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{{drugbox
{{DrugProjectFormSinglePage
| IUPAC_name = 1-isobutyl-1''H''-imidazo[4,5-''c'']quinolin-4-amine
|authorTag=
| image = Imiquimod.svg
 
| width = 180px
 
| CAS_number = 99011-02-6
<!--Overview-->
| ATC_prefix = D06
 
| ATC_suffix = BB10
|genericName=
| PubChem = 57469
 
| DrugBank = APRD01030
 
| C = 14 |H = 16 |N = 4
 
| molecular_weight = 240.304 [[Gram|g]]/[[Mole (unit)|mol]]
|aOrAn=
| bioavailability =  
 
| protein_bound =  
a
| metabolism =  
 
| elimination_half-life = 20 hours (topical dose), 2 hours (subcutaneous dose)
|drugClass=
| licence_EU = Aldara
 
| licence_US = Imiquimod
 
| pregnancy_AU      = B1
 
| pregnancy_US      = C
|indication=
| pregnancy_category=
 
| legal_AU          = <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
 
| legal_CA          = <!--             / Schedule I, II, III, IV, V, VI, VII, VIII -->
 
| legal_UK          = POM
|hasBlackBoxWarning=
| legal_US          = Rx-only
 
| legal_status      =  
Yes
| routes_of_administration = [[Topical]]
 
}}
|adverseReactions=
{{SI}}
 
 
 
<!--Black Box Warning-->
 
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=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
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=====Condition1=====
 
* Dosing Information
 
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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
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=====Condition1=====
 
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* Dosing Information
 
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There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
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=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
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|monitoring=
 
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* Description
 
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===Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
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: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
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<!--Precautions with Alcohol-->
 
|alcohol=
 
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->


==Overview==
|brandNames=
'''Imiquimod''' ([[International Nonproprietary Name|INN]], marketed by [[3M]] under the trade name '''Aldara''') is a prescription medication that acts as an immune response modifier.


==Uses==
* ®<ref>{{Cite web | title = | url = }}</ref>
Imiquimod is a patient-applied cream used to treat certain diseases of the skin, including [[skin cancer]] ([[basal cell carcinoma]], [[Bowen's disease]]<ref>{{cite journal |author=van Egmond S, Hoedemaker C, Sinclair R |title=Successful treatment of perianal Bowen's disease with imiquimod |journal=Int J Dermatol |volume=46 |issue=3 |pages=318-9 |year=2007 |pmid=17343595}}</ref>, superficial [[squamous cell carcinoma]], some superfical [[malignant melanoma]]s and [[actinic keratosis]]) as well as [[genital warts]] (Condylomata Acuminata). It has also been tested for treatment of [[Molluscum contagiosum]]. It causes [[interferon]] production which triggers the patient's immune response against these tumors. 


It is also used pre-operatively to shrink basal cell cancer and melanoma in situ (especially Lentigo Maligna) before [[Mohs surgery]].
<!--Look-Alike Drug Names-->


Side effects include redness and irritation of the skin during treatment.
|lookAlike=


== History ==
* A® — B®<ref name="www.ismp.org">{{Cite web  | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
The original FDA approval was on February 27, 1997, FDA Application No. (NDA) 020723, by Graceway.<!-- ref FDA licensing, see link in infobox-->


Since then, the label has been revised many times.  Adverse side effects have been reported, in some cases serious and systemic. Some patients have been suffering from severe auto-immune or neuro-immune effects for years.{{Fact|date=August 2007}}
<!--Drug Shortage Status-->


== Mechanism of action ==
|drugShortage=
}}


The exact mode in which imiquimod and its analogs activate the immune system is not yet known. Nevertheless, it is known that Imiquimod activates immune cells by [[Ligand_(biochemistry)|ligating]] the [[TLR 7|toll-like receptor 7]] (TLR7), commonly involved in pathogen recognition, on the cell surface.<ref name="Evans">Hemmi, H., ''et al.'' Small anti-viral compounds activate immune cells via the TLR7 MyD88-dependent signaling pathway. ''Nat Immunol.''. '''2002''' ''3''(2):196-200. PMID 11812998.</ref> Cells activated by imiquimod via TLR-7 secrete [[cytokines]] (primarily [[Interferon_type_I#IFN-.CE.B1|interferon-α]] (IFN-α), [[interleukin-6]] (IL-6) and [[Tumor necrosis factor-alpha|tumor necrosis factor-α]] (TNF-α)). <ref name="Sauder">Sauder, D.N., Imiquimod: modes of action. ''British Journal of Dermatology''. 2003 '''149'''(Suppl. 66):5-8. PMID 14616337</ref> There is evidence that imiquimod, when applied to skin, can lead to the activation of [[Langerhans cells]], which subsequently migrates to local lymph nodes to activate the adaptive immune system.<ref name="Miller">Miller, R.L., ''et al.'' Imiquimod applied topically: a novel immune response modifier and a new class of drug. ''Int J Immunopharmacol''. 1999 Jan;'''21'''(1):1-14. PMID 10411278</ref> Other cell types activated by imiquimod include [[natural killer cells]], [[macrophages]] and [[B-lymphocytes]].<ref name="Miller" />  
<!--Pill Image-->


==References==
{{PillImage
<references/>
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
|drugName=
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
|pillColor=
|pillShape=
|pillSize=
|pillScore=
}}


==External links==
<!--Label Display Image-->
* {{MedlinePlusDrugInfo|medmaster|a698010}}
* {{DermNet|treatments/imiquimod}}
* [http://www.npsradar.org.au/site.php?page=1&content=/npsradar/content/imiquimod.html NPS RADAR]
* [http://www.aldara.com Aldara.com]


{{Antibiotics and chemotherapeutics for dermatological use}}
{{LabelImage
{{Antivirals}}
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


[[Category:Antivirals]]
{{LabelImage
[[Category:Chemotherapeutic agents]]
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


<!--Category-->


[[de:Imiquimod]]
[[Category:Drug]]
[[nl:Imiquimod]]
[[pl:Imikwimod]]
[[th:อีมิควิมอด]]
{{jb1}}
{{WikiDoc Help Menu}}
{{WikiDoc Sources}}

Revision as of 18:02, 9 October 2014

Imiquimod
Black Box Warning
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];

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Imiquimod is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

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 Imiquimod in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Imiquimod 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 Imiquimod 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 Imiquimod in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Imiquimod01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Imiquimod 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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