Label: OLMESARTAN MEDOXOMIL tablet, film coated
- NDC Code(s): 50228-339-10, 50228-339-30, 50228-339-90, 50228-340-10, view more
- Packager: ScieGen Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 8, 2021
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS ...
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Table of ContentsTable of Contents
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SPL UNCLASSIFIED SECTIONOlmesartan Medoxomil Tablets
- BOXED WARNING (What is this?)
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1 INDICATIONS AND USAGEOlmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of ...
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2 DOSAGE AND ADMINISTRATION2.1 Adult Hypertension - Dosage must be individualized. The usual recommended starting dose of olmesartan medoxomil tablets is 20 mg once daily when used as monotherapy in patients who are not ...
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3 DOSAGE FORMS AND STRENGTHS5 mg yellow, round, film coated tablets, debossed with - “SG” on one side and - “339” on other side. 20 mg ...
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4 CONTRAINDICATIONSDo not co-administer aliskiren with olmesartan medoxomil in patients with diabetes - [See Drug Interactions - (7.3)] ...
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5 WARNINGS AND PRECAUTIONS5.1 Fetal Toxicity - Olmesartan medoxomil can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system (RAS ...
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6 ADVERSE REACTIONS6.1 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 INTERACTIONS7.1 Agents Increasing Serum Potassium - Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - Olmesartan medoxomil 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 OVERDOSAGELimited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic ...
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11 DESCRIPTIONOlmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT - 1 subtype angiotensin II receptor ...
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12 CLINICAL PHARMACOLOGY12.1 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 TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Olmesartan medoxomil was not carcinogenic when administered by dietary administration to rats for up to 2 years. The highest dose ...
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14 CLINICAL STUDIES14.1 Adult Hypertension - The antihypertensive effects of olmesartan medoxomil have been demonstrated in seven placebo-controlled studies at doses ranging from 2.5 mg to 80 mg for 6 to 12 weeks ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGOlmesartan Medoxomil Tablets, USP supplied as yellow, round, film coated tablets, non-scored tablets containing 5 mg of olmesartan medoxomil, as white, round, film coated, non-scored tablets ...
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17 PATIENT COUNSELING INFORMATIONPregnancy: Advise female patients of childbearing age about the consequences of exposure to olmesartan medoxomil during pregnancy. Discuss treatment options with women planning to become ...
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Package/Label Principal Display PanelNDC 50228-339-30 - Olmesartan Medoxomil - Tablets, USP - 5 mg - 30 Tablets Rx Only - ScieGen Pharmaceuticals, Inc. NDC ...
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INGREDIENTS AND APPEARANCEProduct Information