Metolazone

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Metolazone
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

Disclaimer

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Black Box Warning

DO NOT INTERCHANGE:
See full prescribing information for complete Boxed Warning.
* Do not interchange Zaroxolyn tablets and other formulations of metolazone that share its slow and incomplete bioavailability and are not therapeutically equivalent at the same doses to Mykrox® tablets, a more rapidly available and completely bioavailable metolazone product. Formulations bioequivalent to Zaroxolyn and formulations bioequivalent to Mykrox should not be interchanged for one another.

Overview

Metolazone is a thiazide-like diuretic that is FDA approved for the {{{indicationType}}} of edema associated with congestive heart failure or renal disease. Metolazone is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive agents. There is a Black Box Warning for this drug as shown here. Common adverse reactions include orthostatic hypotension, electrolyte disturbances, hyperuricemia, dizziness, and fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Edema
  • Dosing Information
  • Dosage
Hypertension
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Metolazone in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

DO NOT INTERCHANGE:
See full prescribing information for complete Boxed Warning.
* Do not interchange Zaroxolyn tablets and other formulations of metolazone that share its slow and incomplete bioavailability and are not therapeutically equivalent at the same doses to Mykrox® tablets, a more rapidly available and completely bioavailable metolazone product. Formulations bioequivalent to Zaroxolyn and formulations bioequivalent to Mykrox should not be interchanged for one another.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

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

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Metolazone 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


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

Condition1
  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

Template:Px
Metolazone
Systematic (IUPAC) name
7-chloro-2-methyl-3-(2-methylphenyl)- 4-oxo-1,2-dihydroquinazoline-6-sulfonamide
Identifiers
CAS number 17560-51-9
ATC code C03BA08
PubChem 4170
DrugBank APRD01109
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 365.835 g/mol
Pharmacokinetic data
Bioavailability ~65%
Metabolism minimal
Half life 14 hours
Excretion primarily urine
Therapeutic considerations
Pregnancy cat.

B

Legal status

Prescription only

Routes Oral

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

Condition1
  • Description

How Supplied

Storage

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

Precautions with Alcohol

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

Brand Names

  • Mykrox®
  • Zaroxolyn®[1]

Look-Alike Drug Names

  • metolazone — methimazole[2]
  • metolazone — metoclopramide[2]

Drug Shortage Status

Price

References

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

  1. ↑ "ZAROXOLYN (metolazone) tablet".
  2. ↑ 2.0 2.1 "http://www.ismp.org". External link in |title= (help)


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