Aldactone/Spironolactone usp IS USED FOR:

Treating swelling and fluid retention inpatients with congestive heart failure, cirrhosis, or kidney problems (nephrotic syndrome). It is also used for treatment of high blood pressure. It may also be used to treat or prevent low blood potassium. It may also be used to treat excess secretion of the hormone aldosterone by the adrenal gland.

Aldactone/Spironolactone is a potassium-sparing diuretic. It works by blocking the hormone aldosterone, causing the kidney to eliminate excess water, save potassium, and lower blood pressure.

DO NOT USE Aldactone/Spironolactone usp IF:

• you are unable to urinate, have severe kidney problems, or have high blood potassium levels
• you are allergic to any ingredient in Aldactone/Spironolactone
• you are taking a potassium supplement, another potassium-sparing diuretic (eg, amiloride , triamterene), or another aldosterone-blocker (eg, eplerenone)

Contact your doctor or health care provider right away if any of these apply to you.

POSSIBLE SIDE EFFECTS OF Aldactone/Spironolactone usp :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abdominal cramping; change in sexual ability; clumsiness; confusion; diarrhea; dizziness; drowsiness; headache; frequent urination; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast tenderness; deepening of voice; dry mouth; enlarged breasts in men; excessive thirst; irregular or lack of menstrual periods; skin rash; slow, irregular, or fast heartbeat; ulcers; unusual muscle weakness; unusual tiredness.

IMPORTANT SAFETY INFORMATION:

• Check with your doctor before you use a salt substitute or a product that has potassium in it.
• Aldactone/Spironolactone can raise your body's potassium levels. This is more likely to occur in people with kidney problems, diabetes, in the elderly, or if the patient is severely ill. Potassium levels must be closely monitored in people with any of these problems or illnesses. If not treated, high potassium levels can be fatal.
• Lab tests, including kidney function, blood pressure, blood potassium, and chemistries, may be performed while you use Aldactone/Spironolactone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Aldactone/Spironolactone may cause dizziness and drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Aldactone/Spironolactone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aldactone/Spironolactone while you are pregnant. Aldactone/Spironolactone is found in breast milk. Do not breast-feed while taking Aldactone/Spironolactone.

BEFORE USING Aldactone/Spironolactone usp :

Some medical conditions may interact with Aldactone/Spironolactone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you have allergies to medicines, foods, or other substances
• if you have menstrual disease
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have high acidity in your body fluids; low sodium levels in your blood; liver, heart, or lung disease; diabetes; or high urea or nitrogen in your blood

Some MEDICINES MAY INTERACT with Aldactone/Spironolactone. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital) or narcotics (eg, morphine) because dizziness upon standing may occur
• Pressor amines (eg, norepinephrine) because their effectiveness may be decreased by Aldactone/Spironolactone
• Lanoxin/Digoxin, digitoxin, Lithobid/lithium, nondepolarizing muscle relaxants (eg, tubocurarine), or quinidine because the risk of their side effects and toxicity may be increased by Aldactone/Spironolactone
• Corticosteroids (eg, Meticorten/prednisone) or ACTH because low blood electrolyte levels may occur
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, Indocin cr/indomethacin) because they may decrease Aldactone/Spironolactone 's effectiveness and increase the risk of kidney problems and high blood potassium
• Angiotensin-converting enzyme (ACE) inhibitors (eg, Vasotec/enalapril ), angiotensin II receptor antagonists (eg, Diovan/valsartan), Neoral/cyclosporine, macrolide immunosuppressives (eg, Prograf/tacrolimus), other potassium sparing diuretics (eg, amiloride , triamterene), other aldosterone-blockers (eg, eplerenone), or potassium supplements because high blood potassium levels may occur (eg, listlessness, confusion, abnormal skin sensations of the arms and legs, heaviness of limbs, slowed heart rate, irregular heart rhythm, potentially life-threatening slow or irregular heartbeat)

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aldactone/Spironolactone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

HOW TO USE Aldactone/Spironolactone usp :

Use Aldactone/Spironolactone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Aldactone/Spironolactone may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
• Take Aldactone/Spironolactone by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of Aldactone/Spironolactone , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If more than one dose is missed, restart the medication and advise your doctor or pharmacist at your next appointment.

Ask your health care provider any questions you may have about how to use Aldactone/Spironolactone.

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.