SPIRONOLACTONE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232)

Saatavilla:

Carilion Materials Management

INN (Kansainvälinen yleisnimi):

SPIRONOLACTONE

Koostumus:

SPIRONOLACTONE 25 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Spironolactone tablets, USP are indicated in the management of: for: Primary Hyperaldosteronism Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). for Patients with: Edematous Conditions For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. Spironolactone tablets, USP are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate. Congestive Heart Failure: Spironolactone leve

Tuoteyhteenveto:

NDC:68151-2776-1 in a BOTTLE of 1 TABLET, FILM COATEDS

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
----------
SPIRONOLACTONE TABLETS, USP
40-9174
Revised – March 2015
RX ONLY
WARNING
SPIRONOLACTONE HAS BEEN SHOWN TO BE A TUMORIGEN IN CHRONIC TOXICITY
STUDIES IN RATS (SEE ).
SPIRONOLACTONE SHOULD BE USED ONLY IN THOSE CONDITIONS DESCRIBED UNDER
INDICATIONS
AND USAGE. UNNECESSARY USE OF THIS DRUG SHOULD BE AVOIDED. PRECAUTIONS
DESCRIPTION
Spironolactone tablets, USP, for oral administration contain 25 mg, 50
mg or 100 mg of the aldosterone
antagonist spironolactone,
17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-
lactone acetate. The molecular formula is C H 0 S and is represented
by the following structural
formula:
Spironolactone, USP is practically insoluble in water, soluble in
alcohol, and freely soluble in benzene
and in chloroform. Inactive ingredients include calcium sulfate, corn
starch, crospovidone, dextrose,
hypromellose, magnesium stearate, maltodextrin, natural peppermint
flavor, polydextrose, polyethylene
glycol, povidone, silicon dioxide, titanium dioxide and triacetin.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Spironolactone is a specific pharmacologic antagonist of aldosterone,
acting primarily through
competitive binding of receptors at the aldosterone-dependent
sodium-potassium exchange site in the
distal convoluted renal tubule. Spironolactone causes increased
amounts of sodium and water to be
excreted, while potassium is retained. Spironolactone acts both as a
diuretic and as an antihypertensive
drug by this mechanism. It may be given alone or with other diuretic
agents that act more proximally in
the renal tubule.
ALDOSTERONE ANTAGONIST ACTIVITY
24324
Increased levels of the mineralocorticoid, aldosterone, are present in
primary and secondary
hyperaldosteronism. Edematous states in which secondary aldosteronism
is usually involved include
congestive heart failure, hepatic cirrhosis, and nephrotic syndrome.
By competing with aldosterone for
receptor sites, spironolactone provides effecti