Oral suspensionOralNon sterile Rx only

Low Dose Naltrexone (LDN) Compounded Oral Liquid Suspension

Oral Suspension Formulation

Low dose naltrexone (LDN) compounded as an oral liquid suspension, dosed by volume. 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

At a Glance

Preparation details for Low Dose Naltrexone (LDN) Compounded Oral Liquid Suspension
Dosage form	Oral suspension
Route	Oral
Active ingredients	Naltrexone hydrochloride
Technology	Oral Suspension Formulation
Strengths in literature	Tablets: 50 mg (FDA label). No FDA labeled low dose strength or oral liquid.
Commercial product	Commercial product in a different dosage form
Strength and directions	Per prescriber
Dispensing	Valid prescription

Speak with our pharmacist Send a prescription

Phone (909) 378-7301. Fax (909) 378-7071

Clinical Advantages

Liquid dose measured by volume
Strength set by the prescriber
Alternative to swallowing a capsule or tablet
Flavor and dye free options on request
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, an oral liquid, or an LDN use. LDN oral liquids are not FDA approved.

What is an oral liquid suspension?

An oral liquid suspension is a liquid medicine that you swallow. The medicine is mixed through a liquid base. The pharmacy makes it to the prescriber's order, and the dose is measured by volume with an oral syringe.

What compounding into an oral liquid provides

A strength set by the prescriber, instead of the fixed 50 mg tablet
A dose measured by volume, so the amount can be matched to the order
A liquid for patients who prefer not to swallow, or cannot swallow, a capsule or tablet
A base, flavor, and dye choice made with the pharmacist for patients who need to avoid an ingredient

A water based liquid has a shorter default beyond use date under USP 795 than a dry capsule: 14 days if it has no preservative, and 35 days if it is preserved [2]. The pharmacist assigns the date for each preparation.

For prescribers

Family medicine, internal medicine, pain management, rheumatology, neurology, geriatrics, and functional or integrative medicine prescribers (MD, DO, NP, PA, ND) whose patients cannot take a capsule
Send the prescription with the strength per mL, the volume, and any flavor 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 dose
Measure each dose with the oral syringe from the pharmacy
Tell your prescriber about every opioid pain medicine you take, including some cough and diarrhea medicines
Tell our pharmacist about allergies to dyes, flavors, or preservatives

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 or an oral liquid, and the FDA has not reviewed this preparation.

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 is a liquid or comes in a lower strength. A prescriber who wants a liquid, or a lower strength, orders it compounded.

Dosage forms and strengths

Strength per mL set by the prescriber
Liquid base chosen with the pharmacist, with flavor or dye free options on request
Volumes matched to the prescription

Dosing is the prescriber's decision.

How Mixwell prepares it

Mixwell compounds these liquids in Chino, California under USP 795 standards for non sterile preparations [2]. Our pharmacist confirms the strength and base with the prescriber and assigns the beyond use date. Finished liquids 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 or oral liquids. Patient selection, dosing, and monitoring are the prescriber's responsibility. Patients should talk with their own healthcare professional before using any medication.

References

Naltrexone hydrochloride tablets USP, 50 mg. Prescribing information. DailyMed
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

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.

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