SPIRONOLACTONE- spironolactone tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Quality Care Products, LLC

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 more than one dru

পণ্য সারাংশ:

Spironolactone Tablets USP, 25 mg are white, film-coated, round tablets, debossed “AN” above “511” on one side and plain on other side. They are available as follows: Bottles of 30:                                      NDC 53746-511-30 Bottles of 60:                                      NDC 53746-511-60 Bottles of 90:                                      NDC 53746-511-90 Bottles of 100:                                    NDC 53746-511-01 Bottles of 500:                                    NDC 53746-511-05 Bottles of 1000:                                  NDC 53746-511-10 Spironolactone Tablets USP, 50 mg are yellow, film-coated, round tablets, debossed “AN” bisect “514” on one side and plain on other side. They are available as follows: Bottles of 30:                                      NDC 53746-514-30 Bottles of 60:                                      NDC 53746-514-60 Bottles of 90:                                      NDC 53746-514-90 Bottles of 100:                                    NDC 53746-514-01 Bottles of 500:                                    NDC 53746-514-05 Bottles of 1000:                                  NDC 53746-514-10 Spironolactone Tablets USP, 100 mg are beige, film-coated, round tablets, debossed “AN” above bisect and “515” below bisect on one side and plain on other side. They are available as follows: Bottles of 30:                                      NDC 53746-515-30 Bottles of 60:                                      NDC 53746-515-60 Bottles of 90:                                      NDC 53746-515-90 Bottles of 100:                                    NDC 53746-515-01 Bottles of 500:                                    NDC 53746-515-05 Bottles of 1000:                                  NDC 53746-515-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

SPIRONOLACTONE- SPIRONOLACTONE TABLET
QUALITY CARE PRODUCTS, 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:
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
DOSAGE AND ADMINISTRATION
Heart Failure: Initiate treatment at 25 mg once daily (2.2).
Hypertension: Initiate treatment at 25 mg to 100 mg daily in either
single or divided doses (2.3).
Edema: Initiate therapy in a hospital setting and titrate slowly. The
recommended initial daily dose is 100 mg in single
or divided doses (2.3).
Primary hyperaldosteronism: Initiate treatment at 100 mg to 400 mg in
preparation for surgery. In patients unsuitable
for surgery use the lowest effective dosage determined for the
individual patient (2.4).
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, and 100 mg (3)
CONTRA