Angiotensin-converting Enzyme (ACE) Inhibitors and Hydrochlorothiazide (Systemic)

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