Pediatric acute-onset neuropsychiatric syndrome (PANS) and its streptococcal-triggered subset, pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS), are characterized by sudden-onset obsessive-compulsive disorder (OCD), tics, and mood changes. Standard treatments include antibiotics to address infections and immunomodulatory therapies, such as IVIG or steroids to reduce inflammation. However, these treatments may cause nausea, vomiting, headaches, and dizziness; they also pose a risk of infection. Adjunct therapies like low-dose naltrexone (LDN) can help modulate the immune system and reduce neuroinflammation.

Understanding the Use of Low-Dose Naltrexone (LDN)

Naltrexone is typically prescribed at a dose of 50 mg for opioid and alcohol dependence.¹ In contrast, low-dose naltrexone refers to off-label use of naltrexone at a dosage of around ≤ 4.5 mg/ day. At these low doses, naltrexone exhibits unique immunomodulating properties rather than the sustained opioid blockade seen at higher doses, allowing it to be prescribed for a variety of indications, including dermatological conditions and supporting women’s health. 

LDN has also been used in a range of inflammatory and autoimmune conditions in adults, including multiple sclerosis and fibromyalgia.² Studies have also indicated that LDN is well-tolerated in children, with an eight-week trial in children with Crohn’s disease reporting that LDN significantly reduced the disease’s severity without serious adverse events.³ This safety profile makes LDN an attractive candidate for other conditions in pediatric patients.

LDN for PANS/PANDAS Treatment

Although it won’t cure the underlying cause of PANS/PANDAS, LDN can be used as part of a personalized treatment plan and not as a replacement for antibiotics or IVIG when those are indicated.^3,4 Because a child’s immune system attacks various parts of the body, including the brain, for patients with PANS/PANDAS, prescribers may consider therapies that restore immune balance.⁵ LDN’s exact mechanisms are still being investigated, but it has been suggested that LDN may directly reduce neuroinflammation by binding to toll-like receptor 4 (TLR4) on microglia, inhibiting their activation and inflammatory cytokine release.⁶ 

While there are no large-scale clinical studies for PANS/PANDAS patients, other studies have suggested that LDN may also help children with pain regulation since individuals with PANS/PANDAS often suffer from headaches and joint pain.^7,4 

Dosing Considerations

LDN (typically ≤ 4.5 mg) is inexpensive and usually formulated by compounding pharmacies since such low strengths are not commercially available. Compounding for pediatric patients requires additional considerations compared with compounding for adults, including the dosage form, which should be personalized to each pediatric patient’s age, weight, and height.⁸ Prescribers can begin with a low dose such as 0.1 mg/kg and gradually titrate up if necessary to minimize initial side effects, which are generally mild, such as vivid dreams or mild agitation.³ 

Compounded LDN Formulations 

LDN therapy requires individualized dosing and formulation, especially for pediatric patients. Because commercially available naltrexone tablets (50 mg) cannot be split accurately to the milligram or microgram range, LDN should be prepared by compounding pharmacists into low-dose capsules or suspensions. This allows precise dosing such as 0.5 mg, 1.5 mg, or 3 mg based on an individual pediatric patient’s needs. 

Compounding also allows LDN to be formulated as a flavored liquid, which is helpful if the child cannot swallow capsules.⁹ Because PANS/PANDAS are episodic conditions, their symptoms often come and go, and providers may need to continue LDN for extended periods. Regular follow-up is advised to track changes in OCD/tic severity, mood, and energy levels, as well as to adjust the dosing by working closely with a trusted compounding pharmacy.  

Why Choose VLS Pharmacy & New Drug Loft?

Accurate dosing is critical to the success of any therapy, especially in pediatric patients. Since naltrexone is currently only commercially available as 50 mg tablets, prescribers will need to consult a licensed compounding pharmacy to ensure accurate LDN dosing for treating PANS/PANDAS. VLS Pharmacy & New Drug Loft can create LDN formulations with patient-specific dosing and administration routes, helping ensure that pediatric patients are receiving accurate doses.

By working closely with a 503A compounding pharmacy, providers can ensure that their low-dose naltrexone (LDN) is precisely tailored to the specific needs of individual pediatric patients suffering from PANS or PANDAS. Our LDN is compounded in non-sterile compounding facility that is USP chapters <795> compliant.

Please comment below with any thoughts or questions.

Reach out to our team to learn about best practices and to partner with our experts on custom compounded medications for your patients. All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.

 

References

1. Singh D, Saadabadi A. Naltrexone. In: StatPearls. StatPearls Publishing; 2025. Accessed July 29, 2025. http://www.ncbi.nlm.nih.gov/books/NBK534811/
2. Li Z, You Y, Griffin N, Feng J, Shan F. Low-dose naltrexone (LDN): A promising treatment in immune-related diseases and cancer therapy. Int Immunopharmacol. 2018;61:178-184. doi:10.1016/j.intimp.2018.05.020
3. Smith JP, Field D, Bingaman SI, Evans R, Mauger DT. Safety and tolerability of low-dose naltrexone therapy in children with moderate to severe Crohn’s disease: a pilot study. J Clin Gastroenterol. 2013;47(4):339-345. doi:10.1097/MCG.0b013e3182702f2b
4. Weinstock LB, Brook JB, Myers TL, Goodman B. Successful treatment of postural orthostatic tachycardia and mast cell activation syndromes using naltrexone, immunoglobulin and antibiotic treatment. BMJ Case Rep. 2018;2018:bcr2017221405. doi:10.1136/bcr-2017-221405
5. PANS and PANDAS: Questions and Answers – National Institute of Mental Health (NIMH). Accessed July 29, 2025. https://www.nimh.nih.gov/health/publications/pandas
6. Toljan K, Vrooman B. Low-Dose Naltrexone (LDN)—Review of Therapeutic Utilization. Med Sci. 2018;6(4):82. doi:10.3390/medsci6040082
7. Theriault C, Oyelola O, Zempsky WT. The Efficacy Of Low-Dose Naltrexone In Pediatric Chronic Pain: A Retrospective Analysis. J Pain. 2023;24(4, Supplement):84-85. doi:10.1016/j.jpain.2023.02.243
8. THE PCCA BLOG | Challenges in Pediatric Compounding: Excipients and Dosage Forms. Accessed July 29, 2025. https://www.pccarx.com/Blog/challenges-in-pediatric-compounding-excipients-and-dosage-forms
9. Carvalho M, Almeida IF. The Role of Pharmaceutical Compounding in Promoting Medication Adherence. Pharmaceuticals. 2022;15(9):1091. doi:10.3390/ph15091091

 

 

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