Benicar HCT

DRUG DESCRIPTION

BENICAR HCT® (olmesartan medoxomil-hydrochlorothiazide) is a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ).

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.

Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3carbonate.

Its empirical formula is C29H30N6O6 and its structural formula is:

Olmesartan medoxomil Structural Formula Illustration

Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution.

BENICAR HCT® is available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, hypromellose, lactose, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide and yellow iron oxide.

What are the possible side effects of olmesartan and hydrochlorothiazide (Benicar HCT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydrochlorothiazide and olmesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have any...

Read All Potential Side Effects and See Pictures of Benicar HCT »

What are the precautions when taking olmesartan medoxomil-hydrochlorothiazide (Benicar HCT)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to olmesartan or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: gout, kidney disease, liver disease, lupus.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or a serious loss of body water (dehydration). Report prolonged...

Read All Potential Precautions of Benicar HCT »


Benicar HCT Consumer (continued)

SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, muscle cramps/weakness, slow/fast/irregular heartbeat, unusual decrease in the amount of urine, unusual dry mouth/thirst, decrease in vision, eye pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to olmesartan or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: gout, kidney disease, liver disease, lupus.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or a serious loss of body water (dehydration). Report prolonged diarrhea or vomiting to your doctor. To prevent dehydration, drink plenty of fluids unless your doctor directs you otherwise.

If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if olmesartan passes into breast milk. Hydrochlorothiazide passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Benicar HCT Patient Information Including Side Effects

Brand Names: Benicar HCT

Generic Name: hydrochlorothiazide and olmesartan (Pronunciation: HYE droe KLOR oh THYE a zide and ol me SAR tan)

  • What is olmesartan and hydrochlorothiazide (Benicar HCT)?
  • What are the possible side effects of olmesartan and hydrochlorothiazide (Benicar HCT)?
  • What is the most important information I should know about olmesartan and hydrochlorothiazide (Benicar HCT)?
  • What should I discuss with my healthcare provider before taking olmesartan and hydrochlorothiazide (Benicar HCT)?
  • How should I take olmesartan and hydrochlorothiazide (Benicar HCT)?
  • What happens if I miss a dose (Benicar HCT)?
  • What happens if I overdose (Benicar HCT)?
  • What should I avoid while taking olmesartan and hydrochlorothiazide (Benicar HCT)?
  • What other drugs will affect olmesartan and hydrochlorothiazide (Benicar HCT)?
  • Where can I get more information?

What is olmesartan and hydrochlorothiazide (Benicar HCT)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Olmesartan is in a group of drugs called angiotensin II receptor antagonists. Olmesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

The combination of olmesartan and hydrochlorothiazide is used to treat high blood pressure (hypertension).

Olmesartan and hydrochlorothiazide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of olmesartan and hydrochlorothiazide (Benicar HCT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydrochlorothiazide and olmesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have any other serious side effects, such as:

  • feeling like you might pass out;
  • chest pain, feeling short of breath, even with mild exertion;
  • fever;
  • swelling, rapid weight gain;
  • urinating more or less than usual, or not at all;
  • jaundice (yellowing of the skin or eyes); or
  • dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, feeling light-headed, fainting, or seizure (convulsions).

Less serious side effects may include:

  • stomach pain, heartburn, diarrhea;
  • joint pain;
  • dizziness, spinning sensation;
  • headache; or
  • dry cough.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about olmesartan and hydrochlorothiazide (Benicar HCT)?

You should not use this medication if you are allergic to olmesartan or hydrochlorothiazide (Carozide, Diaqua, Ezide HCTZ, HydroDiuril, Microzide, and others), or if you are unable to urinate.

Do not use this medication without telling your doctor if you are pregnant. Olmesartan and hydrochlorothiazide may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of olmesartan and hydrochlorothiazide.

In rare cases, hydrochlorothiazide and olmesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

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