Spironolactone (Tablet, Film Coated)
Primary Hyperaldosteronism: Spironolactone tablets may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.<br/>Long Test: Spironolactone tablets are administered at a daily dosage of 400 mg for three to four weeks. Correction of hypokalemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.<br/>Short Test: Spironolactone tablets are administered at a daily dosage of 400 mg for four days. If serum potassium increases during spironolactone tablet administration but drops when spironolactone tablet is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered. After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone tablets may be administered in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone tablets may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.<br/>Edema in Adults (Congestive Heart Failure, Hepatic Cirrhosis or Nephrotic Syndrome): An initial daily dosage of 100 mg of spironolactone tablets 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, spironolactone tablets 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 administered in either single or divided daily doses. If, after five days, an adequate diuretic response to spironolactone tablets has not occurred, a second diuretic which acts more proximally in the renal tubule may be added to the regimen. Because of the additive effect of spironolactone tablets when administered concurrently with such diuretics, an enhanced diuresis usually begins on the first day of combined treatment; combined therapy is indicated when more rapid diuresis is desired. The dosage of spironolactone tablets should remain unchanged when other diuretic therapy is added.<br/>Essential Hypertension: For adults, an initial daily dosage of 50 to 100 mg of spironolactone tablets administered in either single or divided doses is recommended. Spironolactone tablets may also be given with diuretics which act more proximally in the renal tubule or with other antihypertensive agents. Treatment with spironolactone tablets should be continued for at least two weeks, since the maximum response may not occur before this time. Subsequently, dosage should be adjusted according to the response of the patient.<br/>Hypokalemia: Spironolactone tablets in a dosage ranging from 25 to 100 mg daily is useful in treating a diuretic-induced hypokalemia, when oral potassium supplements or other potassium-sparing regimens are considered inappropriate.
Spironolactone oral tablets contain 25 mg, 50 mg or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7��-mercapto-3-oxo-17��-pregn-4-ene-21-carboxylic acid��-lactone acetate, which has the following structural formula, molecular formula, and molecular weight: CHOSM.W.=416.59 Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Each tablet for oral administration contains 25 mg, 50 mg or 100 mg of spironolactone and the following inactive ingredients: calcium sulfate dihydrate, colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, peppermint flavor, polydextrose, polyethethylene glycol, povidone, pregelatinized (corn) starch, sodium lauryl sulfate, titanium dioxide and triacetin.
Spironolactone tablets are contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, or hyperkalemia.
Spironolactone Tablets are available containing 25 mg, 50 mg or 100 mg of spironolactone. The 25 mg tablet is a white, film-coated round, unscored, biconvex, beveled edge tablet debossed with M over 146 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-2146-01bottles of 100 tablets NDC 0378-2146-05bottles of 500 tablets The 50 mg tablet is a white, film-coated round, biconvex, beveled edge tablet debossed with M over 243 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0243-01bottles of 100 tablets NDC 0378-0243-05bottles of 500 tablets The 100 mg tablet is a white, film-coated round, biconvex, beveled edge tablet debossed with M over 437 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-0437-01bottles of 100 tablets NDC 0378-0437-05bottles of 500 tablets STORE AT CONTROLLED ROOM TEMPERATURE 15��TO 30��C (59��TO 86��F). PROTECT FROM LIGHT. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
WARNING: Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats . Spironolactone should be used only in those conditions described under INDICATIONS AND USAGE. Unnecessary use of this drug should be avoided.
dailymed-ingredient:calcium_sulfate_dihydrate, dailymed-ingredient:colloidal_silicon_dioxide, dailymed-ingredient:croscarmellose_sodium, dailymed-ingredient:crospovidone, dailymed-ingredient:hypromellose, dailymed-ingredient:lactose_monohydrate, dailymed-ingredient:magnesium_stearate, dailymed-ingredient:peppermint_flavor, dailymed-ingredient:polydextrose, dailymed-ingredient:polyethethylene_glycol, dailymed-ingredient:povidone, dailymed-ingredient:pregelatinized_(corn)_starch, dailymed-ingredient:sodium_lauryl_sulfate, dailymed-ingredient:titanium_dioxide, dailymed-ingredient:triacetin
The oral LDof spironolactone is greater than 1,000 mg/kg in mice, rats, and rabbits. Acute overdosage of spironolactone may be manifested by 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 withimpaired renal function.<br/>Treatment: Induce vomiting or evacuate the stomach by lavage. There is no specific antidote. Treatment is supportive to maintain hydration, electrolyte balance, and vital functions. Patients who have renal impairment may develop spironolactone-induced hyperkalemia. In such cases, spironolactone should be discontinued immediately. With severe hyperkalemia, the clinical situation dictates the procedures to be employed. These include the intravenous administration of calcium chloride solution, sodium bicarbonate solution and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation. These are temporary measures to be repeatedas required. Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered. Persistent hyperkalemia may require dialysis.
Spironolactone (Tablet, Film Coated)
The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity. Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting. Endocrine: Gynecomastia , inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding. Carcinoma of the breast has been reported in patients taking spironolactone but a cause and effect relationship has not been established. Hematologic: Agranulocytosis. Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis. Nervous System/Psychiatric: Mental confusion, ataxia, headache, drowsiness, lethargy. Liver/Biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration. Renal: Renal dysfunction (including renal failure).
Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with spironolactone therapy. Excessive potassium intake may cause hyperkalemia in patients receiving spironolactone . Spironolactone should not be administered concurrently with other potassium-sparing diuretics. Spironolactone, when used with ACE inhibitors or indomethacin, even in the presence of a diuretic, has been associated with severe hyperkalemia. Extreme caution should be exercised when spironolactone is given concomitantly with these drugs. Spironolactone should be used with caution in patients with impaired hepatic function because minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Lithium generally should not be given with diuretics .
Spironolactone tablets are indicated in the management of:<br/>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).<br/>Edematous Conditions for Patients with::<br/>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. Spironolactone tablets are also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate.<br/>Cirrhosis of the Liver Accompanied by Edema and/or Ascites: Aldosterone levels may be exceptionally high in this condition. Spironolactone tablets are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium.<br/>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.<br/>Essential Hypertension: Usually in combination with other drugs, spironolactone tablets are indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate.<br/>Hypokalemia: For the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate. Spironolactone tablets are also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.<br/>Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes the 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. Spironolactone tablets are 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.