SPIRONOLACTONE- 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:

Preferred Pharmaceuticals Inc.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 mor

পণ্য সারাংশ:

Spironolactone Tablets, USP 25 mg are brown colored, round, biconvex, film-coated tablets debossed with ‘TL 216’ on one side and plain on the other side, supplied as:   Bottle of 30   Tablets            NDC 68788-6895-3 Bottle of 60   Tablets            NDC 68788-6895-6 Bottle of 90   Tablets            NDC 68788-6895-9 Spironolactone Tablets, USP 100 mg are brown colored, round, biconvex, film-coated tablets debossed with ‘TL 218’ on one side and scored on the other side, supplied as:   Bottle of 30   Tablets            NDC 68788-6900-3 Bottle of 60   Tablets            ND  68788-6900-6 Bottle of 90   Tablets            NDC 68788-6900-9 Protect from light. Dispense in tight, light-resistant, child resistant container as defined in the USP.   Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

SPIRONOLACTONE- SPIRONOLACTONE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
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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 aldosterone antagonist indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, and 100 mg (3)
CONTRAINDICATIONS
Spironolactone tablets are contraindicated in patients with (4):
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
THE MOST COMMON ADVERSE REACTION WITH SPIRONOLACTONE TREATMENT IS
GYNECOMASTIA (5.4, 6). TO REPORT
SUSPECTED ADVERSE REACTIONS, CONTACT JUBILANT CADISTA PHARMACEUTICALS
INC. AT 1-800-313-4623 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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)
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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