SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Mylan Institutional Inc.

INN (International Name):

SPIRONOLACTONE

Sammensetning:

SPIRONOLACTONE 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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: Congestive heart failure: - For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures; - The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate; - The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate. Cirrhosis of the liver accompanied by edema and/or ascites: - Aldosterone levels may be exceptionally high in this cond

Produkt oppsummering:

Spironolactone and Hydrochlorothiazide Tablets, USP are available containing 25 mg of spironolactone, USP and 25 mg of hydrochlorothiazide, USP. The 25 mg/25 mg tablets are ivory, round, unscored tablets debossed with M over 41 on one side of the tablet and blank on the other side. They are available as follows: NDC 42292-017-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12688 9/21

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE- SPIRONOLACTONE AND
HYDROCHLOROTHIAZIDE TABLET
MYLAN INSTITUTIONAL INC.
----------
DESCRIPTION
Each tablet of spironolactone and hydrochlorothiazide contains 25 mg
of
spironolactone, USP and 25 mg of hydrochlorothiazide, USP.
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, molecular
formula and molecular weight:
C
H
O
S
M.W. = 416.57
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-2 _H_-1,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following
structural formula,
molecular formula and molecular weight:
24
32
4
C
H
ClN
O
S
M.W. = 297.74
Hydrochlorothiazide is slightly soluble in water and freely soluble in
sodium hydroxide
solution.
Each tablet for oral administration contains 25 mg of spironolactone
and 25 mg of
hydrochlorothiazide and the following inactive ingredients: colloidal
silicon dioxide, corn
starch, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum
Lake, lactose
monohydrate, magnesium stearate, L-menthol, microcrystalline
cellulose, peppermint oil,
sodium lauryl sulfate and sodium starch glycolate (potato).
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. Hyd