spironolactone - Northwind Health Company, LLC

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Tablets: 25 mg are white to off-white, round, biconvex, film-coated tablets debossed with '660' on one side and plain on the other side. Tablets: 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. Tablets: 100 mg are white to off-white, round, biconvex, film-coated tablets debossed with '662' on one side and scored on the other side.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Spironolactone tablets are contraindicated in the patients with: Hyperkalemia Addison's disease Concomitant use of eplerenone

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions ( 5.1 )] Hypotension and Worsening Renal Function [see Warnings and Precautions ( 5.2 )] Electrolyte and Metabolic Abnormalities [see Warnings and Precautions ( 5.3 )] Gynecomastia [see Warnings and Precautions ( 5.4 )] Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites [see Use in Specific Populations ( 8.7 )] The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting. Reproductive: Decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain. Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia. Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis. Metabolism: Hyperkalemia, electrolyte disturbances [see Warnings and Precautions ( 5.1 , 5.3 )] , hyponatremia, hypovolemia. 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). Skin: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritis.

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

The oral LD 50 of spironolactone is greater than 1,000 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. Treatment: Induce vomiting or evacuate the stomach by lavage. There is no specific antidote. Treatment is supportive to maintain hydration, electrolyte balance, and vital functions. Patients who have renal impairment may develop hyperkalemia. In such cases, discontinue spironolactone.

11 DESCRIPTION

DESCRIPTION SECTION

Spironolactone tablets, USP 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, USP is practically insoluble in water, soluble in ethyl acetate and alcohol, freely soluble in benzene and in chloroform, slightly soluble in menthanol and very slightly soluble in fixed oils. Inactive ingredients include calcium sulfate dihydrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, peppermint flavor, povidone and sodium lauryl sulfate. Additionally each tablet contains opadry II white 33F28398 which contains hydroxylpropyl methyl cellulose, lactose monohydrate, polyethylene glycol, talc and titanium dioxide.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

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 51655-861-52 in bottles of 30 tablets NDC 51655-861-26 in bottles of 90 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).

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Patients who receive spironolactone should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes. Manufactured by: Zydus Lifesciences Ltd., Baddi, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 12/25

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-861-26