SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Physicians Total Care, Inc.

INN (Nama Internasional):

SPIRONOLACTONE

Komposisi:

SPIRONOLACTONE 25 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Spironolactone 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: 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. Aldosterone levels may be exceptionally high in this condition. Spironolactone and hydrochlorothiazide tablets are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium. For nephrotic patients when treatment of the und

Ringkasan produk:

Spironolactone and Hydrochlorothiazide Tablets are available containing 25 mg of spironolactone, USP and 25 mg of hydrochlorothiazide, USP. The tablets are ivory, round, biconvex tablets debossed with M above the score and 41 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 54868-0699-2   bottles of 30 tablets NDC 54868-0699-1   bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REV JANUARY 2005 SPHZ:R16

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE - SPIRONOLACTONE AND
HYDROCHLOROTHIAZIDE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
WARNING
Spironolactone has been shown to be a tumorigen in chronic toxicity
studies in rats (see
PRECAUTIONS). Spironolactone and hydrochlorothiazide should be used
only in those
conditions described under INDICATIONS AND USAGE. Unnecessary use of
this drug should
be avoided.
Fixed-dose combination drugs are not indicated for initial therapy of
edema or hypertension.
Edema or hypertension requires therapy titrated to the individual
patient. If the fixed combination
represents the dosage so determined, its use may be more convenient in
patient management. The
treatment of hypertension and edema is not static but must be
reevaluated as conditions in each
patient warrant.
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. = 416.59
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-
24
32
4
benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following
structural formula, molecular
formula, and molecular weight:
C H ClN O S
M.W. = 297.75
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,
D&lC yellow #10 aluminum lake HT,
FD&C yellow #6 aluminum lake HT, lactose, magnesium stearate,
microcrystalline cellulose, menthol,
peppermint oil, sodium lauryl sulfate, sodium starch glycolate and
starch.
ACTIONS/CLINIC