Important Safety Information: Naltrexone | Compounded Oral

What is this?

This Important Safety Information summarizes key warnings and precautions for naltrexone, an opioid receptor antagonist used to support treatment for alcohol dependence, opioid dependence, and, in certain clinical settings, other provider-directed uses. Naltrexone works by blocking the effects of opioids in the brain. This compounded formulation has not been reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. It 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 swelling of the face, lips, tongue, or throat

• Liver injury or hepatitis, especially at higher doses

• Opioid withdrawal symptoms if opioids are still present in the body

• Increased sensitivity to opioids after stopping naltrexone, which may increase overdose risk

• Depression or mood changes in some individuals

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

Who Should NOT Take Naltrexone

Do not take this medication if you:

• Are currently using opioid medications or opioid-containing products

• Have acute opioid withdrawal

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

• Have severe liver disease or acute hepatitis

• Are unable to remain opioid-free prior to starting therapy

Before Taking Naltrexone, Tell Your Healthcare Provider if You:

• Have liver disease or abnormal liver function tests

• Use prescription, over the counter, herbal supplements, or recreational drugs

• Drink alcohol regularly

• Have a history of depression or other mental health conditions

• Are pregnant, planning pregnancy, or breastfeeding

• Smoke or use tobacco products

Provide a complete list of all medications, supplements, and substances you use, as interactions may occur.

Possible Side Effects

Common (mild to moderate):

• Nausea

• Headache

• Dizziness

• Fatigue

• Anxiety or sleep disturbances

• Stomach discomfort

Serious (seek medical care immediately):

• Rash, hives, swelling of the face or throat, difficulty breathing

• Severe abdominal pain

• Dark urine or yellowing of the skin or eyes

• Severe mood changes or suicidal thoughts

• Signs of liver problems

While Taking Naltrexone

Tell your healthcare provider immediately if you:

• Develop symptoms of liver injury such as fatigue, nausea, dark urine, or yellowing of the skin

• Experience severe mood changes or depression

• Attempt to override the opioid-blocking effects by taking opioids

• Develop new or worsening symptoms

It may take time for this medication to begin working and for you to notice changes.

Overdose

Symptoms of overdose may include:

• Severe nausea or vomiting

• Drowsiness

• Dizziness

• Liver-related symptoms

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

Missed Dosage

If you miss a scheduled dose:

• Take the missed dose when you remember unless it is close to your next scheduled dose

• Skip the missed dose if it is near the time for your next dose

• Do not double doses

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

Storage

• Store at room temperature unless otherwise directed on your label

• Keep out of reach of children and pets

• Follow specific storage instructions provided on your prescription label

Medication Disposal

Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication or pour it down household drains. 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 your medical history, goals, or lab results.

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 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.