RAMIPRIL capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Aidarex Pharmaceuticals LLC

INN (Nama Antarabangsa):

RAMIPRIL

Komposisi:

RAMIPRIL 5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Ramipril capsules, USP 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 w

Ringkasan produk:

Ramipril Capsules USP , 5 mg are red/red size ‘4’ hard gelatin capsules imprinted with ‘D’ on red cap and ‘07’ on red body with black edible ink filled with white to almost white powder.                 Bottles of 30                                  NDC 33261-0903-30                 Bottles of 90                                  NDC 33261-0903-90                Ramipril Capsules USP , 10 mg are blue/blue size ‘4’ hard gelatin capsules imprinted with ‘D’ on blue cap and ‘08’ on blue body with black edible ink filled with white to almost white powder.                 Bottles of 30                                  NDC 33261-0967-30                 Bottles of 90                                  NDC 33261-0967-90                 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in well-closed container with safety closure.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

RAMIPRIL- RAMIPRIL CAPSULE
AIDAREX PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RAMIPRIL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RAMIPRIL CAPSULES, USP.
RAMIPRIL CAPSULES USP, 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).
RECENT MAJOR CHANGES
Indications and Usage: Hypertension (1.1) 11/2013
Contraindications 10/2013
Warnings and Precautions: Anaphylactoid and Possibly Related Reactions
(5.1) 9/2013
Warnings and Precautions: Dual Blockade of the
Renin-Angiotensin-Aldosterone System (5.7) 10/2013
INDICATIONS AND USAGE
Ramipril capsules, USP 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).
Ramipril capsules, USP 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).
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
adj