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 PO qd

Left Ventricular Hypertrophy

• Dosing Information

• 100 mg PO qd

Ménière's Disease

• Dosing Information

• 50–200 mg PO qd

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

• Anuria
• Hypersensitivity to chlorthalidone or other sulfonamide-derived drugs

Warnings

• Thalitone® (chlorthalidone USP) should be used with caution in severe renal disease. In patients with renal disease, chlorthalidone or related drugs may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

• Chlorthalidone should be used with caution in patients with impaired hepatic function or progressive liver disease, because minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

• Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma.

• The possibility of exacerbation or activation of systemic lupus erythematosus has been reported with thiazide diuretics which are structurally related to chlorthalidone. However, systemic lupus erythematosus has not been reported following chlorthalidone administration.

Precautions

• General

• Hypokalemia and other electrolyte abnormalities, including hyponatremia and hypochloremic alkalosis, are common in patients receiving chlorthalidone. These abnormalities are dose-related but may occur even at the lowest marketed doses of chlorthalidone. Serum electrolytes should be determined before initiating therapy and at periodic intervals during therapy. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. All patients taking chlorthalidone should be observed for clinical signs of electrolyte imbalance, including dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, palpitations, and gastrointestinal disturbances, such as nausea and vomiting.
• Digitalis therapy may exaggerate metabolic effects of hypokalemia especially with reference to myocardial activity.
• Any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life-threatening. In cases of actual salt depletion, appropriate replacement is the therapy of choice.
• Thiazide-like diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.
• Calcium excretion is decreased by thiazide-like drugs. Pathological changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been observed in a few patients on thiazide therapy. The common complications of hyperparathyroidism such as renal lithiasis, bone resorption and peptic ulceration have not been seen.

• Uric acid

• Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone.

• Other

• Increases in serum glucose may occur and latent diabetes mellitus may become manifest during chlorthalidone therapy. Chlorthalidone and related drugs may decrease serum protein-bound iodine (PBI) levels without signs of thyroid disturbance.

• Laboratory Tests

• Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.
• All patients receiving chlorthalidone should be observed for clinical signs of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

• Whenever adverse reactions are moderate or severe, chlorthalidone dosage should be reduced or therapy withdrawn.

• The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency.

Central Nervous System

Dizziness, vertigo, paresthesias, headache, and xanthopsia

Cardiovascular

Orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates or narcotics.

Gastrointestinal

Anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), and pancreatitis

Hematologic Reactions

Leukopenia, agranulocytosis, thrombocytopenia, and aplastic anemia

Hypersensitivity

Purpura, photosensitivity, rash, urticaria, necrotizing angiitis (cutaneous vasculitis), and Lyell's syndrome (toxic epidermal necrolysis)

Miscellaneous

Hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, and impotence

Drug Interactions

• Chlorthalidone may add to or potentiate the action of other antihypertensive drugs.
• Insulin requirements in diabetic patients may be increased, decreased or unchanged. Higher dosage of oral hypoglycemic agents may be required.
• Chlorthalidone and related drugs may increase the responsiveness to tubocurarine.
• Chlorthalidone and related drugs may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.
• Lithium renal clearance is reduced by chlorthalidone, increasing the risk of lithium toxicity.

Drug/Laboratory Test Interactions

• Chlorthalidone and related drugs may decrease serum PBI levels without signs of thyroid disturbance.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category B

• Pregnancy/Teratogenic Effects

• Reproduction studies have been performed in the rat and the rabbit at doses up to 420 times the human dose and have revealed no evidence of harm to the fetus due to chlorthalidone. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

• Pregnancy/Non-Teratogenic Effects

• Thiazides cross the placental barrier and appear in cord blood. The use of chlorthalidone and related drugs in pregnant women requires that the anticipated benefits of the drug be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in the adult.

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

• Thiazides are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from chlorthalidone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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

• Patients should inform their doctor if they have:

• Allergic reaction to chlorthalidone or other diuretics or have asthma
• Kidney disease
• Liver disease
• Gout
• Systemic lupus erythematosus
• Taking other drugs such as cortisone, digitalis, lithium carbonate, or drugs for diabetes

• Patients should be cautioned to contact their physician if they experience any of the following symptoms of potassium loss: excess thirst, tiredness, drowsiness, restlessness, muscle pains or cramps, nausea, vomiting or increased heart rate or pulse.

• Patients should also be cautioned that taking alcohol can increase the chance of dizziness occurring.

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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