IRBESARTAN tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N)

Sẵn có từ:

AvPAK

INN (Tên quốc tế):

IRBESARTAN

Thành phần:

IRBESARTAN 75 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic cl

Tóm tắt sản phẩm:

Irbesartan Tablets USP, 75 mg are white, capsule shaped, biconvex tablets debossed with ‘158’ on one side and ‘H’ on the other side. They are supplied as follows: NDC 50268-440-15 (10 tablets per card, 5 cards per carton). Irbesartan Tablets USP, 150 mg are white, capsule shaped, biconvex tablets debossed with‘159’ on one side and ‘H’ on the other side. They are supplied as follows: NDC 50268-441-15 (10 tablets per card, 5 cards per carton). Irbesartan Tablets USP, 300 mg are white, capsule shaped, biconvex tablets debossed with ‘160’ on one side and ‘H’ on the other side. They are supplied as follows: NDC 50268-442-15 (10 tablets per card, 5 cards per carton). Dispensed in Blister Punch Material. For Institutional Use Only. Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature] Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 09/19 AV Rev. 07/23 (P)

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

IRBESARTAN- IRBESARTAN TABLET
AVPAK
----------
IRBESARTAN TABLETS USP
RX ONLY
WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning .
• When pregnancy is detected, discontinue irbesartan tablets as soon
as possible.
(5.1)
• Drugs that act directly on the renin-angiotensin system can cause
injury and
death to the developing fetus. (5.1)
5.3 IMPAIRED RENAL FUNCTION
Changes in renal function including acute renal failure can be caused
by drugs that
inhibit the reninangiotensin system. Patients whose renal function may
depend in
part on the activity of the reninangiotensin system (e.g., patients
with renal artery
stenosis, chronic kidney disease, severe heart failure, or volume
depletion) may be
at particular risk of developing acute renal failure or death on
irbesartan. Monitor
renal function periodically in these patients. Consider withholding or
discontinuing
therapy in patients who develop a clinically significant decrease in
renal function on
irbesartan [see Drug Interactions (7.3)].
DESCRIPTION
Irbesartan USP is an angiotensin II receptor (AT1 subtype) antagonist.
Irbesartan USP is a non-peptide compound, chemically described as a
2-butyl-3-[p-(o-
1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.
Its empirical formula is C
H
N
O, and the structural formula:
Irbesartan USP is a white to off-white crystalline powder with a
molecular weight of
428.5. It is a nonpolar compound with a partition coefficient
(octanol/water) of 10.1 at
25
28
6
pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene
chloride and practically
insoluble in water.
Irbesartan is available for oral administration in unscored tablets
containing 75 mg, 150
mg, or 300 mg of Irbesartan USP. Inactive ingredients include: calcium
stearate,
carboxy methyl cellulose calcium, colloidal silicon dioxide,
microcrystalline cellulose and
povidone.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Angiotensin II is a potent vasoconstrictor formed from angiotensin I
in a reaction
catalyzed by angiotensin-c