Hydroquinone

Hydroquinone
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: Kiran Singh, M.D. [2]

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Overview

Hydroquinone is a hyperpigmentation 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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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 Hydroquinone Warnings' in the drug label.

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 Hydroquinone Drug Interactions in the drug label.

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 the compatibility of Hydroquinone and IV administrations.

Overdosage

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

Pharmacology

There is limited information regarding Hydroquinone Pharmacology in the drug label.

Mechanism of Action

• Hydroquinone inhibits the enzymatic oxidation of tyrosine to 3-(3,4-dihydroxyphenyl) alanine (dopa) and suppresses metabolic processes of melanocytes, thus producing 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 (15-30°C / 59-86°F).
• Close cap securely after each use.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

(Patient Counseling Information)

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

References

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

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