RAMIPRIL capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Blenheim Pharmacal, Inc.

INN (Kansainvälinen yleisnimi):

RAMIPRIL

Koostumus:

RAMIPRIL 10 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Ramipril capsules, USP are indicated for the treatment of hypertension, to  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

Tuoteyhteenveto:

Ramipril Capsules USP , 1.25 mg are yellow/yellow size ‘4’ hard gelatin capsules imprinted with ‘D’ on yellow cap and ‘05’ on yellow body with black edible ink filled with white to almost white powder.                 Bottles of 30                                  NDC 65862-474-30                 Bottles of 100                                NDC 65862-474-01                 Bottles of 1000                              NDC 65862-474-99                 10 x 10 Unit-dose Capsules           NDC 65862-474-10 Ramipril Capsules USP , 2.5 mg are orange/orange size ‘4’ hard gelatin capsules imprinted with ‘D’ on orange cap and ‘06’ on orange body with black edible ink filled with white to almost white powder.                 Bottles of 30                                  NDC 65862-475-30                 Bottles of 100                                NDC 65862-475-01                 Bottles of 500                                NDC 65862-475-05                 Bottles of 1000                              NDC 65862-475-99                 10 x 10 Unit-dose Capsules           NDC 65862-475-10 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 65862-476-30                 Bottles of 100                                NDC 65862-476-01                 Bottles of 500                                NDC 65862-476-05                 Bottles of 1000                              NDC 65862-476-99                 10 x 10 Unit-dose Capsules           NDC 65862-476-10 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 65862-477-30                 Bottles of 100                                NDC 65862-477-01                 Bottles of 500                                NDC 65862-477-05                 Bottles of 1000                              NDC 65862-477-99                 10 x 10 Unit-dose Capsules           NDC 65862-477-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in well-closed container with safety closure.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

RAMIPRIL- RAMIPRIL CAPSULE
BLENHEIM PHARMACAL, INC.
----------
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 05/2013
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) 05/2013
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
adjus