Amiloride

Amiloride
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: Gerald Chi

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Black Box Warning

See full prescribing information for complete Boxed Warning. * Like other potassium-conserving agents, amiloride may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) which, if uncorrected, is potentially fatal. Hyperkalemia occurs commonly (about 10%) when amiloride is used without a kaliuretic diuretic. This incidence is greater in patients with renal impairment, diabetes mellitus (with or without recognized renal insufficiency), and in the elderly. When amiloride is used concomitantly with a thiazide diuretic in patients without these complications, the risk of hyperkalemia is reduced to about 1-2 percent. It is thus essential to monitor serum potassium levels carefully in any patient receiving amiloride, particularly when it is first introduced, at the time of diuretic dosage adjustments, and during any illness that could affect renal function.

Overview

Amiloride is a potassium-sparing diuretic that is FDA approved for the {{{indicationType}}} of congestive heart failure or hypertension adjunctive with thiazide diuretics or other kaliuretic-diuretic agents. There is a Black Box Warning for this drug as shown here. Common adverse reactions include rash, diarrhea, loss of appetite, nausea, vomiting, asthenia, cramp, dizziness, headache, cough, and dyspnea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Congestive Heart Failure or Hypertension

• Dosing Information

• 5 mg tablet daily, should be added to the usual antihypertensive or diuretic dosage of a kaliuretic diuretic.

• The dosage may be increased to 10 mg per day, if necessary.
• More than two 5 mg tablets of amiloride daily usually are not needed, and there is little controlled experience with such doses.
• If persistent hypokalemia is documented with 10 mg, the dose can be increased to 15 mg, then 20 mg, with careful monitoring of electrolytes.

• In treating patients with congestive heart failure after an initial diuresis has been achieved, potassium loss may also decrease and the need for amiloride should be re-evaluated.

• Dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.

• If it is necessary to use amiloride alone, the starting dosage should be one 5 mg tablet daily. This dosage may be increased to 10 mg per day, if necessary.

• More than two 5 mg tablets usually are not needed, and there is little controlled experience with such doses. If persistent hypokalemia is documented with 10 mg, the dose can be increased to 15 mg, then 20 mg, with careful monitoring of electrolytes.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Edema, Associated with Thiazolidinedione Use

• Dosing Information

• 10 mg once daily

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness 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 Amiloride in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Contraindications

• Condition1

Warnings

See full prescribing information for complete Boxed Warning. * Like other potassium-conserving agents, amiloride may cause hyperkalemia (serum potassium levels greater than 5.5 mEq per liter) which, if uncorrected, is potentially fatal. Hyperkalemia occurs commonly (about 10%) when amiloride is used without a kaliuretic diuretic. This incidence is greater in patients with renal impairment, diabetes mellitus (with or without recognized renal insufficiency), and in the elderly. When amiloride is used concomitantly with a thiazide diuretic in patients without these complications, the risk of hyperkalemia is reduced to about 1-2 percent. It is thus essential to monitor serum potassium levels carefully in any patient receiving amiloride, particularly when it is first introduced, at the time of diuretic dosage adjustments, and during any illness that could affect renal function.

Description

Adverse Reactions

Clinical Trials Experience

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

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Postmarketing Experience

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

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

Condition1

Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

Condition1

Description

How Supplied

There is limited information regarding Amiloride How Supplied in the drug label.

Storage

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

Precautions with Alcohol

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

Brand Names

Midamor®

Look-Alike Drug Names

• aMILoride — amLODIPine

Drug Shortage Status

Price

References

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