Nasal Support
SprayNasalNon sterile Rx only

Gentamicin / Itraconazole / Mupirocin / EDTA Nasal Spray

Mucoadhesive Nasal Base

A compounded nasal spray with gentamicin, itraconazole, mupirocin, and EDTA in MucoLox, prepared in Chino, CA to a prescriber's order for sinus care.

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

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

Clinical Advantages

  • Multiple actives in one base
  • Custom strength available
  • Applied topically
  • Non sterile preparation

How It Works

What is Gentamicin / Itraconazole / Mupirocin / EDTA Nasal Spray?

Gentamicin / Itraconazole / Mupirocin / EDTA Nasal Spray is a compounded nasal spray combining two antibiotics, an antifungal, and a chelating agent in MucoLox, a mucoadhesive nasal base. Ear, nose, and throat specialists order it for hard to treat chronic sinusitis, usually after sinus surgery and guided by a culture.

What MucoLox is designed to do

MucoLox is a mucoadhesive base, meaning it is designed to cling to the moist lining of the nose instead of draining away like a plain liquid [4].

  1. Plain nasal liquids are usually cleared from the nose within about 15 to 30 minutes by the lining's natural cleaning action [5].
  2. Mucoadhesive bases are designed to hold medicine against that lining longer, so local medicines stay in contact with the tissue longer [4][5].
  3. A spray delivers a small, measured amount rather than the large volume of a sinus rinse.
  4. How long this specific spray stays in the nose has not been measured in people, and the base's manufacturer has tested its retention only on oral tissue in the laboratory.

How the ingredients work

  1. Gentamicin is an aminoglycoside antibiotic that stops bacteria from making proteins [7].
  2. Mupirocin blocks a bacterial enzyme and is active against Staphylococcus aureus, a common bacterium in hard to treat sinusitis [2].
  3. Itraconazole is an azole antifungal.
  4. Edetate disodium binds metals such as iron and calcium. It is included for a proposed effect against the protective films bacteria form, which has not been tested in patients.

When prescribers choose it

  • Otolaryngologists and rhinologists managing chronic sinusitis that persists after sinus surgery
  • Prescribers treating a culture proven infection in patients who have not responded to standard care
  • Prescribers who want local treatment rather than another course of oral antibiotics

Clinical Details

What does the evidence show?
  • The 2021 International Consensus Statement on Allergy and Rhinology: Rhinosinusitis gives topical antibiotics for chronic rhinosinusitis a recommendation against, graded A, because high level evidence fails to show consistent benefit. It gives topical antifungals a strong recommendation against, based on a meta analysis that found no benefit over placebo [1].
  • Jervis-Bardy and colleagues (2012, The Laryngoscope) randomized patients with Staphylococcus aureus chronic sinusitis that persisted after surgery to mupirocin rinses or saline, twice daily for a month. Mupirocin cleared the bacteria in 88.9% of patients versus 0% with saline, but symptoms did not differ between groups, and improvements were not seen 2 to 6 months later [2].
  • A review of 57 patients treated with mupirocin rinses after sinus surgery found that 73.7% grew Staphylococcus aureus again, on average 144 days after treatment [3].
  • No study has tested this four ingredient combination, and no study has measured how long MucoLox stays in the human nose.

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

No commercial product combines these four ingredients or delivers them as a nasal spray, so an ENT who wants them together orders the spray compounded. Guidelines recommend against routine topical antibiotics and antifungals for chronic sinusitis, so this is a specialist decision for specific, often culture guided, cases [1].

Dosage forms and strengths

  • Gentamicin 0.25%, itraconazole 0.2%, mupirocin 0.2%, and edetate disodium, or strengths the prescriber sets
  • MucoLox mucoadhesive nasal base
  • Spray container, labeled with the number of sprays per dose

Dosing, duration, and follow up cultures are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this spray in Chino, California under USP 795 standards for non sterile preparations [6]. Our pharmacist confirms the strengths and directions with the prescriber before compounding. Batch records document every preparation, and finished sprays ship across California.

Safety information

Gentamicin injection carries a boxed warning for kidney damage and for damage to hearing and balance that is usually permanent, with the highest risk in people with kidney problems and at high or prolonged doses. Its label also advises against combining it with other drugs that can harm the ears or kidneys, and notes that aminoglycosides can cause fetal harm in pregnancy [7]. A nasal spray delivers far less drug than an injection, but how much is absorbed from this spray has not been measured.

Topical antibiotics can encourage resistant bacteria. In the mupirocin review above, resistance after treatment was uncommon, at 2.4%, but it did occur [3]. Nasal stinging, irritation, or bleeding are possible with any nasal spray.

A sinus infection with fever, swelling around the eyes, vision changes, or severe headache needs prompt medical care. Patient selection, dosing, monitoring, and duration are the prescriber's responsibility.

References
  1. Orlandi RR, Kingdom TT, Smith TL, et al. International consensus statement on allergy and rhinology: rhinosinusitis 2021. Int Forum Allergy Rhinol. 2021;11(3):213 to 739. doi:10.1002/alr.22741
  2. Jervis-Bardy J, Boase S, Psaltis A, Foreman A, Wormald PJ. A randomized trial of mupirocin sinonasal rinses versus saline in surgically recalcitrant staphylococcal chronic rhinosinusitis. Laryngoscope. 2012;122(10):2148 to 2153. doi:10.1002/lary.23486
  3. Jervis-Bardy J, Wormald PJ. Microbiological outcomes following mupirocin nasal washes for symptomatic, Staphylococcus aureus positive chronic rhinosinusitis following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2012;2(2):111 to 115. doi:10.1002/alr.20106
  4. Chaturvedi M, Kumar M, Pathak K. A review on mucoadhesive polymer used in nasal drug delivery system. J Adv Pharm Technol Res. 2011;2(4):215 to 222. doi:10.4103/2231-4040.90876
  5. Boddupalli BM, Mohammed ZNK, Nath RA, Banji D. Mucoadhesive drug delivery system: an overview. J Adv Pharm Technol Res. 2010;1(4):381 to 387. doi:10.4103/0110-5558.76436
  6. United States Pharmacopeia. General Chapter 795, Pharmaceutical Compounding: Nonsterile Preparations. USP NF. Official November 1, 2023.
  7. Gentamicin sulfate injection, USP. Prescribing information, boxed warning. DrugCentral label

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

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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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Want to learn more about Gentamicin / Itraconazole / Mupirocin / EDTA Nasal Spray

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 Gentamicin / Itraconazole / Mupirocin / EDTA Nasal Sprayfor practitioners across Southern California.

(909) 378-7301

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