Angiotensin-converting Enzyme (ACE) Inhibitors (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, the following should be considered:

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to benazepril, captopril, cilazapril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy - Use of ACE inhibitors during pregnancy, especially in the second and third trimesters (after the first three months) can cause low blood pressure, severe kidney failure, too much potassium, or even death in the newborn. 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 you are taking:

• Benazepril - Benazepril has not been shown to cause birth defects in animals when given in doses more than 3 times the highest recommended human dose.
• Captopril - Studies in rabbits and rats at doses up to 400 times the recommended human dose have shown that captopril causes an increase in deaths 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.
• Fosinopril - Studies in rats have shown that fosinopril causes the fetus to be smaller than normal. Studies in rabbits have shown that fosinopril causes fetal death, probably due to extremely low blood pressure. In rats, birth defects such as skeletal and facial deformities were seen. However, it is not clear that the deformities were related to fosinopril. Birth defects were not seen in 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 given up to 90 times the recommended human dose, and studies in rabbits given up to 0.7 times the recommended human dose, did not show that moexipril causes birth defects in animals.
• Perindopril - Studies in rabbits given up to 50 times the recommended human dose, and monkeys given up to 17 times the recommended human dose, did not show that perindopril causes birth defects in animals.
• Quinapril - Studies in rats have shown that quinapril causes lower birth weights and changes in kidney structure of the fetus. However, birth defects were not seen in rabbits given quinapril.
• Ramipril - Studies in animals have shown that ramipril causes lower birth weights.
• Trandolapril - Studies in rabbits, rats, and monkeys did not show that trandolapril causes any birth defects in animals.

Breast-feeding - �

• Benazepril, captopril, enalapril enalaprilat, and fosinopril - These medicines pass into breast milk.
• Cilazapril, lisinopril, moexipril, perindopril, quinapril, ramipril, and trandolapril - It is not known whether these medicines pass into breast milk. However, these medicines have 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. 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 - This medicine has been tested in a limited number of 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.

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

• Alcohol or
• Diuretics (water pills) - Effects on blood pressure may be increased. In addition, some diuretics make the increase in potassium in the blood caused by ACE inhibitors even greater

• 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

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, or increased effect of insulin on control of blood sugar

• Heart or blood vessel disease or
• Low sodium diet - Lowering blood pressure may make problems resulting from these conditions worse

• Kidney disease or
• Liver disease - ACE inhibitors" effects may be increased because of slower removal of medicine from the body

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

• Systemic lupus erythematosus (SLE) - Increased risk of blood problems caused by ACE inhibitors

• Previous reaction to any ACE inhibitor or previous occurrence involving hoarseness; swelling of face, mouth, hands, or feet; or sudden trouble in breathing - Reaction is more likely to occur again