Low-Dose Naltrexone (LDN): What Patients Should Know About Compounded LDN
If you or someone you love has been prescribed Low-Dose Naltrexone, commonly referred to as LDN, you may have questions about what it is, why it may need to be compounded, and how a compounding pharmacy can prepare a patient-specific prescription.
At Center Pharmacy, our compounding team works with patients and licensed prescribers to prepare customized medication strengths and dosage forms when prescribed for an individual patient's needs.
What Is Naltrexone?
Naltrexone is a prescription medication that is FDA-approved for certain uses related to alcohol dependence and opioid dependence. FDA-approved naltrexone products are commercially available in specific strengths and dosage forms.
The term Low-Dose Naltrexone, or LDN, is commonly used to describe naltrexone prescribed at doses lower than those associated with its FDA-approved indications.
Use of naltrexone at low doses for indications that have not been approved by the FDA is considered off-label use. A licensed healthcare provider is responsible for determining whether an off-label medication or a patient-specific compounded preparation is appropriate for an individual patient.
Why Is Low-Dose Naltrexone Compounded?
Commercially manufactured oral naltrexone is available in a 50 mg tablet. When a licensed prescriber determines that an individual patient requires a different strength or dosage form that is not commercially available, a compounded medication may be prescribed to meet that patient's specific needs.
A compounding pharmacy can prepare a patient-specific naltrexone prescription according to the strength and dosage form ordered by the prescriber.
Depending on the prescription and individual patient's needs, a compounded preparation may be available in different strengths or dosage forms. The appropriate prescription, strength, dosage form, and directions for use are determined by the patient's licensed healthcare provider.
What Are Compounded Medications?
Compounding allows appropriately licensed pharmacies to prepare patient-specific medications based on prescriptions from licensed healthcare providers.
Compounded medications may be considered when a patient's medical needs cannot be met by an FDA-approved, commercially available drug, such as when a different strength or dosage form is prescribed.
It is important for patients to understand that compounded medications are not FDA-approved. The FDA does not review compounded medications for safety, effectiveness, or quality before they are marketed.
Patients should discuss the potential benefits, risks, alternatives, and appropriate use of any prescribed medication with their healthcare provider.
Is LDN Right for You?
Whether Low-Dose Naltrexone is appropriate for an individual patient is a decision that should be made between the patient and a licensed healthcare provider.
If you have questions about LDN, speak with your healthcare provider about the available evidence, potential risks, drug interactions, alternative treatments, and whether an off-label use of naltrexone may be appropriate for your individual circumstances.
If your healthcare provider determines that a patient-specific compounded naltrexone preparation is appropriate, they can send a prescription to a compounding pharmacy with the prescribed strength, dosage form, and directions for use.
Compounded LDN at Center Pharmacy
Center Pharmacy is a Florida-licensed compounding pharmacy that prepares patient-specific compounded prescriptions pursuant to orders from licensed healthcare providers.
When we receive a prescription for compounded naltrexone, our compounding team prepares the medication according to the prescriber's specifications and applicable pharmacy standards.
Our pharmacists are also available to communicate with patients and prescribers regarding available strengths, dosage forms, prescription requirements, and other pharmacy-related questions about compounded preparations.
Getting Your Prescription at Center Pharmacy
If your healthcare provider has prescribed a compounded naltrexone preparation, the prescription can be sent directly to Center Pharmacy.
Once we receive the prescription, our pharmacy team will process and prepare the medication according to the prescriber's instructions. Patients can pick up completed prescriptions at our Cape Coral pharmacy or, when eligible, use our free local delivery service within our delivery area.
Have questions about filling a compounded prescription? Contact Center Pharmacy and our pharmacy team will be happy to assist you.
Important Information About Compounded Medications
Compounded medications are not FDA-approved. The FDA does not review compounded medications for safety, effectiveness, or quality before they are marketed.
The use of naltrexone for indications outside its FDA-approved labeling is considered off-label. Information provided on this page is for general educational purposes and is not intended to make claims regarding the safety or effectiveness of compounded Low-Dose Naltrexone for the diagnosis, treatment, cure, or prevention of any disease or medical condition.
Medication decisions should be made by a patient and their licensed healthcare provider based on the patient's individual medical needs.