ALTACE® Capsules Principal Display Panel (ramipril) | Pfizer Medical Information - US

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

PRINCIPAL DISPLAY PANEL - 1.25 mg Capsule Bottle Label

NDC 61570-110-01

Pfizer

Altace®
(ramipril) capsules, for oral use

1.25 mg

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 1.25 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 2.5 mg Capsule Bottle Label

NDC 61570-111-01

Pfizer

Altace®
(ramipril) capsules, for oral use

2.5 mg

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 2.5 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 5 mg Capsule Bottle Label

NDC 61570-112-01

Pfizer

Altace®
(ramipril) capsules, for oral use

5 mg

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 5 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL - 10 mg Capsule Bottle Label

NDC 61570-120-01

Pfizer

Altace®
(ramipril) capsules, for oral use

10 mg

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 10 mg Capsule Bottle Label

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue ALTACE as soon as possible (5.6).
Drugs that act directly on the renin-...

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1 INDICATIONS AND USAGE

1.1 Hypertension

ALTACE is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the...

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2 DOSAGE AND ADMINISTRATION

2.1 Hypertension

The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Adjust dose according to blood...

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3 DOSAGE FORMS AND STRENGTHS

ALTACE (ramipril) is supplied as hard gelatin capsules containing 1.25 mg, 2.5 mg, 5 mg, and 10 mg of ramipril.

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4 CONTRAINDICATIONS

ALTACE is contraindicated in patients who are hypersensitive to this product or any other ACE inhibitor (e.g., a patient who has experienced...

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5 WARNINGS AND PRECAUTIONS

5.1 Anaphylactoid and Possibly Related Reactions

Presumably because drugs that act...

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6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the...

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7 DRUG INTERACTIONS

7.1 Diuretics

Patients on diuretics, especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal...

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10 OVERDOSAGE

Single oral doses of ramipril in rats and mice of 10 g/kg–11 g/kg resulted in significant lethality. In dogs, oral doses as high as 1 g/kg induced only mild gastrointestinal distress. Limited data on human...

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11 DESCRIPTION

Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°–112°C...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Ramipril and ramiprilat inhibit ACE in human subjects and animals. Angiotensin converting enzyme is a peptidyl...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of a tumorigenic effect was found when ramipril was given by gavage to...

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14 CLINICAL STUDIES

14.1 Hypertension

ALTACE has been compared with other ACE inhibitors, beta-blockers, and thiazide diuretics as monotherapy for hypertension. It...

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16 HOW SUPPLIED/STORAGE AND HANDLING

ALTACE is available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules. Descriptions of ALTACE capsules are summarized below.

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17 PATIENT COUNSELING INFORMATION

Angioedema

Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially...

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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.