RAMIPRIL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Exelan Pharmaceuticals, Inc.

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. They may be used alone or in combination with thiazide diuretics. Ramipril capsules are contraindicated in patients who are hypersensitive to this product or any other ACE inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Do not co-administer ramipril capsules with aliskiren: - in patients with diabetes Pregnancy Category D third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue ramipril as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after e

Product summary:

Ramipril Capsules, USP 1.25 mg are hard gelatin capsules size “4”, yellow opaque body with yellow opaque cap imprinted with IG271 on cap and 1.25 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 76282-271-01), 500 (76282-271-05) and 1000 (NDC 76282-271-10). Ramipril Capsules, USP 2.5 mg are hard gelatin capsules size “4”, orange opaque body with orange opaque cap imprinted with IG272 on cap and 2.5 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 76282-272-01), 500 (NDC 76282-272-05) and 1000 (NDC 76282-272-10). Ramipril Capsules, USP 5 mg capsules are hard gelatin capsules size “4”, red opaque body with red opaque cap imprinted with IG273 on cap and 5 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 76282-273-01), 500 (NDC 76282-273-05) and 1000 (NDC 76282-273-10). Ramipril Capsules, USP 10 mg are hard gelatin capsules size “4”, blue opaque body with blue opaque cap imprinted with IG274 on cap and 10 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 76282-274-01), 500 (NDC 76282-274-05) and 1000 (NDC 76282-274-10). Dispense in well-closed container with safety closure. Store at controlled room temperature between 20° and 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RAMIPRIL- RAMIPRIL CAPSULE
EXELAN 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 CAPSULES 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
Warnings and Precautions, Hyperkalemia (5.8) 9/2015
INDICATIONS AND USAGE
Ramipril capsules, USP is an angiotensin converting enzyme (ACE)
inhibitor indicated for the treatment of hypertension, to
lower blood pressure. They may be used alone or in combination with
thiazide diuretics (1.1).
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).
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 to previous treatment with an ACE inhibitor, or a
history of hereditary or idiopathic angioedema. (4).
Do not co-administer aliskiren with ramipril in patients with
diabetes. (4)
WARNINGS AND PRECAUTIONS
Angioedema, increased risk in patients with a prior history (5.1)
Hypotension and hyperkalemia (5.5, 5.8)
Renal impairment: monitor renal function during therapy (5.3)
Avoid concomitant use of an ACE inhibitor and angiotensin blocker
(5.7)
Rare cholestatic jaundice and hepatic failure (5.2)
Rare neutropenia and agranulocytosis (5.4)
ADVERSE REACTIONS
The most common adverse reactions in patients with hypertension
in