Pronunciation:

ol-me-SAR-tan me-DOX-oh-mil

Brand Names:

• Benicar

Dosage Forms:

• Tablet

Warnings:

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, olmesartan medoxomil should be discontinued as soon as possible .

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Angiotensin II Receptor Antagonist

Uses of This Medicine:

Olmesartan 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.

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy—

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using 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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.