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| Active Ingredient | Naltrexone Hydrochloride (5mg per capsule) |
| Dosage Form | Capsule |
| Route of Administration | Oral |
| Keep Out of Reach of Children | WARNING: Accidental ingestion by a child or individual dependent on opioids could cause a severe and sudden opioid withdrawal reaction. Keep in a secure location out of reach of others. |
| Contraindications | • Current opioid use or physical dependence on opioids. • Acute opioid withdrawal. • Failure to pass a naloxone challenge test. • Acute hepatitis or liver failure. • Hypersensitivity to Naltrexone or any ingredient in the formulation. |
| Warnings & Precautions | • Opioid Toxicity after Discontinuation: Patients becoming opioid-free after a period of naltrexone use may have reduced tolerance and are at high risk of fatal overdose if they relapse. • Hepatotoxicity: Although associated with higher doses, monitor liver function tests. • Depression and Suicidality: Monitor patients for the emergence or worsening of depression or suicidal thoughts. • Unintended Precipitation of Withdrawal: Will cause severe withdrawal in opioid-dependent individuals. |
| Adverse Reactions | Potential adverse reactions include, but are not limited to: difficulty sleeping, anxiety, headaches, joint pain, abdominal cramps, nausea, vomiting, dizziness, and vivid dreams. These often diminish with continued therapy. |
| Drug Interactions | Contraindicated with Opioids. May also interact with opioid-containing medications (e.g., some antidiarrheals and cough suppressants). |
| Patient Counseling | Advise the patient to: • Never use any opioids (e.g., heroin, morphine, oxycodone) or illicit drugs. • Inform all healthcare providers they are taking naltrexone. • Carry medical identification stating they are on naltrexone. • Be aware that naltrexone blocks the effects of opioid analgesics; non-opioid alternatives must be used for pain control. • Take as directed, usually once daily. |
| Compliance Notice | This is a compounded drug. The FDA has not evaluated this product for safety, quality, or efficacy. This product is not FDA-approved. |
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.
Frequently Asked Questions (FAQs)
The cost of Naltrexone 5mg Capsules is $$0.00
Naltrexone 5mg Capsules is manufactured by The Pharmacy Hub.
You can purchase Naltrexone 5mg Capsules on our website at https://supplies.pipelinemedical.com/product/detail/naltrexone-5mg-capsules-641039