PERINDOPRIL ERBUMINE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K)

Dostępny od:

Aurobindo Pharma Limited

INN (International Nazwa):

PERINDOPRIL ERBUMINE

Skład:

PERINDOPRIL ERBUMINE 2 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. Perindopril erbumine tablets may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. Perindopril erbumine tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. Perindopril erbumine tablets can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. Perindopril erbumine tablets are contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor. Perindopril erbumine tablets are also contraindicated in patients with hereditary or idiopathic angioedema. Do not co-administer aliskiren with perindopril erbumine tablets in patients with diabetes. [see Drug Interactions (7.8) ] Perindopril erbumine tablets are contraindicated in combination with neprilysin inhibitor (e.g., sacubitril). Do not administer perindopril erbumine tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.1) ]. Pregnancy Category D [see Boxed Warning and Warnings and Precautions (5.4)] .  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 oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue perindopril erbumine as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue perindopril erbumine, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to perindopril erbumine for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4) ] . Radioactivity was detectable in fetuses after administration of 14 C-perindopril to pregnant rats. Milk of lactating rats contained radioactivity following administration of 14 C-perindopril. It is not known whether perindopril is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when perindopril erbumine is given to nursing mothers. Neonates With a History of in utero Exposure to Perindopril Erbumine:   If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Perindopril, which crosses the placenta, can theoretically be removed from the neonatal circulation by these means, but limited experience has not shown that such removal is central to the treatment of these infants. Safety and effectiveness of perindopril erbumine in pediatric patients have not been established. The mean blood pressure effect of perindopril was somewhat smaller in patients over 60 than in younger patients, although the difference was not significant. Plasma concentrations of both perindopril and perindoprilat were increased in elderly patients compared to concentrations in younger patients. No adverse effects were clearly increased in older patients with the exception of dizziness and possibly rash. Start at a low dose and titrate slowly as needed. Monitor for dizziness because of potential for falls. Experience with perindopril erbumine in elderly patients at daily doses exceeding 8 mg is limited. Dosage adjustment may be necessary in renally impaired patients [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)] . The bioavailability of perindoprilat is increased in patients with impaired hepatic function [see Clinical Pharmacology (12.3)] .

Podsumowanie produktu:

Perindopril Erbumine T ablets USP, 2 mg are white to off-white colored round biconvex, uncoated tablets, with debossing “D” on one side and “5” & “7” on either side of the breakline on another side.                Bottles of 100               NDC 65862-286-01 Perindopril Erbumine T ablets USP, 4 mg are white to off-white colored capsule shaped uncoated tablets, with debossing “D” on one side and “5” & “8” on either side of the breakline on another side.                Bottles of 100               NDC 65862-287-01 Perindopril Erbumine T ablets USP, 8 mg are white to off-white colored round biconvex uncoated tablets, with debossing “D” on one side and “5” & “9” on either side of breakline on another side.                Bottles of 100               NDC 65862-288-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep out of the reach of children. For further information, please call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

PERINDOPRIL ERBUMINE - PERINDOPRIL ERBUMINE TABLET
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PERINDOPRIL ERBUMINE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PERINDOPRIL ERBUMINE
TABLETS.
PERINDOPRIL ERBUMINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1993
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE PERINDOPRIL ERBUMINE AS SOON
AS POSSIBLE
_[SEE WARNINGS AND PRECAUTIONS (5.4)]_.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS _[SEE WARNINGS AND PRECAUTIONS (5.4)]_.
INDICATIONS AND USAGE
Perindopril erbumine tablets are indicated for the treatment of
patients with essential hypertension.
(1.1)
Perindopril erbumine tablets are indicated for treatment of patients
with stable coronary artery disease
to reduce the risk of cardiovascular mortality or nonfatal myocardial
infarction. (1.2)
DOSAGE AND ADMINISTRATION
Hypertension
The recommended initial dose is 4 mg once a day. The dosage may be
titrated upward until blood
pressure, when measured just before the next dose, is controlled or to
a maximum of 16 mg per day.
(2.1)
Stable Coronary Artery Disease
Perindopril erbumine tablets should be given at an initial dose of 4
mg once daily for 2 weeks, and then
increased, as tolerated, to a maintenance dose of 8 mg once daily.
(2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg, 4 mg and 8 mg (3)
CONTRAINDICATIONS
Angioedema related to previous treatment with an ACE inhibitor, or a
history of hereditary or idiopathic
angioedema. (4, 5.1)
Do not co-administer aliskiren with perindopril erbumine tablets in
patients with diabetes (4, 7.8)
Do not take a neprilysin inhibitor with perindopril erbumine tablets
(4).
Do not administer perindopril erbumine tablets within 36 hours of
switching to or from
sacubitril/valsartan (4).
WARNINGS AND PRECAUTIONS
Watch for anaphylactoid