Prasterone: Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag= | |authorTag={{AV}} | ||
|OTC=Yes | |||
|genericName=prasterone | |||
|aOrAn=a | |||
|drugClass= immunologic factor | |||
|genericName= | |indicationType=treatment | ||
|indication=of temporary relief of symptoms related to adrenal glands such as fatigue and low energy. | |||
|adverseReactions=<!--Black Box Warning--> | |||
|blackBoxWarningTitle=Title | |||
|aOrAn= | |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | ||
a | |||
|drugClass= | |||
| | |||
| | |||
|adverseReactions= | |||
<!--Black Box Warning--> | |||
|blackBoxWarningTitle= | |||
Title | |||
|blackBoxWarningBody= | |||
<i><span style="color:#FF0000;">ConditionName: </span></i> | |||
* Content | * Content | ||
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<!--FDA-Labeled Indications and Dosage (Adult)--> | <!--FDA-Labeled Indications and Dosage (Adult)--> | ||
|fdaLIADAdult======Fatigue and Low energy===== | |||
|fdaLIADAdult= | *For temporary relief of symptoms related to adrenal glands such as [[fatigue]] and [[low energy]]. | ||
===== | |||
*For temporary relief of symptoms related to adrenal glands such as fatigue and low energy. | |||
| Line 52: | Line 23: | ||
<!--Guideline-Supported Use (Adult)--> | <!--Guideline-Supported Use (Adult)--> | ||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
|offLabelAdultGuideSupport= | |||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
<!--Non–Guideline-Supported Use (Adult)--> | <!--Non–Guideline-Supported Use (Adult)--> | ||
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
|offLabelAdultNoGuideSupport= | |||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | |||
<!--Pediatric Indications and Dosage--> | <!--Pediatric Indications and Dosage--> | ||
<!--FDA-Labeled Indications and Dosage (Pediatric)--> | <!--FDA-Labeled Indications and Dosage (Pediatric)--> | ||
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | |||
|fdaLIADPed= | |||
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Off-Label Use and Dosage (Pediatric)--> | <!--Off-Label Use and Dosage (Pediatric)--> | ||
<!--Guideline-Supported Use (Pediatric)--> | <!--Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
|offLabelPedGuideSupport= | |||
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Non–Guideline-Supported Use (Pediatric)--> | <!--Non–Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
|offLabelPedNoGuideSupport= | |||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Contraindications--> | <!--Contraindications--> | ||
|contraindications= | |contraindications= | ||
<!--Warnings--> | <!--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. | |||
*If pregnant or breast-feeding, ask a health professional before use. | |||
*Tamper seal: "Sealed for Your Protection." | *Tamper seal: "Sealed for Your Protection." | ||
| Line 114: | Line 53: | ||
====Precautions==== | ====Precautions==== | ||
* Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away. | * Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away. | ||
<!--Adverse Reactions--> | <!--Adverse Reactions--> | ||
<!--Clinical Trials Experience--> | <!--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. | |||
<!--Postmarketing Experience--> | <!--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. | |||
<!--Drug Interactions--> | <!--Drug Interactions--> | ||
|drugInteractions= | |drugInteractions= | ||
<!--Use in Specific Populations--> | <!--Use in Specific Populations--> | ||
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|useInPregnancyFDA= | |useInPregnancyAUS=There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | ||
* If pregnant or breast-feeding, ask a health professional before use. | |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. | |||
|useInPregnancyAUS= | |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. | |||
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | |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. | |||
|useInLaborDelivery= | |useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment. | ||
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | |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. | |||
|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 and Monitoring--> | ||
|administration=*Sublingual | |||
|administration= | |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. | |||
<!--IV Compatibility--> | <!--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--> | <!--Overdosage--> | ||
|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label. | |||
|overdose= | |||
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label. | |||
<!--Pharmacology--> | <!--Pharmacology--> | ||
<!--Drug box 2--> | <!--Drug box 2--> | ||
|drugBox=<!--Mechanism of Action--> | |||
|drugBox= | |mechAction=<!--Structure--> | ||
|structure=<!--Pharmacodynamics--> | |||
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<!--Mechanism of Action--> | |||
|mechAction= | |||
<!--Structure--> | |||
|structure= | |||
<!--Pharmacodynamics--> | |||
|PD= | |||
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<!--Pharmacokinetics--> | <!--Pharmacokinetics--> | ||
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label. | |||
|PK= | |||
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label. | |||
<!--Nonclinical Toxicology--> | <!--Nonclinical Toxicology--> | ||
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label. | |||
|nonClinToxic= | |||
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label. | |||
<!--Clinical Studies--> | <!--Clinical Studies--> | ||
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label. | |||
|clinicalStudies= | |||
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label. | |||
<!--How Supplied--> | <!--How Supplied--> | ||
|howSupplied=<!--Patient Counseling Information--> | |||
|howSupplied= | |fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | ||
<!--Patient Counseling Information--> | |||
|fdaPatientInfo= | |||
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | |||
<!--Precautions with Alcohol--> | <!--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--> | <!--Brand Names--> | ||
|brandNames=<!--Look-Alike Drug Names--> | |||
|brandNames= | |lookAlike=<!--Drug Shortage Status--> | ||
<!--Look-Alike Drug Names--> | |||
|lookAlike= | |||
<!--Drug Shortage Status--> | |||
|drugShortage= | |drugShortage= | ||
}} | }} | ||
<!--Label Display Image--> | <!--Label Display Image--> | ||
Revision as of 13:18, 16 April 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]
Disclaimer
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Prasterone is a immunologic factor that is FDA approved for the treatment of of temporary relief of symptoms related to adrenal glands such as fatigue and low energy.. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Fatigue and Low energy
- 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
There is limited information regarding Prasterone Contraindications in the drug label.
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
There is limited information regarding Clinical Trial Experience of Prasterone in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Prasterone in the drug label.
Drug Interactions
There is limited information regarding Prasterone Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
- If pregnant or breast-feeding, ask a health professional before use.
Pregnancy Category (AUS):
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
- Sublingual
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
}}