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ALTACE® Capsules Index Section (ramipril)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: FETAL TOXICITY

1 INDICATIONS AND USAGE

1.1 Hypertension

1.2 Reduction in the Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes

1.3 Heart Failure Post-Myocardial Infarction

2 DOSAGE AND ADMINISTRATION

2.1 Hypertension

2.2 Reduction in Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes

2.3 Heart Failure Post-Myocardial Infarction

2.4 General Dosing Information

2.5 Dosage Adjustment

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylactoid and Possibly Related Reactions

5.2 Hepatic Failure and Impaired Liver Function

5.3 Renal Impairment

5.4 Neutropenia and Agranulocytosis

5.5 Hypotension

5.6 Fetal Toxicity

5.7 Dual Blockade of the Renin-Angiotensin System

5.8 Hyperkalemia

5.9 Cough

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

6.3 Clinical Laboratory Test Findings

7 DRUG INTERACTIONS

7.1 Diuretics

7.2 Agents Increasing Serum Potassium

7.3 Other Agents Affecting RAS

7.4 Lithium

7.5 Gold

7.6 Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

7.7 mTOR Inhibitors or Other Drugs Known to Cause Angioedema

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Hypertension

14.2 Reduction in Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes

14.3 Heart Failure Post-Myocardial Infarction

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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