Minoxidil (topical)

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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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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
- 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
- heart disease
- 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.
- 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
- 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

## 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

## Package and Label Display Panel
Compare to Mens 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

# 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%.

# 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