RAMIPRIL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

RAMIPRIL

Composition:

RAMIPRIL 1.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ramipril is 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 mechanisms

Product summary:

Ramipril Capsules, USP 1.25 mg capsules are supplied as yellow, opaque capsules with “54 328” printed in black ink on the cap and body, containing a white to off-white powder. NDC 0054-0106-25: Bottle of 100 Capsules 2.5 mg capsules are supplied as orange, opaque capsules with “54 794” printed in black ink on the cap and body, containing a white to off-white powder. NDC 0054-0107-25: Bottle of 100 Capsules NDC 0054-0107-29: Bottle of 500 Capsules NDC 0054-0107-20: 10x10 Unit-Dose 5 mg capsules are supplied as red, opaque capsules with “54 145” printed in black ink on the cap and body, containing a white to off-white powder. NDC 0054-0108-25: Bottle of 100 Capsules NDC 0054-0108-29: Bottle of 500 Capsules NDC 0054-0108-20: 10x10 Unit-Dose 10 mg capsules are supplied as blue, opaque capsules with “54 602” printed in black ink on the cap and body, containing a white to off-white powder. NDC 0054-0109-25: Bottle of 100 Capsules NDC 0054-0109-29: Bottle of 500 Capsules Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RAMIPRIL- RAMIPRIL CAPSULE
HIKMA PHARMACEUTICALS USA INC.
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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._
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•
INDICATIONS AND USAGE
Ramipril 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).
In patients 55 years or older at high risk of developing a major
cardiovascular event, ramipril is indicated to
reduce the risk of myocardial infarction, stroke, or death from
cardiovascular causes (1.2).
Ramipril is 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).
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 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
adjustment in special situations. (2.5).
DOSAGE FORMS AND ST