Understand how BENICAR and BENICAR HCT work
Selected Important Safety Information
For important safety information, please see below.
BENICAR HCT (olmesartan medoxomil-hydrochlorothiazide) is a prescription medicine used to lower high blood pressure (hypertension). Medicines that lower blood pressure lower the chance of having a stroke or heart attack.
Patients may require more than one type of blood pressure lowering medication. Along with lowering blood pressure, a complete treatment plan to lower the chance of a stroke or heart attack may include exercise, a diet low in sodium, stopping smoking, controlling cholesterol, treatment or prevention of blood clots, and controlling blood sugar.
BENICAR HCT may be used alone or with other medicines used to treat high blood pressure.
BENICAR HCT is not for use as the first medicine to treat high blood pressure.
Important Safety Information for BENICAR HCT®
WARNING: FETAL TOXICITY
Do not co-administer aliskiren with BENICAR HCT in patients with diabetes.
BENICAR HCT is contraindicated in patients with anuria or hypersensitivity to any component of BENICAR HCT.
WARNINGS AND PRECAUTIONS
Fetal Toxicity: BENICAR HCT is Pregnancy Category D.
Hypotension in Volume- or Salt-Depleted Patients: In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (eg, those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with BENICAR HCT.
Impaired Renal Function: Patients whose renal function may depend in part upon the activity of the renin-angiotensin-aldosterone system (eg, patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion), may be at particular risk of developing acute renal failure on BENICAR HCT. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on BENICAR HCT.
Safety and effectiveness of BENICAR HCT in patients with severe renal impairment (CrCl ≤30 mL/min) have not been established.
Sprue-like Enteropathy: Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of BENICAR HCT in cases where no other etiology is identified.
Hepatic Impairment: Thiazides (a component in BENICAR HCT) may cause minor alterations of fluid and electrolyte balance that may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.
Electrolyte and Metabolic Imbalances: BENICAR HCT contains hydrochlorothiazide, which can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia, which may be difficult to treat despite potassium repletion. BENICAR HCT also contains olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalemia. Monitor serum electrolytes periodically. Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
Hypersensitivity Reaction: Hypersensitivity reactions to HCTZ (a component in BENICAR HCT) may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Systemic Lupus Erythematosus: Thiazides (a component in BENICAR HCT) have been reported to cause exacerbation or activation of systemic lupus erythematosus.
Acute Myopia and Secondary Angle-Closure Glaucoma: Thiazides can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Discontinue HCTZ (a component in BENICAR HCT) as rapidly as possible in these patients.
Laboratory Tests: Lab abnormalities may include increased blood creatinine levels and hyperkalemia (olmesartan medoxomil) and increased cholesterol and triglyceride levels (HCTZ).
Non-Steroidal Anti-Inflammatory Agents: Concurrent administration of non-steroidal anti-inflammatory drugs (NSAIDs) may lead to increased risk of renal impairment (including possible acute renal failure) and loss of antihypertensive effect of BENICAR HCT.
Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on BENICAR HCT and other agents that affect the RAS. Do not co-administer aliskiren with BENICAR HCT in patients with diabetes. Avoid use of aliskiren with BENICAR HCT in patients with renal impairment (GFR <60 mL/min).
Concurrent Use with Colesevelam Hydrochloride: Concurrent administration of colesevelam hydrochloride with BENICAR HCT reduces the systemic exposure and peak plasma concentration of olmesartan. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose.
Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of olmesartan or thiazide diuretics. Monitor lithium levels in patients receiving BENICAR HCT and lithium.
Antidiabetic Drugs: Dosage adjustment of the antidiabetic drug may be required.
Cholestyramine and Colestipol: Reduced absorption of thiazides. Consider administering BENICAR HCT 4 hours before or 4–6 hours after the administration of the resin.
Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia.
Adverse reactions reported in >2% of patients taking BENICAR HCT and more frequently than placebo included nausea (3% vs 0%), hyperuricemia (4% vs 2%), dizziness (9% vs 2%), and upper respiratory tract infection (7% vs 0%).
USE IN SPECIFIC PATIENT POPULATIONS
Nursing Mothers: Avoid use while nursing; discontinue either nursing or the drug.
Please see Full Prescribing Information for BENICAR HCT.
For important safety information, please see below.
All FDA-approved drugs have product information, a document that contains information healthcare providers need to know when prescribing FDA-approved drugs.
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