Glutathione

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Glutathione
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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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

Glutathione is an amino acid supplement that is FDA approved for the treatment of chronic fatigue, muscle aches and pain. Common adverse reactions include cutaneous eruptions.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • For temporary relief of chronic fatigue, muscle aches and pain, lowered immune response, and sensitivity to environmental chemicals.

Dosage

  • 10 drops orally, 3 times a day.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • Prior hypersensitivity to glutathione

Warnings

  • If pregnant or breast-feeding, ask a health care professional before use.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

Adverse Reactions

Clinical Trials Experience

  • cutaneous eruptions

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Glutathione in the drug label.

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Glutathione in women who are pregnant.
Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Glutathione overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

This image is provided by the National Library of Medicine.

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Images

Drug Images

Package and Label Display Panel

Glutathione fig.jpg
This image of the FDA label is provided by the National Library of Medicine.
Glutathione ingredients and appearance.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 Glutathione in the drug label.

Precautions with Alcohol

  • Alcohol-Glutathione interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

GLUTATHIONE

Look-Alike Drug Names

There is limited information regarding Glutathione 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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