Minoxidil (oral)

Minoxidil (oral)
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

WARNINGS See full prescribing information for complete Boxed Warning. * Minoxidil tablets contain the powerful antihypertensive agent, minoxidil, which may produce serious adverse effects. It can cause pericardial effusion, occasionally progressing to tamponade, and angina pectoris may be exacerbated. Minoxidil should be reserved for hypertensive patients who do not respond adequately to maximum therapeutic doses of a diuretic and two other antihypertensive agents. In experimental animals, minoxidil caused several kinds of myocardial lesions as well as other adverse cardiac effects. Minoxidil must be administered under close supervision, usually concomitantly with therapeutic doses of a beta-adrenergic blocking agent to prevent tachycardia and increased myocardial workload. It must also usually be given with a diuretic, frequently one acting in the ascending limb of the loop of Henle, to prevent serious fluid accumulation. Patients with malignant hypertension and those already receiving guanethidine should be hospitalized when minoxidil is first administered so that they can be monitored to avoid too rapid, or large orthostatic, decreases in blood pressure.

Overview

Minoxidil (oral) is a vasodilator that is FDA approved for the {{{indicationType}}} of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of diuretic plus two other antihypertensive drugs. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypotension, hirsutism, hypertrichosis, fluid retention, and hypernatremia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Refractory Hypertension Associated with End Organ Damage

• Dosing Information

• Initial Dosage

• 5 mg/day PO as single dose or 2 divided doses; adjust in 100% increments as required

• Maintenance Dosage

• 10-40 mg/day ORALLY daily in 1-2 divided doses; maximum 100 mg/day

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Minoxidil (oral) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Minoxidil (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Refractory Hypertension Associated with End Organ Damage

• Dosing Information

• Dosage
• Initial Dosage

• 0.2 mg/kg/day PO in a single dose or as 2 divided doses; adjust as required up to 50 mg/day

• Maintenance Dosage

• 0.25-1 mg/kg/day PO in a single dose or as 2 divided daily doses; maximum 50 mg/day

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Minoxidil (oral) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Minoxidil (oral) in pediatric patients.

Contraindications

• Pheochromocytoma

• Minoxidil tablets are contraindicated in pheochromocytoma, because it may stimulate secretion of catecholamines from the tumor through its antihypertensive action.

• Hypersensitivity

• Minoxidil tablets are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

WARNINGS See full prescribing information for complete Boxed Warning. * Minoxidil tablets contain the powerful antihypertensive agent, minoxidil, which may produce serious adverse effects. It can cause pericardial effusion, occasionally progressing to tamponade, and angina pectoris may be exacerbated. Minoxidil should be reserved for hypertensive patients who do not respond adequately to maximum therapeutic doses of a diuretic and two other antihypertensive agents. In experimental animals, minoxidil caused several kinds of myocardial lesions as well as other adverse cardiac effects. Minoxidil must be administered under close supervision, usually concomitantly with therapeutic doses of a beta-adrenergic blocking agent to prevent tachycardia and increased myocardial workload. It must also usually be given with a diuretic, frequently one acting in the ascending limb of the loop of Henle, to prevent serious fluid accumulation. Patients with malignant hypertension and those already receiving guanethidine should be hospitalized when minoxidil is first administered so that they can be monitored to avoid too rapid, or large orthostatic, decreases in blood pressure.

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Minoxidil (oral) in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Minoxidil (oral) 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 Minoxidil (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Minoxidil (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Minoxidil (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Minoxidil (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Minoxidil (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Minoxidil (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Minoxidil (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Minoxidil (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Minoxidil (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Minoxidil (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Minoxidil (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Minoxidil (oral) in the drug label.

Condition1

Description

IV Compatibility

There is limited information regarding IV Compatibility of Minoxidil (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Minoxidil (oral) in the drug label.

Pharmacology

There is limited information regarding Minoxidil (oral) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Minoxidil (oral) Mechanism of Action in the drug label.

Structure

There is limited information regarding Structure of Minoxidil (oral) in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Minoxidil (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Minoxidil (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Minoxidil (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Minoxidil (oral) in the drug label.

Condition1

Description

How Supplied

There is limited information regarding Minoxidil (oral) How Supplied in the drug label.

Storage

There is limited information regarding Minoxidil (oral) 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 Minoxidil (oral) in the drug label.

Precautions with Alcohol

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

Brand Names

• Loniten®

Look-Alike Drug Names

• Loniten® — Lipitor®

Drug Shortage Status

Price

References

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

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