SPIRONOLACTONE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

RedPharm Drug, Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Spironolactone Tablets USP, 25 mg are white to off-white, round, biconvex, film-coated tablets debossed with '660' on one side and plain on the other side and are supplied as follows: NDC 68382-660-06 in bottles of 30 tablets NDC 68382-660-16 in bottles of 90 tablets NDC 68382-660-01 in bottles of 100 tablets NDC 68382-660-05 in bottles of 500 tablets NDC 68382-660-10 in bottles of 1000 tablets NDC 68382-660-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Spironolactone Tablets USP, 50 mg are white to off-white, oval shaped, biconvex, film-coated tablets debossed with '661' on the scored side and plain on the other side and are supplied as follows: NDC 68382-661-06 in bottles of 30 tablets NDC 68382-661-16 in bottles of 90 tablets NDC 68382-661-01 in bottles of 100 tablets NDC 68382-661-05 in bottles of 500 tablets NDC 68382-661-10 in bottles of 1000 tablets NDC 68382-661-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Spironolactone Tablets USP, 100 mg are white to off-white, round, biconvex, film-coated tablets debossed with '662' on one side and scored on the other side and are supplied as follows: NDC 68382-662-06 in bottles of 30 tablets NDC 68382-662-16 in bottles of 90 tablets NDC 68382-662-01 in bottles of 100 tablets NDC 68382-662-05 in bottles of 500 tablets NDC 68382-662-10 in bottles of 1000 tablets NDC 68382-662-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Protect from light. Dispense in a tight, light-resistant container (USP).

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

SPIRONOLACTONE- SPIRONOLACTONE TABLET
REDPHARM DRUG, INC.
----------
SPIRONOLACTONE 25MG TABLETS
1 INDICATIONS AND USAGE
1.1 HEART FAILURE
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.
1.2 HYPERTENSION
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 drug to achieve blood pressure
goals. For specific
advice on goals and management, see published guidelines, such as
those of the
National High Blood Pressure Education Program's Joint National
Committee on
Prevention, Detection, Evaluation, and Treatment of High Blood
Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic
classes and with
different mechanisms of action, have been shown in randomized
controlled trials to
reduce cardiovascular morbidity and mortality, and it can be concluded
that it is blood
pressure reduction, and not some other pharmacologic property of the
drugs, that is
largely responsible for those benefits. The largest and most
consistent cardiovascular
outcome benefit has been a reduction in the risk of stroke, but
reductions in myocardial
infarction and cardiovascular mortality also have been seen regularly.
E