Ramipril

Ramipril is an ACE inhibitor. ACE stands for angiotensin-converting enzyme.

Ramipril is used to treat high blood pressure (hypertension) and in adults who have heart failure after a heart attack, to lower the risk of death from cardiovascular causes and to reduce hospital stays for heart failure.

Ramipril is also used in people 55 years or older who are at high risk of a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes along with at least one other risk factor. In these people, ramipril is used to reduce the risk of heart attack, stroke, or death from cardiovascular causes.

Ramipril may also be used for purposes not listed in this medication guide.

Take ramipril exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Ramipril can be taken with or without food.

Capsules

Swallow the capsule whole.

If you have trouble swallowing the capsule, you may open it and sprinkle the medicine into a half-cup (4 ounces) of water, apple juice, or applesauce to make swallowing easier. Swallow without chewing, and take all of the mixture so that you get the full dose. You may store the mixture for up to 24 hours at room temperature, or up to 48 hours in a refrigerator.

Oral solution

Use an oral dosing syringe or an oral dosing cup to measure the prescribed amount correctly. You can obtain these from your pharmacy.

While you are taking ramipril

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking ramipril. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

Your blood pressure will need to be checked often, and you may need frequent blood tests to check your potassium levels.

If you have diabetes and take insulin or an oral diabetes medicine, check your blood sugar closely when you start ramipril, especially during the first month, because your blood sugar may fall too low.

Drink plenty of water each day while you are taking this medication.

If you need surgery, tell the surgeon ahead of time that you are using this medicine.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Ramipril carries a Boxed Warning for harm to an unborn baby (fetal toxicity).

Do not use ramipril if you are pregnant. If you become pregnant, stop taking this medicine right away and tell your doctor. Ramipril can cause injury or death to the unborn baby. Use effective birth control.

Angioedema

Angioedema is a serious allergic type of swelling. It can happen with any ACE inhibitor, including ramipril, and it can involve swelling in the throat and voice box that makes it hard to breathe. Angioedema is most likely after the first dose of ramipril, but it can also start much later, sometimes months or even years after you begin treatment.

Tell your doctor right away if you notice swelling of your face, eyes, lips, or tongue, or if you have difficulty breathing. Stop taking ramipril until you have spoken with the doctor who prescribed it.

Angioedema can also affect the intestines. Tell your doctor if you develop stomach pain, with or without nausea or vomiting.

You should not use ramipril if you have ever had angioedema while taking an ACE inhibitor, or if you have a history of hereditary or idiopathic angioedema.

Other important warnings

Do not take ramipril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use ramipril together with any medication that contains aliskiren (a blood pressure medicine).

You should not use ramipril if you are allergic to it, or if:

• you have ever had a severe allergic reaction to any other ACE inhibitor (benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, or trandolapril);
• you have ever had angioedema, including hereditary or idiopathic angioedema; or
• you recently took a heart medicine called sacubitril.

Do not take ramipril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use ramipril together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking ramipril with aliskiren if you have kidney disease.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);
• an electrolyte imbalance (such as high levels of potassium in your blood);
• liver disease;
• a collagen-vascular disease such as lupus or scleroderma;
• narrowing of the arteries to your kidneys (renal artery stenosis);
• if you are on a low-salt diet;
• if you are also taking telmisartan (Micardis); or
• if you are taking an mTOR inhibitor such as temsirolimus, sirolimus, or everolimus.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Ramipril can cause injury or death to the unborn baby. Use effective birth control.

You should not breast-feed while using this medicine. A single 10 mg dose of ramipril produced amounts in breast milk too small to detect. However, repeated doses may lead to low levels in breast milk that cannot be predicted from a single dose, and a breastfed baby could develop serious problems including low blood pressure, high potassium, and reduced kidney function.

Safety and effectiveness in children have not been established. The oral solution is not recommended in children younger than 2 years of age.

Serious side effects

Get emergency medical help if you have any signs of an allergic reaction to ramipril: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. This swelling, called angioedema, is most likely after your first dose but can begin months or even years after you start treatment. In clinical trials, ACE inhibitors caused angioedema more often in Black patients than in non-Black patients.

Angioedema can also affect the intestines and cause severe stomach pain, with or without nausea or vomiting.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out, or fainting (stop taking ramipril and call your doctor if you faint);
• jaundice (yellowing of your skin or eyes);
• little or no urination;
• fever, chills, sore throat; or
• high potassium: nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects

Common ramipril side effects may include:

• cough;
• low blood pressure;
• headache;
• dizziness; or
• fatigue, weakness, tired feeling.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual adult dose for hypertension

• Initial dose: 2.5 mg orally once a day for patients not receiving a diuretic
• Maintenance dose: 2.5 to 20 mg per day orally, given as a single dose or in 2 equally divided doses

Usual adult dose to reduce the risk of heart attack, stroke, or death from cardiovascular causes

• 2.5 mg orally once a day for 1 week
• Then 5 mg orally once a day for the next 3 weeks
• Then increase as tolerated to a maintenance dose of 10 mg orally once a day

Usual adult dose for heart failure after a heart attack

• Initial dose: 2.5 mg orally twice a day. If blood pressure drops too low at this dose, the dose may be lowered to 1.25 mg twice a day
• Maintenance dose: after 1 week, the dose is increased as tolerated toward a target of 5 mg orally twice a day, with increases about 3 weeks apart

Dose adjustments

Kidney impairment:

• Hypertension: initial dose 1.25 mg once a day, titrated upward until blood pressure is controlled, to a maximum total daily dose of 5 mg
• Heart failure after a heart attack: initial dose 1.25 mg once a day, which may be increased to 1.25 mg twice a day and up to a maximum of 2.5 mg twice a day

Volume depletion or renal artery stenosis: initial dose 1.25 mg once a day.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not use salt substitutes or potassium supplements while taking ramipril, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Tell your doctor about all your current medicines. Many drugs can interact with ramipril, especially:

• a diuretic ("water pill"), or any other blood pressure medications;
• other medicines that act on the renin-angiotensin system, such as angiotensin receptor blockers or aliskiren;
• medicines or supplements that raise potassium, including potassium supplements, potassium-containing salt substitutes, and potassium-sparing diuretics;
• lithium;
• gold injections to treat arthritis;
• an mTOR inhibitor such as temsirolimus, sirolimus, or everolimus, or a neprilysin inhibitor such as sacubitril, either of which may raise the risk of angioedema;
• insulin or oral diabetes medicine; or
• NSAIDs (nonsteroidal anti-inflammatory drugs): aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete, and many other drugs may interact with ramipril. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Store the capsules at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Store the oral solution in a refrigerator at 2°C to 8°C (36°F to 46°F). Keep it in its original packaging. After the bottle is opened, store it between 20°C to 25°C (68°F to 77°F) and use within 60 days.