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Basic Drug Info
Drug Name:Spironolactone and Hydrochlorothiazide
Manufacturer:Mylan Pharmaceuticals Inc.
Other Info:Mylan Pharmaceuticals Inc.Morgantown, WV 26505REV JANUARY 2005SPHZ:R16



Clinical Trials:


Indications and Usage

Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONS section).

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:
Tumorigenicity -- A measurement of the tumor-producing/cancer cell-producing potency of an agent. The carcinogenicity value is usually expressed as milligrams of agent administered per tumor developed.

Contraindications

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.
Anuria -- Absence of urine formation. It is usually associated with complete bilateral ureteral (URETER) obstruction, complete lower urinary tract obstruction, or unilateral ureteral obstruction when a solitary kidney is present.

Acute Kidney Insufficiency -- Conditions in which the function of KIDNEYS deteriorates suddenly in a matter of days or even hours. It is characterized by the sudden drop in GLOMERULAR FILTRATION RATE; (GMR). The most severe stage is when the GFR drops below 15 ml per min (ACUTE KIDNEY FAILURE).

Liver Failure -- Severe inability of the LIVER to perform its normal metabolic functions, as evidenced by severe JAUNDICE and abnormal serum levels of AMMONIA; BILIRUBIN; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; LACTIC DEHYDROGENASE; and albumin/globulin ratio. (Blakiston's Gould Medical Dictionary, 4th ed)

Warnings

Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with spironolactone and hydrochlorothiazide therapy.

Excessive potassium intake may cause hyperkalemia in patients receiving spironolactone and hydrochlorothiazide (see PRECAUTIONS: General).

Spironolactone and hydrochlorothiazide 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 and hydrochlorothiazide is given concomitantly with these drugs (see PRECAUTIONS: Drug Interaction).Spironolactone and hydrochlorothiazide 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 (see PRECAUTIONS: Drug Interactions).Thiazides should be used with caution in severe renal disease.

In patients with renal disease, thiazides may precipitate azotemia.

Cumulative effects of the drug may develop in patients with impaired renal function.Thiazides may add to or potentiate the action of other antihypertensive drugs.Sensitivity reactions to thiazides may occur in patients with or without a history of allergy or bronchial asthma.Sulfonamide derivatives, including thiazides, have been reported to exacerbate or activate systemic lupus erythematosus.

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