Spironolactone description, usages, side effects, indications, overdosage, supplying and lots more!

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Spironolactone

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

PRECAUTIONSINDICATIONS AND USAGE

SPIRONOLACTONE DESCRIPTION


Spironolactone




CLINICAL PHARMACOLOGY







PHARMACOKINETICS







CLINICAL STUDIES















INDICATIONS & USAGE



Primary Hyperaldosteronism for:





Edematous Conditions For Patients With:




Essential Hypertension


Hypokalemia


Severe heart failure (NYHA class IIIIV)



PRECAUTIONS: Pregnancy
There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

SPIRONOLACTONE CONTRAINDICATIONS



WARNINGS


PRECAUTIONS: General
CLINICAL STUDIES, Severe heart failureDOSAGE AND ADMINISTRATION, Severe heart failure

PRECAUTIONS: Drug Interactions

PRECAUTIONS

General








INFORMATION FOR PATIENTS



LABORATORY TESTS



DRUG INTERACTIONS










DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY






PREGNANCY

Teratogenic Effects


NURSING MOTHERS




PEDIATRIC USE



SPIRONOLACTONE ADVERSE REACTIONS



PRECAUTIONS


WARNINGSPRECAUTIONS




OVERDOSAGE






DOSAGE & ADMINISTRATION







WARNINGS: Hyperkalemia in patients with severe heart failure

HOW SUPPLIED















INACTIVE INGREDIENT

calcuim sulfate
corn starch
crospovidone
dextrose
hypromellose
magnesium stearate
maltodextrin
natural peppermint flavor
polydextrose
polyethylene glycol
povidone
silicon dioxide

titanium dioxide
triacetin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
















Spironolactone


Spironolactone






Spironolactone

Spironolactone TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-680(NDC:0228-2803)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SPIRONOLACTONE SPIRONOLACTONE 25 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM SULFATE
STARCH, CORN
CROSPOVIDONE
DEXTROSE
HYPROMELLOSES
MAGNESIUM STEARATE
maltodextrin
PEPPERMINT
POLYDEXTROSE
polyethylene glycol
povidone
SILICON DIOXIDE
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
white 7 mm R803 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-680-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040353 2011-05-12


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