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Spironolactone and Hydrochlorothiazide (Tablet)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1563

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Spironolactone and Hydrochlorothiazide (Tablet)
dailymed-instance:dosage
Optimal dosage should be established by individual titration of the components .<br/>Edema in Adults (Congestive Heart Failure, Hepatic Cirrhosis, or Nephrotic Syndrome): The usual maintenance dose of spironolactone and hydrochlorothiazide tablets is 100 mg each of spironolactone and hydrochlorothiazide daily, administered in a single dose or in divided doses, but may range from 25 mg to 200 mg of each component daily depending on the response to the initial titration. In some instances it may be desirable to administer separate tablets of either spironolactone or hydrochlorothiazide in addition to spironolactone and hydrochlorothiazide tablets in order to provide optimal individual therapy. The onset of diuresis with spironolactone and hydrochlorothiazide occurs promptly and, due to prolonged effect of the spironolactone component, persists for two to three days after spironolactone and hydrochlorothiazide is discontinued.<br/>Essential Hypertension: Although the dosage will vary depending on the results of titration of the individual ingredients, many patients will be found to have an optimal response to 50 mg to 100 mg each of spironolactone and hydrochlorothiazide daily, given in a single dose or in divided doses. Concurrent potassium supplementation is not recommended when spironolactone and hydrochlorothiazide is used in the long-term management of hypertension or in the treatment of most edematous conditions, since the spironolactone content of spironolactone and hydrochlorothiazide tablets is usually sufficient to minimize loss induced by the hydrochlorothiazide component.
dailymed-instance:descripti...
Each tablet of spironolactone and hydrochlorothiazide contains 25 mg of spironolactone, USP and 25 mg of hydrochlorothiazide, USP. Spironolactone, an aldosterone antagonist, is 17-hydroxy-7��-mercapto-3-oxo-17��-pregn-4-ene-21-carboxylic acid��-lactone acetate and 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. Hydrochlorothiazide, a diuretic and antihypertensive, is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula, molecular formula, and molecular weight: CHClNOSM.W. = 297.75 Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 25 mg of spironolactone and 25 mg of hydrochlorothiazide and the following inactive ingredients: colloidal silicon dioxide, D&C yellow #10 aluminum lake HT, FD&C yellow #6 aluminum lake HT, lactose, magnesium stearate, microcrystalline cellulose, menthol, peppermint oil, sodium lauryl sulfate, sodium starch glycolate and starch.
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Spironolactone and hydrochlorothiazide tablets are contraindicated in patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, or hyperkalemia, and in patients who are allergic to thiazide diuretics or to other sulfonamide-derived drugs. Spironolactone and hydrochlorothiazide may also be contraindicated in acute or severe hepatic failure.
dailymed-instance:supply
Spironolactone and Hydrochlorothiazide Tablets are available containing 25 mg of spironolactone, USP and 25 mg of hydrochlorothiazide, USP. The tablets are ivory, round, biconvex tablets debossed with M above the score and 41 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0141-01bottles of 100 tablets NDC 0378-0141-05bottles of 500 tablets Store at 20��to 25��C (68��to 77��F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
dailymed-instance:boxedWarn...
WARNING: Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats . Spironolactone and hydrochlorothiazide should be used only in those conditions described under INDICATIONS AND USAGE. Unnecessary use of this drug should be avoided. Fixed-dose combination drugs are not indicated for initial therapy of edema or hypertension. Edema or hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension and edema is not static but must be reevaluated as conditions in each patient warrant.
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dailymed-instance:overdosag...
The oral LDof spironolactone is greater than 1,000 mg/kg in mice, rats, and rabbits. The oral LDof hydrochlorothiazide is greater than 10 g/kg in both mice and rats. 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 (less commonly seen with spironolactone and hydrochlorothiazide because the hydrochlorothiazide component tends to produce hypokalemia), or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. However, because this product contains both spironolactone and hydrochlorothiazide, the toxic effects may be intensified, and signs of thiazide overdosage may be present. These include electrolyte imbalance such as hypokalemia and/or hyponatremia. The potassium-sparing action of spironolactone may predominate and hyperkalemia may occur, especially in patients with impaired renal function. BUN determinations have been reported to rise transiently with hydrochlorothiazide. There may be CNS depression with lethargy or even coma.<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 and hydrochlorothiazide 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 repeated as required. Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered. Persistent hyperkalemia may require dialysis.
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Spironolactone and Hydrochlorothiazide
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Spironolactone and Hydrochlorothiazide (Tablet)
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The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.<br/>Hydrochlorothiazide: Body as a whole: Weakness. Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialoadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity: Anaphylactic reactions, necrotizing angitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura. Metabolic: Electrolyte imbalance , hyperglycemia, glycosuria, hyperuricemia. Musculoskeletal: Muscle spasm. Nervous System/Psychiatric: Vertigo, paresthesias, dizziness, headache, restlessness. Renal: Renal failure, renal dysfunction, interstitial nephritis . Skin: Erythema multiforme, pruritus. Special Senses: Transient blurred vision, xanthopsia.<br/>Spironolactone: 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).
dailymed-instance:indicatio...
Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats . Spironolactone and hydrochlorothiazide tablets should be used only in those conditions described below. Unnecessary use of this drug should be avoided. Spironolactone and Hydrochlorothiazide Tablets are Indicated for:<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. The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate. The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate.<br/>Cirrhosis of the Liver Accompanied by Edema and/or Ascites: Aldosterone levels may be exceptionally high in this condition. Spironolactone and hydrochlorothiazide 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: For patients with essential hypertension in whom other measures are considered inadequate or inappropriate. In hypertensive patients for the treatment of a diuretic-induced hypokalemia when other measures are considered inappropriate.<br/>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. Spironolactone and hydrochlorothiazide 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.
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Spironolactone and Hydrochlorothiazide