Altace

Yes

ACE inhibitors, including ramipril, are harmful to the fetus and, therefore, should not be used during pregnancy.

Ramipril should not be administered to women who are breastfeeding.

Dosage Forms & Strengths

capsule

• 1.25mg
• 2.5mg
• 5mg
• 10mg

Hypertension

Initial (not on diuretic): 2.5 mg PO qDay

Initial (with diuretic): 1.25 mg PO qDay

Maintenance: 2.5-20 mg/day PO qDay or divided q12hr

Heart Failure (Post-Myocardial Infarction)

Stable patients with CHF signs within a few days of acute MI

Initial: 2.5 mg PO q12hr; may titrate to 5 mg PO q12hr; decrease to 1.25 mg q12hr if hypotension occurs; monitor for >2 hr after initial dose and reduce concomitant diuretic if hypotension occurs

Maintenance: After 1 week, increase dose (if tolerated) to target dose of 5 mg q12hr

Myocardial Infarction/Stroke Prevention

Reduce risk of MI, stroke, or death from cardiovascular causes in patients ≥55 years

Initial: 2.5 mg PO qDay for 1 week, THEN 5 mg qDay for 3 weeks

Maintenance: Increase as tolerated to 10 mg qDay; for hypertensive or recently post-MI patients, give 5 mg PO BID

Dosing considerations

• Reduce risk of MI, stroke, or death from cardiovascular causes in patients ≥55 years at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, or peripheral vascular disease, or of diabetes that is accompanied by at least 1 other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria)

Diabetic Nephropathy (Off-label)

Initial (not on diuretic): 2.5 mg PO qDay

Initial (with diuretic): 1.25 mg PO qDay

Maintenance: 2.5-20 mg PO qDay; daily dose may be either increased or divided BID if antihypertensive effect is diminished toward the end of the dosing interval

Dosage Modifications

Renal impairment

• CrCl <40 mL/min and concomitant diuretic therapy: Not to exceed 5 mg/day (25% of normal dose)
• Renal/heart failure: 1.25 mg PO qDay; may increase to 1.25 mg q12hr and to a maximum dose of 2.5 mg q12hr depending on clinical response and tolerability
• Renal failure and hypertension: 1.25 mg PO qDay initially; may titrate upward, not to exceed 5 mg/day
• Geriatric patients: At increased risk for renal dysfunction; adjust dose to renal clearance and monitor closely

Dosing Considerations

Requires weeks for full effect; to start, use low dose and titrate every 1-2 weeks

qDay dosing may result in diminished antihypertensive effect at end of day in some patients; consider increase in dosage or dosing interval (q12hr)

If BP is not adequately treated, consider adding diuretic

Consider ACE inhibitor in high-risk patients, even if no hypertension or CHF

Abrupt discontinuance not associated with rapid increase in BP  

Administration

Swallow capsule whole; can also open capsule and sprinkle contents on small amount of applesauce or mixed in 120 mL of water or apple juice; mixture can be stored for <24 hours at room temperature or <48 hours under refrigeration

Safety and efficacy not established

Altace is a prescription medication used to treat high blood pressure and congestive heart failure. It is also used to reduce the risk of heart attacks, stroke, and death from cardiovascular (heart or blood vessel) causes.

Altace belongs to a group of drugs called angiotensin converting enzyme (ACE) inhibitors, which relax blood vessels to lower blood pressure and make the heart more efficient.

This medication comes in capsule form and is taken once or twice a day, with or without food. Capsules must be swallowed whole or can be opened and sprinkled on applesauce or mixed in 4 oz. of water or apple juice.

Common side effects of Altace include headache, fatigue, and cough. Altace can also cause dizziness. Do not drive or operate heavy machinery until you know how Altace affects you.

Serious side effects have been reported with Altace including:

• Angioedema (a serious hypersensitivy reaction). Tell your healthcare profession right away if you have signs or symptoms of angioedema, which include:
  • swelling of face, eyes, lips, tongue, larynx and extremities
  • difficulty in swallowing or breathing
  • hoarseness (having difficulty making sounds when trying to speak)
• Hyperkalemia (high levels of potassium in the blood). This medication may lead to increased levels of potassium, which could lead to side effects such as heart arrhythmias (irregular heartbeat) and nausea.
• Hypotension (low blood pressure). Excessive perspiration and dehydration may lead to an excessive fall in blood pressure (hypotension). Vomiting or diarrhea may also lead to a fall in blood pressure.
• Decline in kidney function. Your doctor may need to perform tests to determine the stability of the function of your kidneys, especially in patients who already have kidney dysfunction. This risk is also present when combined with angiotensin receptor blockers (ARBs) or aliskiren.
• Neutropenia (rare). Report any sign of infection such as sore throat or fever, which may be a sign of neutropenia (a decreased amount of white blood cells).
• Liver failure (rare). Report any signs or symptoms of hepatic failure, including:
  • yellowing of the skin or eyes
  • nausea
  • vomiting
  • fatigue
  • itching

Do not take Altace if you:

• have a history of angioedema related to previous treatment with an ACE inhibitor, or a history of angioedema altogether
• are allergic to Altace or any of this medication's ingredients

Before taking Altace, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of angioedema
• have decreased liver or kidney function
• are taking any potassium-containing salt substitutes
• are pregnant or are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

If you have diabetes, do not use ramipril together with any medication that contains aliskiren (such as Amturnide, Tekturna, Tekamlo).

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 4 500

ACE inhibitors are recommended as one of several preferred agents for the initial management of hypertension; other options include angiotensin II receptor antagonists, calcium-channel blockers, and thiazide diuretics.501 502 503 504 While there may be individual differences with respect to specific outcomes, these antihypertensive drug classes all produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes.500 501 502 504 Individualize choice of therapy; consider patient characteristics (e.g., age, ethnicity/race, comorbidities, cardiovascular risk) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, cost).500 501 502 503 504 515

ACE inhibitors may be preferred in hypertensive patients with heart failure, ischemic heart disease, diabetes mellitus, chronic kidney disease, or cerebrovascular disease or post-MI.500 501 502 504 520 523 524 525 526 527 534 535 536 543

Black hypertensive patients generally tend to respond better to monotherapy with calcium-channel blockers or thiazide diuretics than to ACE inhibitors.14 67 68 86 87 500 501 504 However, diminished response to an ACE inhibitor is largely eliminated when administered concomitantly with a calcium-channel blocker or thiazide diuretic.14 16 17 500 504

The optimum BP threshold for initiating antihypertensive drug therapy is controversial.501 504 505 506 507 508 515 523 530 Further study needed to determine optimum BP thresholds/goals; individualize treatment decisions.501 503 507 515 526 530

JNC 7 recommends initiation of drug therapy in all patients with uncomplicated hypertension and BP ≥140/90 mm Hg;500 JNC 8 panel recommends SBP threshold of 150 mm Hg for patients ≥60 years of age.501 Although many experts agree that SBP goal of <150 mm Hg may be appropriate for patients ≥80 years of age,502 504 505 530 application of this goal to those ≥60 years of age is controversial, especially for those at higher cardiovascular risk.501 502 505 506 508 511 515

In the past, initial antihypertensive drug therapy was recommended for patients with diabetes mellitus or chronic kidney disease who had BP ≥130/80 mm Hg;500 503 current hypertension management guidelines generally recommend a BP threshold of 140/90 mm Hg for these individuals (same as for the general population of patients without these conditions), although a goal of <130/80 mm Hg may still be considered.501 502 503 504 520 530 535 536 541

Mortality Reduction after Acute MI with Heart Failure

Reduction of the risk of mortality in hemodynamically stable patients who have demonstrated clinical signs of heart failure within a few days following acute MI.1 2 12 18 21 24 27 28 524 Also may reduce rate of heart failure-associated hospitalization and progression to severe and/or resistant heart failure.1 2 12 18 21 24 27 28 524

Prevention of Major Cardiovascular Events

Reduction of the risk of cardiovascular death, MI, and stroke in patients ≥55 years of age who are at high risk for cardiovascular events (e.g., those with a history of CAD, stroke, peripheral vascular disease, or diabetes mellitus in addition to ≥1 other cardiovascular risk factor [e.g., hypertension, elevated total cholesterol and/or decreased HDL-cholesterol concentrations, smoking, documented microalbuminuria]) but who are not known to have low ventricular ejection fraction or heart failure.1 47 48

Reduction in the incidence of diabetic complications and in new diagnosis of diabetes also reported.47 48

Heart Failure

Management of heart failure†, usually in conjunction with other agents such as cardiac glycosides, diuretics, and β-adrenergic blocking agents (β-blockers).70 71 72 73 74 524 800

Some evidence indicates that therapy with an ACE inhibitor (enalapril) may be less effective than angiotensin receptor-neprilysin inhibitor (ARNI) therapy (e.g., sacubitril/valsartan) in reducing cardiovascular death and heart failure-related hospitalization.702 800

ACCF, AHA, and the Heart Failure Society of America (HFSA) recommend that patients with chronic symptomatic heart failure and reduced left ventricular ejection fraction (LVEF) (NYHA class II or III) who are able to tolerate an ACE inhibitor or angiotensin II receptor antagonist be switched to therapy containing an ARNI to further reduce morbidity and mortality.701 800

Diabetic Nephropathy

A recommended agent in the management of patients with diabetes mellitus and persistent albuminuria† who have modestly elevated (30–300 mg/24 hours) or higher (>300 mg/24 hours) levels of urinary albumin excretion; slows rate of progression of renal disease in such patients.81 82 83 84 85 520 535 536

• Prodrug; has little pharmacologic activity until metabolized to ramiprilat.1

• Suppresses the renin-angiotensin-aldosterone system.1

In the U.S.

• Altace

Available Dosage Forms:

• Tablet
• Capsule

Therapeutic Class: Antihypertensive

Pharmacologic Class: ACE Inhibitor

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:

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

• 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

• 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:

• Cough

• Nausea
• vomiting

• 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.

NDC 61570-111-01

Pfizer

Altace®
(ramipril) capsules, for oral use

2.5 mg

100 Capsules
Rx only

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
• Azathioprine
• Azilsartan
• Azilsartan Medoxomil
• Candesartan Cilexetil
• Canrenoate
• Eplerenone
• Eprosartan
• Everolimus
• Irbesartan
• Lithium
• Losartan
• Mercaptopurine
• Olmesartan Medoxomil
• Potassium
• Sirolimus
• Spironolactone
• 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
• Azosemide
• Bromfenac
• Bufexamac
• Bumetanide
• Bupivacaine
• Bupivacaine Liposome
• Capsaicin
• Celecoxib
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Furosemide
• Gold Sodium Thiomalate
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Nesiritide
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piretanide
• Piroxicam
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Valdecoxib

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

Other drugs may interact with Altace, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Summary of Use during Lactation

Because no information is available on the use of ramipril during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Benazepril, Captopril, Enalapril, Quinapril

References

LactMed Record Number

237

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.