Minoxidil (topical)

Minoxidil (topical)
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: Adeel Jamil, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Minoxidil (topical) is a vasodilator that is FDA approved for the treatment of to regrow hair on the top of the scalp in men. Common adverse reactions include scalp irritation or redness and unwanted facial hair growth.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• To regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Dosing Information

• apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
• using more or more often will not improve results
• continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Minoxidil (topical) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

• For external use only. For use by men only.

• Flammable: Keep away from fire or flame

Do not use if

• you are a woman
• your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
• you have no family history of hair loss
• your hair loss is sudden and/or patchy
• you do not know the reason for your hair loss
• you are under 18 years of age. Do not use on babies and children.
• your scalp is red, inflamed, infected, irritated, or painful
• you use other medicines on the scalp

Ask a doctor before use if you have

• heart disease

When using this product

• do not apply on other parts of the body
• avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
• some people have experienced changes in hair color and/or texture
• it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
• the amount of hair regrowth is different for each person. This product will not work for all men.

Stop use and ask a doctor if

• chest pain, rapid heartbeat, faintness, or dizziness occurs
• sudden, unexplained weight gain occurs
• your hands or feet swell
• scalp irritation or redness occurs
• unwanted facial hair growth occurs
• you do not see hair regrowth in 4 months

May be harmful if used when pregnant or breast-feeding

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Minoxidil (topical) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Minoxidil (topical) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Minoxidil (topical) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Minoxidil (topical) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Minoxidil (topical) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Minoxidil (topical) in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Topical solution

Monitoring

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

IV Compatibility

There is limited information regarding the compatibility of Minoxidil (topical) and IV administrations.

Overdosage

There is limited information regarding Minoxidil (topical) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Minoxidil (topical)
Systematic (IUPAC) name
6-Piperidin-1-ylpyrimidine-2,4-diamine 3-oxide
Identifiers
CAS number	38304-91-5
ATC code	C02DC01 D11AX01 (WHO)
PubChem	4201
DrugBank	DB00350
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	209.251 g/mol
Pharmacokinetic data
Bioavailability	?
Metabolism	Primarily hepatic
Half life	4.2 hours
Excretion	renal
Therapeutic considerations
Pregnancy cat.	C
Legal status	P(UK) for topical use, otherwise POM. Cannot be prescribed on the NHS.
Routes	Oral / topical

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

• Store at 20º to 25ºC (68º to 77ºF).
• Keep tightly closed.

Images

Drug Images

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Package and Label Display Panel

Compare to Men’s Rogaine® Extra Strength active ingredient

MINOXIDIL TOPICAL SOLUTION USP, 5%

Hair Regrowth Treatment For Men

Clinically proven to help regrow hair

Reactivates hair follicles to stimulate growth

Unscented

EXTRA STRENGTH

FDA Approved

Not For Use By Women

1 – 60 mL (2 fl oz) Bottle

One Month Supply

This image is provided by the National Library of Medicine.

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Patient Counseling Information

• see hair loss pictures on side of this carton
• before use, read all information on carton and enclosed leaflet
• keep the carton. It contains important information.
• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men
• in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

This image is provided by the National Library of Medicine.

Precautions with Alcohol

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

Brand Names

There is limited information regarding Minoxidil (topical) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Minoxidil (topical) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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