Glutathione

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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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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

## 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

# 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