Description
Perindopril and amlodipine 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.
Perindopril 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.
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.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
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 perindopril and amlodipine 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 perindopril and amlodipine combination in the elderly. However, elderly patients are more likely to have unwanted effects (eg, dizziness, rash) or age-related liver problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
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
- Valsartan
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
- Haloperidol
- Irbesartan
- Itraconazole
- Ketoconazole
- Lacosamide
- Landiolol
- Lithium
- Losartan
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:
- Angioedema (swelling of the face, lips, tongue, or throat), history of or
- Diabetes patients who are also taking aliskiren (Tekturna®)—Should not be used in these patients.
- Aortic stenosis (heart valve problem), severe or
- Congestive heart failure, severe or
- Heart disease, severe—Use with caution. May cause side effects to become worse.
- Heart failure or
- Kidney disease, severe or
- Liver disease—Use is not recommended in patients with these conditions.
Proper Use
In addition to using 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.
Remember that this medicine will not cure your high blood pressure, but it does help control it. 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.
This medicine comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Dosing
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.
- For oral dosage form (tablets):
- For high blood pressure:
- Adults—At first, one tablet containing perindopril 3.5 milligrams (mg) and amlodipine 2.5 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than perindopril 14 mg and amlodipine 10 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 it is less than 12 hours until your next regular dose, take your next dose at the 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, lips, tongue, or throat while you are using this medicine.
Check with 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, shortness of breath, 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). Do not drive or do anything else that could be dangerous if you are dizzy. 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.
Check with your doctor right away if you have bloody urine, decrease in frequency or amount of urine, 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.
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.
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.
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: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea, 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.
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:
More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- rapid weight gain
- tingling of the hands or feet
- unusual weight gain or loss
Incidence not known
- Arm, back, or jaw pain
- bloody urine
- blurred vision
- chest pain or discomfort
- chest tightness or heaviness
- confusion
- decreased frequency or amount of urine
- difficult breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast or irregular heartbeat
- increased thirst
- irregular heartbeat
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- lower back or side pain
- nausea
- nervousness
- numbness or tingling in the hands, feet, or lips
- pain or discomfort in the arms, jaw, back or neck
- stomach pain
- sweating
- unusual tiredness or weakness
- vomiting
- weakness or heaviness of the legs
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
- dizziness
- headache
Incidence not known
- Diarrhea
- rash
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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