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ALTACE® Capsules Highlights (ramipril)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ALTACE safely and effectively. See full prescribing information for ALTACE.
ALTACE® (ramipril) capsules, for oral use
Initial U.S. Approval: 1991

WARNING: FETAL TOXICITY

See full prescribing information for complete boxed warning

  • When pregnancy is detected, discontinue ALTACE as soon as possible (5.6).
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.6).

RECENT MAJOR CHANGES

Contraindications (4) 04/2017
Warnings and Precautions, Anaphylactoid and Possibly Related Reactions (5.1) 04/2017

INDICATIONS AND USAGE

ALTACE is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics (1.1).

In patients 55 years or older at high risk of developing a major cardiovascular event, ALTACE is indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).

ALTACE is indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3).

DOSAGE AND ADMINISTRATION

Hypertension: Initial dose is 2.5 mg to 20 mg once daily. Adjust dosage according to blood pressure response after 2–4 weeks of treatment. The usual maintenance dose following titration is 2.5 mg to 20 mg daily as a single dose or equally divided doses (2.1).

Reduction in the risk of myocardial infarction, stroke, or death from cardiovascular causes: 2.5 mg once daily for 1 week, 5 mg once daily for 3 weeks, and increased as tolerated to a maintenance dose of 10 mg once daily (2.2).

Heart failure post-myocardial infarction: Starting dose of 2.5 mg twice daily. If patient becomes hypotensive at this dose, decrease dosage to 1.25 mg twice daily. Increase dose as tolerated toward a target dose of 5 mg twice daily, with dosage increases about 3 weeks apart (2.3).

Dosage adjustment: See respective sections pertaining to dosage adjustment in special situations (2.5).

DOSAGE FORMS AND STRENGTHS

Capsule: 1.25 mg, 2.5 mg, 5 mg, 10 mg (3)

CONTRAINDICATIONS

Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema (4).

ALTACE is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ALTACE within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (4).

Do not co-administer aliskiren with ALTACE in patients with diabetes (4).

WARNINGS AND PRECAUTIONS

Angioedema, increased risk in patients with a prior history (5.1)

Hypotension and hyperkalemia (5.5, 5.8)

Renal impairment: monitor renal function during therapy (5.3)

Avoid concomitant use of an ACE inhibitor and angiotensin blocker (5.7)

Rare cholestatic jaundice and hepatic failure (5.2)

Rare neutropenia and agranulocytosis (5.4)

ADVERSE REACTIONS

The most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough (6.1).


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Diuretics: Possibility of excessive hypotension (7.1).

Lithium: Use with caution (7.4).

Gold: Nitritoid reactions have been reported (7.5).

NSAIDS use may lead to increased risk of renal impairment and loss of antihypertensive effect (7.6).

mTOR inhibitor or neprilysin inhibitor use may increase angioedema risk (7.7).

USE IN SPECIFIC POPULATIONS

Pregnancy: Discontinue drug if pregnancy is detected (5.6, 8.1).

Nursing mothers: ALTACE use is not recommended in nursing mothers (8.3).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2017

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch