Drugplain

OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE 12.5 mg/1

OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE · TABLET, FILM COATED · REMEDYREPACK INC.

1 Recall on Record
Plain English

OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE is a tablet, film coated containing olmesartan medoxomil and hydrochlorothiazide at 12.5 mg/1, taken oral. Manufactured by REMEDYREPACK INC..

Key Facts

Brand Name
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
Generic Name
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE
NDC Code (Product)
70518-4517
Manufacturer
REMEDYREPACK INC.
Strength
12.5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA204801
Drug Class
Thiazide Diuretic [EPC]
Marketing Start
11/10/2025

Recall History

1 Recall on Record
Class II12/19/2018

Teva Pharmaceuticals USA

Failed dissolution specifications

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea15 reports
fatigue15 reports
asthenia11 reports
dizziness10 reports
vomiting9 reports
drug ineffective8 reports
headache8 reports
nausea8 reports
dyspnoea7 reports
hypertension7 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 indicated for the initial therapy of hypertension [see Dosage and Administration (2) ]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint Nat…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide tablets is 40 mg/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy. Dose can be titrated up to 40 mg/25 mg if necessary. The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide tablets is 20 mg/12.5 mg once daily in patients whose blood pressure is not adequately controlled with hydrochlorothiazide monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide. Dose can be titrated up to 40 mg/25 mg if necessary. Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of olmesartan medoxomil and hydrochlorothiazide tablets. Recommended starting dose in patients not adequately controlled with olmesartan monotherapy, 40/12.5 mg ( 2 ) Recommended starting dose in patients not adequately controlled with hydrochlorothiazide monotherapy, 20/12.5 mg ( 2 ) Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40 mg / 25 mg olmesartan / hydrochlorothiazide ( 2 )

Contraindications

4 CONTRAINDICATIONS Olmesartan medoxomil and hydrochlorothiazide tablets are contraindicated: In patients with hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide tablets [see Adverse Reactions (6.1 , 6.2) ] In patients with anuria [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] For coadministration with aliskiren in patients with diabetes [see Drug Interactions (7.4) ]. Hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide ( 4 ) Anuria ( 4 ) Do not co-administer aliskiren with olmesartan medoxomil and hydrochlorothiazide in patients with diabetes. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Lithium: Risk of lithium toxicity ( 7.2 ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Reduced diuretic, natriuretic and antihypotensive effects; increased risk of renal toxicity ( 7.3 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.4 ) Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.5 ) Antidiabetic drugs: Dosage adjustment may be required ( 7.6 ) Cholestyramine and colestipol: Reduced absorption of thiazides ( 7.6 ) 7.1 Agents Increasing Serum Potassium Coadministration of olmesartan medoxomil and hydrochlorothiazide with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or hydrochlorothiazide. Monitor serum lithium levels during concomitant use. 7.3 Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) Olmesartan medoxomi…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions with olmesartan medoxomil and hydrochlorothiazide are described elsewhere: Hypotension in Volume- or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Electrolyte and Metabolic Imbalances [see Warnings and Precautions (5.5) ] Acute Myopia and Secondary Angle-Closure Glaucoma [see Warnings and Precautions (5.6) ] Systemic Lupus Erythematosus [see Warnings and Precautions (5.7) ] Sprue-Like Enteropathy [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥2%) are nausea, hyperuricemia, dizziness, and upper respiratory infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-332-1088 or www.fda.gov/medwatch . 6.1 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 compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Olm…

Frequently Asked Questions

What is OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE used for?

OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE contains OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE a controlled substance?

OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE is not classified as a controlled substance by the DEA.

What is the generic name for OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE?

The generic name for OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE is OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE. There are 5 other brand versions of OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE.

What is the NDC code for OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE 12.5 mg/1?

The NDC (National Drug Code) for OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE 12.5 mg/1 is 70518-4517, listed by REMEDYREPACK INC..

Product NDC

70518-4517

Package NDC

70518-4517-0

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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