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:''Marinol is also a commercial name for an [[ethanol]]-based liquid fuel sold for use in [[portable stove]]s, sold under this name at least in Finland.
{{DrugProjectFormSinglePage
{{drugbox
|authorTag={{KS}}
| IUPAC_name = ()-(6aR,10aR)-6,6,9-trimethyl-3-pentyl-
|aOrAn=a
6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol
|hasBlackBoxWarning=Yes
| image = Marinol2.jpg
|adverseReactions=<!--Black Box Warning-->
| image = Dronabinol.png
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
| CAS_number = 1972-08-3
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| ATC_prefix = A04
 
| ATC_suffix = AD10
* Content
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| PubChem = 16078
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| DrugBank = APRD00571
 
| C=21 | H=30 | O=2
<!--FDA-Labeled Indications and Dosage (Adult)-->
| molecular_weight = 314.462 g/mol
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| protein_bound = 97%
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* Dosing Information
'''Marinol''', a registered trademark of [[Unimed Pharmaceuticals]], Inc. is the commercial name for a product containing dronabinol, an analog of Δ<sup>9</sup>-[[tetrahydrocannabinol]] (THC). THC is a naturally occurring component in [[cannabis (drug)|cannabis]].
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
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* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
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=====Condition2=====
 
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* Dosing Information
 
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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)-->
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* Class of Recommendation:
 
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* Dosing Information
 
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<!--Contraindications-->
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<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
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<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
 
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=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
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|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
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|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.
 
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Marinol is an [[Food and Drug Administration|FDA]]-approved [[cannabinoid]] and is prescribed as an appetite stimulant, primarily for [[AIDS]], [[chemotherapy]] and [[gastric bypass]] patients.  Compare [[Sativex]], a mouth spray for [[neuropathic pain]] of [[multiple sclerosis]] sufferers approved for use in [[Canada]] and in the [[US]] as of 2006. While Marinol can serve as an anti-emetic and appetite booster, its immunomodulative effect should be taken into account in the treatment of any compromised immune condition.
<!--How Supplied-->
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


==Comparisons to medicinal cannabis==
<!--Precautions with Alcohol-->
Marinol is known to produce side-effects similar to cannabis intoxication.  Some have posited that Marinol lacks beneficial properties of cannabis, which contains more than 60 cannabinoids, including [[cannabidiol]] (CBD), thought to be the major anti-convulsant that helps multiple sclerosis patients, and [[cannabichromene]] (CBC), an [[anti-inflammatory]] which may contribute to the [[Analgesic|pain-killing]] effect of cannabis. Others have countered that the effects of all of cannabis's cannabinoids have not been completely studied and are not fully understood to be beneficial.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


It takes over one hour for Marinol to reach full effect, compared to minutes for [[Cannabis smoking|smoked]] or vaporized cannabis.  Some patients accustomed to inhaling just enough cannabis smoke to manage symptoms have complained of too-intense intoxication via Marinol's predetermined dosages.  This powerful psychoactive effect, however, has led to recreational use of Marinol.[http://www.erowid.org/experiences/exp.php?ID=54221] Many have said that Marinol produces a more acute psychedelic effect than cannabis and it has been speculated that this disparity can be explained by the moderating effect of the many non-THC cannibinoids present in cannabis. Mark Kleiman, director of the Drug Policy Analysis Program at UCLA's School of Public Affairs had this to say about Marinol-- "It wasn't any fun and made the user feel bad," Kleiman says, "so it could be approved without any fear that it would penetrate the recreational market, and then used as a club with which to beat back the advocates of whole cannabis as a medicine."<ref name="Respectable Reefer">{{cite news|last=Greenberg|first=Gary|title=Respectable Reefer|publisher=Mother Jones|date=[[2005-11-01]]|url=http://www.motherjones.com/news/feature/2005/11/Respectable_Reefer-3.html|accessdate = 2007-04-03}}</ref> United States federal law currently registers Dronabinol as a [[Schedule III]] drug, but all other Cannabis remains [[Schedule I]], except [[Nabilone]].  Some taking Marinol to manage nausea have stated that often the Marinol capsule is expelled before it can take effect. {{Fact|date=February 2007}}
<!--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>


Dronabinol, in a single study, may be worse than placebo for neuropathic pain associated with spinal cord injury.<ref name="pmid23874121">{{cite journal| author=Snedecor SJ, Sudharshan L, Cappelleri JC, Sadosky A, Desai P, Jalundhwala YJ et al.| title=Systematic review and comparison of pharmacologic therapies for neuropathic pain associated with spinal cord injury. | journal=J Pain Res | year= 2013 | volume= 6 | issue=  | pages= 539-47 | pmid=23874121 | doi=10.2147/JPR.S45966 | pmc=PMC3712802 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=23874121  }} </ref>
<!--Drug Shortage Status-->
|drugShortage=
}}
{{PillImage
|fileName=No image.jpg
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<!--Pill Image-->


==Regulatory history==
Since at least 1986, the trend has been for THC in general, and especially the Marinol preparation, to be downgraded to less and less stringently-controlled schedules of controlled substances, in the U.S. and internationally.


On [[July 13]], [[1986]], the [[Drug Enforcement Administration]] (DEA) issued a Final Rule and Statement of Policy authorizing the "Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules From Schedule I to Schedule II"(DEA 51 FR 17476-78). This permitted medical use of Marinol, albeit with the severe restrictions associated with Schedule II status. For instance, refills of Marinol prescriptions were not permitted. At its 1045th meeting, on [[April 29]], [[1991]], the [[Commission on Narcotic Drugs]], in accordance with article 2, paragraphs 5 and 6, of the [[Convention on Psychotropic Substances]], decided that delta-9-tetrahydrocannabinol (also referred to as delta-9-THC) and its stereochemical variants should be transferred from Schedule I to Schedule II of that Convention. This released Marinol from the restrictions imposed by Article 7 of the Convention[http://www.ukcia.org/pollaw/lawlibrary/conventiononpsychotropicsubstances1971.html].


An abstract published in the April-June 1998 issue of the [[Journal of Psychoactive Drugs]] found that "Healthcare professionals have detected no indication of scrip-chasing or doctor-shopping among the patients for whom they have prescribed dronabinol"[http://www.a1b2c3.com/drugs/mj017.htm]. The authors suggested that Marinol had a low potential for abuse.
<!--Label Display Image-->


In 1999, Marinol was rescheduled from Schedule II to III of the [[Controlled Substances Act]], reflecting a finding that THC had a potential for abuse less than that of [[cocaine]], and [[heroin]]. This rescheduling comprised part of the argument for a 2002 petition for [[cannabis rescheduling in the United States]], in which petitioner [[Jon Gettman]] noted, "Cannabis is a natural source of dronabinol (THC), the ingredient of Marinol™, a Schedule III drug.  There are no grounds to schedule cannabis in a more restrictive schedule than Marinol™"[http://www.drugscience.org/pt/b.htm].


At its 33rd meeting, the [[World Health Organization]] Expert Committee on Drug Dependence recommended transferring tetrahydrocannabinol to Schedule IV of the Convention, citing its medical uses and low abuse potential. This would put THC in the Convention's least stringently-controlled Schedule.


==External links==
*http://www.marinol.com/
* [http://www.themarinol.com/ Marinol]
* [http://www.medicalmarijuanaprocon.org/bin/procon/procon.cgi?database=5-B-Subs-3.db&command=viewone&op=t&id=6&rnd=916.3616038633891 Is Marinol better medicine than marijuana?] Debate on Marinol in a pro-con format


==References==
{{reflist|2}}
*Calhoun, S. R., Galloway, G. P., and Smith, D. E. (1998). Abuse potential of dronabinol (Marinol). Journal of Psychoactive Drugs, 30, 187-196.
*[http://www.marijuananews.com/marijuananews/cowan/dea_moves_marinol_to_schedule_th.htm DEA Moves Marinol To Schedule Three, But Leaves Marijuana in Schedule One. The Magic of Sesame Oil], [[Richard Cowan]], MarijuanaNews.Com.
*[http://www.drugscience.org/pt/b.htm Petition to Reschedule Cannabis (Marijuana) per 21 CFR §1308.44(b)], Filed [[October 9]] [[2002]] with the DEA by the [[Coalition for Rescheduling Cannabis]].
{{Antiemetics and antinauseants}}
{{cannabinoids}}


[[de:Dronabinol]]
<!--Category-->
[[fr:Dronabinol]]
[[it:Dronabinol]]
[[he:מרינול]]
[[hu:Marinol]]
[[nl:Dronabinol]]
[[hr:Tetrahidrokanabinol]]


[[Category:Cannabis]]
[[Category:Drug]]
[[Category:Cannabinoids]]
[[Category:Antiemetics]]
[[Category:Drugs]]

Revision as of 16:40, 9 February 2015

Dronabinol
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]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Black Box Warning

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

Overview

Dronabinol 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
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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 Dronabinol in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dronabinol 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 Dronabinol 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 Dronabinol 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 Dronabinol in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Dronabinol01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Dronabinol 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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