Drugplain

olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide 5 mg/1

olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide · TABLET, FILM COATED · Slate Run Pharmaceuticals, LLC

No Recall History
Plain English

olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide is a tablet, film coated containing olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide at 5 mg/1, taken oral. Manufactured by Slate Run Pharmaceuticals, LLC.

Key Facts

Brand Name
olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide
Generic Name
olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide
NDC Code (Product)
70436-016
Manufacturer
Slate Run Pharmaceuticals, LLC
Strength
5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA210718
Drug Class
Thiazide Diuretic [EPC]
Marketing Start
05/15/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

product odour abnormal2 reports
product taste abnormal2 reports
chest discomfort1 reports
completed suicide1 reports
drug ineffective1 reports
fear1 reports
headache1 reports
hypertension1 reports
hypertensive crisis1 reports
hypotension1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. 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, amlodipine, 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 National Committee on Prevention, Detection, Evaluation, and Treatment of High Bl…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Dose once daily. Dosage may be increased in 2 week intervals, as needed. The maximum recommended dose of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets is 40 mg/10 mg/25 mg. Dose selection should be individualized based on previous therapy. • Dose once daily. Dosage may be increased after 2 weeks to a maximum dose of 40 mg/10 mg/25 mg once daily ( 2 ). • Dose selection should be individualized based on previous therapy ( 2 ).

Contraindications

4 CONTRAINDICATIONS Because of the hydrochlorothiazide component, olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are contraindicated in patients with anuria, hypersensitivity to any component, or hypersensitivity to other sulfonamide-derived drugs. Do not co-administer aliskiren with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets in patients with diabetes [See Drug Interactions ( 7.2 )] . • Anuria: Hypersensitivity to sulfonamide-derived drugs ( 4 ). • Do not co-administer aliskiren with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets in patients with diabetes ( 4 ).

Drug Interactions

7 DRUG INTERACTIONS Olmesartan medoxomil ( 7.1 ): • Nonsteroidal anti-inflammatory drugs (NSAIDS): May lead to increased risk of renal impairment and loss of antihypertensive effect. • Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. • Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. • Lithium: Increases in serum lithium concentrations and lithium toxicity. Amlodipine ( 7.2 ): • Limit simvastatin to 20 mg daily when coadministered. • Increased exposure to cyclosporin and tacrolimus • Increased amlodipine exposure when coadministered with CYP3A inhibitors Hydrochlorothiazide ( 7.3 ): • Antidiabetic drugs: Dosage adjustment of antidiabetic may be required. • Cholestyramine and colestipol: Reduced absorption of thiazides. • NSAIDs: Can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. 7.1 Drug Interactions with Olmesartan Medoxomil Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2%) are dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214 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. Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets In the controlled trial of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, patients were randomized to olmesartan medoxomil/amlodipine/hydrochlorothiazide 40 mg/10 mg/25 mg, olmesartan medoxomil/amlodipine 40 mg/10 mg, olmesartan medoxomil/hydrochlorothiazide 40 mg/25 mg, or amlodipine/hydrochlorothiazide 10 mg/25 mg. Subjects who received triple combination therapy were treated between two and four weeks with o…

Frequently Asked Questions

What is olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide used for?

olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide contains olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide a controlled substance?

olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide is not classified as a controlled substance by the DEA.

What is the generic name for olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide?

The generic name for olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide is olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide. There are no other listed brand versions of olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide.

What is the NDC code for olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide 5 mg/1?

The NDC (National Drug Code) for olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide 5 mg/1 is 70436-016, listed by Slate Run Pharmaceuticals, LLC.

Product NDC

70436-016

Package NDC

70436-016-04

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

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