Ramipril 5 mg Capsules — Generic For Altace — Aurobindo

These highlights do not include all the information needed to use RAMIPRIL CAPSULES safely and effectively. See full prescribing information for RAMIPRIL CAPSULES.

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 ramipril 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).

Indications And Usage

Ramipril capsules are 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, ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2).

Ramipril capsules are 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 to 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, and 10 mg (3)

Contraindications

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

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

Do not co-administer aliskiren with ramipril capsules 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)

• 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)

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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or 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: Ramipril use is not recommended in nursing mothers (8.3).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2021