RAMIPRIL capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Medsource Pharmaceuticals

ІПН (Міжнародна Ім'я):

RAMIPRIL

Склад:

RAMIPRIL 10 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 with differ

Огляд продуктів:

Ramipril Capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg in hard gelatin capsules. Ramipril Capsules USP, 1.25 mg are supplied as yellow opaque capsules with "54 328" printed in black ink. Ramipril Capsules USP, 2.5 mg are supplied as orange opaque capsules with "54 794" printed in black ink. Ramipril Capsules USP, 5 mg are supplied as red opaque capsules with "54 145" printed in black ink. Ramipril Capsules USP, 10 mg are supplied as blue opaque capsules with "54 602" printed in black ink. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in light-resistant, tight container with child-resistant closure.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

RAMIPRIL- RAMIPRIL CAPSULE
MEDSOURCE PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RAMIPRIL CAPSULES USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RAMIPRIL CAPSULES
USP.
RAMIPRIL CAPSULES USP, ORAL
INITIAL U.S. APPROVAL: 1991
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
When pregnancy is detected, discontinue Ramipril Capsules USP 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
5/2013
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)
5/2013
INDICATIONS AND USAGE
Ramipril Capsules USP are an angiotension 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 dose ( 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 perta