RAMIPRIL capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
04-04-2023

Aktiv ingrediens:

RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G)

Tilgjengelig fra:

Bryant Ranch Prepack

INN (International Name):

RAMIPRIL

Sammensetning:

RAMIPRIL 5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Ramipril capsules are 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different

Produkt oppsummering:

NDC: 63629-1254-1: 30 Capsules in a BOTTLE NDC: 63629-1254-2: 20 Capsules in a BOTTLE NDC: 63629-1254-3: 90 Capsules in a BOTTLE NDC: 63629-1254-4: 60 Capsules in a BOTTLE NDC: 63629-1254-5: 10 Capsules in a BOTTLE

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

                                RAMIPRIL- RAMIPRIL CAPSULE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
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