Benicar HCT 12.5 mg/1
olmesartan medoxomil-hydrochlorothiazide · TABLET, FILM COATED · Cosette Pharmaceuticals, Inc.
Benicar HCT is a tablet, film coated containing olmesartan medoxomil-hydrochlorothiazide at 12.5 mg/1, taken oral. Manufactured by Cosette Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Benicar HCT
- Generic Name
- olmesartan medoxomil-hydrochlorothiazide
- NDC Code (Product)
0713-0863- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Strength
- 12.5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA021532
- Drug Class
- Thiazide Diuretic [EPC]
- Marketing Start
- 09/01/2022
Recall History
Daiichi Sankyo Pharma Development
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Daiichi Sankyo Pharma Development
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Daiichi Sankyo Pharma Development
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. BENICAR HCT is 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 BENICAR HCT. 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 B…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended starting dose of BENICAR HCT is 40/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy. Dose can be titrated up to 40 /25 mg if necessary. The recommended starting dose of BENICAR HCT is 20/12.5 mg once daily in patients whose blood pressure is not adequately controlled with HCT monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide. Dose can be titrated up to 40 /25 mg if necessary. Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of BENICAR HCT. 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 BENICAR HCT is contraindicated: In patients with hypersensitivity to any component of BENICAR HCT [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 [ s ee Drug Interactions (7.4) ]. Hypersensitivity to any component of BENICAR HCT ( 4 ) Anuria ( 4 ) Do not co-administer aliskiren with BENICAR HCT 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 BENICAR HCT 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 medoxomil In patients who are elderly, v…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions with BENICAR HCT 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 Cosette Pharmaceuticals, Inc. at 1-800-922-1038 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 and hydrochlo…
Frequently Asked Questions
What is Benicar HCT used for?
Benicar HCT contains olmesartan medoxomil-hydrochlorothiazide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Benicar HCT a controlled substance?
Benicar HCT is not classified as a controlled substance by the DEA.
What is the generic name for Benicar HCT?
The generic name for Benicar HCT is olmesartan medoxomil-hydrochlorothiazide. There are 6 other brand versions of olmesartan medoxomil-hydrochlorothiazide.
What is the NDC code for Benicar HCT 12.5 mg/1?
The NDC (National Drug Code) for Benicar HCT 12.5 mg/1 is 0713-0863, listed by Cosette Pharmaceuticals, Inc..
Other Olmesartan Brands
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- olmesartan medoxomil-hydrochlorothiazide12.5 mg/142291-925
- olmesartan medoxomil-hydrochlorothiazide12.5 mg/142291-924
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)