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|Lotensin HCT

ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITORS AND HYDROCHLOROTHIAZIDE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Accuretic ⁶
• Capozide ²
• Lotensin HCT ¹
• Prinzide ⁴
• Uniretic ⁵
• Vaseretic ³
• Zestoretic ⁴

In Canada—

• Accuretic ⁶
• Prinzide ⁴
• Vaseretic ³
• Zestoretic ⁴

† Not commercially available in Canada.

Category

• Antihypertensive—Benazepril and Hydrochlorothiazide; Captopril and Hydrochlorothiazide; Enalapril and Hydrochlorothiazide; Lisinopril and Hydrochlorothiazide; Moexipril and Hydrochlorothiazide; Quinapril and Hydrochlorothiazide
• Vasodilator, congestive heart failure—Captopril and Hydrochlorothiazide; Enalapril and Hydrochlorothiazide; Lisinopril and Hydrochlorothiazide

Description

This combination 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.

The exact way in which benazepril, captopril, enalapril, lisinopril, moexipril, and quinapril work is not known. They block an enzyme in the body that is necessary to produce a substance that causes blood vessels to tighten. As a result, they relax 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 may also be used for other conditions as determined by your doctor.

This medicine is available only with doctor"s prescription, in the following dosage forms:

• Oral
• Benazepril and Hydrochlorothiazide
  • Tablets (U.S.)
• Captopril and Hydrochlorothiazide
  • Tablets (U.S.)
• Enalapril and Hydrochlorothiazide
  • Tablets (U.S. and Canada)
• Lisinopril and Hydrochlorothiazide
  • Tablets (U.S. and Canada)
• Moexipril and Hydrochlorothiazide
  • Tablets (U.S.)
• Quinapril and Hydrochlorothiazide
  • Tablets (U.S. and Canada)

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 the angiotensin-converting enzyme (ACE) inhibitors and hydrochlorothiazide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to benazepril, enalapril, captopril, lisinopril, moexipril, quinapril, sulfonamides (sulfa drugs), bumetanide, furosemide, acetazolamide, dichlorphenamide, or methazolamide or to hydrochlorothiazide or any of the other thiazide diuretics (water pills). Also tell your health care professional if you are allergic to any other substances, such as foods, sulfites or other preservatives, or dyes.

Pregnancy—Studies with this combination medicine have not been done in pregnant women. However, use of any of the ACE inhibitors during pregnancy, especially in the second and third trimesters (after the first three months), can cause low blood pressure, kidney failure, too much potassium, or even death in newborns. Therefore, it is important that you check with your doctor immediately if you think that you may be pregnant . Be sure that you have discussed this with your doctor before taking this medicine. In addition, if your medicine contains:

• Benazepril —Studies in rats, mice and rabbits at doses up to 300 times the recommended human dose showed no evidence of birth defects.
• Captopril —Studies in rabbits and rats at doses up to 400 times the recommended human dose have shown that captopril causes an increase in death of the fetus and newborn. Also, captopril has caused deformed skulls in the offspring of rabbits given doses 2 to 70 times the recommended human dose.
• Enalapril —Studies in rats at doses many times the recommended human dose have shown that use of enalapril causes the fetus to be smaller than normal. Studies in rabbits have shown that enalapril causes an increase in fetal death. Enalapril has not been shown to cause birth defects in rats or rabbits.
• Lisinopril —Studies in mice and rats at doses many times the recommended human dose have shown that use of lisinopril causes a decrease in successful pregnancies, a decrease in the weight of infants, and an increase in infant deaths. It has also caused a decrease in successful pregnancies and abnormal bone growth in rabbits. Lisinopril has not been shown to cause birth defects in mice, rats, or rabbits.
• Moexipril —Studies in rats and rabbits did not show moexipril to cause birth defects.
• Quinapril —Studies in rats showed quinapril caused reduced body weights but did not show it to cause birth defects in either rats or rabbits.
• Hydrochlorothiazide —Hydrochlorothiazide has not been shown to cause birth defects or other problems in animal studies. However, when hydrochlorothiazide is used during pregnancy, it may cause side effects including jaundice, blood problems, and low potassium in the newborn baby.

Breast-feeding—

• Benazepril —Passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.
• Captopril —Passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.
• Enalapril —Passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.
• Lisinopril —It is not known whether lisinopril passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.
• Moexipril —It is not known whether moexipril passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.
• Quinapril —Passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.
• Hydrochlorothiazide —Passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—Children may be especially sensitive to the blood pressure-lowering effect of ACE inhibitors. This may increase the chance of side effects or other problems during treatment. Extra caution may be necessary when using hydrochlorothiazide in infants with jaundice because it can make this condition worse. Therefore, it is especially important that you discuss with the child"s doctor the good that this medicine may do as well as the risks of using it.

Older adults—Dizziness or lightheadedness and symptoms of too much potassium loss may be more likely to occur in the elderly, who may be more sensitive to the effects of this medicine.

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 taking ACE inhibitors and hydrochlorothiazide it is especially important that your health care professional know if you are taking any of the following:

• Cholestyramine or
• Colestipol—Use with thiazide diuretics may prevent the diuretic from working properly; the diuretic should be taken at least 1 hour before or 4 hours after cholestyramine or colestipol

• Diabetes medication (insulin or tablets)—Blood sugar levels may change; extra care in self monitoring is necessary

• Digitalis glycosides (heart medicine)—If potassium levels in the body are decreased, symptoms of digitalis toxicity may occur

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

• Lithium (e.g., Lithane)—Risk of lithium overdose, even at low doses, may be increased

• Potassium-containing medicines or supplements or
• Salt substitutes or
• Low-salt milk—Use of these substances with ACE inhibitors may result in an unusually high potassium level in the blood, which can lead to heart rhythm and other problems

• Tetracycline—Use with quinapril will decrease the effects of tetracycline

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

• Diabetes mellitus (sugar diabetes)—Increased risk of potassium levels in the body becoming too high

• Gout (or history of)—Hydrochlorothiazide may increase the amount of uric acid in the body, which can lead to gout

• Heart or blood vessel disease or
• Heart attack or stroke (recent)—Lowering blood pressure may make problems resulting from these conditions worse

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

• Kidney transplant—Increased risk of kidney disease caused by ACE inhibitors

• Pancreatitis (inflammation of the pancreas)—Hydrochlorothiazide can make this condition worse

• Systemic lupus erythematosus (SLE) (or history of)—Hydrochlorothiazide may worsen the condition, and there is an increased risk of blood problems caused by ACE inhibitors

• Previous reaction to benazepril, captopril, enalapril, lisinopril, moexipril, or quinapril involving hoarseness; swelling of face, mouth, hands, or feet; or sudden trouble in breathing—Reaction is more likely to occur again

Proper Use of This Medicine

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

For patients taking captopril and hydrochlorothiazide or moexipril and hydrochlorothiazide :

• This medicine is best taken on an empty stomach 1 hour before meals, unless you are otherwise directed by your doctor.

For patients taking this medicine for high blood pressure :

• 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 cause you to have an unusual feeling of tiredness when you begin to take it. You may also notice an increase in the amount of urine or in your frequency of urination. After you have taken the medicine for a while, these effects should lessen. In general, to keep the increase in urine from affecting your sleep:

• If you are to take a single dose a day, take it in the morning after breakfast.
• If you are to take more than one dose a day, take the last dose no later than 6 p.m., unless otherwise directed by your doctor.

However, it is best to plan your dose or doses according to a schedule that will least affect your personal activities and sleep. Ask your health care professional to help you plan the best time to take this medicine.

Dosing—The dose of these medicines 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 these medicines. 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 benazepril and hydrochlorothiazide combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 tablet once a day.
    • Children—Use and dose must be determined by your doctor.

• For captopril and hydrochlorothiazide combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 tablet two or three times a day.
    • Children—Dose is based on body weight and must be determined by your doctor.

• For enalapril and hydrochlorothiazide combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 tablet once or twice a day.
    • Children—Dose is based on body weight and must be determined by your doctor.

• For lisinopril and hydrochlorothiazide combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 or 2 tablets once a day.
    • Children—Dose must be determined by your doctor.

• For moexipril and hydrochlorothiazide combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 or 2 tablets once a day.
    • Children—Use and dose must be determined by your doctor.

• For quinapril and hydrochlorothiazide combination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 tablet once or twice a day.
    • Children—Use and dose must be determined by your doctor.

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

Dizziness or lightheadedness may occur, especially after the first dose of this medicine. Make sure you know how you react to the 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.

Check with your doctor if you have signs of infection, such as sore throat, fever, and/or chills. Infections may be a sign of low white blood cell count (neutropenia).

Check with your doctor if you have strong stomach pain. This could be a symptom of a condition called intestinal angioedema. Your doctor may have to use a CT scan or an ultrasound to diagnose this condition.

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 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.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

For patients taking captopril and hydrochlorothiazide :

• Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

For patients taking this medicine for high blood pressure :

• 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.

For diabetic patients :

• Hydrochlorothiazide (contained in this combination medicine) may raise blood sugar levels. While you are taking this medicine, be especially careful in testing for sugar in your urine.

Hydrochlorothiazide (contained in this combination medicine) may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you first begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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.

Seek medical attention immediately or call your doctor if any of the following side effects occur:

Check with your doctor as soon as possible if any of the following side effects occur:

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:

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

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, ACE inhibitors and hydrochlorothiazide are used in certain patients with the following medical condition:

• Congestive heart failure

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Revised: 11/09/2004

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