SPIRONOLACTONE- spironolactone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc

INN (International Name):

SPIRONOLACTONE

Composition:

SPIRONOLACTONE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Spironolactone tablets, USP 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, USP 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 exceptiona

Product summary:

Spironolactone Tablets, USP are available as follows: 25 mg ― Each white to off-white, round, film coated tablet, imprinted with on one side and 803 on the other side contains 25 mg of Spironolactone, USP.  Tablets are supplied in: bottles of 30 NDC 68788-9124-3 bottles of 60 NDC 68788-9124-6 bottles of 90 NDC 68788-9124-9 Pharmacist: Dispense in a tight, light-resistant, child-resistant container. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9174   Revised — March 2015: Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SPIRONOLACTONE- SPIRONOLACTONE TABLET
PREFERRED PHARMACEUTICALS, INC
----------
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
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 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
Increased levels of the mineralocorticoid, aldosterone, are present in
primary and secondary
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32
4
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