Label: VALSARTAN tablet
- NDC Code(s): 50090-7312-0, 50090-7312-1
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 43547-370
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 16, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
- BOXED WARNING (What is this?)
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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 ...
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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 ...
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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 ...
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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)].
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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
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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 ...
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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 ...
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VALSARTAN
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INGREDIENTS AND APPEARANCEProduct Information