Aldactone Tablets - Active Ingredient And Chemical structure
The active ingredient contained in Aldactone Tablets is Spironolactone. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. The structure is shown below
Generic Forms and Brand names of Spironolactone
Aldactone Tablets manufactured by RPG Life Science Ltd., India is an effective treatment for edema and ascites of congestive heart failure, hepatic cirrhosis, the nephrotic syndrome, and idiopathic edema as well as that due to malignant effusions especially if not responding well to conventional diuretics.
Aldactone is also indicated for lowering blood pressure in essential hypertension, correcting hypokalemic alkalosis in severe hypertension and in the treatment of myasthenia gravis. Aldactone which has the active ingredient Spironolactone is also sold as Novo-Spiroton, Aldactazide, Spiractin, Spirotone, Verospiron, Berlactone and under various other brand names.
Aldactone Tablets Preparations
Aldactone Tablets is available as tablets of 25 mg and 100 mg . Aldactone oral tablets contain 25 mg or 100 mg of the active ingredient spironolactone respectively.
Aldactone Tablets - Storage Requirements
Aldactone Tablets are to be stored at room temperature (15°C to 30°C). Store away from heat, moisture, and light.
Aldactone Tablets - Uses
Spironolactone in the form of Aldactone Tablets is used in the short term preoperative treatment of patients with primary hyperaldosteronism. Used for the long term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery.
Aldactone (spironolactone) is also used in the management of Edematous conditions for patients with:
Congestive heart failure: For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures.
Cirrhosis of the liver accompanied by edema and/or ascites: Aldactone is indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium.
The nephrotic syndrome:For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.
Essential hypertension: Usually in combination with other drugs, Aldactone is indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate.
Hypokalemia:For the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate. Aldactone is also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.
Severe heart failure:To increase survival, and to reduce the need for hospitalization for heart failure when used in addition to standard therapy.
Aldactone Tablets - Contraindications and Warnings
Aldactone is contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, or hyperkalemia.
Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with Aldactone therapy.
All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance, e.g., hypomagnesemia, hyponatremia, hypochloremic alkalosis, and hyperkalemia.
Aldactone Tablets - Dosage
Edema in adults (congestive heart failure, hepatic cirrhosis, or nephrotic syndrome).
An initial daily dosage of 100 mg of Aldactone administered in either single or divided doses is recommended, but may range from 25 to 200 mg daily.
Essential hypertension.
For adults, an initial daily dosage of 50 to 100 mg of Aldactone administered in either single or divided doses is recommended. Aldactone may also be given with diuretics which act more proximally in the renal tubule or with other antihypertensive agents. Treatment with Aldactone should be continued for at least two weeks, since the maximum response may not occur before this time.
Hypokalemia.
Aldactone in a dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium sparing regimens are considered inappropriate.
Severe heart failure (NYHA class III – IV).
Treatment should be initiated with Aldactone 25 mg once daily if the patient’s serum potassium is =5.0 mEq/L and the patient’s serum creatinine is = 2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once-daily dose may have their dosage reduced to 25 mg every other day.
Side Effects Of Aldactone Tablets
The most common side effects of Aldactone Tablets are
Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.
Endocrine: Gynecomastia (see Precautions), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding. Carcinoma of the breast has been reported in patients taking Aldactone but a cause and effect relationship has not been established.
Hematologic: Agranulocytosis.
Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.
Metabolism: Hyperkalemia.
Nervous system /psychiatric: Mental confusion, ataxia, headache, drowsiness, lethargy.
Liver / biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with Aldactone administration.
Renal: Renal dysfunction (including renal failure).
