Spironolactone/Hydrochlorothiazide

Spironolactone/Hydrochlorothiazide
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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)

congestive heart failure, hepatic cirrhosis, or nephrotic syndrome

• Dosing Information (Optimal dosage should be established by individual titration of the components)

• 25-200 mg/day depending on the response to the initial titration
• usually maintaining dosage: 100 mg/day

Essential hypertension

• Dosing Information

• 50-100 mg/day (depending on the results of titration of the individual ingredients)

Off-Label Use and Dosage (Adult)

Non–Guideline-Supported Use

Acne vulgaris

• Dosing information

• 50-200 mg PO
• optimal dosage: 150-200 mg PO

Ascites of patients in cirrhosis of liver

• Dosing information

• 100-400 mg/day (300-600 mg/day satisfies 50%-90% patients)
• recommended initial dosage: 100-200 mg PO qd
• 225 mg/day

Proteinuria in Chronic renal failure

• Dosing information

• 25 mg/day

Proteinuria in diabetic nephropathy

• Dosing information

• 25 mg in addition to an ACE inhibitor or angiotensin II receptor antagonist

Hirsutism

• Dosing information

• spironolactone plus cyproterone/ethinyl estradiol or flutamide alone were both significantly effective for the treatment of women with moderate to severe hirsutism in a prospective, randomized, clinical trial

Idiopathic edema

• Dosing information

• spironolactone 50-200 mg every morning or hydrochlorothiazide 25 mg every morning

Myocardial infarction

• Dosing information

• 25 mg/day

Prophylaxis of osteopenia; - Polycystic ovary syndrome

• Dosing information

• 100 mg PO qd

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)

Non–Guideline-Supported Use

Primary aldosteronism

• Dosing information

• initial dosage: 400 mg/day with gradual reduction to 200 mg/day

Contraindications

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

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.

Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with ALDACTAZIDE therapy. Excessive potassium intake may cause hyperkalemia in patients receiving ALDACTAZIDE (see Precautions: General).

Concomitant administration of ALDACTAZIDE with the following drugs or potassium sources may lead to severe hyperkalemia:

• other potassium-sparing diuretics
• ACE inhibitors
• angiotensin II receptor antagonists
• aldosterone blockers
• non-steroidal anti-inflammatory drugs (NSAIDs), e.g., indomethacin
• heparin and low molecular weight heparin
• other drugs known to cause hyperkalemia
• potassium supplements
• diet rich in potassium
• salt substitutes containing potassium

ALDACTAZIDE 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 ALDACTAZIDE is given concomitantly with these drugs (see Precautions: Drug interactions).

ALDACTAZIDE 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. Acute Myopia and Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. PRECAUTIONS General Serum Electrolyte Abnormalities Spironolactone can cause hyperkalemia. The risk of hyperkalemia may be increased in patients with renal insufficiency, diabetes mellitus or with concomitant use of drugs that raise serum potassium (see Drug Interactions). Hydrochlorothiazide can cause hypokalemia and hyponatremia. The risk of hypokalemia may be increased in patients with cirrhosis, brisk diuresis, or with concomitant use of drugs that lower serum potassium. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Monitor serum electrolytes periodically. Other Metabolic Disturbances Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients. Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving ALDACTAZIDE. Gynecomastia Gynecomastia may develop in association with the use of spironolactone; physicians should be alert to its possible onset. The development of gynecomastia appears to be related to both dosage level and duration of therapy and is normally reversible when ALDACTAZIDE is discontinued. In rare instances, some breast enlargement may persist when ALDACTAZIDE is discontinued. Somnolence Somnolence and dizziness have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.

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.