RAMIPRIL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BluePoint Laboratories

INN (International Name):

RAMIPRIL

Composition:

RAMIPRIL 1.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.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 dr

Product summary:

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 68001-140-04 in bottle of 30 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 68001-142-00 in bottle of 100 capsules NDC 68001-142-03 in bottle of 500 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 68001-143-00 in bottle of 100 capsules NDC 68001-143-03 in bottle of 500 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 68001-141-00 in bottle of 100 capsules NDC 68001-141-03 in bottle of 500 capsules 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RAMIPRIL- RAMIPRIL CAPSULE
BLUEPOINT LABORATORIES
----------
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 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
1. Contraindications (4) 04/2017
Warnings and Precautions, Anaphylactoid and
1. Possibly Related Reactions (5.1). 04/2017
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
adjustment in special situations ( 2.5).
DOSAGE FORMS AND STRENGTHS
Capsules: 1.25 mg, 2.5 mg, 5 mg, 10 mg ( 3)
CONTRAINDICATIONS
Angioe