Fibromyalgia Support
CapsuleOralNon sterile Rx only

Low Dose Naltrexone (LDN) Compounded Capsules

Capsule Formulation

Low dose naltrexone (LDN) compounded as custom strength capsules for prescribers. FDA labels naltrexone only as a 50 mg tablet. Chino, CA.

Reviewed by Linda Pungpravat, Compounding Pharmacist, RPh Mixwell Compounding Pharmacy, Chino, CA

  • USP <795> compliant
  • USP <800> hazardous drug lab
  • PCCA member

Clinical Advantages

  • Strength set by the prescriber
  • Capsule strengths the 50 mg tablet does not offer
  • Dye free and allergen free options on request
  • Prepared for one patient by prescription
  • Non sterile preparation

How It Works

What is low dose naltrexone (LDN)?

Naltrexone is an opioid antagonist, which means it blocks opioid receptors. The FDA approved naltrexone hydrochloride as a 50 mg tablet. The label lists treatment of alcohol dependence and blockade of the effects of opioids given from outside the body [1].

Low dose naltrexone, or LDN, is the name used for naltrexone prepared at strengths below the 50 mg tablet. No FDA label describes a low dose strength or an LDN use. LDN capsules are not FDA approved.

What is a compounded capsule?

A capsule is a shell that holds a measured amount of medicine mixed with an inactive filler. A compounding pharmacy weighs each dose to the prescriber's order, so the strength is not limited to the 50 mg tablet.

What compounding into capsules provides

  • A strength set by the prescriber, instead of the fixed 50 mg tablet
  • A filler chosen by the pharmacist, with dye free or allergen free options on request
  • A capsule is a dry, nonaqueous form. USP 795 gives nonaqueous solid dosage forms a default beyond use date of up to 180 days [2]
  • Doses packaged to match the prescription

For prescribers

  • Family medicine, internal medicine, pain management, rheumatology, neurology, and functional or integrative medicine prescribers (MD, DO, NP, PA, ND) who want a strength the 50 mg tablet does not offer
  • Send the prescription with the strength per capsule, the quantity, and any filler or dye needs. Call (909) 378-7301 to speak with our pharmacist
  • Review the label contraindications, including opioid analgesics, before prescribing [1]

For patients

  • Your prescriber decides if this is right for you and sets the strength
  • Tell your prescriber about every opioid pain medicine you take, including prescription and some cough or diarrhea medicines
  • Tell our pharmacist about allergies to dyes or fillers

Clinical Details

What does the evidence show?
  • The FDA approved naltrexone hydrochloride 50 mg tablets for alcohol dependence and for blockade of the effects of opioids given from outside the body [1].
  • The label states naltrexone has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions [1].
  • No FDA label describes a low dose strength, and the FDA has not reviewed LDN capsules.

Findings come from the cited studies and do not promise any individual outcome.

Why is it compounded, and how is it typically used?

Why it is compounded

Naltrexone is FDA approved as a 50 mg tablet [1]. No approved product comes in a lower strength. A prescriber who wants a lower strength orders it compounded.

Dosage forms and strengths

  • Strength per capsule set by the prescriber
  • Filler chosen with the pharmacist, dye free on request
  • Quantities matched to the prescription

Dosing is the prescriber's decision.

How Mixwell prepares it

Mixwell compounds these capsules in Chino, California under USP 795 standards for non sterile preparations [2]. Our pharmacist confirms the strength with the prescriber and assigns the beyond use date. Finished capsules ship across California, including Chino Hills, Ontario, Pomona, Diamond Bar, and Rancho Cucamonga.

Safety information

Naltrexone labeling lists these contraindications: taking opioid analgesics, current opioid dependence including methadone or buprenorphine, acute opioid withdrawal, a failed naloxone challenge or positive opioid urine screen, and hypersensitivity [1].

The label warns of liver injury, of precipitated opioid withdrawal that can need hospital care, and of fatal overdose if a patient takes opioids at prior doses after treatment lowers tolerance. It reports depression and suicidal thoughts in postmarketing use and notes that emergency pain control may need more opioid than usual [1].

Common reactions listed on the label are nausea, headache, dizziness, nervousness, fatigue, insomnia, vomiting, anxiety, and sleepiness. The label advises using naltrexone in pregnancy only if the benefit justifies the risk [1].

These warnings come from the 50 mg tablet label. No FDA labeling describes low dose strengths. Patient selection, dosing, and monitoring are the prescriber's responsibility. Patients should talk with their own healthcare professional before using any medication.

References
  1. Naltrexone hydrochloride tablets USP, 50 mg. Prescribing information. DailyMed
  2. United States Pharmacopeia. General Chapter 795, Pharmaceutical Compounding: Nonsterile Preparations. USP NF. Official November 1, 2023.

What to include on the prescription

  • APIs and strengths
  • Base or vehicle
  • Quantity
  • Directions for use
  • Refills
  • Allergies or dye free needs
Call (909) 378-7301 Fax (909) 378-7071

Related Solutions

Low Dose Naltrexone (LDN) Compounded Oral Liquid SuspensionORAL SUSPENSION Low Dose Naltrexone (LDN) Compounded Sublingual TrochesTROCHE Low Dose Naltrexone (LDN) Compounded Topical CreamTOPICAL Naltrexone Nasal Spray (MucoLox™)SPRAY Commonly prescribed for Fibromyalgia Support

Compounded in Chino, CA. Delivered across California.

  • Chino
  • Chino Hills
  • Ontario
  • Pomona
  • Diamond Bar
  • Rancho Cucamonga
  • Eastvale
Mixwell Compounding Pharmacy 13788 Roswell Ave, Ste 158, Chino, CA 91710
(909) 378-7301

Compounded medications are not reviewed or approved by the FDA. Dispensed only with a valid prescription. Mixwell is a non sterile pharmacy and does not prepare sterile products or injectables. Compounded preparations are not presented as superior to commercially available products, and nothing here promises a specific result. Mixwell does not accept insurance. Call for pricing.

Call pharmacist Send Rx

Want to learn more about Low Dose Naltrexone (LDN) Compounded Capsules

Are you a healthcare provider or patient in Chino, Chino Hills, Ontario, Eastvale, Rancho Cucamonga, or Upland? Mixwell Pharmacy provides specialized pharmaceutical support throughout San Bernardino, Los Angeles, and Orange Counties. Contact our Chino laboratory to learn how we facilitate customized Low Dose Naltrexone (LDN) Compounded Capsulesfor practitioners across Southern California.

(909) 378-7301

Serving Los Angeles County, Orange County, San Bernardino County, Riverside County, Ventura County, and the Inland Empire