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Aldactone®
spironolactone tablets, USP

Also see:
Microzide Norvasc
Drug Uses
Aldactone is in a class of drugs called
potassium-sparing diuretics (water pill). It is used to reduce the amount of
fluid in your body without causing the loss of potassium. Aldactone is used to
treat edema (swelling) and hypertension (high blood pressure). Aldactone is also
used to treat potassium deficiency and hyperaldosteronism (a hormonal disorder).
How Taken
Aldactone comes as a tablet to take by mouth. It
usually is taken once a day in the morning with breakfast or twice a day with
breakfast and lunch. Follow the directions on your prescription label carefully,
and ask your doctor or pharmacist to explain any part you do not understand.
Take Aldactone exactly as directed. Do not take more or less of it or take it
more often than prescribed by your doctor. Aldactone controls high blood
pressure but does not cure it. Continue to take Aldactone even if you feel well.
Do not stop taking Aldactone without talking to your doctor.
Warnings/Precautions
Before taking Aldactone, tell your doctor if you
have kidney disease; have liver disease; have diabetes mellitus; have high
levels of potassium in your blood; or are taking a potassium supplement or an
angiotensin-converting-enzyme inhibitor (ACE inhibitor). You may not be able to
take Aldactone, or you may require a dosage adjustment or special monitoring
during treatment if you have any of the conditions listed above. Aldactone is in
the FDA pregnancy category D. This means that Aldactone is known to harm an
unborn baby. Do not take Aldactone if you are pregnant. It is not known whether
Aldactone passes into breast milk. Do not take Aldactone without first talking
to your doctor if you are breast-feeding a baby.
Missed Dose
Take the missed dose as soon as you remember it.
However, if it is almost time for your next dose, skip the missed dose and
continue your regular dosing schedule. Do not take a double dose to make up for
a missed one.
Possible Side Effects
Stop taking Aldactone and seek emergency medical
attention if you experience any of the following serious side effects: an
allergic reaction (difficulty breathing; closing of your throat; swelling of
your lips, tongue, or face; or hives); an irregular heartbeat, shortness of
breath, fatigue, confusion, weakness, numbness, or tingling (caused by high
levels of potassium in your blood); or decreased urination. Other, less serious
side effects may be more likely to occur. Continue to take Aldactone and talk to
your doctor if you experience unusual headache or dizziness; nausea, diarrhea,
or a decrease in appetite; dry mouth; bloating; muscle cramps; or lowering of
the voice, excessive hair growth, or enlarged breasts. Side effects other than
those listed here may also occur. Talk to your doctor about any side effect that
seems unusual or that is especially bothersome.
Storage
Keep this medicine in the container it came in,
tightly closed, and out of reach of children. Store it at room temperature and
away from excess heat and moisture (not in the bathroom). Throw away any
medicine that is outdated or no longer needed. Talk to your pharmacist about the
proper disposal of your medicine.
Overdose
Acute over dosage of Aldactone may be manifested
by drowsiness, mental confusion, nausea, vomiting, dizziness, or diarrhea. Seek
emergency medical attention.
More Information
Aldactone is also used in combination with other
medicines to treat precocious puberty or myasthenia gravis. Aldactone also may
be used to treat certain female patients with abnormal facial hair. Talk to your
doctor about the possible risks of using this medicine for your condition.
Spironolactone is a potassium-sparing diuretic
(water pill) that prevents your body from absorbing too much salt and keeps your
potassium levels from getting too low.
Spironolactone is used to diagnose or treat a condition in which you have too
much aldosterone in your body. Aldosterone is a hormone produced by your adrenal
glands to help regulate the salt and water balance in your body.
Spironolactone also treats fluid retention (edema) in people with congestive
heart failure, cirrhosis of the liver, or a kidney disorder called nephrotic
syndrome. This medication is also used to treat or prevent hypokalemia (low
potassium levels in the blood). Spironolactone may also be used for purposes.
WARNING
Spironolactone has been shown to be a tumorigen in chronic toxicity studies in
rats (see PRECAUTIONS). Aldactone should be used only in those conditions
described under INDICATIONS AND USAGE. Unnecessary use of this drug should be
avoided.
DESCRIPTION
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.
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.
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