Drugplain

Tribenzor 10 mg/1

olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide · TABLET, FILM COATED · Cosette Pharmaceuticals, Inc.

1 Recall on Record
Plain English

Tribenzor is a tablet, film coated containing olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide at 10 mg/1, taken oral. Manufactured by Cosette Pharmaceuticals, Inc..

Key Facts

Brand Name
Tribenzor
Generic Name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
NDC Code (Product)
0713-0878
Manufacturer
Cosette Pharmaceuticals, Inc.
Strength
10 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA200175
Drug Class
Thiazide Diuretic [EPC]
Marketing Start
09/01/2022

Recall History

1 Recall on Record
Class II07/12/2014

Daiichi Sankyo Pharma Development

Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

sprue-like enteropathy230 reports
gastrooesophageal reflux disease141 reports
acute kidney injury105 reports
weight decreased105 reports
diarrhoea104 reports
dizziness102 reports
constipation77 reports
haemorrhoids76 reports
chronic kidney disease72 reports
nausea67 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Tribenzor is 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 Tribenzor. 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 Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with differ…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Dose once daily. Dosage may be increased in 2-week intervals, as needed. The maximum recommended dose of Tribenzor is 40/10/25 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 /10 /25 mg once daily ( 2 ). Dose selection should be individualized based on previous therapy ( 2 ).

Contraindications

4 CONTRAINDICATIONS Because of the hydrochlorothiazide component, Tribenzor is contraindicated in patients with anuria, hypersensitivity to any component, or hypersensitivity to other sulfonamide-derived drugs. Do not co-administer aliskiren with Tribenzor in patients with diabetes [ See Drug Interactions ( 7.2 )]. Anuria: Hypersensitivity to sulfonamide-derived drugs ( 4 ). Do not co-administer aliskiren with Tribenzor 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 compromised rena…

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, Cosette Pharmaceuticals, Inc. at 1-800-922-1038 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. Tribenzor In the controlled trial of Tribenzor, patients were randomized to Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide 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 combination therapies. Safety data from this study were obtained in 574 patients with hypertension who …

Frequently Asked Questions

What is Tribenzor used for?

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

Is Tribenzor a controlled substance?

Tribenzor is not classified as a controlled substance by the DEA.

What is the generic name for Tribenzor?

The generic name for Tribenzor is olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide. There are 9 other brand versions of olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide.

What is the NDC code for Tribenzor 10 mg/1?

The NDC (National Drug Code) for Tribenzor 10 mg/1 is 0713-0878, listed by Cosette Pharmaceuticals, Inc..

Product NDC

0713-0878

Package NDC

0713-0878-30

Other Olmesartan Brands

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

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