Spironolactone/Hydrochlorothiazide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
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Black Box Warning
|
WARNING
See full prescribing information for complete Boxed Warning.
WARNING
Spironolactone, an ingredient of ALDACTAZIDE, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions). ALDACTAZIDE 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. |
Overview
Spironolactone/Hydrochlorothiazide is {{{aOrAn}}} Aldosterone antagonist that is FDA approved for the {{{indicationType}}} of Edematous conditions of congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, nephrotic syndrome, essential hypertension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include gynecomastia, diarrhea, nausea and vomiting, neurologic: Somnolence,reproductive: disorder of menstruation, impotence.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
<h4>Condition 1</h4>
- Dosing Information
- (Dosage)
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Spironolactone/Hydrochlorothiazide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Spironolactone/Hydrochlorothiazide Contraindications in the drug label.
Warnings
|
WARNING
See full prescribing information for complete Boxed Warning.
WARNING
Spironolactone, an ingredient of ALDACTAZIDE, has been shown to be a tumorigen in chronic toxicity studies in rats (see Precautions). ALDACTAZIDE 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. |
There is limited information regarding Spironolactone/Hydrochlorothiazide Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Spironolactone/Hydrochlorothiazide Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Spironolactone/Hydrochlorothiazide Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Spironolactone/Hydrochlorothiazide Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Spironolactone/Hydrochlorothiazide in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Spironolactone/Hydrochlorothiazide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Spironolactone/Hydrochlorothiazide during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Spironolactone/Hydrochlorothiazide in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Spironolactone/Hydrochlorothiazide in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Spironolactone/Hydrochlorothiazide in geriatric settings.
Gender
There is no FDA guidance on the use of Spironolactone/Hydrochlorothiazide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Spironolactone/Hydrochlorothiazide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Spironolactone/Hydrochlorothiazide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Spironolactone/Hydrochlorothiazide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Spironolactone/Hydrochlorothiazide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Spironolactone/Hydrochlorothiazide in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Spironolactone/Hydrochlorothiazide Administration in the drug label.
Monitoring
There is limited information regarding Spironolactone/Hydrochlorothiazide Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Spironolactone/Hydrochlorothiazide and IV administrations.
Overdosage
There is limited information regarding Spironolactone/Hydrochlorothiazide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Spironolactone/Hydrochlorothiazide Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Spironolactone/Hydrochlorothiazide Mechanism of Action in the drug label.
Structure
There is limited information regarding Spironolactone/Hydrochlorothiazide Structure in the drug label.
Pharmacodynamics
There is limited information regarding Spironolactone/Hydrochlorothiazide Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Spironolactone/Hydrochlorothiazide Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Spironolactone/Hydrochlorothiazide Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Spironolactone/Hydrochlorothiazide Clinical Studies in the drug label.
How Supplied
There is limited information regarding Spironolactone/Hydrochlorothiazide How Supplied in the drug label.
Storage
There is limited information regarding Spironolactone/Hydrochlorothiazide Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Spironolactone/Hydrochlorothiazide Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Spironolactone/Hydrochlorothiazide interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Spironolactone/Hydrochlorothiazide Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Spironolactone/Hydrochlorothiazide Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.