Amphotericin B Vaginal Suppository

Suppository Base

A compounded amphotericin B vaginal suppository, prepared in Chino, CA to a prescriber's order for yeast vaginitis that has not responded to azoles.

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 Amphotericin B Vaginal Suppository
Dosage form	Suppository
Route	Vaginal
Active ingredients	Amphotericin B
Technology	Suppository Base
Strengths in literature	Amphotericin B 50 mg vaginal suppository, nightly for 14 days, in the published case series
Commercial product	Commercial product in a different dosage form
Strength and directions	Per prescriber
Dispensing	Valid prescription

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

Clinical Advantages

Custom strength available
Rectal or vaginal route
Dye free option
Multiple actives in one base
No U.S. commercial equivalent

How It Works

What is Amphotericin B Vaginal Suppository?

Amphotericin B Vaginal Suppository is a compounded preparation of amphotericin B, a polyene antifungal, in a suppository base that melts at body temperature. Gynecologists and infectious disease specialists order it for vaginal yeast infections, often caused by non albicans Candida species, that persist after standard azole treatment.

How it works

Amphotericin B binds ergosterol in the fungal cell membrane, making the membrane leak and the cell die.
It acts through a different mechanism than azole antifungals, which is why prescribers consider it when azoles have not worked.
The suppository base melts at body temperature and releases the drug in the vagina.
Strength and duration are set by the prescriber, and the published case series used 50 mg nightly for 14 days [1].

When prescribers choose it

Gynecologists managing vaginal yeast infection that persists after azole therapy
Infectious disease specialists treating non albicans Candida, such as C. glabrata
Vulvovaginal specialty clinics managing recurrent or refractory cases
Prescribers who have already tried or ruled out boric acid and approved alternatives

Clinical Details

What does the evidence show?

Phillips (2005, American Journal of Obstetrics and Gynecology) identified 32 patients with non albicans Candida vaginitis. Ten had persistent infection after conventional antifungal treatment and received amphotericin B 50 mg vaginal suppositories nightly for 14 days. Eight of the 10 initially showed no further infection, and one of those responded to a second course but failed a third [1].
White and colleagues (2001, Sexually Transmitted Infections) reported using combined topical flucytosine and amphotericin B for refractory vaginal C. glabrata infections [2].
The evidence review behind the 2021 CDC STI treatment guidelines found boric acid appears useful for symptomatic non albicans yeast infections, and noted ibrexafungerp as a newly FDA approved treatment for vaginal yeast infection [3].
For C. glabrata vaginitis that does not respond to oral azoles, the IDSA 2016 candidiasis guideline lists intravaginal boric acid and nystatin suppositories as alternatives, and a third option of topical 17% flucytosine cream alone or combined with 3% amphotericin B cream, a weak recommendation based on low quality evidence. It does not address amphotericin B suppositories specifically [4].

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

Amphotericin B is marketed in the United States for intravenous use, and no vaginal amphotericin B product has been approved. A prescriber who wants it delivered vaginally orders a compounded suppository.

Dosage forms and strengths

Strength set by the prescriber, with 50 mg nightly for 14 days used in the published case series [1]
Suppository base selected for melting at body temperature
Combinations with flucytosine when the prescriber orders them [2]
Dye free versions on request

Published evidence comes from a small case series and case reports, and guidelines list boric acid and other options first [1][3][4]. Strength, frequency, and duration are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds these suppositories in Chino, California under USP 795 standards for non sterile preparations [5]. Our pharmacist confirms the strength and the suppository base with the prescriber before compounding, and the label carries storage instructions. Batch records document every preparation, and finished suppositories ship across California.

Safety information

Published experience with vaginal amphotericin B is limited to small case series and case reports, so safety data are limited [1][2]. Recurrences can occur after an initial response, as they did in the published series [1].

Persistent or recurrent vaginal symptoms warrant culture and species identification to guide treatment, rather than repeated empiric courses [3]. Patient selection, dosing, monitoring, and duration are the prescriber's responsibility.

References

Phillips AJ. Treatment of non albicans Candida vaginitis with amphotericin B vaginal suppositories. Am J Obstet Gynecol. 2005;192(6):2009 to 2012. doi:10.1016/j.ajog.2005.03.034
White DJ, Habib AR, Vanthuyne A, Langford S, Symonds M. Combined topical flucytosine and amphotericin B for refractory vaginal Candida glabrata infections. Sex Transm Infect. 2001;77(3):212 to 213. doi:10.1136/sti.77.3.212
Nyirjesy P, Brookhart C, Lazenby G, Schwebke J, Sobel JD. Vulvovaginal candidiasis: a review of the evidence for the 2021 Centers for Disease Control and Prevention of Sexually Transmitted Infections Treatment Guidelines. Clin Infect Dis. 2022;74(Suppl 2):S162 to S168. Oxford Academic
Pappas PG, Kauffman CA, Andes DR, et al. Clinical practice guideline for the management of candidiasis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis. 2016;62(4):e1 to e50. doi:10.1093/cid/civ933
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
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Diamond Bar
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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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