Recurrent Vaginal Yeast Infection Support
CreamVaginalNon sterile Rx only

Nystatin Vaginal Cream (Ellage®)

Topical Cream Base

A compounded nystatin vaginal cream in Ellage base, prepared in Chino, CA to a prescriber's order for yeast infections, including those that resist azoles.

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

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

Clinical Advantages

  • Custom strength available
  • Rectal or vaginal route
  • Dye free option
  • Non sterile preparation

How It Works

What is Nystatin Vaginal Cream?

Nystatin Vaginal Cream is a compounded preparation of nystatin, a polyene antifungal, in Ellage, a vaginal cream base. Prescribers order it for vaginal yeast infections, particularly recurrent infections or those caused by Candida glabrata that have not responded to azole antifungals such as fluconazole.

How it works

  1. Nystatin binds to sterols in the fungal cell membrane, which changes its permeability and lets the cell's contents leak out [1].
  2. It works through a different mechanism than azole antifungals, which is why prescribers consider it when azoles have not worked.
  3. Nystatin is not absorbed from intact skin or mucous membranes, so it acts where it is applied [1].
  4. It has no activity against bacteria, protozoa, trichomonads, or viruses [1].

When prescribers choose it

  • Gynecologists managing recurrent vaginal yeast infection
  • Prescribers treating C. glabrata that has not responded to oral azoles
  • Vulvovaginal specialty clinics wanting an antifungal outside the azole class
  • Prescribers who prefer a cream to a compressed vaginal tablet

Clinical Details

What does the evidence show?
  • A randomized trial of 293 women with recurrent vaginal yeast infection compared vaginal nystatin suppositories with oral fluconazole. Cure rates after initial therapy were similar, 78.3% versus 73.8%. For infections caused by C. glabrata, cure rates were 64.3% with nystatin and 12.5% with fluconazole [2].
  • In the same trial, nystatin succeeded in five of nine patients whose yeast was resistant to fluconazole, while fluconazole failed in all seven such patients [2].
  • For C. glabrata vaginitis that does not respond to oral azoles, the IDSA 2016 candidiasis guideline lists nystatin vaginal suppositories, 100,000 units daily for 14 days, as an alternative, a strong recommendation based on low quality evidence [3].
  • An expert consensus on recurrent vaginal yeast infection notes that nystatin may not be as effective as azoles for typical infections [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

The FDA approved nystatin vaginal product is a compressed insert containing 100,000 units [1]. Some prescribers prefer a cream that coats the vaginal tissue, or need a strength or base the insert does not offer, so they order a compounded cream.

Dosage forms and strengths

  • Strength set by the prescriber, with 100,000 units daily for 14 days used in labeling and guidelines [1][3]
  • Ellage vaginal cream base
  • Dye free versions on request
  • Measured doses for vaginal application, as the prescriber directs

The label advises confirming the diagnosis by smear or culture before treatment [1]. Strength, frequency, and duration are the prescriber's decision.

How Mixwell prepares it

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

Safety information

Nystatin is not absorbed from intact skin or mucous membranes, which limits its effects to where it is applied [1]. Because it does not act on bacteria or trichomonads, symptoms caused by bacterial vaginosis or trichomoniasis will not respond, and the label asks for confirmation of the diagnosis before therapy [1].

For ordinary yeast infections, azoles may be more effective [4]. Patient selection, dosing, monitoring, and duration are the prescriber's responsibility.

References
  1. Nystatin Vaginal Inserts, USP, 100,000 units. Prescribing information. Drugs.com label
  2. Vaginal nystatin versus oral fluconazole for the treatment for recurrent vulvovaginal candidiasis. PubMed 25416649
  3. 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
  4. Phillips NA, Bachmann G, Haefner H, Martens M, Stockdale C. Topical treatment of recurrent vulvovaginal candidiasis: an expert consensus. Womens Health Rep. 2022;3(1):38 to 42. doi:10.1089/whr.2021.0065
  5. 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

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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 Nystatin Vaginal Cream (Ellage®)

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 Nystatin Vaginal Cream (Ellage®)for practitioners across Southern California.

(909) 378-7301

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