Label: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE tablet
- NDC Code(s): 62332-149-08, 62332-149-10, 62332-149-30, 62332-149-90, view more
- Packager: Alembic Pharmaceuticals Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 20, 2021
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN ...
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Table of ContentsTable of Contents
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BOXED WARNING
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WARNING: FETAL TOXICITY
• When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide as soon as possible [see Warnings and Precautions (5.1)].
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• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)].
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1 INDICATIONS AND USAGEOlmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not ...
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2 DOSAGE AND ADMINISTRATIONThe recommended starting dose of olmesartan medoxomil and hydrochlorothiazide tablet is 40 mg/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan ...
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3 DOSAGE FORMS AND STRENGTHSOlmesartan medoxomil and hydrochlorothiazide tablets are supplied as film-coated, non-scored tablets: • 20 mg/12.5 mg yellow, round, biconvex tablets debossed with ‘346’on one side and ‘L’ on ...
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4 CONTRAINDICATIONSOlmesartan medoxomil and hydrochlorothiazide tablets are contraindicated: • In patients with hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide tablets ...
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5 WARNINGS AND PRECAUTIONS5.1 Fetal Toxicity - Pregnancy Category D - Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases ...
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6 ADVERSE REACTIONSThe following adverse reactions with olmesartan medoxomil and hydrochlorothiazide tablets are described elsewhere: · Hypotension in Volume-or Salt-Depleted Patients [see Warnings and ...
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7 DRUG INTERACTIONS7.1 Agents Increasing Serum Potassium - Coadministration of olmesartan medoxomil and hydrochlorothiazide tablets with other drugs that raise serum potassium levels may result in hyperkalemia ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal ...
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10 OVERDOSAGEOlmesartan medoxomil Limited data are available related to overdosage of olmesartan medoxomil in humans. The most likely manifestations of overdosage would be hypotension and tachycardia ...
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11 DESCRIPTIONOlmesartan medoxomil and hydrochlorothiazide tablets are combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Olmesartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II). Angiotensin II is the ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Olmesartan medoxomil and hydrochlorothiazide No carcinogenicity studies with olmesartan medoxomil and hydrochlorothiazide have ...
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14 CLINICAL STUDIESOlmesartan medoxomil and hydrochlorothiazide In clinical trials 1230 patients were exposed to the combination of olmesartan medoxomil (2.5 mg to 40 mg) and hydrochlorothiazide (12.5 mg to 25 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGOlmesartan medoxomil and hydrochlorothiazide tablets are supplied as: 20 mg/12.5 mg: Yellow film coated, round, biconvex tablets debossed with ‘346’ on one side and ‘L’ on other side. NDC ...
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17 PATIENT COUNSELING INFORMATIONPregnancy: Advise female patients of childbearing age about the consequences of exposure to olmesartan medoxomil and hydrochlorothiazide tablets during pregnancy. Discuss treatment options with ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 20 mg/ 12.5 mgNDC 62332-149-30 - Olmesartan Medoxomil and - Hydrochlorothiazide Tablets - 20 mg/12.5 mg - Rx only - 30 Tablets - Alembic
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 40 mg/ 12.5 mgNDC 62332-150-30 - Olmesartan Medoxomil and - Hydrochlorothiazide Tablets - 40 mg/12.5 mg - Rx only - 30 Tablets - Alembic
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 40 mg/ 25 mgNDC 62332-151-30 - Olmesartan Medoxomil and - Hydrochlorothiazide Tablets - 40 mg/25 mg - Rx only - 30 Tablets - Alembic
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INGREDIENTS AND APPEARANCEProduct Information