Understand how BENICAR and BENICAR HCT work

  • The reason why BENICAR and BENICAR HCT can help lower your high blood pressure is the way that they work.

    Both BENICAR and BENICAR HCT have a specific medical agent designed to block angiotensin II, a natural chemical in your body that can raise blood pressure by causing blood vessels to tighten and narrow.

    By blocking this specific chemical both BENICAR and BENICAR HCT help lower blood pressure by helping your blood vessels relax and widen.

    BENICAR HCT also adds a second medicine that decreases water content, since retaining too much water can raise blood pressure.

  • Watch how BENICAR works

    DSBN16101746  09/16

    INDICATIONS:

    BENICAR (olmesartan medoxomil) 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. BENICAR may be used alone or with other medicines used to treat high blood pressure.

    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.

     

    Important Safety Information for BENICAR®

    WARNING: DO NOT TAKE BENICAR DURING PREGNANCY

    • BENICAR can cause harm or death to an unborn baby
    • Talk with your doctor about other ways to lower your blood pressure if you become pregnant
    • If you get pregnant while taking BENICAR, tell your doctor immediately

    Please see the WARNINGS AND PRECAUTIONS section of the Full Product Information about Fetal Toxicity.

    Do not take BENICAR if you:

    • Take medicine that contains aliskiren and you have diabetes or kidney problems

     

    Children that are less than 1 year of age must not receive BENICAR for high blood pressure.
    Children of any age should not take BENICAR.

    Before taking BENICAR tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor if you are breast-feeding or plan to breast-feed. A medicine in BENICAR can pass into your breast milk. This may harm your baby. You and your doctor should decide if you will take BENICAR or breast-feed. You should not do both.

    Let your doctor know about any health conditions you may have
    Tell your doctor if you are allergic to any of the ingredients in BENICAR (see Full Product Information for a list of the ingredients in BENICAR). Also let your doctor know if you have any of the health conditions listed below:

    Before you take BENICAR:

    Let your doctor know if you have these, or any other, medical conditions:

    • Kidney problems
    • A lot of diarrhea or are vomiting

    Tell your doctor about all the medicines you take

    Some of your other medicines and BENICAR could affect each other. This may cause serious side effects.

    These medicines may include prescription and nonprescription medicines, vitamins, and herbal supplements:

    If you take BENICAR, tell your doctor if you also take:

    • Water pills (diuretics)
    • Other medicines for high blood pressure or a heart problem
    • Potassium supplements or a salt substitute that contains potassium
    • Pain or arthritis medicines, such as aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs)
    • Welchol® (colesevelam hydrochloride)
    • Lithium for certain types of depression

    About drug interactions

    Some of your other medicines and BENICAR could affect each other. This may cause serious side effects. Take BENICAR as prescribed by your doctor. Talk with your doctor before you stop taking BENICAR.

    Know about possible side effects of BENICAR

    Serious side effects may include injury or death to an unborn baby; low blood pressure (hypotension), which may cause you to feel faint or dizzy; and kidney problems, which may get worse in people with kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose. Tell your doctor if you get swelling in your feet, ankles, or hands, or have unexplained weight gain. These may be signs of kidney problems. If you have heart failure, your doctor should also check your kidney function before prescribing these medicines. Tell your doctor if you are experiencing these symptoms.

    Serious side effects may also include severe, chronic diarrhea with considerable weight loss, which may develop months to years after starting BENICAR. Tell your doctor if you are experiencing these symptoms.

    Additional side effects of BENICAR

    The most common side effect of BENICAR was dizziness.

    Tell your doctor if you have any side effect that bothers you or does not go away. Not all the possible side effects of BENICAR have been mentioned in the Important Safety Information. For more information, talk with your doctor or pharmacist. Call your doctor for medical advice about side effects.

    To report side effects, contact Daiichi Sankyo, Inc., at 1-877-437-7763 or the FDA at 1-800-332-1088 or www.fda.gov/medwatch.

    Please see Full Prescribing Information for BENICAR.

  • Watch how BENICAR HCT works

    DSBN16101747  09/16

    INDICATIONS:

    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

    • When pregnancy is detected, discontinue BENICAR HCT as soon as possible
    • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS AND PRECAUTIONS: Fetal Toxicity

     

    CONTRAINDICATIONS

    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).

    DRUG INTERACTIONS

    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

    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.

Selected Important Safety Information

BENICAR and BENICAR HCT may cause kidney problems, which may get worse in people with kidney disease. Talk to your doctor if you have kidney problems.

For important safety information, please see below.