Pronunciation:

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

Brand Names:

• Benicar

Dosage Forms:

• Tablet

Warnings:

Discontinue olmesartan medoxomil as soon as possible once pregnancy is detected since drugs that act directly on the renin-angiotensin system can case injury and death in a developing fetus .

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Angiotensin II Receptor Antagonist

Uses of This Medicine:

Olmesartan is used alone or together with other medicines 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. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Olmesartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes the blood vessels to tighten. As a result, olmesartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

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—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of olmesartan in children. However, this medicine has not been shown to be effective in children younger than 6 years of age. Use of olmesartan is not recommended in children younger than 1 year of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olmesartan in the elderly.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aliskiren

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Lithium
• Trimethoprim

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Colesevelam

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—Use may lead to kidney problems.

• Dehydration or
• Diabetes or
• Electrolyte imbalance (eg, high or low potassium or sodium in the blood) or
• Kidney disease—Use with caution. May make these conditions worse.

• Diabetes patients who are also using aliskiren (Tekturna®) or
• Patients with kidney problems who are taking aliskiren (Tekturna®)—Should not be used in these patients.

Proper Use of This Medicine:

In addition to taking this medicine, treatment for your high blood pressure may include weight control and a change in the foods you eat, especially foods high in sodium (salt). 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. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might 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.

If your child cannot swallow the tablets, your doctor may give him/her an oral liquid that is to be prepared by a pharmacist.

To use the oral liquid:

• Shake the oral liquid well before each use.
• Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
• Store the oral liquid in the refrigerator for up to 4 weeks. Throw away any unused medicine after 4 weeks.

If you are also using colesevelam (Welchol®), take it at least 4 hours after taking Benicar®.

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—At first, 20 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg once a day.
    • Children 6 to 16 years of age weighing 35 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 to 40 mg once a day. If the child cannot swallow the tablets, an oral suspension is recommended.
    • Children 6 to 16 years of age weighing at least 20 kg and less than 35 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 10 to 20 mg once a day. If the child cannot swallow the tablets, an oral suspension is recommended.
    • Children 1 to 5 years of age—Use and dose must be determined by your doctor.
    • Children younger than 1 year of age—Use is not recommended.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

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 or your child become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water, and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Severe, chronic diarrhea with weight loss may develop months to years after taking this medicine. Tell your doctor right away if you have these symptoms.

Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

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.

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

Blood in the urine

body aches or pain

chills

cough or cough producing mucus

difficulty with breathing

ear congestion

fever

headache

loss of voice

runny or stuffy nose

sneezing

sore throat

tightness in the chest

unusual tiredness or weakness

Rare

Bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

chest pain

cloudy urine

difficult, burning, or painful urination

fast, pounding, or irregular heartbeat or pulse

frequent urge to urinate

joint pain, stiffness, or swelling

lower back, side, or stomach pain

swelling of the feet or lower legs

Incidence not known

Confusion

dark-colored urine

diarrhea (severe) with weight loss

dizziness

hives or itching

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

muscle cramps or spasms

muscle pain or stiffness

nausea or vomiting

weakness or heaviness of the legs

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

Symptoms of overdose

Blurred vision

chest pain or discomfort

dizziness, faintness, or lightheadedness

sweating

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

Back pain

diarrhea

dry mouth

flushed, dry skin

fruit-like breath odor

general feeling of discomfort or illness

increased hunger

increased thirst

increased urination

loss of appetite

muscle aches

pain or tenderness around the eyes and cheekbones

shivering

tender, swollen glands in the neck

trouble sleeping

trouble swallowing

unexplained weight loss

Rare

Acid or sour stomach

belching

difficulty with moving

feeling of constant movement of self or surroundings

heartburn

indigestion

rapid weight gain

rash

sensation of spinning

tingling of the hands or feet

unusual weight gain or loss

Incidence not known

Hair loss or thinning of the hair

lack or loss of strength

redness of the skin

welts

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

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