Docosanol: Difference between revisions

Jump to navigation Jump to search
Kiran Singh (talk | contribs)
No edit summary
Kiran Singh (talk | contribs)
No edit summary
Line 1: Line 1:
{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{KS}}
|authorTag={{KS}}
|genericName=docosanol
|aOrAn=a
|aOrAn=a
|hasBlackBoxWarning=Yes
|indicationType=treatment
|indication=[[cold sores]], [[fever]] blisters on the face or lips
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
Line 17: Line 19:
* Shortens healing time and duration of symptoms:
* Shortens healing time and duration of symptoms:
[[Tingling]], pain, burning, and/or [[itching]]
[[Tingling]], pain, burning, and/or [[itching]]
|offLabelAdultGuideSupport======Condition1=====


* Developed by:


* Class of Recommendation:


* Strength of Evidence:
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Dosing Information


:* Dosage
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


=====Condition2=====


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====


* Dosing Information
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


:* Dosage


=====Condition2=====


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|fdaLIADPed======Condition1=====


* Dosing Information


:* Dosage
|warnings='''For external use only'''


=====Condition2=====
'''Do not use'''


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
* If you are allergic to any ingredient in this product


<!--Off-Label Use and Dosage (Pediatric)-->
'''When using this product'''
Apply only to affected areas
* Do not use in or near the eyes
* Avoid applying directly inside your mouth
* Do not share this product with anyone. This may spread infection.


<!--Guideline-Supported Use (Pediatric)-->
'''Stop use and ask a doctor if'''
|offLabelPedGuideSupport======Condition1=====


* Developed by:
* Your cold sore gets worse or the cold sore is not healed within 10 days
* Keep out of reach of children.
* If swallowed, get medical help or contact a poison control center right away.


* 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.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=* Condition1
<!--Warnings-->
|warnings=* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|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.
|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-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
Line 241: Line 80:
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


<!--Administration and Monitoring-->
|administration=* Oral


* Intravenous
|administration=* Topical
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description


<!--IV Compatibility-->
 
 
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


<!--Overdosage-->
|overdose====Acute Overdose===


====Signs and Symptoms====
|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 


* Description


====Management====
|structure=


* Description


===Chronic Overdose===
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*


<!--Structure-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|structure=*


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
 
|storage=* Store at 20 o-25 oC (68 o-77 oF)
* Do not freeze
|fdaPatientInfo='''Adults and children 12 years or over''':
* Wash hands before and after applying cream
* Apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle).
* Early treatment ensures the best results
* Rub in gently but completely
* Use 5 times a day until healed
 
 
'''Children under 12 years''': ask a doctor
 
==FREQUENTLY ASKED QUESTIONS==:
 
'''How is ABREVA different from the over-the-counter cold sore remedies I have already been using?'''
 
* Abreva is the only FDA approved non-prescription cold sore medicine that can actually shorten healing time and the duration of symptoms. The sooner you start using ABREVA, the sooner you can begin healing your cold sore.
 
'''Who can use ABREVA?'''
 
* Adults and children 12 years and over can use ABREVA.
 
'''How often can I apply ABREVA?'''


<!--Pharmacokinetics-->
* ABREVA should be used five times a day until the cold sore is healed. Apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results.
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


<!--Nonclinical Toxicology-->
'''Can I apply cosmetics on top of ABREVA?'''
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


<!--Clinical Studies-->
* Yes, cosmetics such as lipstick may be applied over ABREVA. However, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection. For best results, remove any cosmetics prior to applying ABREVA.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


<!--How Supplied-->
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url =  }}</ref>
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}
Line 311: Line 149:
}}
}}
{{LabelImage
{{LabelImage
|fileName={{PAGENAME}}11.png
|fileName=Abreva.jpg
}}
}}
{{LabelImage
{{LabelImage
|fileName={{PAGENAME}}11.png
|fileName=Abreva ingredients and appearance.png
}}
}}
<!--Pill Image-->
<!--Pill Image-->

Revision as of 19:11, 22 January 2015

Docosanol
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: Kiran Singh, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Docosanol is a {{{drugClass}}} that is FDA approved for the treatment of cold sores, fever blisters on the face or lips. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Treats cold sores/fever blisters on the face or lips
  • Shortens healing time and duration of symptoms:

Tingling, pain, burning, and/or itching

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Docosanol Contraindications in the drug label.

Warnings

For external use only

Do not use

  • If you are allergic to any ingredient in this product

When using this product Apply only to affected areas

  • Do not use in or near the eyes
  • Avoid applying directly inside your mouth
  • Do not share this product with anyone. This may spread infection.

Stop use and ask a doctor if

  • Your cold sore gets worse or the cold sore is not healed within 10 days
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a poison control center right away.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Docosanol in the drug label.

Drug Interactions

There is limited information regarding Docosanol Drug Interactions in the drug label.

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 Docosanol in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Topical

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

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

Mechanism of Action

There is limited information regarding Docosanol Mechanism of Action in the drug label.

Structure

There is limited information regarding Docosanol Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Docosanol How Supplied in the drug label.

Storage

  • Store at 20 o-25 oC (68 o-77 oF)
  • Do not freeze

Images

Drug Images

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

Patient Counseling Information

Adults and children 12 years or over:

  • Wash hands before and after applying cream
  • Apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle).
  • Early treatment ensures the best results
  • Rub in gently but completely
  • Use 5 times a day until healed


Children under 12 years: ask a doctor

==FREQUENTLY ASKED QUESTIONS==:

How is ABREVA different from the over-the-counter cold sore remedies I have already been using?

  • Abreva is the only FDA approved non-prescription cold sore medicine that can actually shorten healing time and the duration of symptoms. The sooner you start using ABREVA, the sooner you can begin healing your cold sore.

Who can use ABREVA?

  • Adults and children 12 years and over can use ABREVA.

How often can I apply ABREVA?

  • ABREVA should be used five times a day until the cold sore is healed. Apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results.

Can I apply cosmetics on top of ABREVA?

  • Yes, cosmetics such as lipstick may be applied over ABREVA. However, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection. For best results, remove any cosmetics prior to applying ABREVA.

Precautions with Alcohol

  • Alcohol-Docosanol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Docosanol Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Docosanol Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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

{{#subobject:

 |Page Name=Docosanol
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Docosanol
 |Label Name=Abreva.jpg

}}

{{#subobject:

 |Label Page=Docosanol
 |Label Name=Abreva ingredients and appearance.png

}}