Midodrine

Midodrine
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

WARNING See full prescribing information for complete Boxed Warning. * Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of midodrine hydrochloride tablets in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to carry out activities of daily living, have not been verified.

Overview

Midodrine is an alpha-adrenergic agonist that is FDA approved for the {{{indicationType}}} of symptomatic orthostatic hypotension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypertension, piloerection, pruritus, shivering, paresthesia, dysuria, urinary retention, and urinary frequency.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Symptomatic Orthostatic Hypotension

• Dosing Information

• The recommended dose of midodrine hydrochloride tablets is 10 mg, 3 times daily.
• Dosing should take place during the daytime hours when the patient needs to be upright, pursuing the activities of daily living. A suggested dosing schedule of approximately 4-hour intervals is as follows: shortly before or upon arising in the morning, midday and late afternoon (not later than 6 P.M.). Doses may be given in 3-hour intervals, if required, to control symptoms, but not more frequently.
• Single doses as high as 20 mg have been given to patients, but severe and persistent systolic supine hypertension occurs at a high rate (about 45%) at this dose. In order to reduce the potential for supine hypertension during sleep, midodrine hydrochloride tablets should not be given after the evening meal or less than 4 hours before bedtime. Total daily doses greater than 30 mg have been tolerated by some patients, but their safety and usefulness have not been studied systematically or established. Because of the risk of supine hypertension, midodrine hydrochloride tablets should be continued only in patients who appear to attain symptomatic improvement during initial treatment.
• The supine and standing blood pressure should be monitored regularly and the administration of midodrine hydrochloride tablets should be stopped if supine blood pressure increases excessively.
• Because desglymidodrine is excreted renally, dosing in patients with abnormal renal function should be cautious; although this has not been systematically studied, it is recommended that treatment of these patients be initiated using 2.5 mg doses.
• Blood levels of midodrine and desglymidodrine were similar when comparing levels in patients 65 or older vs. younger than 65 and when comparing males vs. females, suggesting dose modifications for these groups are not necessary.

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 Midodrine in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

• Dosing in children has not been adequately studied.

Contraindications

• Condition1

Warnings

WARNING See full prescribing information for complete Boxed Warning. * Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of midodrine hydrochloride tablets in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to carry out activities of daily living, have not been verified.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

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 Midodrine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

Condition1

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

1 : 1 mixture (racemate)Midodrine
Systematic (IUPAC) name
(RS)- N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]glycinamide
Identifiers
CAS number	133163-28-7
ATC code	C01CA17
PubChem	4195
DrugBank	DB00211
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	254.282 g/mol
SMILES	eMolecules & PubChem
Synonyms	2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxy-ethyl]-acetamide
Pharmacokinetic data
Bioavailability	?
Metabolism	?
Half life	?
Excretion	?
Therapeutic considerations
Pregnancy cat.	?
Legal status
Routes	?

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

• Midodrine Hydrochloride Tablets, for oral administration, are available as:

• 2.5 mg: White, round, flat-faced, bevelled edge, debossed “E“ over “40” on one side and bisected on the other side and supplied as:

NDC 0185-0040-01 bottles of 100

NDC 0185-0040-05 bottles of 500

• 5 mg: Reddish-orange, round, flat-faced, bevelled edge, debossed “E“ over “43” on one side and bisected on the other side and supplied as:

NDC 0185-0043-01 bottles of 100

NDC 0185-0043-05 bottles of 500

• 10 mg: Blue-grey, round, flat-faced, bevelled edge, debossed, “E“ over “149” on one side and bisected on the other side and supplied as:

NDC 0185-0149-01 bottles of 100

NDC 0185-0149-05 bottles of 500

• Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
• Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

Storage

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

Precautions with Alcohol

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

Brand Names

• Proamatine®
• Orvaten®

Look-Alike Drug Names

• midodrine — Midrin®

Drug Shortage Status

Price

References

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

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