Aldactone Tablets (Spironolactone) – Product Information
Aldactone Tablets manufactured by RPG Life Science Ltd. are used to treat essential hypertension (high blood pressure with an unknown cause), oedematous disorders(swelling with fluid), including congestive cardiac failure, diagnosis and treatment of primary aldosteronism, reducing or preventing potassium loss due to thiazide diuretics, add-on therapy in malignant hypertension, prevention of low amounts of potassium in the blood in patients taking digitalis, treatment of hirsutism, treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate and other conditions. Aldactone 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 acts by working against the effects of a hormone called aldosterone. Too much aldosterone causes increased amounts of sodium (a mineral) and water to be retained by the kidneys, while too much potassium is removed from the body.
Aldactone also has a moderate ability to act against male sex hormones (anti-androgenic effect). Because of this, Aldactone is effective in the treatment of female hirsutism (excess body hair). It reduces hair growth, thickness and hair colour.
Aldactone Tablets - Contraindications
Aldactone is contraindicated in patients that have hypersensitivity to Spironolactone or any inactive component of this medicine. Aldactone Tablets are also contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, Addison's disease or hyperkalemia, pregnancy or with concomitant use of eplerenone.
Aldactone Tablets - Dosage
The recommended dosage of Aldactone Tablets for various indications is given below:
Establishing the diagnosis of Primary Hyperaldosteronism:
Long test: ALDACTONE is administered at a daily dosage of 400 mg for three to four
weeks.
Short test: ALDACTONE is administered at a daily dosage of 400 mg for four days.
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. When given as the sole agent for diuresis, Aldactone should be continued for at least five days at the initial dosage level, after which it may be adjusted to the optimal therapeutic or maintenance level.
Essential hypertension:
For adults, an initial daily dosage of 50 to 100 mg of Aldactone administered in either single or divided doses is recommended.
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 started with Aldactone 25 mg once daily if the patient’s serum potassium is equal to 5.0 mEq/L and the patient’s serum creatinine is equal to 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 may have their dosage reduced to 25 mg every other day.
Side Effects of Aldactone Tablets
The side effects of Aldactone Tablets include:
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).
Aldactone Tablets - More Details
For more details please read the prescription information or watch the presentation below:
