ALTACE- ramipril capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Pfizer Laboratories Div Pfizer Inc

INN (Διεθνής Όνομα):

RAMIPRIL

Σύνθεση:

RAMIPRIL 1.25 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

ALTACE is 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 mechanisms o

Περίληψη προϊόντος:

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. 1.25 mg yellow Bottle of 100 61570-110-01 2.5 mg orange Bottle of 100 61570-111-01 5 mg red Bottle of 100 61570-112-01 10 mg Process Blue Bottle of 100 61570-120-01 Dispense in well-closed container with safety closure. Store at controlled room temperature (59°–86°F).

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

ALTACE- RAMIPRIL CAPSULE
PFIZER LABORATORIES DIV PFIZER INC
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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_
•
•
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