Drugplain

olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide 10 mg/1

olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide · TABLET, FILM COATED · Par Health USA, LLC

No Recall History
Plain English

This is a combination blood pressure medication containing three active ingredients: olmesartan (an angiotensin II receptor blocker), amlodipine (a calcium channel blocker), and hydrochlorothiazide (a thiazide diuretic). It is taken by mouth as a tablet to help lower blood pressure in patients with hypertension.

Key Facts

Brand Name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Generic Name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
NDC Code (Product)
49884-789
Manufacturer
Par Health USA, LLC
Strength
10 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA206137
Drug Class
Thiazide Diuretic [EPC]
Marketing Start
10/26/2016

Recall History

No Recall History

Side Effects Reported to FDA

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

dizziness4 reports
drug interaction3 reports
fatigue3 reports
chest discomfort2 reports
dehydration2 reports
diarrhoea2 reports
dyspnoea2 reports
hyperkalaemia2 reports
muscle spasms2 reports
oedema peripheral2 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 (CV) 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…

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 40/10/25 mg. Dose selection should be individualized based on previous therapy. Dose one daily. Dosage may be increased after 2 weeks to a maximum dose of 40/10/25 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 is contraindicated in patients with anuria, hypersensitivity to any component, or hypersensitivity to other sulfonamide-derived drugs. Do not coadminister 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 coadminister aliskiren with olmesartan medoxomil, amlodipine and hydrochlorothiazide 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 20mg 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 compromised renal fun…

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 Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-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 In the controlled trial of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets, patients were randomized to olmesartan medoxomil/amlodipine/hydrochlorothiazide tablets 40/10/25 mg, olmesartan medoxomil/amlodipine 40/10 mg, olmesartan medoxomil/hydrochlorothiazide 40/25 mg, or amlodipine/hydrochlorothiazide 10/25 mg. Subjects who received triple combination therapy were treated between two and four weeks with one of the three dual combina…

Frequently Asked Questions

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

This is a combination blood pressure medication containing three active ingredients: olmesartan (an angiotensin II receptor blocker), amlodipine (a calcium channel blocker), and hydrochlorothiazide (a thiazide diuretic). It is taken by mouth as a tablet to help lower blood pressure in patients with hypertension.

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

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

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

The generic name for olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide is olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide. There are 3 other brand versions of olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide.

What is the NDC code for olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide 10 mg/1?

The NDC (National Drug Code) for olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide 10 mg/1 is 49884-789, listed by Par Health USA, LLC.

Product NDC

49884-789

Package NDC

49884-789-09

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

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