Spironolactone and hydrochlorothiazide (patient information)

Spironolactone and hydrochlorothiazide (patient information)
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: Kiran Singh, M.D. [2]

Disclaimer

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Spironolactone and hydrochlorothiazide (patient information) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Spironolactone and hydrochlorothiazide (patient information) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Spironolactone and hydrochlorothiazide (patient information) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Spironolactone and hydrochlorothiazide (patient information) in pediatric patients.

Contraindications

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Contraindications in the drug label.

Warnings

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Spironolactone and hydrochlorothiazide (patient information) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Spironolactone and hydrochlorothiazide (patient information) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Spironolactone and hydrochlorothiazide (patient information) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Spironolactone and hydrochlorothiazide (patient information) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Spironolactone and hydrochlorothiazide (patient information) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Spironolactone and hydrochlorothiazide (patient information) in geriatric settings.

Gender

There is no FDA guidance on the use of Spironolactone and hydrochlorothiazide (patient information) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Spironolactone and hydrochlorothiazide (patient information) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Spironolactone and hydrochlorothiazide (patient information) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Spironolactone and hydrochlorothiazide (patient information) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Spironolactone and hydrochlorothiazide (patient information) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Spironolactone and hydrochlorothiazide (patient information) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Administration in the drug label.

Monitoring

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Spironolactone and hydrochlorothiazide (patient information) and IV administrations.

Overdosage

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) 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 and hydrochlorothiazide (patient information) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Mechanism of Action in the drug label.

Structure

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) How Supplied in the drug label.

Storage

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) 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 and hydrochlorothiazide (patient information) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Spironolactone and hydrochlorothiazide (patient information) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Spironolactone and hydrochlorothiazide (patient information) 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.

IMPORTANT WARNING:

Spironolactone has caused tumors in laboratory animals. Talk to your doctor about the risks and benefits of using this medicine for your condition.

Why is this medication prescribed

The combination of spironolactone and hydrochlorothiazide, a 'water pill,' is used to treat high blood pressure and fluid retention caused by various conditions, including heart disease. It causes the kidneys to eliminate unneeded water and salt from the body into the urine.

This medicine is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used

The combination of spironolactone and hydrochlorothiazide comes as a tablet to take by mouth. It usually is taken once a day in the morning with food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take spironolactone and hydrochlorothiazide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

This medication controls high blood pressure but does not cure it. Continue to take spironolactone and hydrochlorothiazide even if you feel well. Do not stop taking spironolactone and hydrochlorothiazide without talking to your doctor.

What special precautions should I follow

Before taking spironolactone and hydrochlorothiazide:

• tell your doctor and pharmacist if you are allergic to spironolactone, hydrochlorothiazide, sulfa drugs, or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially aspirin; captopril (Capoten); digoxin (Lanoxin); enalapril (Vasotec); lisinopril (Prinivil, Zestril); lithium (Eskalith, Lithobid); medications for arthritis, diabetes, or high blood pressure; potassium supplements; and vitamins. Do not take this medicine if you are taking amiloride or triamterene.
• tell your doctor if you have or have ever had diabetes, gout, or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking spironolactone and hydrochlorothiazide, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking spironolactone and hydrochlorothiazide.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• remember that alcohol can add to the drowsiness caused by this drug.

What special dietary instructions should I follow

Follow your doctor's directions for a low-salt or low-sodium diet and daily exercise program. Avoid potassium-containing salt substitutes. Limit your intake of potassium-rich foods (e.g., bananas, prunes, raisins, and orange juice). Ask your doctor for advice on how much of these foods you may have.

What should I do if I forget a dose? Return to top Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Mild side effects

Spironolactone and hydrochlorothiazide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• upset stomach
• vomiting
• diarrhea
• loss of appetite
• stomach pain
• gas
• frequent urination
• dizziness
• headache
• enlarged or painful breasts
• irregular menstrual periods
• drowsiness

Severe side effects

If you experience any of the following symptoms, call your doctor immediately:

• muscle weakness or cramps
• rapid, excessive weight loss
• fatigue
• slow or irregular heartbeat
• sore throat
• unusual bruising or bleeding
• yellowing of the skin or eyes
• skin rash
• vomiting blood
• fever
• confusion

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medicine in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medicine that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medicine.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly, and blood tests should be done occasionally.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Aldactazide®
• Spironazide®
• Spirozide®