Hydroquinone
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.
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.
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
- Drug 1
- Drug 2
- Drug 3
- Drug 4
- Drug 5
Drug 1
(Description)
Drug 2
(Description)
Drug 3
(Description)
Drug 4
(Description)
Drug 5
(Description)
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
(Description)
Pregnancy Category (AUS):
(Description)
Labor and Delivery
(Description)
Nursing Mothers
(Description)
Pediatric Use
(Description)
Geriatic Use
(Description)
Gender
(Description)
Race
(Description)
Renal Impairment
(Description)
Hepatic Impairment
(Description)
Females of Reproductive Potential and Males
(Description)
Immunocompromised Patients
(Description)
Others
(Description)
Administration and Monitoring
Administration
Topical
- Avoid exposure of treated areas to sunlight.
- Avoid contact with eyes.
Monitoring
- Repigmentation
IV Compatibility
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
TPN/TNA
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
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
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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
(Description with picture)
Pharmacodynamics
(Description)
Pharmacokinetics
(Description)
Nonclinical Toxicology
(Description)
Clinical Studies
Condition 1
(Description)
Condition 2
(Description)
Condition 3
(Description)
How Supplied
(Description)
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
- (Paired Confused Name 1a) — (Paired Confused Name 1b)
- (Paired Confused Name 2a) — (Paired Confused Name 2b)
- (Paired Confused Name 3a) — (Paired Confused Name 3b)
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.