Aldactone (spironolactone) is a specific pharmacologic antagonist of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule.
Aldactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Aldactone acts both as a diuretic and as an antihypertensive drug by this mechanism. It may be given alone or with other diuretic agents which act more proximally in the renal tubule.
Aldactone is effective in lowering the systolic and diastolic blood pressure in patients with primary hyperaldosteronism. It is also effective in most cases of essential hypertension, despite the fact that aldosterone secretion may be within normal limits in benign essential hypertension.
Through its action in antagonizing the effect of aldosterone, Aldactone inhibits the exchange of sodium for potassium in the distal renal tubule and helps to prevent potassium loss.
Aldactone has not been demonstrated to elevate serum uric acid, to precipitate gout, or to alter carbohydrate metabolism.
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.
Contraindications
Aldactone is contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, or hyperkalemia.
Important safety information:
* Aldactone may cause dizziness and drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Aldactone with caution.
* Aldactone 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.
* 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.
* 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.
Possible side effects of Aldactone:
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.
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.
If OVERDOSE is suspected:
Contact your local poison control center or emergency room immediately. Symptoms may include: lightheadedness; nausea; vomiting; weakness.
General information:
* 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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