Hydroquinone, octinoxate and oxybenzone: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|genericName=hydroquinone, octinoxate and oxybenzone
|aOrAn=a
|aOrAn=a
|indicationType=treatment
|indicationType=treatment
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==


* Dosing Information
* 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
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage


<!--Off-Label Use and Dosage (Adult)-->
==Dosage==


<!--Guideline-Supported Use (Adult)-->
* 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.
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


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<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|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.


<!--Warnings-->
* 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.
|warnings=* Description


====Precautions====
* 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.


* Description
* 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.


<!--Adverse Reactions-->
* 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.


<!--Clinical Trials Experience-->
* 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.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.



Revision as of 15:58, 1 April 2015

Hydroquinone, octinoxate and oxybenzone
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];

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Overview

Hydroquinone, octinoxate and oxybenzone is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

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

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

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

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

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

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

There is no FDA guidance on the use of Hydroquinone, octinoxate and oxybenzone with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Hydroquinone, octinoxate and oxybenzone with respect to pediatric patients.

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

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Hydroquinone, octinoxate and oxybenzone01.png
This image is provided by the National Library of Medicine.

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

Storage

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

Images

Drug Images

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Package and Label Display Panel

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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

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

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