Description
Amlodipine and benazepril is a combination of medicines that are 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. Lowering blood pressure can reduce the risk of strokes and heart attacks.
Amlodipine is a calcium channel blocker (CCB). It affects the movement of calcium into the cells of the heart and blood vessels. This relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart.
Benazepril is an angiotensin-converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that causes the blood vessels to tighten. This relaxes the blood vessels and lowers blood pressure.
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
Appropriate studies have not been performed on the relationship of age to the effects of amlodipine and benazepril combination in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amlodipine and benazepril combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults, which may require an adjustment in the dose for patients receiving amlodipine and benazepril combination.
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.
Drug Interactions
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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Aliskiren
- Sacubitril
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.
- Abametapir
- Alteplase, Recombinant
- Amiloride
- Aspirin
- Atazanavir
- Avacopan
- Azathioprine
- Azilsartan
- Azilsartan Medoxomil
- Candesartan
- Canrenoate
- Carbamazepine
- Ceritinib
- Clarithromycin
- Clonidine
- Clopidogrel
- Conivaptan
- Cyclosporine
- Dantrolene
- Darunavir
- Digoxin
- Domperidone
- Droperidol
- Epirubicin
- Eplerenone
- Eprosartan
- Erythromycin
- Everolimus
- Fedratinib
- Fexinidazole
- Fosnetupitant
- Furosemide
- Irbesartan
- Itraconazole
- Lacosamide
- Lithium
- Losartan
- Mavacamten
- Melphalan
- Mercaptopurine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aceclofenac
- Acemetacin
- Amprenavir
- Amtolmetin Guacil
- Aprepitant
- Boceprevir
- Bromfenac
- Bufexamac
- Bumetanide
- Bupivacaine
- Bupivacaine Liposome
- Capsaicin
- Celecoxib
- Choline Salicylate
- Cimetidine
- Ciprofloxacin
- Clofazimine
- Clonixin
- Cobicistat
- Crizotinib
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Diflunisal
- Diltiazem
- Dipyrone
- Dronedarone
- Droxicam
- Duvelisib
- Ethacrynic Acid
- Etodolac
- Etofenamate
- Etoricoxib
- Etozolin
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
- Floctafenine
- Fluconazole
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:
- Angina (severe chest pain), history of or
- Electrolyte imbalance (eg, low sodium in the blood) or
- Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
- Kidney disease or
- Liver disease—Use with caution. May make these conditions worse.
- Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history of—May increase risk of this condition occurring again.
- Aortic stenosis (heart valve problem), severe or
- Heart disease, severe, history of or
- Heart failure, severe, history of—Use with caution. May cause side effects to become worse.
- Congestive heart failure, severe—Use may lead to kidney problems.
- Diabetes or
- Kidney problems—Increased risk of potassium levels in the body becoming too high.
- Diabetic patients who are also taking aliskiren (Tekturna®)—Should not be used in these patients.
Proper Use
In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.
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 might 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, strokes, or kidney disease.
You may take this medicine with or without food. Take it at the same time each day.
This medicine comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.
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—At first, one capsule (amlodipine 2.5 milligrams [mg] and benazepril 10 mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than amlodipine 10 mg and benazepril 40 mg per day.
- Children—Use and dose must be determined by your doctor.
- For high blood pressure:
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.
If more than 12 hours have passed since you missed your last dose, skip the missed dose and take the next dose at your regular time.
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
You should not use this medicine together with sacubitril. Do not use this medicine and sacubitril/valsartan (Entresto®) within 36 hours of each other.
This medicine may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Call your doctor right away if you have severe stomach pain (with or without nausea or vomiting). This could be a symptom of a condition called intestinal angioedema.
This medicine may cause angina (chest pain) or a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, or sweating.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position or if you have been taking a diuretic (water pill). If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, call your doctor right away.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Ask your doctor before you use any medicine, supplement, or salt substitute that contains potassium.
Check with your doctor right away if you become sick while taking this medicine, especially with severe nausea, vomiting, or diarrhea that does not stop. These conditions may cause you to lose too much water and lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.
Before having any type of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine.
This medicine may be less effective in black patients. Black patients also have an increased risk of swelling of the hands, arms, face, mouth, or throat. Talk with your doctor if you have concerns about this.
Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.
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:
Less common
- Confusion
- dizziness, lightheadedness, or fainting
- fast or irregular heartbeat
- nervousness
- numbness or tingling in the hands, feet, or lips
- swelling of the ankles, feet, or lower legs
- weakness or heaviness of the legs
Rare
- Bleeding gums
- chills
- fever
- nausea or vomiting
- nosebleeds
- pale skin
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stomach pain or bloating with fever, nausea, or vomiting
- swelling of the face, mouth, hands, or feet
- trouble with swallowing or breathing (sudden) or hoarseness
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
Incidence not known
- Chest pain
- heartburn
- pain or burning in the throat
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
- Cough (dry and continuous)
- feeling of warmth
- redness of the face, neck, arms, and occasionally upper chest
- sleepiness
Incidence not known
- Belching
- blistering, crusting, irritation, itching, or reddening of the skin
- body aches or pain
- cracked, dry, or scaly skin
- decreased interest in sexual intercourse
- difficulty having a bowel movement
- frequent urination
- inability to have or keep an erection
- increased volume of pale, dilute urine
- indigestion
- lack or loss of strength
- loss in sexual ability, desire, drive, or performance
- muscle or bone pain
- shakiness in the legs, arms, hands, or feet
- stomach discomfort or upset
- sudden sweating
- swelling
- tender, swollen glands in the neck
- trembling or shaking of the hands or feet
- trouble with sleeping
- voice changes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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