Chlorthalidone

Chlorthalidone
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: Gerald Chi

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Overview

Chlorthalidone is a thiazide-like diuretic that is FDA approved for the {{{indicationType}}} of hypertension and edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Common adverse reactions include dizziness, lightheadedness, and hyperuricemia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Therapy should be initiated with the lowest possible dose, then titrated according to individual patient response. A single dose given in the morning with food is recommended; divided doses are unnecessary.

Hypertension

• Dosing Information

• Initial dose: 15 mg PO qd.

• If the response is insufficient after a suitable trial, the dosage may be increased to 30 mg and then to a single daily dose of 45–50 mg.
• If additional control is required, the addition of a second antihypertensive drug is recommended.
• Increases in serum uric acid and decreases in serum potassium are dose-related over the 15–50 mg/day range and beyond.

Edema

• Dosing Information

• Initial dose: Adults, initially 30–60 mg PO qd or 60 mg PO qod.

• Some patients may require 90–120 mg at these intervals or up to 120 mg daily. Dosages above this level, however, do not usually produce a greater response.

• Maintenance dose: maintenance doses may often be lower than initial doses and should be adjusted according to the individual patient.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Chlorthalidone in adult patients.

Non–Guideline-Supported Use

Hypertension as in Stroke Prophylaxis

• Dosing Information

• 12.5–25 mg/day

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorthalidone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in children have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Chlorthalidone in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorthalidone in pediatric patients.

Contraindications

• Condition1

Warnings

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Chlorthalidone in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Chlorthalidone in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category B

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category C

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Chlorthalidone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Chlorthalidone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Chlorthalidone with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Chlorthalidone with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Chlorthalidone with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Chlorthalidone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Chlorthalidone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Chlorthalidone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Chlorthalidone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Chlorthalidone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Chlorthalidone in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Chlorthalidone in the drug label.

Condition1

Description

IV Compatibility

There is limited information regarding IV Compatibility of Chlorthalidone in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Chlorthalidone in the drug label.

Pharmacology

Mechanism of Action

There is limited information regarding Chlorthalidone Mechanism of Action in the drug label.

Structure

There is limited information regarding Structure of Chlorthalidone in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Chlorthalidone in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Chlorthalidone in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Chlorthalidone in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Chlorthalidone in the drug label.

Condition1

Description

How Supplied

• White, kidney-shaped, compressed tablets coded M/024 containing 15 mg of chlorthalidone in bottles of 100 (NDC 61570-024-01).

• Storage: Store below 30°C (86°F).

Storage

There is limited information regarding Chlorthalidone 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 Patient Counseling Information of Chlorthalidone in the drug label.

Precautions with Alcohol

Orthostatic hypotension may occur and may be aggravated by alcohol. Patients should be cautioned that taking alcohol can increase the chance of dizziness occurring.

Brand Names

Thalitone®

Look-Alike Drug Names

N/A

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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