RAMIPRIL tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Northwind Pharmaceuticals

INN (Mezinárodní Name):

RAMIPRIL

Složení:

RAMIPRIL 5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Hypertension Ramipril capsules USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Heart Failure Post-Myocardial Infarction 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). 8.1 Pregnancy 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 inc

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

RAMIPRIL- RAMIPRIL TABLET
NORTHWIND PHARMACEUTICALS
----------
RAMIPRIL
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).
INDICATIONS & USAGE
Hypertension
Ramipril capsules USP are indicated for the treatment of hypertension.
It may be used alone or in
combination with thiazide diuretics.
Heart Failure Post-Myocardial Infarction
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)].
DOSAGE & ADMINISTRATION
2.1 Hypertension
The recommended initial dose for patients not receiving a diuretic is
2.5 mg once a day. Adjust dose
according to blood pressure response. The usual maintenance dosage
range is 2.5 mg to 20 mg per day
administered as a single dose or in two equally divided doses. In some
patients treated once daily, the
antihypertensive effect may diminish toward the end of the dosing
interval. In such patients, consider an
increase in dosage or twice daily administration. If blood pressure is
not controlled with ramipril
capsules alone, a diuretic can be added.
2.3 Heart Failure Post-Myocardial Infarction
For the treatment of post-myocardial infarction patients who have
shown signs of congestive heart
failure, the recommended starting dose of ramipril capsules is 2.5 mg
twice daily (5 mg per day). A
patient who becomes hypotensive at this dose may be switched to 1.25
mg twice daily. After one week
at the starting dose, increase dose (if tolerated) toward a target
dose of 5 mg twice daily, with dosage
increases being about 3 weeks apart.
After the initial dose of