Dosing & Uses
Dosage Forms & Strengths
Physicians may prescribe hydroquinone products through 503A and 503B compounding facilities
FDA alert explains there are no FDA-approved or otherwise legally marketed OTC skin lightening products
Melanin Hyperpigmentation
Used for gradual bleaching of hyperpigmented skin conditions (eg, chloasma, melisma, freckles, senile lentigines) and other unwanted areas of melanin hyperpigmentation
Apply sparingly to affected areas BID and rub in thoroughly
Generally 2-4% compounded topical creams are prescribed
Dosage Forms & Strengths
Physicians may prescribe hydroquinone products through 503A and 503B compounding facilities
FDA alert explains there are no FDA-approved or otherwise legally marketed OTC skin lightening products
Melanin Hyperpigmentation
Used for gradual bleaching of hyperpigmented skin conditions (eg, chloasma, melisma, freckles, senile lentigines) and other unwanted areas of melanin hyperpigmentation
Generally 2-4% compounded topical creams are prescribed
<12 years: Safety and efficacy not established
≥12 years: Apply sparingly to affected areas BID and rub in thoroughly
Adverse Effects
Frequency Not Defined
Mild skin irritation and sensitization (burning, stinging)
Dermatitis
Dryness
Erythema
Inflammatory reaction
Warnings
Contraindications
Hypersensitivity
Sunburn
Use as depilatory drug
Cautions
May contain sulfites that may cause allergic-type reactions
May cause skin rashes, facial swelling, and ochronosis
Avoid unnecessary exposure to sunlight
Limit application to areas no larger than arms, hands, face, and neck
Do not apply near eyes or mucous membranes, to cut, abraded, or sunburned skin, after shaving or using a depilatory agent; or over miliaria rubra (prickly heat)
Individuals with sensitive skin may experience temporary burning/stinging sensation
Pregnancy & Lactation
Pregnancy
Unknown extent of systemic absorption
Lactation
Unknown if distributed in breast milk; use caution
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Elicits reversible depigmentation of the skin by inhibiting enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA); also suppresses other melanocyte metabolic processes; sun exposure reverses effect and cause repigmentation
Pharmacokinetics
Onset and duration: Varies per individual
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| hydroquinone topical - | 4 % cream |  | |
| hydroquinone topical - | 4 % cream |  | |
| hydroquinone topical - | 4 % cream |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
hydroquinone topical
HYDROQUINONE - TOPICAL
(hi-dro-KWIN-own)
COMMON BRAND NAME(S): Eldoquin, Epiquin Micro, Lustra, Melanex
USES: Hydroquinone is used to lighten the dark patches of skin (also called hyperpigmentation, melasma, "liver spots," "age spots," freckles) caused by pregnancy, birth control pills, hormone medicine, or injury to the skin.This medicine works by blocking the process in the skin that leads to discoloration.
HOW TO USE: Follow all directions on the product package, or use as directed by your doctor. Before using, apply a small amount of this medicine to an area of unbroken skin, and check the area within 24 hours for any serious side effects. If the test area is itching, red, puffy, or blistering, do not use this product and contact your doctor. If there is just mild redness, then treatment with this product may begin.Apply this medication to the affected areas of skin, usually twice daily or as directed by your doctor. This medication is for use on the skin only. If it is used incorrectly, unwanted skin lightening may occur. Avoid getting this product in your eyes or on the inside of your nose or mouth. If you do get this medication in those areas, flush with plenty of water.This medication may make the treated areas of skin more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing on the treated areas of skin when outdoors.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.Tell your doctor if your condition lasts or gets worse after 2 months.
SIDE EFFECTS: See also How to Use.Mild burning, stinging, redness, and dryness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.If your doctor has prescribed this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Stop using hydroquinone and tell your doctor right away if you have any serious side effects, including: blistering, skin cracking, blue-black darkening of the skin.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using hydroquinone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, other skin conditions (such as eczema, psoriasis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms after swallowing may include: shaking (tremors), seizures.
NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another skin problem unless told to do so by your doctor. A different medication may be necessary in that case.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised November 2022. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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