Spironolactone And Hydrochlorothiazide

Generic Name: spironolactone and hydrochlorothiazide

Thiazide Diuretic [EPC]Over-the-Counter (OTC)

Brand Names:

Spironolactone And Hydrochlorothiazide

DESCRIPTION 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-7α-mercapto-3-oxo-17α - pregn-4-ene-21-carboxylic acid γ-lactone acetate and has the following structural formula, molecular formula and molecular weight: Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.

Overview

DESCRIPTION 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-7α-mercapto-3-oxo-17α - pregn-4-ene-21-carboxylic acid γ-lactone acetate and has the following structural formula, molecular formula and molecular weight: Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.

Uses

INDICATIONS AND USAGE Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, 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.

Dosage

DOSAGE AND ADMINISTRATION 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 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.

Side Effects

ADVERSE REACTIONS The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity. 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. Eye Disorders: Acute myopia and acute angle-closure glaucoma (see Warnings ). Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.

Interactions

Drug interactions 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 (see Precautions ). Corticosteroids, ACTH Intensified electrolyte depletion, particularly hypokalemia, may occur. Pressor amines (e.g., norepinephrine) Both spironolactone and hydrochlorothiazide reduce the vascular responsiveness to norepinephrine.

Warnings

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 ). CONTRAINDICATIONS Spironolactone and hydrochlorothiazide 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.

Pregnancy

Pregnancy Teratogenic effects Hydrochlorothiazide Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg hydrochlorothiazide/kg, respectively, provided no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Spironolactone Teratology studies with spironolactone have been carried out in mice and rabbits at doses of up to 20 mg/kg/day.

Storage

HOW SUPPLIED Spironolactone and Hydrochlorothiazide Tablets, USP are available containing 25 mg of spironolactone, USP and 25 mg of hydrochlorothiazide, USP. The 25 mg/25 mg tablets are ivory, round, unscored tablets debossed with M over 41 on one side of the tablet and blank on the other side.

Frequently Asked Questions

What is Spironolactone And Hydrochlorothiazide used for?

INDICATIONS AND USAGE Spironolactone, an ingredient of spironolactone and hydrochlorothiazide tablets, 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.

What are the side effects of Spironolactone And Hydrochlorothiazide?

ADVERSE REACTIONS The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity. 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. Eye Disorders: Acute myopia and acute angle-closure glaucoma (see Warnings ). Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.

Can I take Spironolactone And Hydrochlorothiazide during pregnancy?

Pregnancy Teratogenic effects Hydrochlorothiazide Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg hydrochlorothiazide/kg, respectively, provided no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Spironolactone Teratology studies with spironolactone have been carried out in mice and rabbits at doses of up to 20 mg/kg/day.

What are the important warnings for Spironolactone And Hydrochlorothiazide?

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 ). CONTRAINDICATIONS Spironolactone and hydrochlorothiazide 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.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.