Drug monograph for the active ingredient in Benicar

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

OLMESARTAN (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Benicar

† Not commercially available in Canada.

Category

• Antihypertensive

Description

Olmesartan(ohl-me-SAR-tan) belongs to the class of medicines called angiotensin II inhibitor antihypertensives. It is used to treat high blood pressure (hypertension).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure also may increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Olmesartan works by blocking the action of a substance in the body that causes blood vessels to tighten. As a result, olmesartan relaxes blood vessels. This lowers blood pressure.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For olmesartan, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to olmesartan. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Use of olmesartan during pregnancy, especially during the second and third trimesters (after the first 3 months), can cause low blood pressure, severe kidney failure, or even death in the newborn. Therefore, it is important that you check with your doctor immediately if you think that you may have become pregnant . Be sure that you have discussed this with your doctor before taking this medicine.

Breast-feeding—It is not known whether olmesartan passes into breast milk. However, olmesartan passes into the milk of lactating rats. Because this medicine may cause serious side effects, breast-feeding is generally not recommended while you are taking olmesartan.

Children—Studies on this medicine have only been done in adult patients, and there is no specific information comparing the use of olmesartan in children with use in other age groups.

Older adults—This medicine has been tested in patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults. Elderly patients may have a greater sensitivity to olmesartan than younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking olmesartan it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Diuretics (water pills)—Effects on blood pressure may be increased

Other medical problems—The presence of other medical problems may affect the use of olmesartan. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure, severe—Lowering of blood pressure by olmesartan may make this condition worse

• Dehydration—Blood pressure-lowering effects of olmesartan may be increased

• Kidney disease or
• Liver disease—Effects of olmesartan may be increased because of slower removal of medicine from the body.

Proper Use of This Medicine

Make certain your health care professional knows if you are on any special diet, such as a low-sodium diet.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

This medicine may be taken with or without food.

Dosing—The dose of olmesartan will be different for different patients. Follow your doctor's orders or the directions on the label . The following information includes only the average doses of olmesartan. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—20 milligrams (mg) once a day. Your doctor may increase your dose to 40 milligrams (mg) once a day if needed.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor checks your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Check with your doctor immediately if you think that you may be pregnant . Olmesartan may cause birth defects or other problems in the baby if taken during pregnancy.

Do not take other medicines unless they have been discussed with your doctor . This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Dizziness or lightheadedness may occur after the first dose of this medicine, especially if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and lead to low blood pressure.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

Avoid alcoholic beverages until you have discussed their use with your doctor . Alcohol may make the low blood pressure effect worse and/or increase the possibility of dizziness or fainting.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Body aches or pain; blood in urine; chills; cough or cough producing mucus; difficulty breathing; ear congestion; fever; headache; loss of voice; nasal congestion; runny nose; shortness of breath; sneezing; sore throat; tightness in chest; unusual tiredness or weakness; wheezing

Rare

Bladder pain; bloody or cloudy urine; difficult, burning, or painful urination; fast, pounding, or irregular heartbeat or pulse; frequent urge to urinate; joint pain, stiffness, or swelling; large amount of fat in the blood; lower back, side, or stomach pain; swelling of feet or lower legs

Frequency not known

Dark-colored urine; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; muscle cramps or spasms; muscle pain or stiffness

Symptoms of overdose

Get emergency help immediately if any of the following symptoms of overdose occur

Blurred vision; chest pain or discomfort; confusion; dizziness, faintness, or lightheadedness; fast, pounding, slow, or irregular heartbeat or pulse; shortness of breath; sweating; unusual tiredness or weakness

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

Less common

Abdominal pain; back pain; blurred vision; body aches or pain; diarrhea; dizziness; dry mouth; fatigue; flushed, dry skin; fruit-like breath odor; general feeling of discomfort or illness; increased hunger; increased thirst; increased urination; loss of appetite; muscle aches and pains; nausea; pain or tenderness around eyes and cheekbones; shivering; sweating; tender, swollen glands in neck; troubled breathing; trouble sleeping; trouble in swallowing; unexplained weight loss; vomiting

Rare

Acid or sour stomach; belching; bloating or swelling of face, arms, hands, lower legs, or feet; chest pain; difficulty in moving; feeling of constant movement of self or surroundings; heartburn; indigestion; muscle pains or stiffness; nausea; rash; rapid weight gain; sensation of spinning; skeletal pain; sleeplessness; stomach pain; swelling or puffiness of face; tingling of hands or feet; unusual weight gain or loss

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 12/26/2002
Revised: 01/31/2005

The information contained in the Thomson Healthcare products is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse or pharmacist can provide you with advice on what is safe and effective for you.

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Copyright © 2004 Thomson Healthcare Inc. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes.

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