Indapamide

Indapamide
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

Indapamide is a thiazide-like diuretic that is FDA approved for the {{{indicationType}}} of hypertension and salt and fluid retention associated with congestive heart failure. Common adverse reactions include hypokalemia, cramp, asthenia, dizziness, headache, lethargy, numbness, fatigue, and malaise.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertension

• Dosing Information

• The adult starting indapamide dose for hypertension is 1.25 mg as a single daily dose taken in the morning.
• If the response to 1.25 mg is not satisfactory after four weeks, the daily dose may be increased to 2.5 mg taken once daily.
• If the response to 2.5 mg is not satisfactory after four weeks, the daily dose may be increased to 5 mg taken once daily, but adding another antihypertensive should be considered.

Edema Of Congestive Heart Failure

• Dosing Information

• The adult starting indapamide dose for edema of congestive heart failure is 2.5 mg as a single daily dose taken in the morning.
• If the response to 2.5 mg is not satisfactory after one week, the daily dose may be increased to 5 mg taken once daily.
• If the antihypertensive response to indapamide is insufficient, indapamide may be combined with other antihypertensive drugs, with careful monitoring of blood pressure. It is recommended that the usual dose of other agents be reduced by 50% during initial combination therapy. As the blood pressure response becomes evident, further dosage adjustments may be necessary.
• In general, doses of 5 mg and larger have not appeared to provide additional effects on blood pressure or heart failure, but are associated with a greater degree of hypokalemia. There is minimal clinical trial experience in patients with doses greater than 5 mg once a day.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Hypercalciuria

• Dosing Information

• 2.5 mg/d

Neurohypophyseal diabetes insipidus

• Dosing Information

• 2.5 mg/d

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Safety and effectiveness of indapamide in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

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

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Indapamide 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

• Usage in Pregnancy

• The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS). Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
• Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Indapamide is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see PRECAUTIONS). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

Condition1

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Indapamide Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

Condition1

• Description

How Supplied

Storage

There is limited information regarding Indapamide 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 Indapamide in the drug label.

Precautions with Alcohol

• Alcohol-Indapamide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Lozol®

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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