Spironazide

Spironolactone (Spironazide), an ingredient of Spironazide, has been shown to be a tumorigen in chronic toxicity studies in rats. Spironazide should be used only in those conditions described below. Unnecessary use of this drug should be avoided.

Spironazide is indicated for:

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;
• 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.

Cirrhosis Of The Liver Accompanied By Edema And/Or Ascites

• Aldosterone levels may be exceptionally high in this condition. Spironazide 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

• 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;
• Spironazide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Spironazide.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

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. Spironazide is indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy (however, see PRECAUTIONS: 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 that is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

Spironazide combination is used to treat high blood pressure (hypertension). It may also be used to treat water retention (edema) in patients with congestive heart failure, liver cirrhosis, or a kidney disorder called nephrotic syndrome.

Spironolactone (Spironazide) helps prevent your body from absorbing too much salt and keeps your potassium levels from getting too low. It can be used to prevent or treat hypokalemia (low potassium levels in the blood).

Spironazide are both diuretic medicines (water pills). They reduce the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

Spironazide is available only with your doctor's prescription.

Optimal dosage should be established by individual titration of the components.

Edema In Adults (Congestive Heart Failure, Hepatic Cirrhosis, Or Nephrotic Syndrome)

The usual maintenance dose of Spironazide is 100 mg each of Spironazide 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 ALDACTONE (Spironolactone (Spironazide)) or Hydrochlorothiazide (Spironazide) in addition to Spironazide in order to provide optimal individual therapy.

The onset of diuresis with Spironazide occurs promptly and, due to prolonged effect of the Spironolactone (Spironazide) component, persists for two to three days after Spironazide is discontinued.

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 Spironazide daily, given in a single dose or in divided doses.

Concurrent potassium supplementation is not recommended when Spironazide is used in the long-term management of hypertension or in the treatment of most edematous conditions, since the Spironolactone (Spironazide) content of Spironazide is usually sufficient to minimize loss induced by the Hydrochlorothiazide (Spironazide) component.

How supplied

Spironazide tablets containing 25 mg of Spironolactone (Spironazide) (ALDACTONE) and 25 mg of Hydrochlorothiazide (Spironazide) are round, tan, film coated, with SEARLE and 1011 debossed on one side and Spironazide and 25 on the other side, supplied as:

Spironazide tablets containing 50 mg of Spironolactone (Spironazide) (ALDACTONE) and 50 mg of Hydrochlorothiazide (Spironazide) are oblong, tan, scored, film coated, with SEARLE and 1021 debossed on the scored side and Spironazide and 50 on the other side, supplied as:

Distributed by: G.D. Searle Division of Pfizer Inc, NY, NY 10017. Revised January 2014

See also:
What is the most important information I should know about Spironazide?

Spironazide tablets are contraindicated in patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, hypercalcemia, hyperkalemia, Addison’s disease, and in patients who are allergic to thiazide diuretics or to other sulfonamide-derived drugs. Spironazide may also be contraindicated in acute or severe hepatic failure.

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

• Take Spironazide by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Spironazide 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 take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Spironazide.
• If you miss a dose of Spironazide, 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.

Ask your health care provider any questions you may have about how to use Spironazide.

Use: Labeled Indications

Edema: Treatment of edema in congestive heart failure (CHF), and nephrotic syndrome, and cirrhosis of the liver accompanied by edema and/or ascites.

Hypertension: Management of mild to moderate hypertension.

See also:
What other drugs will affect Spironazide?

ACE inhibitors Angiotensin II receptor antagonists, aldosterone blockers, potassium supplements, heparin, low molecular weight heparin, and other drugs known to cause hyperkalemia:Concomitant administration may lead to severe hyperkalemia.

Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.

Antidiabetic drugs (e.g., oral agents, insulin): Dosage adjustment of the antidiabetic drug may be required.

Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, may occur.

Pressor amines (e.g., norepinephrine): Both Spironazide reduce the vascular responsiveness to norepinephrine. Therefore, caution should be exercised in the management of patients subjected to regional or general anesthesia while they are being treated with Spironazide.

Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine): Possible increased responsiveness to the muscle relaxant may result.

Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.

Nonsteroidal anti-inflammatory drugs (NSAIDs): In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing, and thiazide diuretics. Combination of NSAIDs, e.g., indomethacin, with potassium-sparing diuretics has been associated with severe hyperkalemia. Therefore, when Spironazide and NSAIDs are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

Digoxin: Spironolactone (Spironazide) has been shown to increase the half-life of digoxin. This may result in increased serum digoxin levels and subsequent digitalis toxicity. Monitor serum digoxin levels and adjust dose accordingly. Thiazide-induced electrolyte disturbances, i.e. hypokalemia, hypomagnesemia, increase the risk of digoxin toxicity, which may lead to fatal arrhythmic events.

Cholestyramine: Hyperkalemic metabolic acidosis has been reported in patients given Spironolactone (Spironazide) concurrently with cholestyramine.

Drug/Laboratory Test Interactions

Thiazides should be discontinued before carrying out tests for parathyroid function. Thiazides may also decrease serum PBI levels without evidence of alteration of thyroid function.

Several reports of possible interference with digoxin radioimmunoassays by Spironolactone (Spironazide) or its metabolites have appeared in the literature. Neither the extent nor the potential clinical significance of its interference (which may be assay specific) has been fully established.

See also:
What are the possible side effects of Spironazide?

The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity.

Hydrochlorothiazide (Spironazide)

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.

Eye Disorders: acute myopia and acute angle-closure glaucoma.

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.

Spironolactone (Spironazide)

Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting.

Reproductive: Gynecomastia, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast pain. Carcinoma of the breast has been reported in patients taking Spironolactone (Spironazide) but a cause and effect relationship has not been established.

Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia.

Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis.

Metabolism:Hyperkalemia, electrolyte disturbances.

Musculoskeletal:Leg cramps.

Nervous System/Psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness.

Liver/Biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with Spironolactone (Spironazide) administration.

Renal: Renal dysfunction (including renal failure).

Skin: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritus.