displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1
Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see
). Spironolactone should be used only in those conditions described under
Indications and Usage
. Unnecessary use of this drug should be avoided.
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Spironolactone tablets USP, for oral administration contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula:
Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.
Inactive ingredients include lactose monohydrate, dibasic calcium phosphate, povidone, peppermint oil, purified talc, pregelatinised starch, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide and iron oxide yellow. In addition, iron oxide red (50 mg and 100 mg tablets) is included in the film coating of specific strengths.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Spironolactone tablets are indicated in the management of:
Primary hyperaldosteronism for:
Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial.
Short-term preoperative treatment of patients with primary hyperaldosteronism.
Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery.
Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).
Edematous conditions for patients with:
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Spironolactone is contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, hyperkalemia, Addison’s disease, and with concomitant use of eplerenone.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.
Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.
Reproductive: Gynecomastia (see
), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast pain. Carcinoma of the breast has been reported in patients taking spironolactone but a cause and effect relationship has not been established.
Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia.
Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.
Metabolism: Hyperkalemia, electrolyte disturbances (see
Musculoskeletal: Leg cramps.
Nervous system /psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness.
Liver / biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.
Renal: Renal dysfunction (including renal failure).
Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritis.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
The oral LD
50 of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits.
Acute overdosage of spironolactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Spironolactone Tablets USP 100 mg tablets are Light peach to peach colored, round, biconvex, film coated tablets with inscription “AF” on one side and breakline on the other side having faint odour of peppermint, supplied as:
Bottles of 30 (NDC 43063-835-30), Bottles of 90 (NDC 43063-835-90)
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]
Protect from light. Dispense in tight, Light-resistant containers.
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4