Prasterone

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Prasterone
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: Aparna Vuppala, M.B.B.S. [2]

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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 androgen that is FDA approved for the treatment of symptoms related to adrenal glands such as fatigue and low energy.. Common adverse reactions include hirsutism, acne, heart rhythm problems, liver problems, hair loss (from the scalp), and oily skin.

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

NONE

Warnings

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

DHEA is a steroid hormone. High doses may cause aggressiveness, irritability, trouble sleeping, and the growth of body or facial hair on women. It also may stop menstruation and lower the levels of HDL, or "good," cholesterol, which could raise the risk of heart disease. Other reported side effects include acne, heart rhythm problems, liver problems, hair loss (from the scalp), and oily skin. It may also alter the body's regulation of blood sugar.[1]

Drug Interactions

There is limited information regarding Prasterone Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • 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

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

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Prasterone
Systematic (IUPAC) name
(3S,8R,9S,10R,13S,14S)-3-hydroxy-10,13-dimethyl-1,2,3,4,7,8,9,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-one; (1S,2R,5S,10R,11S,15S)-5-Hydroxy-2,15-dimethyltetracyclo[8.7.0.02,7.011,15]heptadec-7-en-14-one
Identifiers
CAS number 53-43-0
ATC code A14AA07
G03EA03 (WHO) (combination with estrogen)
PubChem 5881
DrugBank DB01708
Chemical data
Formula C19H28O2 
Mol. mass 288.424 g/mol
SMILES eMolecules & PubChem
Synonyms (3β)-3-Hydroxyandrost-5-en-17-one
Physical data
Melt. point 148.5 °C (299 °F)
Pharmacokinetic data
Bioavailability ?
Metabolism Hepatic
Half life 12 hours
Excretion Urinary:?%
Therapeutic considerations
Pregnancy cat.

?

Legal status

Prescription Only (S4)(AU) ?(CA) OTC(US)

Routes Oral

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

Package and Label Display Panel

Prasterone.png
This image of the FDA label is provided by the National Library of Medicine.
Prasterone02.png
This image of the FDA label is provided by the National Library of Medicine.

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.

  1. "DHEA".

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