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 INFORMATION
    These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: FETAL TOXICITY

    •  When pregnancy is detected, discontinue olmesartan medoxomil and    hydrochlorothiazide as soon as possible [see Warnings and    Precautions (5.1)].
    •  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  USAGE
    Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not ...
  • 2 DOSAGE  AND  ADMINISTRATION
    The 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 ...
  • 3 DOSAGE FORMS  AND  STRENGTHS
    Olmesartan 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 ...
  • 4 CONTRAINDICATIONS
    Olmesartan medoxomil and hydrochlorothiazide tablets are contraindicated: •  In patients with hypersensitivity to any component of olmesartan    medoxomil and hydrochlorothiazide tablets ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 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 ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions with olmesartan medoxomil and hydrochlorothiazide tablets are described elsewhere: ·         Hypotension in Volume-or Salt-Depleted Patients [see Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 Agents Increasing Serum Potassium - Coadministration of olmesartan medoxomil and hydrochlorothiazide tablets with other drugs that raise serum potassium levels may result in hyperkalemia ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 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 ...
  • 10 OVERDOSAGE
    Olmesartan medoxomil   Limited data are available related to overdosage of olmesartan medoxomil in humans. The most likely manifestations of overdosage would be hypotension and tachycardia ...
  • 11 DESCRIPTION
    Olmesartan medoxomil and hydrochlorothiazide tablets are combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 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 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Olmesartan medoxomil and hydrochlorothiazide   No carcinogenicity studies with olmesartan medoxomil and hydrochlorothiazide have ...
  • 14 CLINICAL STUDIES
    Olmesartan 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Olmesartan 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 ...
  • 17 PATIENT COUNSELING INFORMATION
    Pregnancy: Advise female patients of childbearing age about the consequences of exposure to olmesartan medoxomil and hydrochlorothiazide tablets during pregnancy. Discuss treatment options with ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 20 mg/ 12.5 mg
    NDC 62332-149-30 - Olmesartan Medoxomil and - Hydrochlorothiazide Tablets - 20 mg/12.5 mg - Rx only - 30 Tablets - Alembic
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 40 mg/ 12.5 mg
    NDC 62332-150-30 - Olmesartan Medoxomil and - Hydrochlorothiazide Tablets - 40 mg/12.5 mg - Rx only - 30 Tablets - Alembic
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 40 mg/ 25 mg
    NDC 62332-151-30 - Olmesartan Medoxomil and - Hydrochlorothiazide Tablets - 40 mg/25 mg - Rx only - 30 Tablets - Alembic
  • INGREDIENTS AND APPEARANCE
    Product Information