Drug Info: A: Angiotensin-converting Enzyme (ACE) Inhibitors and Hydrochlorothiazide (Systemic)

Some commonly used brand names are:

In the U.S.—

In Canada—

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

This combination belongs to the class of medicines calledhigh blood pressure medicines (antihypertensives). It is usedto treat high blood pressure (hypertension).

High blood pressure adds to the workload of the heart andarteries. If it continues for a long time, the heart andarteries may not function properly. This can damage the bloodvessels of the brain, heart, and kidneys, resulting in astroke, heart failure, or kidney failure. High blood pressuremay also increase the risk of heart attacks. These problemsmay be less likely to occur if blood pressure iscontrolled.

The exact way in which benazepril, captopril, enalapril,lisinopril, moexipril, and quinapril work is not known. Theyblock an enzyme in the body that is necessary to produce asubstance that causes blood vessels to tighten. As a result,they relax blood vessels. This lowers blood pressure andincreases the supply of blood and oxygen to the heart.Hydrochlorothiazide helps reduce the amount of salt and waterin the body by acting on the kidneys to increase the flow ofurine; this also helps to lower blood pressure.

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

This medicine is available only with doctor'sprescription, 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)

In deciding to use a medicine, the risks of taking themedicine must be weighed against the good it will do. This isa decision you and your doctor will make. For theangiotensin-converting enzyme (ACE) inhibitors andhydrochlorothiazide, the following should be considered:

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

Pregnancy—Studies with thiscombination 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 thefirst three months), can cause low blood pressure, kidneyfailure, too much potassium, or even death in newborns. Therefore, it is important that you check with yourdoctor immediately if you think that you may be pregnant. Be sure that you have discussed this with your doctorbefore taking this medicine. In addition, if your medicinecontains:

• Benazepril—Studies in rats, mice and rabbitsat doses up to 300 times the recommended human dose showedno evidence of birth defects.
• Captopril—Studies in rabbits and rats at dosesup to 400 times the recommended human dose have shown thatcaptopril causes an increase in death of the fetus andnewborn. Also, captopril has caused deformed skulls in theoffspring of rabbits given doses 2 to 70 times therecommended human dose.
• Enalapril—Studies in rats at doses many timesthe recommended human dose have shown that use of enalaprilcauses the fetus to be smaller than normal. Studies inrabbits have shown that enalapril causes an increase infetal death. Enalapril has not been shown to cause birthdefects in rats or rabbits.
• Lisinopril—Studies in mice and rats at dosesmany times the recommended human dose have shown that useof lisinopril causes a decrease in successful pregnancies,a decrease in the weight of infants, and an increase ininfant deaths. It has also caused a decrease in successfulpregnancies and abnormal bone growth in rabbits. Lisinoprilhas not been shown to cause birth defects in mice, rats, orrabbits.
• Moexipril—Studies in rats and rabbits did notshow moexipril to cause birth defects.
• Quinapril—Studies in rats showed quinaprilcaused reduced body weights but did not show it to causebirth defects in either rats or rabbits.
• Hydrochlorothiazide—Hydrochlorothiazide hasnot been shown to cause birth defects or other problems inanimal studies. However, when hydrochlorothiazide is usedduring pregnancy, it may cause side effects includingjaundice, blood problems, and low potassium in the newbornbaby.

Breast-feeding—

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

Children—Children may be especiallysensitive to the blood pressure–lowering effect of ACEinhibitors. This may increase the chance of side effects orother problems during treatment. Extra caution may benecessary when using hydrochlorothiazide in infants withjaundice because it can make this condition worse. Therefore,it is especially important that you discuss with the child'sdoctor the good that this medicine may do as well as therisks of using it.

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

Other medicines—Although certainmedicines should not be used together at all, in other casestwo different medicines may be used together even if aninteraction might occur. In these cases, your doctor may wantto change the dose, or other precautions may be necessary.When taking ACE inhibitors and hydrochlorothiazide it isespecially important that your health care professional knowif you are taking any of the following:

• Cholestyramine or
• Colestipol—Use with thiazide diuretics mayprevent the diuretic from working properly; the diureticshould be taken at least 1 hour before or 4 hours aftercholestyramine or colestipol

• Diabetes medication (insulin or tablets)—Bloodsugar levels may change; extra care in self monitoring isnecessary

• Digitalis glycosides (heart medicine)—Ifpotassium levels in the body are decreased, symptoms ofdigitalis toxicity may occur

• Diuretics (water pills)—Effects on blood pressuremay 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 ACEinhibitors may result in an unusually high potassium levelin the blood, which can lead to heart rhythm and otherproblems

• Tetracycline—Use with quinapril will decrease theeffects of tetracycline

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

• Gout (or history of)—Hydrochlorothiazide mayincrease the amount of uric acid in the body, which can leadto gout

• Heart or blood vessel disease or
• Heart attack or stroke (recent)—Lowering bloodpressure may make problems resulting from these conditionsworse

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

• Kidney transplant—Increased risk of kidney diseasecaused by ACE inhibitors

• Pancreatitis (inflammation of thepancreas)—Hydrochlorothiazide can make this conditionworse

• Systemic lupus erythematosus (SLE) (or historyof)—Hydrochlorothiazide may worsen the condition, andthere is an increased risk of blood problems caused by ACEinhibitors

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

To help you remember to take your medicine, try to getinto 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 hourbefore meals, unless you are otherwise directed by yourdoctor.

For patients taking this medicine for high blood pressure :

• In addition to the use of the medicine your doctor hasprescribed, treatment for your high blood pressure mayinclude weight control and care in the types of foods youeat, especially foods high in sodium. Your doctor will tellyou which of these are most important for you. You shouldcheck with your doctor before changing your diet.
• Many patients who have high blood pressure will notnotice any signs of the problem. In fact, many may feelnormal. It is very important that you take your medicine exactly as directed and that youkeep your appointments with your doctor even if you feelwell.
• Remember that this medicine will not cure your highblood pressure but it does help control it. Therefore, youmust continue to take it as directed if you expect to loweryour blood pressure and keep it down. You may have to take high blood pressure medicine forthe rest of your life . If high blood pressure is nottreated, it can cause serious problems such as heartfailure, blood vessel disease, stroke, or kidneydisease.

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

• If you are to take a single dose a day, take it in themorning after breakfast.
• If you are to take more than one dose a day, take thelast dose no later than 6 p.m., unless otherwise directedby your doctor.

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

Dosing—

The dose of these medicines will be different fordifferent patients. Follow your doctor's orders or the directions on thelabel. The following information includes only theaverage doses of these medicines. If your dose is different, do not change it unlessyour doctor tells you to do so.

The number of tablets that you take depends on thestrength of the medicine.

• For benazepril and hydrochlorothiazidecombination
• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 tablet once a day.
    • Children—Use and dose must be determined byyour doctor.

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

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

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

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

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

Missed dose—

If you miss a dose of this medicine, take it as soon aspossible. However, if it is almost time for your next dose,skip the missed dose and go back to your regular dosingschedule. 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, orin other damp places. Heat or moisture may cause themedicine to break down.
• Do not keep outdated medicine or medicine no longerneeded. Be sure that any discarded medicine is out of thereach of children.

It is important that your doctor check your progress atregular visits to make sure that this medicine is workingproperly and to check for unwanted effects.

Dizziness or lightheadedness may occur, especially afterthe first dose of this medicine. Make sure you know how youreact to the medicine before you drive, use machines, or doanything else that could be dangerous if you are dizzy.

Check with your doctor right away if you become sick whiletaking this medicine, especially with severe or continuingnausea and vomiting or diarrhea. These conditions may causeyou to lose too much water and lead to low bloodpressure.

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

Dizziness, lightheadedness, or fainting may also occur ifyou exercise or if the weather is hot. Heavy sweating cancause loss of too much water and low blood pressure. Useextra care during exercise or hot weather.

Avoid alcoholic beverages until you have discussed theiruse with your doctor. Alcohol may make the low bloodpressure effect worse and/or increase the possibility ofdizziness or fainting.

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

For patients taking captopril and hydrochlorothiazide :

• Before you have any medical tests, tell the doctor incharge that you are taking this medicine. The results ofsome tests may be affected by this medicine.

For patients taking this medicine for high blood pressure :

• Do not take other medicines unless they have beendiscussed with your doctor. This especially includesover-the-counter (nonprescription) medicines for appetitecontrol, asthma, colds, cough, hay fever, or sinusproblems, since they may tend to increase your bloodpressure.

For diabetic patients:

• Hydrochlorothiazide (contained in this combinationmedicine) may raise blood sugar levels. While you aretaking this medicine, be especially careful in testing forsugar in your urine.

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

• Stay out of direct sunlight, especially between thehours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wearsunglasses.
• Apply a sun block product that has a skin protectionfactor (SPF) of at least 15. Some patients may require aproduct with a higher SPF number, especially if they have afair 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 least15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

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

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

Along with its needed effects, a medicine may cause someunwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

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

• Rare
  • Swelling of face, mouth, hands, or feet; trouble inswallowing or breathing (sudden); hoarseness ; feverand chills
  
  

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

• Less common
  • Dizziness, lightheadedness, or fainting; skin rash,with or without itching, fever, or joint pain
  
  

• Rare
  • Chest pain; joint pain; lower back or side pain;stomach pain (severe) with nausea and vomiting; unusualbleeding or bruising; yellow eyes or skin
  
  

• Signs and symptoms of too much or too littlepotassium in the body
  • Dryness of mouth; increased thirst; irregularheartbeat; mood or mental changes; muscle cramps orpain; numbness or tingling in hands, feet, or lips;weakness or heaviness of legs; weak pulse
  
  

Other side effects may occur that usually do not needmedical attention. These side effects may go away duringtreatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effectscontinue or are bothersome:

• More common
  • Cough (dry, persistent)
  
  

• Less common
  • Diarrhea; headache; increased sensitivity of skinto sunlight (skin rash, itching, redness or otherdiscoloration of skin or severe sunburn after exposureto sunlight) ; loss of appetite; loss of taste; stomachupset; unusual tiredness
  
  

Other side effects not listed above may also occur in somepatients. If you notice any other effects, check with yourdoctor.

Once a medicine has been approved for marketing for acertain use, experience may show that it is also useful forother medical problems. Although this use is not included inproduct labeling, ACE inhibitors and hydrochlorothiazide areused in certain patients with the following medicalcondition:

• Congestive heart failure

Other than the above information, there is no additionalinformation relating to proper use, precautions, or sideeffects for this use.