Pronunciation:

ol-me-SAR-tan me-DOX-oh-mil, hye-droe-klor-oh-THYE-a-zide

Brand Names:

• Benicar HCT

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, hydrochlorothiazide/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—

Angiotensin II Receptor Antagonist/Thiazide Combination

Pharmacologic—

Angiotensin II Receptor Antagonist

Chemical—

Thiazide

Uses of This Medicine:

Olmesartan and hydrochlorothiazide is a combination medicine that belongs to the class of medicines called high blood pressure medicines (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 may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Olmesartan works by blocking a substance in the body that causes blood vessels to tighten. As a result, olmesartan relaxes blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart. Hydrochlorothiazide helps reduce the amount of salt and water in the body by acting on the kidneys to increase the flow of urine; this also helps to lower blood pressure.

This combination also may be used for other conditions as determined by your doctor.

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 been done only in adult patients, and there is no specific information comparing use of olmesartan and hydrochlorothiazide combination in children with use in other age groups.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, older adults may be more sensitive to the effects of olmesartan and hydrochlorothiazide and should be monitored by the doctor.

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—

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.

• Dofetilide

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:

• Fluid or electrolyte (e.g., potassium, chloride, sodium) imbalance (due to excessive perspiration, vomiting, diarrhea, etc.)—The side effects of olmesartan and hydrochlorothiazide may be increased.

• Diabetes mellitus (sugar diabetes) or
• Gout or
• Hyperglycemia or
• Hyperuricemia—These conditions may be made worse by hydrochlorothiazide.

• Hypersensitivity to olmesartan, hydrochlorothiazide, sulfa drugs or any of its components

• Kidney disease or
• Liver disease—These conditions may be aggravated by olmesartan and hydrochlorothiazide

• Sympathectomy—Blood pressure–lowering effects may be increased

• Systemic lupus erythematosus (SLE)—Symptoms of this condition may be made worse with use of hydrochlorothiazide

Proper Use of This Medicine:

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—1 tablet (20 mg/12.5 mg) once a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Precautions While Using This Medicine:

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

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

Do not take other medicines unless they have been discussed with your doctor. This especially includes potassium supplements or salt substitutes that contain potassium, since they may change your blood potassium levels, or 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, lightheadedness, or fainting may occur with this medicine. 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 experience these effects.

Use extra care during exercise or hot weather. Heavy sweating can cause loss of too much water and result in low blood pressure.

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.

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.

For diabetic patients:

• Hydrochlorothiazide may raise blood sugar levels. Check with your doctor if any changes in your blood sugar levels occur.

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:

Symptoms of fluid and electrolyte imbalance

Dry mouth

increased thirst

muscle cramps or pain

nausea or vomiting

unusual tiredness or weakness

weak and/or irregular heartbeat

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:

More common

Chest pain

chills

cough

dizziness

ear congestion or pain

fever

head congestion

hoarseness or other voice changes

nasal congestion

runny nose

sneezing

sore throat

Less common

Joint pain stiffness, or swelling

lower back, side, or stomach pain

swelling of face, feet or lower legs

Incidence unknown

Acid or sour stomach

belching

blood in urine

convulsions

decrease in amount of urine

diarrhea

difficult breathing

difficulty in moving

dizziness

dizziness, faintness, or lightheadedness when getting up from lying or sitting position

fainting

feeling of constant movement of self or surroundings

fruit-like breath odor

heartburn

increased hunger

indigestion

joint pain

large amount of fat in the blood

loss of appetite

mood changes

muscle pain or stiffness

nervousness

numbness or tingling in hands, feet, or lips

numbness, tingling, pain, or weakness in hands or feet

pain in lower back or side

rash

redness in joints

seizures

sensation of spinning

shortness of breath

stomach discomfort, upset, or pain

swelling or puffiness of face

thirst

tingling of hands or feet

trembling

weakness or heaviness of legs

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