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Home > Medical Reference > Encyclopedia (English)



 

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U.S. Brand Names:

Aldactazide®

Synonyms:

Spironolactone and Hydrochlorothiazide

Generic Available:

Yes

Canadian Brand Names:

Aldactazide 25®; Aldactazide 50®; Novo-Spirozine

Use:

Management of mild to moderate hypertension; treatment of edema in congestive heart failure and nephrotic syndrome, and cirrhosis of the liver accompanied by edema and/or ascites

Pregnancy Risk Factor:

C

Pregnancy Implications:

See individual agents.

Lactation:

Enters breast milk/use caution

Contraindications:

Hypersensitivity to spironolactone, hydrochlorothiazide or any component of the formulation, thiazides, or sulfonamide-derived drugs; anuria; renal decompensation; hyperkalemia

Warnings/Precautions:

Based on hydrochlorothiazide component: Avoid in severe renal disease (ineffective). Electrolyte disturbances (hypokalemia, hypochloremic alkalosis, hyponatremia) can occur. Use with caution in severe hepatic dysfunction; hepatic encephalopathy can be caused by electrolyte disturbances. Gout can be precipitate in certain patients with a history of gout, a familial predisposition to gout, or chronic renal failure. Cautious use in diabetics; may see a change in glucose control. Hypersensitivity reactions can occur. Can cause SLE exacerbation or activation. Use with caution in patients with moderate or high cholesterol concentrations. Photosensitization may occur. Correct hypokalemia before initiating therapy.

Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated in product labeling, however, a risk of cross-reaction exists in patients with allergy to any of these compounds; avoid use when previous reaction has been severe.

Based on spironolactone component: Avoid potassium supplements, potassium-containing salt substitutes, a diet rich in potassium, or other drugs that can cause hyperkalemia. Monitor for fluid and electrolyte imbalances. Gynecomastia is related to dose and duration of therapy. Diuretic therapy should be carefully used in severe hepatic dysfunction; electrolyte and fluid shifts can cause or exacerbate encephalopathy.

Adverse Reactions:

See individual agents.

Drug Interactions:

See individual agents.

Ethanol/Nutrition/Herb Interactions:

Food: Avoid food with high potassium content and potassium-containing salt substitutes.

Herb/Nutraceutical: Avoid natural licorice (causes sodium and water retention and increases potassium loss).

Pharmacodynamics/Kinetics:

See individual agents.

Dosage:

Oral:

Children: 1.66-3.3 mg/kg/day (of spironolactone) in 2-4 divided doses

Adults:

Hydrochlorothiazide 25 mg and spironolactone 25 mg: 1/2-8 tablets daily

Hydrochlorothiazide 50 mg and spironolactone 50 mg: 1/2-4 tablets daily in 1-2 doses

Patient Education:

See individual agents. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Nursing Implications:

May interfere with digoxin serum assays; monitor blood pressure, serum electrolytes, renal function

Cardiovascular Considerations:

Combination therapy for the treatment of hypertension should be individualized for each patient. Potential advantages for hydrochlorothiazide and spironolactone combination therapy may include improved compliance and synergistic reductions in blood pressure with an accompanied reduction in side effects (eg, hypokalemia). Thiazide and spironolactone also are effective in the management of heart failure. See Special Cardiovascular Considerations for individual agents.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause lethargy or anorexia

Mental Health: Effects on Psychiatric Treatment:

May decrease lithium clearance resulting in an increase in serum lithium levels and potential lithium toxicity; monitor serum lithium levels

Dosage Forms:

Tablet: Hydrochlorothiazide 25 mg and spironolactone 25 mg

Aldactazide®:

25/25: Hydrochlorothiazide 25 mg and spironolactone 25 mg

50/50: Hydrochlorothiazide 50 mg and spironolactone 50 mg

International Brand Names:

Aldactazide 25® (CA); Aldactazide 50® (CA); Novo-Spirozine (CA)

References

Chobanian AV, Bakris GL, Black HR, et al, "The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: The JNC 7 Report,"JAMA, 2003, 289(19):2560-71.

"Consensus Recommendations for the Management of Chronic Heart Failure. On Behalf of the Membership of the Advisory Council to Improve Outcomes Nationwide in Heart Failure,"Am J Cardiol, 1999, 83(2A):1A-38A.

Kaplan NM and Sever PS, "Combination Therapy: A Key to Comprehensive Patient Care,"Am J Hypertens, 1997, 10(7 Pt 2):127S.

Moser M and Black HR, "The Role of Combination Therapy in the Treatment of Hypertension,"Am J Hypertens, 1998, 11(6 Pt 2):73S-8S, 95S-100S.

Pitt B, Zannad F, Remme WJ, et al, "The Effect of Spironolactone on Morbidity and Mortality in Patients With Severe Heart Failure. Randomized Aldactone Evaluation Study Investigators,"N Engl J Med, 1999, 341(10):709-17.

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