Minoxidil (oral)
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.
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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
- Minoxidil tablets are contraindicated in pheochromocytoma, because it may stimulate secretion of catecholamines from the tumor through its antihypertensive action.
- 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.
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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
- 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.[1]
Brand Names
- Loniten®
Look-Alike Drug Names
- Loniten® — Lipitor®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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