Benicar and Benicar HCT are prescription drugs used to Lovegra lower high blood pressure (hypertension). Benicar HCT is not for use as the first medicine to treat your high blood pressure.

The content provided herein is for informational purposes only and does not constitute or substitute for professional medical advice, diagnosis, or treatment. Talk to your doctor for more information about your specific condition.

The photos depict models, not actual patients or healthcare professionals.

Important Safety Information

WARNING: DO NOT TAKE BENICAR OR BENICAR HCT DURING PREGNANCY
If you become pregnant, stop taking Benicar or Benicar HCT. Call your doctor right away. Benicar and Benicar HCT can cause injury or death to an unborn baby. If you plan to become pregnant, talk with your doctor about other treatments to lower blood pressure. Please see the WARNING section of the full product information about avoiding use in pregnancy.

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

Do not take Benicar HCT if you:

• Have severe kidney disease
• Have low or no urine output
• Are allergic to other sulfonamide type medicines

Tell your doctor if you are allergic to any of the ingredients in Benicar or Benicar HCT (see the Prescribing Information for a list of the ingredients in Benicar or Benicar HCT). Also, tell your doctor if you have liver or kidney problems or if you have lupus. If you are vomiting, have a lot of diarrhea, or have any other medical conditions, be sure to tell your doctor.

Tell your doctor about all the medicines you take. These medicines may include prescription and nonprescription medicines, vitamins, and herbal supplements. If you are taking Benicar or Benicar HCT, be sure to tell your doctor if you are taking:

• 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)

If you are taking Benicar HCT, also tell your doctor if you are taking:

• Diabetes medicine, including insulin
• Narcotic pain medicine
• Sleeping pills and antiseizure medicines called barbiturates
• Lithium for certain types of depression
• Steroids
• Cholesterol medicines

Some of your other medicines and Benicar or Benicar HCT could affect each other. This may cause serious side effects. Take Benicar or Benicar HCT as prescribed by your doctor. If you choose to stop taking Benicar or Benicar HCT, talk with your doctor first.

Benicar and Benicar HCT may cause serious side effects. These 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 of Benicar or Benicar HCT. 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.

Other serious side effects of Benicar HCT include allergic reactions due to the thiazide diuretic (water pill), and changes in body salts (such as sodium and potassium) and fluids. Tell your doctor if you have these signs and symptoms: dry mouth, thirst, weakness, tiredness or sleepiness, restlessness, confusion, seizures, muscle pains or cramps, muscle tiredness, dizziness or fainting, having little or no urine output, fast heartbeat, or nausea and vomiting.

Hydrochlorothiazide (an ingredient in Benicar HCT) can also cause eye problems, which may lead to vision loss. Symptoms can happen within hours to weeks of starting Benicar HCT. Tell your doctor if you have a decrease in vision or eye pain.

The most common side effect of Benicar and Benicar HCT was dizziness. Other side effects of Benicar HCT included upper respiratory tract infections, more uric acid in the blood, and nausea. Tell your doctor if a side effect bothers you or does not go away.

Tell your doctor if you have side effects. These are not all the possible side effects of Benicar or Benicar HCT. For more information, talk with your doctor or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects by calling 1-877-437-7763 or the FDA at 1-800-FDA-1088.

Please see full Prescribing Information for Benicar and Benicar HCT, including boxed WARNING regarding avoiding use in Pregnancy.

IMPORTANT SAFETY INFORMATION FOR BENICAR, BENICAR HCT, AND AZOR

WARNING: AVOID USE IN PREGNANCY

When pregnancy is detected, discontinue BENICAR, BENICAR HCT Scifil, or AZOR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. See WARNINGS AND PRECAUTIONS, Fetal/Neonatal Morbidity and Mortality.

Due to the olmesartan medoxomil component, BENICAR, BENICAR HCT, and AZOR have the following Warnings and Precautions:

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, BENICAR HCT, or AZOR. Treatment should start under close medical supervision.

Impaired Renal Function

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected.

The prescribing information for BENICAR HCT also includes the following warnings regarding its hydrochlorothiazide component:

BENICAR HCT is not recommended in patients with severe renal impairment. BENICAR HCT is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Fetal/Neonatal Morbidity and Mortality

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Hepatic Impairment

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Hypersensitivity Reaction

Hypersensitivity reactions to hydrochlorothiazide 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

Thiazide diuretics 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. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Discontinue hydrochlorothiazide as rapidly as possible in these patients. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Lithium Interaction

Lithium generally should not be given with thiazides.

Due to the amlodipine component, AZOR has the following additional Warnings and Precautions:

Vasodilation

Since the vasodilation attributable to amlodipine in AZOR is gradual in onset, acute hypotension has rarely been reported after oral administration. Nonetheless, caution, as with any other peripheral vasodilator, should be exercised when administering AZOR, particularly in patients with severe aortic stenosis.

Severe Obstructive Coronary Artery Disease

Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.

Congestive Heart Failure

In general, calcium channel blockers should be used with caution in patients with heart failure.

Hepatic Impairment

Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t_1/2) is 56 hours in patients with severely impaired hepatic function, caution should be exercised when administering AZOR to patients with severe hepatic impairment. Initial therapy with AZOR is not recommended in hepatically impaired patients.

Geriatric Use

Elderly patients have decreased clearance of amlodipine. Initial therapy with AZOR is not recommended in patients ≥75 years old.

Adverse Reactions

BENICAR/BENICAR HCT

The withdrawal rates due to adverse reactions were similar with BENICAR and BENICAR HCT to placebo: BENICAR (2.4% vs 2.7%); BENICAR HCT (2.0% vs 2.0%).

The incidence of adverse reactions with BENICAR and BENICAR HCT was similar to placebo.

• The only adverse reaction that occurred in >1% of patients treated with BENICAR and more frequently than placebo was dizziness (3% vs 1%)
• 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%)

AZOR

The only adverse reaction that occurred in greater than or equal to 3% of patients treated with AZOR and more frequently than placebo was edema. The placebo-subtracted incidence was 5.7% (5/20 mg), 6.2% (5/40 mg), 13.3% (10/20 mg), and 11.2% (10/40 mg). The edema incidence for placebo was 12.3%.

Adverse reactions seen at lower rates but at about the same or greater incidence as in patients receiving placebo included hypotension, orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, and nocturia.

In individual clinical trials of amlodipine and olmesartan medoxomil, other commonly reported adverse reactions included headache, dizziness, and flushing.

Laboratory Tests

There was a greater decrease in hemoglobin and hematocrit with AZOR compared to either component alone.

Dosage and Administration

No initial dosage adjustments are recommended with BENICAR in elderly or in moderate to marked renal impairment*/hepatic dysfunction.

• In patients with possible depletion of intravascular volume (eg, patients on diuretics, particularly with impaired renal function), BENICAR should be initiated under close medical supervision and consideration given to use of a lower starting dose

For BENICAR HCT, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range.