Prasterone: Difference between revisions

Jump to navigation Jump to search
Aparna Vuppala (talk | contribs)
No edit summary
 
Aparna Vuppala (talk | contribs)
No edit summary
Line 1: Line 1:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d6edd874-495c-4eb5-bf3d-72c2ee41fc88
{{DrugProjectFormSinglePage
|authorTag=
 
 
<!--Overview-->
 
|genericName=
 
 
 
|aOrAn=
 
a
 
|drugClass=
 
 
 
|indication=
 
 
 
|hasBlackBoxWarning=
 
Yes
 
|adverseReactions=
 
 
 
<!--Black Box Warning-->
 
|blackBoxWarningTitle=
Title
 
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>
 
* Content
 
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=
 
=====Condition1=====
*For temporary relief of symptoms related to adrenal glands such as fatigue and low energy.
 
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport=
 
 
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=
 
 
 
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=
 
 
 
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=
 
 
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport=
 
 
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
 
|contraindications=
 
*
 
<!--Warnings-->
 
|warnings=
 
*Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.
 
*If pregnant or breast-feeding, ask a health professional before use.
 
*Tamper seal: "Sealed for Your Protection."
 
*Do not use if seal is broken or missing.
 
====Precautions====
 
* Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.
<!--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.
 
 
<!--Drug Interactions-->
 
|drugInteractions=
 
* Drug
:* Description
 
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=
* If pregnant or breast-feeding, ask a health professional before use.
 
|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=
*If pregnant or breast-feeding, ask a health professional before use.
 
|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
 
 
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
 
<!--IV Compatibility-->
 
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
 
|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=
 
 
<!--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.
 
<!--Nonclinical Toxicology-->
 
|nonClinToxic=
 
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
 
|clinicalStudies=
 
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
 
|howSupplied=
 
<!--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.
 
<!--Brand Names-->
 
|brandNames=
 
<!--Look-Alike Drug Names-->
 
|lookAlike=
 
 
<!--Drug Shortage Status-->
 
|drugShortage=
}}
 
 
 
<!--Label Display Image-->
 
{{LabelImage
|fileName={{PAGENAME}}.png|This image is provided by the National Library of Medicine.}}
 
{{LabelImage
|fileName={{PAGENAME}}02.png|This image is provided by the National Library of Medicine.}}
 
<!--Category-->
 
[[Category:Drug]]

Revision as of 13:13, 16 April 2015

Prasterone
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

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.

Black Box Warning

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

Overview

Prasterone 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
  • For temporary relief of symptoms related to adrenal glands such as fatigue and low energy.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.
  • If pregnant or breast-feeding, ask a health professional before use.
  • Tamper seal: "Sealed for Your Protection."
  • Do not use if seal is broken or missing.

Precautions

  • Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

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

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • If pregnant or breast-feeding, ask a health professional before use.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Prasterone in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

  • If pregnant or breast-feeding, ask a health professional before use.

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Prasterone 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 Prasterone Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Prasterone 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:

 |Label Page=Prasterone
 |Label Name=Prasterone.png

}}


{{#subobject:

 |Label Page=Prasterone
 |Label Name=Prasterone02.png

}}