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Important Safety Information Regarding Compounded Glutathione Products

Please be aware that compounded drugs are not FDA-approved and do not undergo the clinical studies required to evaluate safety and efficacy for commercially available products. Compounded products may still be legally prescribed, and your healthcare provider may issue you a prescription for compounded glutathione based on your medical consultation.

FDA Warning:

Glutathione injections have not been evaluated or approved by the U.S. Food and Drug Administration (FDA) for any specific medical use, dosage, or safety profile. The safety and effectiveness of glutathione injections for any condition are not established by the FDA. If you prefer FDA-approved treatments, consult your healthcare provider for alternatives.

Glutathione is a naturally occurring antioxidant tripeptide (glutamine, cysteine, glycine). Injectable glutathione may be used off-label, as determined appropriate by your provider, to support antioxidant defenses, liver detoxification, immune function, or skin health.

Speak with your healthcare provider to see if glutathione may be right for you.

Glutathione may cause serious side effects, including:

• Severe allergic reactions. Stop using glutathione and seek medical attention if you experience swelling of the face, lips, tongue, or throat; difficulty breathing; rash or hives; fainting; or very rapid heartbeat.
  
  
• Bronchospasm or asthma exacerbation. Discontinue use and contact your provider if you develop wheezing, chest tightness, or shortness of breath.
  
  
• Hemolytic anemia in people with G6PD deficiency. Tell your provider if you have been diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency or unexplained episodes of anemia.
  
  

Who should not use glutathione:

• Do not use glutathione if you are allergic to glutathione or any of its ingredients.
  
  
• Do not use glutathione if you have G6PD deficiency.
  
  
• Do not use glutathione if you have uncontrolled asthma or have experienced glutathione-induced bronchospasm in the past.
  
  
• Do not use glutathione if you are pregnant or plan to become pregnant, or if you are breastfeeding, unless specifically advised by your provider.
  
  
• Do not use glutathione if you have an active infection, fever, or active cancer unless cleared by a specialist.
  
  

Before starting glutathione, tell your healthcare provider if you have any other medical conditions, including if you:

• Have liver or kidney disease.
  
  
• Have chronic lung conditions, including asthma or COPD.
  
  
• Are receiving chemotherapy or other antioxidant therapies.
  
  
• Are taking prescription medications, over-the-counter medicines, vitamins, or herbal supplements.
  
  

Serious side effects can occur with glutathione. You or a caregiver should carefully monitor for these side effects, especially at the beginning of treatment and with dosage changes. Glutathione may cause serious side effects, including those listed above.

The most common side effects of glutathione may include:

Injection-site pain, redness, or swelling; headache; light-headedness; flushing; mild nausea; abdominal discomfort; diarrhea; or fatigue. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Glutathione administration:

Glutathione is typically administered as a subcutaneous or intramuscular injection, 200 mg – 800 mg one to three times weekly, as directed by your provider. Use aseptic technique, inject slowly (about 20–30 seconds), and rotate injection sites to minimize irritation. You should not change your dosing regimen or stop taking glutathione as prescribed without first discussing with your healthcare provider.

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

You are encouraged to report negative side effects of prescription products:

Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch

This information is not comprehensive. Please discuss with your healthcare provider any questions or concerns you have regarding glutathione.

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