Label: LOSARTAN POTASSIUM tablet, film coated
- NDC Code(s): 70518-3489-0, 70518-3489-1
- Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 43547-360
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 19, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use LOSARTAN POTASSIUM TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM TABLETS. LOSARTAN ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGE1.1 Hypertension - Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood ...
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2 DOSAGE AND ADMINISTRATION2.1 Hypertension - Adult Hypertension - The usual starting dose of losartan potassium tablets is 50 mg once daily. The dosage can be increased to a maximum dose of 100 mg once daily as needed to ...
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3 DOSAGE FORMS AND STRENGTHSLosartan potassium tablets USP, 25 mg, are white to off-white, round, convex, beveled edge, film-coated tablets, debossed with S on one side and 111 on the other.
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4 CONTRAINDICATIONSLosartan potassium is contraindicated: In patients who are hypersensitive to any component of this product. For coadministration with aliskiren in patients with diabetes.
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5 WARNINGS AND PRECAUTIONS5.1 Fetal Toxicity - Losartan potassium 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 REACTIONS6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly ...
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7 DRUG INTERACTIONS7.1 Agents Increasing Serum Potassium - Coadministration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - Losartan potassium 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 OVERDOSAGESignificant lethality was observed in mice and rats after oral administration of 1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m ...
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11 DESCRIPTIONLosartan potassium is an angiotensin II receptor blocker acting on the AT - 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1- ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)] is a potent vasoconstrictor, the primary ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Losartan potassium was not carcinogenic when administered at maximally tolerated dosages to rats and mice for 105 and 92 weeks ...
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14 CLINICAL STUDIES14.1 Hypertension - Adult Hypertension - The antihypertensive effects of losartan potassium were demonstrated principally in 4 placebo-controlled, 6-to 12-week trials of dosages from 10 to 150 mg ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGLosartan potassium tablets USP, are white to off-white film-coated tablets supplied as follows: Losartan 25mg, round, tablet, engraving (reverse) S (111), NDC: 70518-3489-00 - NDC ...
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17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy - Advise female patients of childbearing age about the consequences of exposure to losartan potassium ...
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SPL UNCLASSIFIED SECTIONThe trademarks depicted herein are owned by their respective companies. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
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PATIENT PACKAGE INSERTDispense with Patient Information available at: www.solcohealthcare.com/druglabeling/losartan-tablets.pdf - Losartan Potassium Tablets, USP - (low-SAHR-tan poe-TASS-ee-uhm) 25 mg, 50 mg, 100 ...
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PRINCIPAL DISPLAY PANELDRUG: Losartan Potassium - GENERIC: Losartan Potassium - DOSAGE: TABLET, FILM COATED - ADMINSTRATION: ORAL - NDC: 70518-3489-0 - NDC: 70518-3489-1 - COLOR: white - SHAPE: ROUND - SCORE: No score - SIZE: 6 ...
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INGREDIENTS AND APPEARANCEProduct Information