FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Tersedia dari:

Aurobindo Pharma Limited

INN (Nama Internasional):

FOSINOPRIL SODIUM

Komposisi:

FOSINOPRIL SODIUM 10 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION . ) In using fosinopril sodium and hydrochlorothiazide, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis ).  ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients  (see WARNINGS:  Head and Neck Angioedema   and Intestinal Angioedema ). Fosinopril sodium and hydrochlorothiazide tablets are contraindicated in patients who are anuric. Fosinopril sodium and hydrochlorothiazide is also contraindicated in patients who are hypersensitive to fosinopril, to any o

Ringkasan produk:

Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are peach colored, round biconvex, uncoated tablets debossed with ‘C 84’ on one side and plain on the other side.         Bottle of 30                      NDC 65862-308-30         Bottle of 100                    NDC 65862-308-01         Bottle of 1,000                  NDC 65862-308-99 Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are peach colored, round biconvex, uncoated tablets debossed with ‘C 85’ on one side and “deep score line” on the other side.         Bottle of 30                       NDC 65862-309-30         Bottle of 100                     NDC 65862-309-01         Bottle of 1,000                   NDC 65862-309-99 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 by keeping bottle tightly closed.   Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520   Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 01/2022

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE - FOSINOPRIL SODIUM AND
HYDROCHLOROTHIAZIDE TABLET
AUROBINDO PHARMA LIMITED
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FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE FOSINOPRIL AND
HYDROCHLOROTHIAZIDE AS SOON AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING FETUS. SEE WARNINGS: FETAL
TOXICITY
DESCRIPTION
Fosinopril sodium, USP is a white to almost white powder, soluble
(>100 mg/mL) in
water, in ethanol, and in methanol, and slightly soluble in hexane.
Fosinopril sodium is
designated chemically as L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-
oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt,
_trans-_; its
structural formula is:
Its molecular formula is C
H
NNaO P, and its molecular weight is 585.65.
Fosinoprilat, the active metabolite of fosinopril, is a non-sulfhydryl
angiotensin-
converting enzyme inhibitor. Fosinopril is converted to fosinoprilat
by hepatic cleavage of
the ester group.
Hydrochlorothiazide, USP is a white or practically white, practically
odorless, crystalline
powder. It is slightly soluble in water; freely soluble in sodium
hydroxide solution, in n-
30
45
7
butylamine, and in dimethylformamide; sparingly soluble in methanol;
and insoluble in
ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide
is designated
chemically as
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide;
its structural formula is:
Its molecular formula is C H ClN O S , and its molecular weight is
297.73.
Hydrochlorothiazide is a thiazide diuretic.
Fosinopril sodium and hydrochlorothiazide tablets, USP are a
combination of fosinopril
sodium, USP and hydrochlorothiazide, USP. They are available for oral
use in two tablet
strengths: fosinopril sodium and hydrochlorothiazide tablets, USP 10
mg/12.5 mg,
containing 10 mg of fosinopril sodium, USP and 12.5 mg of
hydrochlorothiazide, USP;
and fosinopril sodium and hydrochloro