Understanding

INDICATIONS:

BENICAR (olmesartan medoxomil) is a prescription medicine used to lower high blood pressure (hypertension) in adult and pediatric patients six years of age or older. 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^®

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:

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:

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 Cosette Pharmaceuticals, Inc., at 1-800-922-1038 or the FDA at 1-800-332-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for BENICAR.

INDICATIONS:

BENICAR HCT (olmesartan medoxomil-hydrochlorothiazide) is a prescription medicine used to lower high blood pressure (hypertension) in adult patients. 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^®

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.