Altace

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

Altace is used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Altace 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, Altace is used to reduce the risk of heart attack, stroke, or death from cardiovascular causes.

Altace is also used in people who are stable but have shown signs of heart failure in the first few days after a heart attack. In these people, Altace can lower the risk of death and reduce hospital stays for heart failure.

Take Altace exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Altace comes as a capsule. Swallow the capsule whole.

If you have trouble swallowing the capsule, it can be opened. Sprinkle the contents on a small amount of applesauce, about 4 ounces, or mix them into 4 ounces (120 mL) of water or apple juice. Take all of the mixture so that you get the full dose. A mixture can be made ahead of time and stored for up to 24 hours at room temperature or up to 48 hours in the refrigerator.

Your blood pressure will need to be checked often, and you may need blood tests.

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 Altace. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

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

If you are being treated for high blood pressure, keep using this medicine 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.

Store at controlled room temperature, 59 to 86 degrees F (15 to 30 degrees C), away from moisture, heat, and light. Keep the container tightly closed when not in use.

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

Do not use Altace if you are pregnant. If you become pregnant, stop taking this medicine right away and tell your doctor. Altace can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

Angioedema

Angioedema is a serious allergic type of swelling. It can happen with any ACE inhibitor, including Altace, 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 Altace 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 Altace 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 Altace if you are allergic to ramipril, or if:

• you have ever had a severe allergic reaction to any 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 Altace 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 Altace 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.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Altace can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breast-feed while you are using ramipril.

Altace is not approved for use by anyone younger than 18 years old.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction to Altace: 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;
• 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 Altace side effects may include:

• headache;
• dizziness;
• cough; 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 medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

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

Tell your doctor about all your current medicines. Many drugs can interact with Altace, 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, 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 Altace. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredient: ramipril

Inactive ingredients: pregelatinized starch NF, gelatin, and titanium dioxide.

The 1.25 mg capsule shell contains yellow iron oxide, the 2.5 mg capsule shell contains D&C yellow #10 and FD&C red #40, the 5 mg capsule shell contains FD&C blue #1 and FD&C red #40, and the 10 mg capsule shell contains FD&C blue #1.

Altace is manufactured and distributed by Pfizer Inc., New York, NY 10001.