RAMIPRIL capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Zydus Pharmaceuticals USA Inc.

INN (Nama Antarabangsa):

RAMIPRIL

Komposisi:

RAMIPRIL 1.25 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

Ramipril Capsules USP, 1.25 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-43" in black ink and yellow opaque body printed with "1.25 mg" in black ink and are supplied as follows: NDC 68382-144-06 in bottle of 30 capsules with child-resistant closure NDC 68382-144-16 in bottle of 90 capsules with child-resistant closure NDC 68382-144-01 in bottle of 100 capsules NDC 68382-144-05 in bottle of 500 capsules NDC 68382-144-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Ramipril Capsules USP, 2.5 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-44" in black ink and orange opaque body printed with "2.5 mg" in black ink and are supplied as follows: NDC 68382-145-06 in bottle of 30 capsules with child-resistant closure NDC 68382-145-16 in bottle of 90 capsules with child-resistant closure NDC 68382-145-01 in bottle of 100 capsules NDC 68382-145-05 in bottle of 500 capsules NDC 68382-145-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Ramipril Capsules USP, 5 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-45" in black ink and red opaque body printed with "5 mg" in black ink and are supplied as follows: NDC 68382-146-06 in bottle of 30 capsules with child-resistant closure NDC 68382-146-16 in bottle of 90 capsules with child-resistant closure NDC 68382-146-01 in bottle of 100 capsules NDC 68382-146-05 in bottle of 500 capsules NDC 68382-146-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Ramipril Capsules USP, 10 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-46" in black ink and blue opaque body printed with "10 mg" in black ink and are supplied as follows: NDC 68382-147-06 in bottle of 30 capsules with child-resistant closure NDC 68382-147-16 in bottle of 90 capsules with child-resistant closure NDC 68382-147-01 in bottle of 100 capsules NDC 68382-147-05 in bottle of 500 capsules NDC 68382-147-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage:          Store at 20o C to 25o C (68o F to 77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with child-resistant closure.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

RAMIPRIL- RAMIPRIL CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
----------
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 tow