 50090-7312 - NDC: 50090-7312-0 30 TABLET in a BOTTLE - NDC: 50090-7312-1 90 TABLET in a BOTTLE
  • 17  PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy:  Advise female patients of childbearing age about the consequences of exposure to valsartan during ...
  • PATIENT INFORMATION
    Valsartan Tablets (val-SAR-tan), USP - What is the most important information I should know about valsartan? Valsartan can cause harm or death to an unborn baby.  • Talk to your healthcare ...
  • VALSARTAN
    Label Image
  • INGREDIENTS AND APPEARANCE
    Product Information