Hydroquinone, octinoxate and oxybenzone

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# Overview
Hydroquinone, octinoxate and oxybenzone is a depigmenting agent that is FDA approved for the treatment of hyperpigmented skin conditions such as chloasma, melasma and freckles.   Common adverse reactions include hypersensitivity.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

# Indications
- ALPHAQUIN HP 4% CREAM is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other undesired areas of melanin hyperpigmentation.

# Dosage
- ALPHAQUIN HP 4% CREAM should be applied to affected areas twice daily, in the morning and before bedtime, or as directed by a physician. Unnecessary solar exposure should be avoided. There is no recommended dosage for children under 12 years of age except under the advice and supervision of a physician. Keep container tightly closed. NOTE: Slight darkening of ALPHAQUIN HP 4% CREAM is normal and does not affect potency of the product.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of Hydroquinone, octinoxate and oxybenzone in adult patients.

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

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- There is limited information regarding FDA-Labeled Use of Hydroquinone, octinoxate and oxybenzone in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
- There is limited information regarding Off-Label Guideline-Supported Use of Hydroquinone, octinoxate and oxybenzone in pediatric patients.

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

# Contraindications
- ALPHAQUIN HP 4% CREAM is contraindicated in persons who have shown hypersensitivity to hydroquinone or any of the other ingredients. The safety of topical treatment of hydroquinone during pregnancy or in children (12 years and under) has not been established.

# Warnings
- Hydroquinone is a skin bleaching agent which may produce undesired effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.
- To evaluate possible susceptibility to irritation or sensitivity, each patient should begin by applying the medication to a small portion of unbroken skin at or near the pigmented area over a period of several days. Minor redness is not necessarily a contraindication, but treatment should be discontinued if itching, excessive inflammation or vesicle formation occurs. Close patient supervision is recommended. Use of ALPHAQUIN HP 4% CREAM in paranasal and infraorbital areas increases the chance of irritations. If no improvement is seen after two months of treatment, use of this product should be discontinued.
- Sunscreen use is an essential aspect of hydroquinone therapy since even minimal sunlight exposure stimulates melanocyte activity. The sunscreens in ALPHAQUIN HP 4% CREAM provide the necessary sun protection during skin bleaching activity. During the depigmentation maintenance treatment subsequent to the intensive depigmentation therapy, sun exposure of the bleached skin should be avoided to prevent repigmentation.
- Contains Sodium Metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
- Keep this and all other medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.
- Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and antiseptic effect may occur if applied to the lips.

# Adverse Reactions

## Clinical Trials Experience
- No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately.

## Postmarketing Experience
- There is limited information regarding Postmarketing Experience of Hydroquinone, octinoxate and oxybenzone in the drug label.

# Drug Interactions
There is limited information regarding Hydroquinone, octinoxate and oxybenzone Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
Pregnancy Category C
- Animal reproduction studies have not been conducted with hydroquinone. It is also not known whether hydroquinone can cause fetal harm when administered on a pregnant woman or can affect reproductive capacity. It is also not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used in pregnant women only when clearly indicated.
Pregnancy Category (AUS):
- There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydroquinone, octinoxate and oxybenzone in women who are pregnant.

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

### Nursing Mothers
- It is not known whether topical administration of hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.

### Pediatric Use
- Safety and effectiveness in children below the age of 12 years has not been established.

### Geriatic Use
- There is no FDA guidance on the use of Hydroquinone, octinoxate and oxybenzone with respect to geriatric patients.

### Gender
- There is no FDA guidance on the use of Hydroquinone, octinoxate and oxybenzone with respect to specific gender populations.

### Race
- There is no FDA guidance on the use of Hydroquinone, octinoxate and oxybenzone with respect to specific racial populations.

### Renal Impairment
- There is no FDA guidance on the use of Hydroquinone, octinoxate and oxybenzone in patients with renal impairment.

### Hepatic Impairment
- There is no FDA guidance on the use of Hydroquinone, octinoxate and oxybenzone in patients with hepatic impairment.

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

### Immunocompromised Patients
- There is no FDA guidance one the use of Hydroquinone, octinoxate and oxybenzone in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Topical

### Monitoring
- There is limited information regarding Monitoring of Hydroquinone, octinoxate and oxybenzone in the drug label.

# IV Compatibility
- There is limited information regarding IV Compatibility of Hydroquinone, octinoxate and oxybenzone in the drug label.

# Overdosage
- There have been no systemic reactions reported from the use of topical hydroquinone treatment. However, treatment should be limited to relatively small areas of the body at one time since some patients may experience a transient skin reddening and a mild burning sensation which does not preclude treatment.

# Pharmacology
There is limited information regarding Hydroquinone, octinoxate and oxybenzone Pharmacology in the drug label.

## Mechanism of Action
- Topical application of hydroquinone produces a reversible depigmentation of the skin by the inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA)  and suppression of other melanocyte metabolic processes . Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas .

## Structure
- Each gram of ALPHAQUIN HP 4% CREAM Contains: ACTIVE: 40 mg of Hydroquinone USP, 7.5% Octyl Methoxycinnamate,5.0% Benzophenone-3 in a cream base of: INACTIVES: Purified Water, Propylene Glycol, Glycerine, Cetyl Alcohol, Cetostearyl Alcohol, Glycolic Acid, Isopropyl Palmitate, Stearyl Alcohol, Sodium Lauryl Sulfate, Sodium Metabisulfite, Citric Acid, Sorbic Acid and Sodium Hydroxide.
- Hydroquinone is 1, 4-Benzenediol, with a chemical formula of C6H6O2 and a molecular weight of 110.11.
The structural formula is:

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Hydroquinone, octinoxate and oxybenzone in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Hydroquinone, octinoxate and oxybenzone in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Hydroquinone, octinoxate and oxybenzone in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Hydroquinone, octinoxate and oxybenzone in the drug label.

# How Supplied
- ALPHAQUIN HP 4% CREAM (Hydroquinone, USP 4%) is supplied as follows:

## Storage
- Store at 20C to 25C (68F to 77F), excursions permitted between 15C and 30C (between 59F and 86F). Brief exposure to temperatures up to 40C (104F) may be tolerated provided the mean kinectic temperature does not exceed 25C (77F); however, such exposure should be minimized. . Protect from freezing. If freezing occurs, warm to room temperature.
- Keep out of the reach of children.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- There is limited information regarding Patient Counseling Information of Hydroquinone, octinoxate and oxybenzone in the drug label.

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

# Brand Names
- ALPHAQUIN HP

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

# Drug Shortage Status

# Price