Monobenzone: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->
|authorTag={{Ammu}}
|OTC=
|genericName=Monobenzone
|aOrAn=a
|aOrAn=a
|indicationType=
|drugClass=hypopigmentation agent
|indication=
|indicationType=treatment
|hasBlackBoxWarning=Yes
|indication=for final depigmentation in extensive Vitiligo
|adverseReactions=<!--Black Box Warning-->
|adverseReactions= Achromia of skin, Permanent, Burning sensation, Dermatitis, Skin irritation, Transient
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=Benoquin Cream 20% is indicated for final depigmentation in extensive Vitiligo.


* Dosing Information
Benoquin Cream 20% is applied topically to permanently depigment normal skin surrounding vitiliginous lesions in patients with disseminated (greater than 50 percent of body surface area) idiopathic vitiligo.


:* Dosage
Benoquin Cream 20% is not recommended in freckling; hyperpigmentation caused by photosensitization following the use of certain perfumes (berlock dermatitis); melasma (chloasma) of pregnancy; or hyperpigmentation resulting from inflammation of the skin. Benoquin Cream 20% is not effective for the treatment of cafe-au-lait spots, pigmented nevi, malignant melanoma or pigmentation resulting from pigments other than melanin (e.g.: bile, silver, or artificial pigments).
 
A thin layer of Benoquin Cream 20% should be applied and rubbed into the pigmented area two or three times daily, or as directed by physician. Prolonged exposure to sunlight should be avoided during treatment with Benoquin Cream 20%, or a sunscreen should be used.
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:  
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====


Depigmentation is usually accomplished after one to four months of Benoquin Cream 20% treatment. If satisfactory results are not obtained after four months of Benoquin Cream 20% treatment, the drug should be discontinued. When the desired degree of depigmentation is obtained, Benoquin Cream 20% should be applied only as often as needed to maintain depigmentation (usually only two times weekly).
|offLabelAdultGuideSupport=
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


Line 72: Line 33:


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


Line 85: Line 39:


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* Benoquin Cream 20% contains a potent depigmenting agent and is not a cosmetic skin bleach. Use of Benoquin Cream 20% is contraindicated in any conditions other than disseminated vitiligo. Benoquin Cream 20% frequently produces irreversible depigmentation, and it must not be used as a substitute for hydroquinone.
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description


<!--Adverse Reactions-->
Benoquin Cream 20% is also contraindicated in individuals with a history of sensitivity or allergic reactions to this product, or any of its ingredients.
|warnings=* Benoquin Cream 20% is a potent depigmenting agent, not a mild cosmetic bleach. Do not use except for final depigmentation in extensive vitiligo.


<!--Clinical Trials Experience-->
Keep this, and all medications out of the reach of children. In case of accidental ingestion, call a physician or a Poison Control Center immediately.
|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.
=====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-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} 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-->
|postmarketing=Mild, transient skin irritation and sensitization, including erythematous and eczematous reactions have occurred following topical application of Benoquin Cream 20%. Although those reactions are usually transient, treatment with Benoquin Cream 20% should be discontinued if irritation, a burning sensation, or dermatitis occur. Areas of normal skin distant to the site of Benoquin Cream 20% application frequently have become depigmented, and irregular, excessive, unsightly, and frequently permanent depigmentation has occurred.
|drugInteractions=* Drug
|drugInteractions=* Drug
:* Description
:* Description

Revision as of 15:11, 17 February 2015

Monobenzone
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: Ammu Susheela, M.D. [2]

Disclaimer

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Overview

Monobenzone is a hypopigmentation agent that is FDA approved for the treatment of for final depigmentation in extensive Vitiligo. Common adverse reactions include Achromia of skin, Permanent, Burning sensation, Dermatitis, Skin irritation, Transient.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Benoquin Cream 20% is indicated for final depigmentation in extensive Vitiligo.

Benoquin Cream 20% is applied topically to permanently depigment normal skin surrounding vitiliginous lesions in patients with disseminated (greater than 50 percent of body surface area) idiopathic vitiligo.

Benoquin Cream 20% is not recommended in freckling; hyperpigmentation caused by photosensitization following the use of certain perfumes (berlock dermatitis); melasma (chloasma) of pregnancy; or hyperpigmentation resulting from inflammation of the skin. Benoquin Cream 20% is not effective for the treatment of cafe-au-lait spots, pigmented nevi, malignant melanoma or pigmentation resulting from pigments other than melanin (e.g.: bile, silver, or artificial pigments). A thin layer of Benoquin Cream 20% should be applied and rubbed into the pigmented area two or three times daily, or as directed by physician. Prolonged exposure to sunlight should be avoided during treatment with Benoquin Cream 20%, or a sunscreen should be used.

Depigmentation is usually accomplished after one to four months of Benoquin Cream 20% treatment. If satisfactory results are not obtained after four months of Benoquin Cream 20% treatment, the drug should be discontinued. When the desired degree of depigmentation is obtained, Benoquin Cream 20% should be applied only as often as needed to maintain depigmentation (usually only two times weekly).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Monobenzone in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Monobenzone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Monobenzone in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Monobenzone in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Monobenzone in pediatric patients.

Contraindications

  • Benoquin Cream 20% contains a potent depigmenting agent and is not a cosmetic skin bleach. Use of Benoquin Cream 20% is contraindicated in any conditions other than disseminated vitiligo. Benoquin Cream 20% frequently produces irreversible depigmentation, and it must not be used as a substitute for hydroquinone.

Benoquin Cream 20% is also contraindicated in individuals with a history of sensitivity or allergic reactions to this product, or any of its ingredients.

Warnings

  • Benoquin Cream 20% is a potent depigmenting agent, not a mild cosmetic bleach. Do not use except for final depigmentation in extensive vitiligo.

Keep this, and all medications out of the reach of children. In case of accidental ingestion, call a physician or a Poison Control Center immediately.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Monobenzone in the drug label.

Postmarketing Experience

Mild, transient skin irritation and sensitization, including erythematous and eczematous reactions have occurred following topical application of Benoquin Cream 20%. Although those reactions are usually transient, treatment with Benoquin Cream 20% should be discontinued if irritation, a burning sensation, or dermatitis occur. Areas of normal skin distant to the site of Benoquin Cream 20% application frequently have become depigmented, and irregular, excessive, unsightly, and frequently permanent depigmentation has occurred.

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 Monobenzone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Monobenzone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Monobenzone with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Monobenzone with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Monobenzone with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Monobenzone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Monobenzone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Monobenzone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Monobenzone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Monobenzone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Monobenzone in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Monobenzone in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Monobenzone in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Monobenzone in the drug label.

Pharmacology

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

Mechanism of Action

Structure

File:Monobenzone01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Monobenzone in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Monobenzone in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Monobenzone in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Monobenzone in the drug label.

How Supplied

Storage

There is limited information regarding Monobenzone Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Monobenzone |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Monobenzone |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Monobenzone in the drug label.

Precautions with Alcohol

  • Alcohol-Monobenzone 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.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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