RAMIPRIL capsule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRIL - UNII:L35JN3I7SJ)

Dostupné s:

Atlantic Biologicals Corps

INN (Mezinárodní Name):

RAMIPRIL

Složení:

RAMIPRIL 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

RAMIPRIL- RAMIPRIL CAPSULE
ATLANTIC BIOLOGICALS CORPS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
RAMIPRIL 5 MG CAPSULE
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RAMIPRIL
SEE FULL PRESCRIBING INFORMATION FOR USING RAMIPRIL
INITIAL U.S. APPROVAL 1991
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 with caution (7.3).
Gold: Nitritoid reactions have been reported (7.4).
USE IN SPECIFIC POPULATIONS
Pregnancy: Discontinue drug if pregnancy is detected (5.6,