RAMIPRIL- ramipril capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

St. Mary's Medical Park Pharmacy

INN (Међународно име):

RAMIPRIL

Састав:

RAMIPRIL 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 diffe

Резиме производа:

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 60760-632-90 BOTTLES OF 90 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 60760-633-90 BOTTLES OF 90 Storage: Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with child-resistant closure.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

RAMIPRIL- RAMIPRIL CAPSULE
ST. MARY'S MEDICAL PARK PHARMACY
----------
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.
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) 09/2013
Warnings and Precautions, Dual Blockade of the
Renin-Angiotensin-Aldosterone System ( 5.7) 10/2013
INDICATIONS AND USAGE
Ramipril capsules, USP 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).
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
adju