Brand Name
Aldactone
Generic Name
CaroSpir
View Brand Information FDA approval date: January 21, 1960
Classification: Aldosterone Antagonist
Form: Tablet, Suspension
What is Aldactone (CaroSpir)?
Spironolactone oral suspension is an antagonist of aldosterone 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.
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Brand Information
Aldactone (spironolactone)
1DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg round, light yellow, film-coated, with SEARLE and 1001 debossed on one side and ALDACTONE and 25 on the other side.
Tablets: 50 mg oval, light orange, scored, film-coated, with SEARLE and 1041 debossed on the scored side and ALDACTONE and 50 on the other side.
Tablets: 100 mg round, peach-colored, scored, film-coated, with SEARLE and 1031 debossed on the scored side and ALDACTONE and 100 on the other side.
2CONTRAINDICATIONS
ALDACTONE is contraindicated in the patients with:
- Hyperkalemia
- Addison's disease
- Concomitant use of eplerenone
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hyperkalemia
- Hypotension and Worsening Renal Function
- Electrolyte and Metabolic Abnormalities
- Gynecomastia
- Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites
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 , 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.
4OVERDOSAGE
The oral LD
Acute overdosage of ALDACTONE 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.
5DESCRIPTION
ALDACTONE oral tablets 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 calcium sulfate, corn starch, flavor, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.
6HOW SUPPLIED/STORAGE AND HANDLING
ALDACTONE 25 mg tablets are round, light yellow, film-coated, with SEARLE and 1001 debossed on one side and ALDACTONE and 25 on the other side, supplied as:
ALDACTONE 50 mg tablets are oval, light orange, scored, film-coated, with SEARLE and 1041 debossed on the scored side and ALDACTONE and 50 on the other side, supplied as:
ALDACTONE 100 mg tablets are round, peach-colored, scored, film-coated, with SEARLE and 1031 debossed on the scored side and ALDACTONE and 100 on the other side, supplied as:
7PATIENT COUNSELING INFORMATION
Patients who receive ALDACTONE should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes.
This product's label may have been updated. For current full prescribing information, please visit
LAB-0231-18.0
8PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
Pfizer
NDC 0025-1001-31
Aldactone
25 mg
100 Tablets
9PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
Pfizer
NDC 0025-1041-31
Aldactone
50 mg
100 Tablets
10PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
Pfizer
NDC 0025-1031-31
Aldactone
100 mg
100 Tablets
