Recurrent Vaginal Yeast Infection Support
CreamVaginalNon sterile Rx only

Ciclopirox 1% Vaginal (Ellage®)

Anhydrous Vaginal Base (Ellage®)

A compounded ciclopirox 1% vaginal preparation in PCCA's Ellage anhydrous base, made in Chino, CA to a prescriber's order. Not FDA approved.

Reviewed by Linda Pungpravat, PharmD, RPh Mixwell Compounding Pharmacy, Chino, CA. Updated

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

Clinical Advantages

  • Anhydrous base made for vaginal use
  • 180 day beyond use date
  • Custom strength available
  • Non sterile preparation

How It Works

What is ciclopirox?

  • Ciclopirox is an antifungal medicine. FDA approved ciclopirox olamine cream 0.77% is labeled for topical treatment of skin infections: tinea pedis, tinea cruris, tinea corporis, candidiasis due to Candida albicans, and tinea versicolor [1].
  • The label says the cream is for topical use only and is not for use in the eyes [1].

The DailyMed ciclopirox labels reviewed here are for skin, shampoo, and solution products. No vaginal ciclopirox product was found among them.

What Ellage is, and what compounding in it provides

Ellage Anhydrous Vaginal is a compounding base made by PCCA. Mixwell prepares ciclopirox 1% in Ellage at the strength the prescriber orders. PCCA's base page does not name ciclopirox. It lists antifungals only as a general category. PCCA describes Ellage as follows [2]:

  • The first anhydrous base in pharmacy compounding developed specifically for vaginal applications
  • Designed to be gentle on vaginal tissue, release drugs, and stay in contact with the mucosa
  • Contains a self emulsifying system that forms a micro emulsion and holds released drugs to the tissue surface longer
  • Water activity below 0.6, so it is classed as an anhydrous vehicle
  • In lab testing, should not change vaginal pH. PCCA notes that added drugs could
  • Made without wheat, milk, egg, soy, fish, peanut, tree nuts, or gluten
  • Works with many drug types, and supports longer beyond use dates because it is anhydrous

These are the manufacturer's descriptions of its base. They are not findings by the FDA, and they are not claims about ciclopirox.

Beyond use date

Mixwell assigns this preparation a 180 day beyond use date. USP 795 sets a default of up to 180 days for nonaqueous dosage forms with a water activity below 0.60 [3].

When prescribers choose it

  • Gynecologists and women's health providers who want a ciclopirox strength and vaginal base that no commercial product offers
  • Prescribers whose patients react to ingredients in other bases

Clinical Details

What does the evidence show?
  • FDA approved ciclopirox olamine cream 0.77% is labeled for topical treatment of certain skin infections. The label says it is for topical use only [1].
  • No ciclopirox product was found on DailyMed with vaginal labeling among the labels reviewed. The FDA has not reviewed this preparation.
  • PCCA does not name ciclopirox for Ellage [2].

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

FDA approved ciclopirox products are made for the skin [1]. A prescriber who chooses ciclopirox in a vaginal base, at a strength they set, orders it compounded. The prescriber decides whether it fits the patient.

Dosage forms and strengths

  • Ciclopirox 1%, or another strength the prescriber sets
  • Ellage anhydrous vaginal base
  • Quantities matched to the prescription

Dosing and duration are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this preparation in Chino, California under USP 795 standards for non sterile preparations [3]. Our pharmacist confirms the strength and base with the prescriber before compounding. Batch records document every preparation, and finished preparations ship across California.

Safety information

The ciclopirox olamine cream label says it is for topical use only and not for use in the eyes. It contraindicates use with hypersensitivity to any of its components. In the label's skin trials, reported reactions were itching, burning, and worsening of signs, each in only one or two patients [1].

The label says there are no adequate, well controlled studies in pregnant women, and that it should be used in pregnancy only if the potential benefit justifies the potential risk. It says safety and effectiveness in children under 10 have not been established [1].

No FDA labeling covers vaginal use of ciclopirox. The label's safety information comes from use on the skin, and it does not say how much is absorbed from the vagina or how a vaginal base affects irritation. Tell your prescriber about any allergies and about pregnancy or breastfeeding. Mixwell can provide the ingredient list for your preparation. Patient selection, dosing, and monitoring are the prescriber's responsibility.

References
  1. Ciclopirox Olamine Cream USP, 0.77%. Prescribing information. DailyMed. DailyMed
  2. Ellage Anhydrous Vaginal. Product information. PCCA. PCCA product page
  3. 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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