Prasterone
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.
- 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
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
- 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
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
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Package and Label Display Panel
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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.
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