FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Health, LLC

INN (International Name):

FOSINOPRIL SODIUM

Composition:

FOSINOPRIL SODIUM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 57237-026-30         Bottle of 100                    NDC 57237-026-01 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 57237-027-30         Bottle of 100                     NDC 57237-027-01 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 by keeping bottle tightly closed.   Distributed by: Rising Health, LLC Saddle Brook, NJ 07663 Made in India Code: TS/DRUGS/19/1993 Revised: 04/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE - FOSINOPRIL SODIUM AND
HYDROCHLOROTHIAZIDE TABLET
RISING HEALTH, LLC
----------
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE FOSINOPRIL AND
HYDROCHLOROTHIAZIDE AS SOON AS
POS S IBLE.
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-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:
30
45
7
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
hydrochlorothiaz