RAMIPRIL- ramipril capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

RAMIPRIL

Composition:

RAMIPRIL 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ramipril capsules 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 different

Product summary:

Ramipril capsules USP are available in 2.5 mg hard gelatin capsules. Descriptions of Ramipril capsules USP are summarized below. Ramipril capsules USP, 2.5 mg are: Size "4" capsules with orange cap, imprinted with 'LUPIN' in black ink and orange body imprinted with 'RAMIPRIL 2.5 mg' in black ink, containing white to off-white powder. NDC 43063-502-30    bottles of 30 Dispense in light-resistant, tight container with child-resistant closure.  Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RAMIPRIL- RAMIPRIL CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
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_
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
Contraindications ( 4) 04/2017
Warnings and Precautions, Anaphylactoid and Possibly Related Reactions
( 5.1)
04/2017
INDICATIONS AND USAGE
Ramipril capsules 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 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
Capsule: 1.25 mg, 2.5 mg, 5 mg, 10 mg ( 3)
CONTRAINDICATIONS
Angioedema related t