Brand Name

    US Brand Name

    Altace


    Description

    Ramipril is used alone or together with other medicines 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.

    Ramipril is an angiotensin-converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, ramipril relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

    Ramipril is also used in some patients with heart failure after a heart attack. After a heart attack, some of the heart muscles weaken and become damaged. These heart muscles may continue to weaken as time goes by. This makes it more difficult for the heart to pump blood. Ramipril may be started within the first few days after a heart attack to increase the survival rate.

    Ramipril is also used to lessen the chance of having heart attacks or strokes in patients 55 years of age or older with serious heart disease.

    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 ramipril 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 ramipril in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require an adjustment in the dose for patients receiving ramipril.

    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.

    • Alteplase, Recombinant
    • Amiloride
    • Aspirin
    • Azathioprine
    • Azilsartan
    • Azilsartan Medoxomil
    • Candesartan
    • Canrenoate
    • Cyclosporine
    • Eplerenone
    • Eprosartan
    • Everolimus
    • Furosemide
    • Irbesartan
    • Levoketoconazole
    • Lithium
    • Losartan
    • Melphalan
    • Mercaptopurine
    • Methotrexate
    • Olmesartan
    • Potassium
    • Potassium Citrate
    • Potassium Phosphate
    • Sirolimus
    • Spironolactone
    • Tacrolimus
    • Telmisartan
    • Triamterene
    • Trimethoprim
    • Valsartan

    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
    • Amtolmetin Guacil
    • Bromfenac
    • Bufexamac
    • Bumetanide
    • Bupivacaine
    • Bupivacaine Liposome
    • Capsaicin
    • Celecoxib
    • Choline Salicylate
    • Clonixin
    • Dexibuprofen
    • Dexketoprofen
    • Diclofenac
    • Diflunisal
    • Dipyrone
    • Droxicam
    • Ethacrynic Acid
    • Etodolac
    • Etofenamate
    • Etoricoxib
    • Etozolin
    • Felbinac
    • Fenoprofen
    • Fepradinol
    • Feprazone
    • Floctafenine
    • Flufenamic Acid
    • Flurbiprofen
    • Gold Sodium Thiomalate
    • Ibuprofen
    • Indomethacin
    • Ketoprofen
    • Ketorolac
    • Lornoxicam
    • Loxoprofen
    • Lumiracoxib
    • Meclofenamate
    • Mefenamic Acid

    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—May increase the risk of this condition occurring again.
    • Collagen vascular disease (an autoimmune disease) or
    • Kidney disease—Increased risk of blood problems.
    • 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 using aliskiren (Tekturna®)—Should not be used in patients with this condition.
    • Electrolyte imbalance (eg, low sodium in the blood) or
    • Fluid imbalance (due to excessive perspiration, vomiting, diarrhea) or
    • Heart or blood vessel disease or
    • Kidney disease or
    • Liver disease—Use with caution. May make these conditions worse.
    • Patients with severe kidney problems who are also taking aliskiren (Tekturna®)—Should avoid use of ramipril.

    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.

    Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. 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 may 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, stroke, or kidney disease.

    The capsule or tablet is usually swallowed whole. If you cannot swallow the capsule, you may open it and sprinkle the contents on a small amount (4 ounces) of applesauce or mix it in 4 ounces of water or apple juice. Eat all of the food or drink all of the liquid to make sure you get the correct amount of medicine.

    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 forms (capsules or tablets):
      • For high blood pressure:
        • Adults—At first, 2.5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day, taken as a single dose or divided into two doses.
        • Children—Use and dose must be determined by your doctor.
      • For heart failure after a heart attack:
        • Adults—At first, 2.5 milligrams (mg) two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 5 mg two times a day.
        • Children—Use and dose must be determined by your doctor.
      • For preventing heart attack or stroke:
        • Adults 55 years of age and older—At first, 2.5 milligrams (mg) once a day for 1 week. For the next 3 weeks, the dose is 5 mg per day as a single dose. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 10 mg per day taken as a single dose or divided into two doses.
        • Adults younger than 55 years of age and 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

    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.

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

    You may store the mixed medicine for 24 hours at room temperature or up to 48 hours in the refrigerator.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood 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. Anaphylaxis 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.

    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.

    Dizziness, lightheadedness, or fainting may occur especially when you get up from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert. Then sit for a few moments before standing to prevent the dizziness from returning.

    Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

    Check with your doctor right away if you have lower back or side pain, decreased frequency or amount of urine, bloody urine, increased thirst, swelling of the face, fingers, or lower legs, weight gain, or increased blood pressure. These could be symptoms of a serious kidney problem.

    Check with your doctor if you have a fever, chills, or sore throat. These may be symptoms of an infection resulting from low white blood cells.

    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 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.

    Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

    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 includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.


    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

    • Blurred vision
    • confusion
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • sweating
    • unusual tiredness or weakness

    Less common

    • Arm, back, or jaw pain
    • chest pain or discomfort
    • chest tightness or heaviness
    • chills
    • cloudy urine
    • cold sweats
    • decrease in urine output or decrease in urine-concentrating ability
    • diarrhea
    • fainting
    • fast or irregular heartbeat
    • shortness of breath

    Rare

    • Seizures
    • unexplained bleeding or bruising

    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:

    More common

    • Cough

    Less common

    • Nausea
    • vomiting

    Rare

    • Feeling of constant movement of self or surroundings
    • muscle pain or stiffness
    • sensation of spinning
    • stomach pain
    • weight loss

    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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