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
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
* 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.
<!--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.
=====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-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=* Oral
* Intravenous
|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.
<!--Overdosage-->
|overdose====Acute Overdose===
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*
<!--Structure-->
|structure=*
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
'''Miltefosine''' ([[International Nonproprietary Name|INN]], trade names '''Impavido''' and '''Miltex''') is an [[antiprotozoal]] [[medication|drug]]. Originally developed as an [[antineoplastic]], it is finding use as an [[antiprotozoal]] drug. It can be administered orally and intravenously.
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
==Current antiprotozoal and antifungal applications==
<!--Clinical Studies-->
''[[Leishmania]]'': Miltefosine is registered and used by [[Zentaris]] GmbH in [[India]], [[Colombia]] and [[Germany]] for the treatment of [[visceral leishmaniasis|visceral]] and [[cutaneous leishmaniasis]], and is undergoing [[clinical trial]]s for this use in several other countries, such as [[Brazil]]<ref name = FAPEPI>{{cite news | last = Cristina | first = Márcia | coauthors = Pedrosa, Robert | title = Hospital de Doenças Tropicais testa droga contra calazar | work = Sapiência | language = Portuguese | publisher = Fundação de Amparo à Pesquisa do Estado do Piauí | date = September 2005 | url = http://www.fapepi.pi.gov.br/sapiencia6/pesquisa3.php | accessdate = 2006-09-01}}</ref> and [[Guatemala]].<ref name = Soto>{{cite journal | author = Soto J, Berman J | title = Treatment of New World cutaneous leishmaniasis with miltefosine. | journal = Trans R Soc Trop Med Hyg | year = 2006 | id = PMID 16930649}}</ref> It is currently the only effective oral treatment for leishmaniasis.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
Miltefosine is one of the few orally administered drugs that is effective against ''[[Leishmania]]'' <ref name="pmid16255674">{{cite journal |author=Berman J |title=Clinical status of agents being developed for leishmaniasis |journal=Expert opinion on investigational drugs |volume=14 |issue=11 |pages=1337–46 |year=2005 |pmid=16255674 |doi=10.1517/13543784.14.11.1337}}</ref>
<!--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.
==Investigatory antiprotozoal and antifungal usage==
<!--Brand Names-->
Miltefosine is being investigated by researchers interested in finding treatments for infections which have become resistant to existing drugs. Animal and in-vitro studies suggest it may have broad anti-protozoal and anti-fungal properties:
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
* Animal studies suggest miltefosine may also be effective against ''[[Trypanosoma cruzi]]'', the [[parasite]] responsible for [[Chagas' disease]]. <ref name = Saraiva>{{cite journal | author = Saraiva V, Gibaldi D, Previato J, Mendonça-Previato L, Bozza M, Freire-De-Lima C, Heise N | title = Proinflammatory and cytotoxic effects of hexadecylphosphocholine (miltefosine) against drug-resistant strains of Trypanosoma cruzi. | journal = Antimicrob Agents Chemother | volume = 46 | issue = 11 | pages = 3472-7 | year = 2002 | id = PMID 12384352 | url = http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=12384352}}</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>
* Several studies have found the drug to be effective against ''[[Cryptococcus neoformans]]'', ''[[Candida]]'', ''[[Aspergillus]]'' and ''[[Fusarium]]''.<ref name = Widmer>{{cite journal | author = Widmer F, Wright L, Obando D, Handke R, Ganendren R, Ellis D, Sorrell T | title = Hexadecylphosphocholine (miltefosine) has broad-spectrum fungicidal activity and is efficacious in a mouse model of cryptococcosis. | journal = Antimicrob Agents Chemother | volume = 50 | issue = 2 | pages = 414-21 | year = 2006 | id = PMID 16436691 | url = http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=16436691}}</ref>
<!--Drug Shortage Status-->
|drugShortage=
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|fileName={{PAGENAME}}11.png
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{{LabelImage
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<!--Pill Image-->
* An in-vitro study found that Miltefosine is effective against metronidazole-resistant variants of [[Trichomonas vaginalis]], a sexually transmitted protozoal disease.<ref name="pmid16344287">{{cite journal |author=Blaha C, Duchêne M, Aspöck H, Walochnik J |title=In vitro activity of hexadecylphosphocholine (miltefosine) against metronidazole-resistant and -susceptible strains of Trichomonas vaginalis |journal=J. Antimicrob. Chemother. |volume=57 |issue=2 |pages=273–8 |year=2006 |pmid=16344287 |doi=10.1093/jac/dki417}}</ref>
* [[Hexadecyltrimethylammonium bromide]], a compound structurally similar to miltefosine, was recently found to exhibit potent ''[[in vitro]]'' activity against ''[[Plasmodium falciparum]]''.<ref name = Choubey2006>{{cite journal | author = Choubey V, Maity P, Guha M, Kumar S, Shrivastava K, Puri SK, Bandyopadhyay U | title = Inhibition of Plasmodium falciparum choline kinase by hexadecyltrimethylammonium bromide: A possible antimalarial mechanism of hexadecyltrimethylammonium bromide. | journal = Antimicrob Agents Chemother | volume = | issue = | pages = | year = 2006 | id = PMID 17145794}}</ref>
<!--Label Display Image-->
==Side effects==
The main [[adverse drug reaction|side effect]]s reported with miltefosine treatment are [[nausea]] and [[vomiting]]. Miltefosine has exhibited [[teratogenicity]], and should not be administered to [[pregnancy|pregnant]] women.
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Black Box Warning
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Miltefosine is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. 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 Miltefosine in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Miltefosine 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 Miltefosine 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 Miltefosine in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Miltefosine in pediatric patients.
Contraindications
Condition1
Warnings
ConditionName:
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 Miltefosine 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 Miltefosine in the drug label.
