RAMIPRIL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, 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. It may be used alone or in combination with thiazide diuretics. Ramipril capsules USP are indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of ramipril to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure [see Clinical Studies (14.3) ] . Ramipril is 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). Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohyd

Product summary:

Ramipril capsules USP are available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules. Ramipril 1.25 mg capsules are supplied as hard gelatin capsules with white opaque body and yellow opaque cap. The body has “RP 1.25 " and the cap has “” both printed in black: Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap. The body has “RP 2.5 " and the cap has “” both printed in black: Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap. The body has “RP 5 " and the cap has “” both printed in black: Ramipril 10 mg capsules are supplied hard gelatin capsules with white opaque body and blue opaque cap. The body has “RP 10 " and the cap has “” both printed in black: Dispense in well-closed container with safety closure. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). (See USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RAMIPRIL - RAMIPRIL CAPSULE
PHYSICIANS TOTAL CARE, 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 USP, ORAL
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
Boxed Warning: Fetal Toxicity 04/2012
Warnings and Precautions: Fetal Toxicity (5.6) 04/2012
INDICATIONS AND USAGE
Ramipril capsules USP are indicated for the treatment of hypertension.
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 2–4
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 to previous treatment with an ACE inhibitor, or a
history of hereditary or idiopathic angioedema (4).
WARNINGS AND PRECAUTIONS
ACE inhibitor use has been associated with the following:
Angioedema, with increased risk in patients with a