Label: LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE- losartan potassium and hydrochlorothiazide tablet, film coated
- NDC Code(s): 63629-2430-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 59746-339
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 11, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM ...
-
Table of ContentsTable of Contents
-
BOXED WARNING
(What is this?)
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue losartan potassium and hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)].
Close -
1 INDICATIONS AND USAGE1.1 Hypertension - Losartan potassium and hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and ...
-
2 DOSAGE AND ADMINISTRATION2.1 Hypertension - The usual starting dose of losartan potassium and hydrochlorothiazide is 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. The dosage can be increased after 3 ...
-
3 DOSAGE FORMS AND STRENGTHSLosartan potassium and hydrochlorothiazide tablets, USP 50/12.5 mg is Yellow, oval, film-coated tablet debossed with “C” on one side and “337” on other side. Losartan potassium and ...
-
4 CONTRAINDICATIONSLosartan potassium and hydrochlorothiazide is contraindicated: In patients who are hypersensitive to any component of this product. In patients with anuria - For coadministration with aliskiren in ...
-
5 WARNINGS AND PRECAUTIONS5.1 Fetal Toxicity - Losartan potassium and hydrochlorothiazide can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second ...
-
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 ...
-
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 ...
-
8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - Losartan potassium and hydrochlorothiazide can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during ...
-
10 OVERDOSAGELosartan Potassium - Significant 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 ...
-
11 DESCRIPTIONLosartan potassium and Hydrochlorothiazide Tablets USP, 50/12.5, Losartan potassium and Hydrochlorothiazide Tablets USP, 100/12.5 and Losartan potassium and Hydrochlorothiazide Tablets USP, 100/25 ...
-
12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Losartan Potassium - Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)], is a potent ...
-
13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Losartan Potassium-Hydrochlorothiazide - No carcinogenicity studies have been conducted with the losartan potassium-hydrochlorothiazide ...
-
14 CLINICAL STUDIES14.1 Losartan Monotherapy - Reduction in the Risk of Stroke: The LIFE study was a multinational, double-blind study comparing losartan and atenolol in 9193 hypertensive patients with ...
-
16 HOW SUPPLIED/STORAGE AND HANDLINGLosartan potassium and Hydrochlorothiazide Tablets USP, 100/25 mg - Yellow, oval, film coated tablet debossed with "C" on one side and "339" on other side. Bottles of 1000 tablets with Plain ...
-
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 ...
-
PATIENT PACKAGE INSERTPatient Information - Losartan potassium and Hydrochlorothiazide Tablets, USP - 50/12.5 mg, 100/12.5 mg, 100/25 mg - (loe sar’ tan poe tas’ ee um and hyd” droe klor” oh thye’ a zide) Rx ...
-
PRINCIPAL DISPLAY PANELLosartan Potassium/Hydrochloro Tab, #1000
-
INGREDIENTS AND APPEARANCEProduct Information