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Indications and Usage for Aldactone

June 26th, 2009 No comments

Aldactone (spironolactone) is indicated in the management of:

Primary hyperaldosteronism for:

Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial.

Short-term preoperative treatment of patients with primary hyperaldosteronism.

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

Long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).

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. Aldactone is also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate.

Cirrhosis of the liver accompanied by edema and/or ascites

Aldosterone levels may be exceptionally high in this condition. Aldactone is indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium.

The 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.

Essential hypertension

Usually in combination with other drugs, Aldactone is indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate.

Hypokalemia

For the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate. Aldactone is also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.

Usage in Pregnancy

The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developing toxemia.

Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy.

Aldactone is indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy. Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is unsupported and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

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Aldactone description

June 26th, 2009 No comments

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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Aldactone warning

June 26th, 2009 No comments

Aldactone 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.

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Aldactone general information

June 26th, 2009 No comments

* If you have any questions about Aldactone , please talk with your doctor, pharmacist, or other health care provider.

* Aldactone is to be used only by the patient for whom it is prescribed. Do not share it with other people.

* If your symptoms do not improve or if they become worse, check with your doctor.

This information is summary only. It does not contain all information about Aldactone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other healthcare provider.

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If Aldactone overdose is suspected

June 26th, 2009 No comments

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include lightheadedness; nausea; vomiting; weakness.

Proper storage of Aldactone:

Store Aldactone at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aldactone out of the reach of children and away from pets.

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Possible side effects of Aldactone

June 26th, 2009 No comments

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:

Diarrhea; drowsiness; headache; nausea; stomach cramping; 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); black, tarry, or bloody stools; change in the amount of urine produced; confusion; dark urine; decreased sexual ability; enlarged breasts in men; irregular or missed menstrual periods; pale stools; severe or persistent stomach pain; symptoms of abnormal fluid or electrolyte levels (eg, fast, slow, or irregular heartbeat; increased thirst; muscle weakness; severe or persistent dry mouth, nausea, or vomiting; severe or persistent dizziness or drowsiness; unusual fatigue or sluggishness; tingling sensation); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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Aldactone important safety information

June 26th, 2009 No comments

* Aldactone may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Aldactone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

* Aldactone can raise your body’s potassium levels. This is more likely to occur in people with kidney problems or 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.

* Check with your doctor before you use a salt substitute or a product that has potassium in it.

* Lab tests, including kidney function, blood pressure, blood potassium, and chemistries, may be performed while you use Aldactone . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

* Use Aldactone with caution in the ELDERLY; they may be more sensitive to its effects.

* Aldactone should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

* PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aldactone while you are pregnant. Aldactone is found in breast milk. Do not breast-feed while taking Aldactone.

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How to use Aldactone

June 26th, 2009 No comments

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

* Take Aldactone by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

* Aldactone 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.

* If you miss a dose of Aldactone , 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.

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Before using Aldactone

June 26th, 2009 No comments

Some medical conditions may interact with Aldactone . 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 are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

* if you have allergies to medicines, foods, or other substances

* if you have high acidity in your body fluids; low blood sodium levels; high blood potassium levels; kidney, liver, or heart disease; diabetes; or high urea or nitrogen in your blood

* if you have menstrual disease

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

* Adrenocorticotropic hormone (corticotropin) (ACTH) or corticosteroids (eg, prednisone) or because low blood electrolyte levels may occur

* Barbiturates (eg, phenobarbital) or narcotics (eg, morphine) because dizziness upon standing may occur

* Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin II receptor antagonists (eg, valsartan), cyclosporine, macrolide immunosuppressives (eg, tacrolimus), other aldosterone-blockers (eg, eplerenone), other potassium sparing diuretics (eg, amiloride, triamterene), 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)

* Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, indomethacin) because they may decrease Aldactone ’s effectiveness and increase the risk of kidney problems and high blood potassium

* Digoxin, digitoxin, lithium, nondepolarizing muscle relaxants (eg, tubocurarine), or quinidine because the risk of their side effects and toxicity may be increased by Aldactone

* Pressor amines (eg, norepinephrine) because their effectiveness may be decreased by Aldactone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aldactone 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.

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Do NOT use Aldactone if

June 26th, 2009 No comments

* you are allergic to any ingredient in Aldactone

* you are unable to urinate, have severe kidney problems, or have high blood potassium levels

* 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.

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