Hydroquinone

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# Overview
Hydroquinone is a dermatological agent that is FDA approved for the treatment of discoloration of skin, hyperpigmentation of skin.   Common adverse reactions include burning sensation, contact dermatitis, localized erythema.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

# Indications
- Skin Lightening
- To gradually lighten hyperpigmentation of the skin such as age spots, liver spots, freckles or hyperpigmentation that can occur as a result of pregnancy or the use of oral contraceptives.

# Dosing
- Use fingertips to apply a thin layer to affected areas. Use both morning and night or as directed by a physician. Gradual lightening of the discolored area can be expected in most cases.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use

# Indications and Dosage
- Discoloration of skin: emulsion, apply topically twice daily to affected area(s) or as directed by physician for no longer than 2 months.
- Hyperpigmentation of skin: cream and gel, with or without sunscreens, apply topically twice daily to the affected area(s) or as directed by physician for no longer than 2 months; rub in well.
- Hyperpigmentation of skin: cream with sunblock, apply topically twice daily to the affected area(s) or as directed by physician for no longer than 2 months; do not rub in.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Hydroquinone in adult patients.

# Pediatric Indications and Dosage

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

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use

# Indications and Dosage
- Safety and efficacy not established in children less than 12 years of age; not recommended for use except under physician supervision.
- Discoloration of skin: 12 years and older; emulsion, apply topically twice daily to affected area(s) or as directed by physician for no longer than 2 months.
- Hyperpigmentation of skin: 12 years and older; cream and gel, with or without sunscreens, apply topically twice daily to the affected area(s) or as directed by physician for no longer than 2 months; rub in well.
- Hyperpigmentation of skin: 12 years and older; cream with sunblock, apply topically twice daily to the affected area(s) or as directed by physician for no longer than 2 months; do not rub in.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Hydroquinone in pediatric patients.

# Contraindications
- Hypersensitivity to hydroquinone or any component of hydroquinone products.
- Pregnancy, safety not established.
- Children 12 years of age and under; safety not established.

# Warnings
There is limited information regarding Warnings of Hydroquinone in  patients.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Hydroquinone Clinical Trials Experience in the drug label.

## Postmarketing Experience
Dermatologic: Burning sensation, contact dermatitis, localized erythema

# Drug Interactions
There is limited information regarding Drug Interactions of Hydroquinone in  patients.

# Use in Specific Populations

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

### Labor and Delivery
There is no FDA guidance on use of Hydroquinone during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Hydroquinone in women who are nursing.

### Pediatric Use
There is no FDA guidance on the use of Hydroquinone in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Hydroquinone in geriatric settings.

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

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

### Renal Impairment
There is no FDA guidance on the use of Hydroquinone in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Hydroquinone in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Hydroquinone in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Hydroquinone in patients who are immunocompromised.

### Others

# Administration and Monitoring

### Administration
Topical
- Avoid exposure of treated areas to sunlight.
- Avoid contact with eyes.

### Monitoring
- Repigmentation

# IV Compatibility
There is limited information regarding IV Compatibility of Hydroquinone in  patients.

# Overdosage
There is limited information regarding Overdose of Hydroquinone in  patients.

# Pharmacology

## Mechanism of Action
- Hydroquinone  acts  by inhibiting the breakdown of tyrosine to 3-(3,4-dihydroxyphenyl) alanine (dopa) and  thus suppresseing metabolic processes of melanocytes,  to produce depigmentation of the skin which is reversible

## Structure
There is limited information regarding Hydroquinone Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Hydroquinone Pharmacodynamics in the drug label.

## Pharmacokinetics
There is limited information regarding Hydroquinone Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Hydroquinone Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Hydroquinone Clinical Studies in the drug label.

# How Supplied
There is limited information regarding Hydroquinone How Supplied in the drug label.

## Storage
- Store at room temperature (15-30C / 59-86F).
- Close cap securely after each use.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Hydroquinone Patient Counseling Information in the drug label.

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

# Brand Names
ACTIVE 4

# Look-Alike Drug Names
There is limited information regarding Hydroquinone Look-Alike Drug Names in the drug label.

# Drug Shortage Status
Drug Shortage

# Price