SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Mylan Pharmaceuticals Inc.

INN (Rahvusvaheline Nimetus):

SPIRONOLACTONE

Koostis:

SPIRONOLACTONE 25 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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: Cirrhosis of the liver accompanied by edema and/or ascites: The nephrotic syndrome: Essential hypertension: Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Progra

Toote kokkuvõte:

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 0378-0403-01 bottles of 100 tablets NDC 0378-0403-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia Revised: 4/2023 ALP:SPHZ:R4 (3528/3)

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE- SPIRONOLACTONE AND
HYDROCHLOROTHIAZIDE TABLET
MYLAN PHARMACEUTICALS 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:
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:
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. Hydrochlorothiazide promotes the excretion of sodium and