Important Safety Information: Naltrexone, Theanine, Selenium | Compounded Formulation

What is this?

This Important Safety Information summarizes key warnings and precautions for Theanine, Selenium, and Naltrexone, a compounded formulation that may be used to support neurological balance, metabolic health, antioxidant support, and behavioral regulation under provider supervision.

L-theanine is an amino acid commonly used to promote calm focus. Selenium is an essential trace mineral involved in antioxidant and thyroid function. Naltrexone is an opioid receptor antagonist used in various clinical settings to support behavior modification and metabolic pathways.

This compounded formulation is not reviewed or approved by the U.S. Food and Drug Administration for safety or efficacy and should only be used exactly as directed by a licensed healthcare provider. This summary does not include all available information. Always read your medication label and follow your provider’s instructions.

Most Serious Warnings

Product can cause:

• Severe allergic reactions, including rash, hives, swelling of the face, lips, tongue, or throat

• Liver problems, including dark urine, yellowing of skin or eyes, abdominal pain, or fatigue

• Mood or behavioral changes, including depression or suicidal thoughts

• High blood pressure with severe headache, dizziness, fainting, or vision changes

• Confusion or neurological changes

• Breathing difficulties, including slow or shallow breathing

• Injection site reactions, irritation, or tissue damage if applicable

Compounded medications may carry sterility or formulation risks due to limited FDA oversight.

Who Should NOT Take This Medication

Do not take this medication if you:

• Have a known allergy to theanine, selenium, naltrexone, or any ingredient in the formulation

• Have acute hepatitis or liver failure

• Are currently using opioid medications or are physically dependent on opioids

• Have uncontrolled high blood pressure without provider clearance

• Are pregnant unless specifically directed by your provider

Before Taking This Medication, Tell Your Healthcare Provider if You:

• Have liver disease or abnormal liver labs

• Have depression, anxiety, or a history of mood disorders

• Have a history of substance use disorder

• Have kidney problems

• Are taking prescription, over the counter, herbal, or supplement products

• Drink alcohol regularly

• Are pregnant, planning pregnancy, or breastfeeding

Possible Side Effects

Common (mild to moderate):

• Headache

• Anxiety or nervousness

• Trouble sleeping

• Dizziness or fatigue

• Nausea, stomach pain, constipation, diarrhea, or decreased appetite

• Muscle cramps

• Dry mouth

• Cold-like symptoms

• Mild injection site irritation if applicable

• L-theanine has been associated with headaches in some individuals.

• Selenium supplementation may require lab monitoring if used long term.

Serious (seek medical care immediately):

• Rash, swelling, wheezing, difficulty breathing

• Signs of liver problems such as dark urine, light-colored stools, yellow skin or eyes

• Severe mood changes or suicidal thoughts

• Severe confusion

• Chest tightness or trouble breathing

• Severe injection site reaction with blistering, dark scab, or open wound

While Taking This Medication

Tell your healthcare provider immediately if you:

• Develop yellowing of the skin or eyes

• Experience worsening depression or mood changes

• Notice severe headache or vision changes

• Develop unusual swelling or allergic symptoms

• Do not experience improvement in symptoms over time

Routine lab monitoring may be required based on your clinical plan.

Pregnancy and Fertility

Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding. The risks and benefits must be reviewed individually. Naltrexone use during pregnancy requires medical supervision.

Overdose

Symptoms of overdose may include:

• Severe nausea or vomiting

• Extreme drowsiness or confusion

• Severe headache

• Liver-related symptoms

• Breathing difficulty

If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.

Missed Dosage

If you miss a dose:

• Take it as soon as you remember unless it is close to your next scheduled dose

• Do not double doses

• Contact your provider if you are unsure how to resume therapy

Storage

• Store according to the instructions on your pharmacy label

• Keep out of reach of children and pets

• Protect from light if indicated

• Do not freeze unless instructed

Medication Disposal

Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication or dispose of it in household drains unless instructed. Ask your pharmacy about medication take-back programs.

Provider Oversight and Order Review

This compounded medication requires review and oversight by licensed Superior Health and Wellness providers. Dosing and therapy schedules must be discussed directly with your provider to ensure safety and clinical appropriateness. Orders may be adjusted based on labs, treatment goals, or response.

Telemedicine Disclosure

This prescription may be issued via telemedicine. If you experience concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.

Disclaimer

This summary does not include all information about Theanine, Selenium, or Naltrexone and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. This compounded medication has not been evaluated or approved by the FDA for safety or efficacy.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.