Additional Information

Description:
Naltrexone Hydrochloride Compounded Capsules are a prescription-only, custom-formulated oral dosage form. This low-dose preparation is designed to meet specific patient needs that cannot be addressed by commercially available, FDA-approved higher-dose options. This product is compounded in a state-licensed facility under stringent quality control protocols.

• Custom Strength: Provides a precise 5mg dose, which is not typically available in commercial formulations.
• Pharmaceutical Grade: Manufactured using USP-grade Naltrexone Hydrochloride.
• Custom Compounded: Prepared in a state-licensed, FDA-registered 503B outsourcing facility (or 503A pharmacy).

• Professional Use: For prescription and monitoring by licensed healthcare providers only.

  Naltrexone is an opioid antagonist. This low-dose formulation is often used off-label to modulate the immune system and reduce inflammation. At low doses, naltrexone is believed to temporarily block opioid receptors, leading to an upregulation of endogenous opioid production and receptor expression. This may result in a subsequent reduction in pro-inflammatory cytokines and modulation of glial cells, producing anti-inflammatory and immunomodulatory effects. It may be utilized by physicians as part of a treatment plan for certain autoimmune conditions, fibromyalgia, chronic pain syndromes, and other inflammatory conditions. The prescribing physician determines the appropriateness based on clinical evaluation.

Disclaimer: This product is compounded with a drug that is not FDA-approved for the low-dose (LDN) regimen. It is provided pursuant to the order of a licensed healthcare professional. The compounded formulation is not a substitute for an FDA-approved naltrexone product where appropriate. Please refer to the safety information below.

Note: The use of Low-Dose Naltrexone (LDN) is an off-label application. It is the responsibility of the prescribing practitioner to ensure the appropriateness of this compounded medication for the intended patient based on their clinical judgement, a thorough patient evaluation, and informed consent.