SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

Spironolactone (UNII: 27O7W4T232) (Spironolactone - UNII:27O7W4T232), Hydrochlorothiazide (UNII: 0J48LPH2TH) (Hydrochlorothiazide - UNII:0J48LPH2TH)

から入手可能:

Sun Pharmaceutical Industries, Inc.

INN（国際名）:

Spironolactone

構図:

Spironolactone 25 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions section). Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and hydrochlorothiazide tablets are indicated for: Edematous conditions for patients with: Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman 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 developing toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Spironolactone and hydrochlorothiazide tablets are indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy

製品概要:

Spironolactone and hydrochlorothiazide tablets, USP are supplied as follows: Spironolactone and hydrochlorothiazide tablets, 25 mg/25 mg are buff, round, unscored, debossed MP 40. Bottles of 100 NDC 53489-144-01 Bottles of 500 NDC 53489-144-05 Bottles of 1000 NDC 53489-144-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Rev 12, December 2022

認証ステータス:

Abbreviated New Drug Application

製品の特徴

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE- SPIRONOLACTONE AND
HYDROCHLOROTHIAZIDE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
RX ONLY
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLETS USP 25 MG / 25 MG
DESCRIPTION
Spironolactone and hydrochlorothiazide oral tablets contain:
spironolactone . . . . . . . . . . . . . . . . 25 mg
hydrochlorothiazide . . . . . . . . . . . . 25 mg
Spironolactone, an aldosterone antagonist, is
17-hydroxy-7α-mercapto-3-oxo-17α-
pregn-4-ene-21-carboxylic acid γ-lactone acetate and has the
following structural
formula:
Spironolactone is practically insoluble in water, soluble in alcohol,
and freely soluble in
benzene and in chloroform.
Hydrochlorothiazide, a diuretic and antihypertensive, is
6-chloro-3,4-dihydro-2H-1,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following
structural formula:
Hydrochlorothiazide is slightly soluble in water and freely soluble in
sodium hydroxide
solution.
Inactive ingredients include anhydrous lactose, colloidal silicon
dioxide, D&C yellow #10
lake, docusate sodium, FD&C yellow #6 lake, magnesium stearate,
microcrystalline
cellulose, peppermint flavor, povidone, sodium benzoate, and sodium
starch glycolate.
ACTIONS / CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Spironolactone and hydrochlorothiazide tablets
are a
combination of two diuretic agents with different but complementary
mechanisms and
sites of action, thereby providing additive diuretic and
antihypertensive effects.
Additionally, the spironolactone component helps to minimize the
potassium loss
characteristically induced by the thiazide component.
The diuretic effect of spironolactone is mediated through its action
as a specific
pharmacologic antagonist of aldosterone, primarily by competitive
binding of receptors
at the aldosterone-dependent sodium-potassium exchange site in the
distal convoluted
renal tubule. Hydrochlorothiazide promotes the excretion of sodium and
water primarily
by inhibiting their reabsorption in the cortical diluting segment of
the distal renal tubule.
Spi