SODIUM DIURIL- chlorothiazide sodium injection

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

chlorothiazide sodium (UNII: SN86FG7N2K) (chlorothiazide - UNII:77W477J15H)

Dostupné s:

Akorn

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Intravenous Sodium DIURIL is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Intravenous Sodium DIURIL has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through el

Přehled produktů:

Intravenous Sodium DIURIL is a dry, sterile lyophilized white powder usually in plug form, supplied in vials containing chlorothiazide sodium equivalent to 0.5 g of chlorothiazide. NDC 76478-711-40. Store at 20° to 25°C (68° to 77°F). See USP Controlled Room Temperature. For single dose only. Use solution immediately after reconstitution (see DOSAGE AND ADMINISTRATION, Directions for Reconstitution). Discard unused portion of the reconstituted solution. ** Calculations based on a human body weight of 50 kg. AKORN Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 ® Registered trademark of Merck & Co., Inc. Whitehouse Station, NJ 08889, U.S.A. OPCH00N Rev. 03/22

Stav Autorizace:

New Drug Application

Charakteristika produktu

SODIUM DIURIL- CHLOROTHIAZIDE SODIUM INJECTION
AKORN
----------
INTRAVENOUS
SODIUM DIURIL
(CHLOROTHIAZIDE SODIUM)
RX ONLY
DESCRIPTION
Intravenous Sodium DIURIL (chlorothiazide sodium) is a diuretic and
antihypertensive. It
is 6-chloro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide
monosodium salt and
its molecular weight is 317.71.
Its empirical formula is C H ClN NaO S and its structural formula is:
Intravenous Sodium DIURIL is a sterile lyophilized white powder and is
supplied in a vial
containing:
Chlorothiazide sodium equivalent to chlorothiazide . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 0.5 g
Inactive ingredients: Mannitol . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . 0.25 g
Sodium hydroxide to adjust pH.
DIURIL (chlorothiazide) is a diuretic and antihypertensive. It is
6-chloro-2_H_-1,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C
H ClN O S and
its structural formula is:
It is a white, or practically white, crystalline powder with a
molecular weight of 295.72,
which is very slightly soluble in water, but readily soluble in dilute
aqueous sodium
hydroxide. It is soluble in urine to the extent of about 150 mg per
100 mL at pH 7.
®
7
5
3
4 2
7
6
3
4 2
CLINICAL PHARMACOLOGY
The mechanism of the antihypertensive effect of thiazides is unknown.
DIURIL
(chlorothiazide) does not usually affect normal blood pressure.
DIURIL (chlorothiazide) affects the distal renal tubular mechanism of
electrolyte
reabsorption. At maximal therapeutic dosage all thiazides are
approximately equal in
their diuretic efficacy.
DIURIL (chlorothiazide) increases excretion of sodium and chloride in
approximately
equivalent amounts. Natriuresis may be accompanied by some loss of
potassium and
bicarbonate.
After oral use diuresis begins within 2 hours, peaks in about 4 hours
and lasts about 6
to 12 hours. Following intravenous use of Sodium DIURIL, onset of the
diuretic ac