Aldactone Tablets for Hypertension & Oedematous Disorders

Aldactone Spironolactone Tablets
Aldactone Tablets are used to treat hypertension,
oedematous disorders, diagnosis and treatment of
primary aldosteronism, reducing or preventing
potassium loss due to thiazide diuretics and other
conditions.
© The Swiss Pharmacy, Geneva Switzerland

Chemical Structure

Active Ingredient
The active pharmaceutical
ingredient present in Aldactone
Tablets is Spironolactone.

Indications
Aldactone Tablets, is used for the treatment of:
1. Essential hypertension (high blood pressure with
an unknown cause)
2. Oedematous disorders (swelling with fluid),
including congestive cardiac failure
3.Diagnosis and treatment of primary aldosteronism
(a hormone disorder causing fluid retention)
4.Add-on therapy in malignant hypertension
5.Reducing or preventing potassium loss due to
thiazide diuretics
6.Prevention of low amounts of potassium in the
blood in patients taking digitalis (a type of heart
medicine)

Indications
7. Long-term maintenance therapy for patients with
bilateral micro or macronodular adrenal
hyperplasia
8. 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.
9.Cirrhosis of the liver accompanied by edema
and/or ascites

Indications
10.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.
11.Hypokalemia: For the treatment of patients with
hypokalemia when other measures are considered
inappropriate or inadequate.
12.Severe heart failure (NYHA class III – IV)
To increase survival, and to reduce the need for
hospitalization for heart failure when used in addition
to standard therapy.

Indications
13.Long-term maintenance therapy for patients with
discrete aldosterone-producing adrenal
adenomas who are judged to be poor operative risks
or who decline surgery.
14. Treatment of hirsutism

Recommended Adult Dosage
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
=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 may have their
dosage reduced to 25 mg every other day.

Contraindications
Aldactone Tablets (Spironolactone) is
contraindicated in patients with the
following conditions:
➔Hypersensitivity to Spironolactone or any
inactive component of this medication.
➔Contraindicated for patients with anuria,
acute renal insufficiency, significant
impairment of renal excretory function, or
hyperkalemia.

Side Effects of Aldactone Tablets
Tell your doctor if you notice any of the
following and they worry you:
Cramping or diarrhoea, nausea or
vomiting, drowsiness, lethargy or generally
feeling unwell, skin rash or itchiness, fever,
unusual hair loss or thinning and
excessive hair growth.

Tell your doctor as soon as possible in case you
notice any of the following:
Frequent infection such as fever, severe chills,
sore throat or mouth ulcers. A few cases of
agranulocytosis (lack of white blood cells) have
been reported in patients taking Aldactone
Tablets.
Breast enlargement. Breast enlargement may
occur in men taking Aldactone Tablets. This
normally goes away when Aldactone Tablets are
stopped. In rare instances some breast
enlargement may persist.

Breast Lumps: Breast lumps and breast cancer
have been reported in patients taking Aldactone
Tablets although Aldactone has not been
shown to cause breast cancer.
If any of the following side effects occur, stop
taking Aldactone and either inform your doctor
immediately or go to Accident and Emergency at
your nearest hospital:
Stomach bleeding, ulcers or gastritis
(inflammation of the stomach), unsteadiness
when walking, leg cramps, headache, mental
confusion or dizziness.

Change in sex drive, impotence (inability
to achieve or maintain an erection), breast
pain, irregular periods or no periods, post-menopausal
bleeding. shortness of breath
and swelling of the legs from fluid build
(may be due to hyperkalaemia that is very
serious)
These are very serious side effects. You
may need urgent medical attention or
hospitalisation.

Warnings And Precautions
➔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.
➔Hyperkalemia in patients with severe heart failure.
Hyperkalemia may be fatal. It is critical to monitor and
manage serum potassium in patients with severe
heart failure receiving Aldactone ..
➔Aldactone should be used with caution in patients
with impaired hepatic function.

Overdose Symptoms
The symptoms of acute overdosage of
Aldactone 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 may occur, especially in patients
with impaired renal function.

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

Aldactone Tablets manufactured by
RPG Life Science Ltd., India.
For more information click here

Aldactone Tablets for Hypertension & Oedematous Disorders

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