RAMIPRIL capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Dispensing Solutions, Inc.

INN (Internationale Bezeichnung):

RAMIPRIL

Zusammensetzung:

RAMIPRIL 10 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 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). Ingestion of a single 10 mg oral dose of ramipril resulted in undetectable amounts of ramipril and its metabolites in breast milk. However, because multiple doses may produce low milk concentrations that are not predictable from a single dose, do not use ramipril in nursing mothers. Safety and effectiveness in pediatric patients have not been established. Irreversible kidney damage has been observed in very young rats given a single dose of ramipril. Of the total number of patients who received ramipril in US clinical studies of ramipril 11% were ≥65 years of age while 0.2% were ≥75 years of age. No overall differences in effectiveness or safety were observed between

Produktbesonderheiten:

Ramipril Capsules USP are available in potencies of 1.25 mg, 2.5 mg, 5 mg, and 10 mg in hard gelatin capsules. Ramipril Capsules USP, 1.25 mg are supplied as yellow opaque capsules with "54 328" printed in black ink. Ramipril Capsules USP, 2.5 mg are supplied as orange opaque capsules with "54 794" printed in black ink. Ramipril Capsules USP, 5 mg are supplied as red opaque capsules with "54 145" printed in black ink. Ramipril Capsules USP, 10 mg are supplied as blue opaque capsules with "54 602" printed in black ink. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in light-resistant, tight container with child-resistant closure.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

RAMIPRIL- RAMIPRIL CAPSULE
DISPENSING SOLUTIONS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RAMIPRIL CAPSULES USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RAMIPRIL CAPSULES
USP.
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS
Dual Blockade of the Renin-Angiotensin-Aldosterone System: Telmisartan
(5.7) 10/2010
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).
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) (3)
CONTRAINDICATIONS
Angioedema related to previous treatment with an ACE inhibitor, or a
history of hereditary or idiopathic angioedema (4).
(4)
WARNINGS AND PRECAUTIONS
ACE inhibitor use has been associated with the following: (5)
Angioedema, with 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)
Increased risk of renal impairment when combined with another blocker
of the renin-angiotensin-aldosterone system
(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
included headache, dizziness, fatigue, and cough (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ROXANE LABORATORIES,
INC. AT 1-800-962-8364 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Diuretics: Possibility of excessive hypotension (7.1).
Lithium: Use wit