RAMIPRIL capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Proficient Rx LP

INN (mednarodno ime):

RAMIPRIL

Sestava:

RAMIPRIL 2.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 oligohydra

Povzetek izdelek:

Ramipril Capsules, USP are available in 5 mg and 10 mg hard gelatin capsules. Descriptions of Ramipril Capsules USP are summarized below. Ramipril Capsules USP, 5 mg are: Size "4" capsules with red cap, imprinted with 'LUPIN' in black ink and red body imprinted with 'RAMIPRIL 5 mg' in black ink, containing white to off-white powder. NDC 63187-073-30    bottles of 30 NDC 63187-073-60    bottles of 60 NDC 63187-073-90    bottles of 90 Ramipril Capsules USP, 10 mg are: Size "4" capsules with light blue cap, imprinted with 'LUPIN' in black ink and light blue body imprinted with 'RAMIPRIL 10 mg' in black ink, containing white to off-white powder. NDC 63187-277-30    bottles of 30 NDC 63187-277-60    bottles of 60 NDC 63187-277-90    bottles of 90 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].

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

RAMIPRIL- RAMIPRIL CAPSULE
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RAMIPRIL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RAMIPRIL.
RAMIPRIL CAPSULES USP, ORAL
INITIAL U.S. APPROVAL: 1991
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
•
RECENT MAJOR CHANGES
Boxed Warning: Fetal Toxicity 04/2012
Warnings and Precautions: Fetal Toxicity (5.6) 04/2012
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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•
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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:
•
•
•
•
•
•
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 LUPIN PHARMACEUTICALS,
INC AT 1-800-
399-2561 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
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).
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).
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 d