Label: VALSARTAN tablet, coated
- NDC Code(s): 72819-181-03, 72819-182-09, 72819-183-09, 72819-184-09
- Packager: Archis Pharma LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 11, 2023
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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 ...
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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 deep yellow colored oval shaped coated tablet, engraved “S026” on one side and break line on other side. 80 mg are pink colored almond shaped coated tablet, engraved “S023” on one side ...
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4 CONTRAINDICATIONS
Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan tablets in patients with diabetes - [See - Drug ...
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5 WARNINGS AND PRECAUTIONS
5.1 Fetal Toxicity - Valsartan tablets 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 ...
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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 tablets, USP are a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT - 1 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 tablets were demonstrated principally in 7 placebo-controlled, 4- to 12-week trials (1 in patients over 65 ...
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16 HOW SUPPLIED/STORAGE AND HANDLING
Valsartan tablets are available as tablets containing valsartan 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles as described below - The 40 mg tablets are scored on one side ...
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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 tablets ...
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Patient Information
Valsartan (val sar′ tan)Tablets, What is the most important information I should know about valsartan tablets? Valsartan tablets can cause harm or death to an unborn baby. Talk to your ...
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PRINCIPAL DISPLAY PANEL - 40 mg NDC 72819-181-03 - Valsartan - Tablets, USP - 40 mg - Rx only 30 Tablets - Each tablet contains: Valsartan, USP 40 mg - Usual Dosage: See packaging insert - for ...
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PRINCIPAL DISPLAY PANEL - 80 mg NDC 72819-182-09 - Valsartan - Tablets, USP - 80 mg - Rx only 90 Tablets - Each tablet contains: Valsartan, USP 80 mg - Usual Dosage: See packaging insert - for ...
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PRINCIPAL DISPLAY PANEL - 160 mg NDC 72819-183-09 - Valsartan - Tablets, USP - 160 mg - Rx only 90 Tablets - Each tablet contains: Valsartan, USP 160 mg - Usual Dosage: See packaging insert - for complete ...
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PRINCIPAL DISPLAY PANEL - 320 mg NDC 72819-184-09 - Valsartan - Tablets, USP - 320 mg - Rx only 90 Tablets - Each tablet contains: Valsartan, USP 320 mg - Usual Dosage: See packaging insert ...
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INGREDIENTS AND APPEARANCEProduct Information