TrocheSublingualNon sterile Rx only

Low Dose Naltrexone (LDN) Compounded Sublingual Troches

Troche Formulation

Low dose naltrexone (LDN) compounded as a troche that dissolves in the mouth. 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 Sublingual Troches
Dosage form	Troche
Route	Sublingual
Active ingredients	Naltrexone hydrochloride
Technology	Troche Formulation
Strengths in literature	Tablets: 50 mg (FDA label). No FDA labeled low dose strength or troche.
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

Dissolves in the mouth, no swallowing a capsule
Strength set by the prescriber
Troche base chosen with the pharmacist
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, a troche, or an LDN use. LDN troches are not FDA approved.

What is a sublingual troche?

A troche, also called a lozenge, is a solid dose that dissolves slowly in the mouth instead of being swallowed whole. Sublingual means the troche is placed under the tongue. A compounding pharmacy makes it to the prescriber's order.

What is a troche base?

The base is the material that holds the medicine in a solid shape and lets it dissolve in the mouth. Troche bases come in several types. One example is NataTroche from PCCA. Its manufacturer describes it as an anhydrous, lipid based base made without polyethylene glycol or gelatin [2]. These are the manufacturer's descriptions.

What compounding into a troche provides

A strength set by the prescriber, instead of the fixed 50 mg tablet
A dose that dissolves in the mouth, for patients who prefer not to swallow a capsule or tablet
A choice of base and flavor made with the pharmacist, including options for patients who need to avoid an ingredient
A nonaqueous base, which USP 795 gives a default beyond use date of up to 180 days, longer than a water based liquid [3]

How naltrexone is absorbed from a troche, and how that compares with a swallowed tablet, is not described in FDA labeling.

For prescribers

Family medicine, internal medicine, pain management, rheumatology, neurology, geriatrics, and functional or integrative medicine prescribers (MD, DO, NP, PA, ND) whose patients prefer a dissolving form
Send the prescription with the strength per troche, the quantity, 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
Follow your prescriber's directions on where to place the troche and how long to let it dissolve
Tell your prescriber about every opioid pain medicine you take, including some cough and diarrhea medicines
Tell our pharmacist about allergies to dyes or flavors

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 a troche, 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 troche or comes in a lower strength. A prescriber who wants a dissolving form, or a lower strength, orders it compounded.

Dosage forms and strengths

Strength per troche set by the prescriber
Troche base chosen with the pharmacist, with flavoring on request
Quantities matched to the prescription

Dosing is the prescriber's decision.

How Mixwell prepares it

Mixwell compounds these troches in Chino, California under USP 795 standards for non sterile preparations [3]. Our pharmacist confirms the strength and base with the prescriber and assigns the beyond use date. Finished troches 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 troches. 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
PCCA. NataTroche troche base, manufacturer description (2019). Used only to describe a base, not as evidence for any clinical claim.
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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