SPIRONOLACTONE tablet, film coated

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Northwind Pharmaceuticals, LLC

INN (আন্তর্জাতিক নাম):

SPIRONOLACTONE

রচনা:

SPIRONOLACTONE 25 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Spironolactone tablets are indicated in the management of: Primary Hyperaldosteronism for: 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). 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. Spironolactone tablets are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate. Cirrhosis of the Liver Accompanied by Edema and/or Ascites: Spironolactone levels may be exceptionally high in th

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED
NORTHWIND PHARMACEUTICALS, LLC
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SPIRONOLACTONE
BOXED WARNING
WARNING
SPIRONOLACTONE HAS BEEN SHOWN TO BE A TUMORIGEN IN CHRONIC TOXICITY
STUDIES IN RATS (SEE
PRECAUTIONS). SPIRONOLACTONE SHOULD BE USED ONLY IN THOSE CONDITIONS
DESCRIBED UNDER
INDICATIONS AND USAGE. UNNECESSARY USE OF THIS DRUG SHOULD BE AVOIDED.
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 (-
lactone acetate. The molecular formula is C24H3204S.
Spironolactone 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, 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: 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
effective therapy for the edema
and ascites in those conditions. Spironolactone counteracts secondary
aldoste