Aldactone (Spironolactone Tablets)

Aldactone (Spironolactone Tablets) is used to treat fluid retention (edema) caused by various conditions, including heart disease, cirrhosis of the liver and nephrotic syndrome; High blood pressure; Hyperaldosteronism ( a condition in which the body produces too much aldoterone, a naturally occurring hormone) and low potassium levels in the blood (hypokalemia).

1. Spironolactone Tablets
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Aldactone (Spironolactone Tablets) is used to treat fluid
retention (edema) caused by various conditions, including
heart disease, cirrhosis of the liver and nephrotic
syndrome; High blood pressure; Hyperaldosteronism ( a
condition in which the body produces too much
aldoterone, a naturally occurring hormone) and low
potassium levels in the blood (hypokalemia).

2. Aldactone Tablets
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Aldactone Tablets are manufactured
by RPG Life Sciences Ltd.
(Website: www.rpglifesciences.com)

3. Spironolactone Tablets – Brand Names
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Spironolactone tablets are available as
Aldactone, Spilactone.

4. Active Ingredient
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The active ingredient contained in Aldactone
tablets is Spironolactone. Each tablet of
Aldactone contains 25mg, 50mg or 100mg of
Spironolactone.

5. Chemical Structure
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The structure of Spironolactone is given
below:

6. Uses of Aldactone Tablets
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Aldactone (Spironolactone Tablets) is used
to treat Congestive cardiac failure; hepatic
cirrhosis with ascites and oedema; malignant
ascites; nephrotic syndrome; diagnosis and
treatment of primary aldosteronism.

7. Spironolactone Dosage

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➢Establishing the diagnosis of Primary Hyperaldosteronism:
Long test: ALDACTONE is given at a daily dosage of 400 mg for
three to four weeks. Short test: ALDACTONE is given 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 only 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.
The dosage of Aldactone tablets (Spironolactone)
is given below:

8. Aldactone Dosage

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➢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 must 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.
The dosage of Aldactone tablets (Spironolactone)
is given below:

9. Storage Instructions

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Aldactone (Spironolactone Tablets)
have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F
to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

10. Warnings

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Aldactone has been observed to be a tumorigen in
chronic toxicity studies in rats. Unnecessary use of this
medicine should be avoided.
Potassium supplements, either in the form of
medication or as a diet rich in potassium, should not
normally be given in along with spironolactone
therapy.
Aldactone (Spironolactone) should not be administered
concurrently with other potassium-sparing diuretics.
Spironolactone must be used with caution in patients
with impaired hepatic function because minor
alterations of fluid and electrolyte balance can
precipitate hepatic coma.
Lithium generally should not be given with diuretics.

11. Aldactone Tablets
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Contraindications
Aldactone is contraindicated in patients with a
hypersensitivity to Spironolactone or any other
component of this medication.
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.

12. Aldactone Side Effects
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➢ Aldactone side effects can include the following:
➢Digestive: Gastric bleeding, ulceration, gastritis, diarrhea
and cramping, nausea, vomiting.
➢Endocrine: Gynecomastia, 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).

13. Spironolactone Overdose
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Symptoms of acute overdosage of
Spironolactone (Aldactone Tablets) are
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 can occur,
especially in patients with impaired renal function.

14. Spironolactone Overdose
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Treatment for Overdose: Induce vomiting
or evacuate the stomach by lavage. There
is no specific antidote for Aldactone
overdose.
Treatment is supportive to maintain
hydration, electrolyte balance, and vital
functions.

15. Spironolactone Tablets During Pregnancy
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Aldactone (Spironolactone Tablets) has
been classified by the US FDA as
Pregnancy Category C.
Animal studies have shown an increased
resorption rate, decreased live fetuses, and
progestational and antiandrogenic effects.
There are no adequate and well-controlled
studies conducted with Aldactone in
pregnant women.
Use of this medicine during pregnancy
requires the benefit be weighed against the
risk to the fetus.

16. Aldactone Tablets
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Aldactone Tablets click here
© Clearsky Pharmacy
Aldactone (Spironolactone Tablets) by
RPG Life Sciences Limited, India.