SPIRONOLACTONE tablet SPIRONOLACTONE tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

NorthStar Rx LLC

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Spironolactone tablets are indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. Spironolactone tablets are usually administered in conjunction with other heart failure therapies. Spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. 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 dru

Podsumowanie produktu:

Spironolactone tablets, USP are supplied as follows: Spironolactone tablets 25 mg, white, round, unscored, debossed MP 35 Spironolactone tablets 50 mg, white, round, film coated, scored, debossed MP 542 Spironolactone tablets 100 mg, white, oval shape, film coated, scored, debossed MP 303 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

SPIRONOLACTONE- SPIRONOLACTONE TABLET
SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED
NORTHSTAR RX LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SPIRONOLACTONE
TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR SPIRONOLACTONE TABLETS.
SPIRONOLACTONE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1960
INDICATIONS AND USAGE
Spironolactone tablets are an aldosterone antagonist indicated for:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, and 100 mg (3)
CONTRAINDICATIONS
Spironolactone Tablets are contraindicated in patients with (4):
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse reaction with spironolactone tablets treatment
is gynecomastia (5.4, 6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NORTHSTAR RX LLC AT
1-800-206-7821 OR
The treatment of NYHA Class III-IV heart failure and reduced ejection
fraction to increase survival,
manage edema, and to reduce the need for hospitalization for heart
failure (1.1).
Use as an add-on therapy for the treatment of hypertension, to lower
blood pressure. Lowering blood
pressure reduces the risk of fatal and nonfatal cardiovascular events,
primarily strokes and
myocardial infarctions (1.2).
The management of edema in adult patients who are cirrhotic when edema
is not responsive to fluid
and sodium restrictions and in the setting of nephrotic syndrome when
treatment of the underlying
disease, restriction of fluid and sodium intake, and the use of other
diuretics produce an inadequate
response (1.3).
Treatment of primary hyperaldosternism for: (1.4).
•
•
Short-term preoperative treatment
Long-term maintenance for patients with discrete aldosterone-producing
adrenal adenomas who
are not candidates for surgery and patients with bilateral micro or
macronodular adrenal
hyperplasia
Heart Failure: Initiate treatment at 25 mg once daily (2.2).
Hypertension: Initiate treatment at 25