SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

제공처:

Bryant Ranch Prepack

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 (however, see Precautions: Pregnancy ). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is unsupported and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate. Spironolactone and hydrochlorothiazide tablets are contraindicated in patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, hypercalcemia, hyperkalemia, Addison's disease, and in patients who are allergic to thiazide diuretics or to other sulfonamide-derived drugs. Spironolactone and hydrochlorothiazide tablets may also be contraindicated in acute or severe hepatic failure.

제품 요약:

Spironolactone and hydrochlorothiazide tablets, USP are supplied as follows: Spironolactone and hydrochlorothiazide tablets, 25 mg/25 mg are buff, round, unscored, debossed MP 40. NDC: 72162-1625-1: 100 Tablets in a BOTTLE, PLASTIC NDC: 72162-1625-3: 30 Tablets in a BOTTLE, PLASTIC NDC: 72162-1625-5: 500 Tablets in a BOTTLE, PLASTIC NDC: 72162-1625-6: 60 Tablets in a BOTTLE, PLASTIC Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE- SPIRONOLACTONE AND
HYDROCHLOROTHIAZIDE TABLET
BRYANT RANCH PREPACK
----------
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.
Spironolactone and