Amlodipine and Benazepril (Oral Route)

Drug Information provided by: Micromedex

ARTICLE SECTIONS

US Brand Names

Lotrel

Description

Amlodipine and benazepril 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 this medicine works is not known. Amlodipine is a type of medicine known as a calcium channel blocker. Calcium channel blocking agents affect the movement of calcium into the cells of the heart and blood vessels. Benazepril is a type of medicine known as an angiotensin-converting enzyme (ACE) inhibitor. It blocks an enzyme in the body that is necessary in producing a substance that causes blood vessels to tighten. The action of both medicines together is to relax blood vessels, lower blood pressure, and increase the supply of blood and oxygen to the heart.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Capsule

Before Using

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.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of amlodipine and benazepril combination in children with use in other age groups.

Geriatric

This medicine has been tested in 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. However, blood levels of amlodipine may be increased in the elderly and elderly people may be more sensitive to the effects of this medicine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	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.

Breastfeeding

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.

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiloride
Amiodarone
Atazanavir
Azathioprine
Canrenoate
Droperidol
Eplerenone
Fentanyl
Potassium
Spironolactone
Triamterene

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:

Bee-sting allergy treatments or
Dialysis—Increased risk of serious allergic reaction occurring

Dehydration—Lowering effects on blood pressure may be increased

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

Heart or blood vessel disease—Lowering blood pressure may make problems resulting from these conditions worse

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

Scleroderma or
Systemic lupus erythematosus (SLE) (or history of)—Increased risk of blood problems caused by ACE inhibitors

Proper Use

Take this medicine exactly as directed by your doctor, at the same time each day. Do not take more of it and do not take it more often than directed.

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 (capsules):
- For high blood pressure:
  - Adults—1 capsule a day. Your doctor may increase your dose if needed.
  - 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly, to check for unwanted effects, and to change the dosage if needed.

If you think that you may have become pregnant, check with your doctor immediately. Use of this medicine, especially during the second and third trimesters (after the first 3 months) of pregnancy, may cause serious injury or even death to the unborn child.

Do not take any other medicines, especially potassium supplements, or salt substitutes that contain potassium unless approved or prescribed by your doctor.

Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you experience these effects.

Check with your doctor if you notice any signs of fever, sore throat, or chills. These could be symptoms of an infection resulting from low white blood cell counts.

Check with your doctor if you notice difficult breathing or swelling of the face, arms, or legs. These could be symptoms of a serious allergic reaction.

Check with your doctor if you become sick while taking this medicine, especially with severe or continuing vomiting or diarrhea. These conditions may cause you to lose too much water, possibly resulting in low blood pressure.

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 result in low blood pressure. Use extra care during exercise or hot weather.

In some patients, tenderness, swelling, or bleeding of the gums may appear soon after treatment with this medicine is started. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

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.

Black patients may be less sensitive to the blood pressure-lowering effects of this medicine. In addition, the risk of a serious allergic reaction involving swelling of the face, mouth, hands, or feet may be increased.

Side Effects

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:

Rare

Swelling of face, mouth, hands, or feet
Trouble in swallowing or breathing (sudden) and/or hoarseness

Incidence not determined

Chest pain
Difficulty in swallowing
Heartburn
Pain or burning in throat
Vomiting
Sores, ulcers, or white spots on lips or tongue or inside the mouth
Stomach pain

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

Less common

Dizziness, lightheadedness, or fainting
Swelling of ankles, feet, or lower legs

Signs and symptoms of too much potassium in the body

Confusion
Irregular heartbeat
Nervousness
Numbness or tingling in hands, feet, or lips
Shortness of breath
Weakness or heaviness of legs

Rare

Bleeding gums, fatigue, nosebleeds, and/or pale skin
Blisters in mouth spreading to trunk, scalp, or other areas
Chills, fever, or sore throat
Nausea or vomiting
Sores in mouth, or on arms, feet, hands, legs, or lips (sudden)
Stomach pain or bloating with fever, nausea, or vomiting
Unusual bleeding or bruising
Yellow eyes or skin

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:

Less common