Rosacea Support
CreamTopicalNon sterile Rx only

Metronidazole / Niacinamide Topical

Topical Bases (WO6®, VersaBase®, XemaTop™)

A compounded topical with metronidazole and niacinamide in a PCCA base, prepared in Chino, CA to a prescriber's order. Not FDA approved.

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 are metronidazole and niacinamide?

  • Metronidazole is a prescription antibiotic of the nitroimidazole class. FDA approved topical metronidazole, sold as a 0.75% gel, a 1% gel, and a 0.75% cream, is labeled for the treatment of inflammatory papules and pustules of rosacea. The labels say how it works in rosacea is unknown, but appears to include an anti inflammatory effect [1][2][3].
  • Niacinamide is a form of vitamin B3.

No FDA approved product combines metronidazole and niacinamide.

What compounding in a PCCA base provides

This preparation is made in a base the pharmacist and prescriber choose from PCCA's options. PCCA describes them as follows:

  • WO6 Anhydrous Topical Gel: water activity below 0.6, which classes it as an anhydrous base. PCCA describes it as smooth and creamy, with no greasy or tacky residue, and emollient, moisturizing and softening the skin [4].
  • VersaBase Cream and VersaBase Gel: VersaBase Cream is a non ionic emulsion cream that PCCA says simulates the skin's natural moisturizing barrier, rubs in quickly, and is odor free and oil free. VersaBase Gel is a transparent, smooth gel that spreads and absorbs easily, is alcohol free, and is made without surfactant emulsifiers, parabens, and propylene glycol [5].
  • XemaTop: a smooth, off white cream with a pH of 4.5 to 6.5, designed for formulations for patients with eczema, psoriasis, and dry skin. PCCA says it replenishes lipids within the skin, supports the skin's structure, helps restore the skin barrier and prevent water loss, and may improve the delivery of common active ingredients [6].

These are the manufacturer's descriptions, not findings by the FDA. PCCA's base pages do not name this combination for these bases.

When prescribers choose it

  • Dermatologists and primary care providers treating rosacea
  • Prescribers who want metronidazole with niacinamide in one topical
  • Prescribers whose patients react to an ingredient in the approved gels, such as propylene glycol or parabens

Clinical Details

What does the evidence show?
  • FDA approved topical metronidazole is labeled for the treatment of inflammatory papules and pustules of rosacea (0.75% gel and 0.75% cream) or inflammatory lesions of rosacea (1% gel) [1][2][3].
  • The labels state that the mechanisms by which metronidazole acts in rosacea are unknown, but appear to include an anti inflammatory effect [1].
  • No FDA approved product combines metronidazole and niacinamide. The FDA has not reviewed this preparation.

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 FDA approved product combines metronidazole and niacinamide. The approved metronidazole gels also contain ingredients such as methylparaben, propylene glycol, and propylparaben, and the 0.75% gel label contraindicates use in people with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation [1]. A prescriber who wants the two medicines together, or a different base, orders it compounded.

Dosage forms and strengths

  • Strength of each ingredient set by the prescriber
  • Base chosen with the prescriber: WO6 Anhydrous Topical Gel, VersaBase Cream or Gel, or XemaTop
  • 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 [7]. Our pharmacist confirms the strengths and the base with the prescriber before compounding. Batch records document every preparation, and finished preparations ship across California.

Safety information

Topical metronidazole labeling says it has been reported to cause tearing of the eyes, so contact with the eyes should be avoided. The patient information for the 1% gel says it is for use on the skin only, not in the mouth, eyes, or vagina [2].

The labels note that oral metronidazole has shown carcinogenic activity in rodents [2][3]. Oral metronidazole has been reported to increase the effect of warfarin and coumarin blood thinners and lengthen prothrombin time, and the effect of topical metronidazole on prothrombin time is not known [1][3].

No FDA labeling states how much of either ingredient is absorbed from this preparation. Patient selection, dosing, and monitoring are the prescriber's responsibility.

References
  1. Metronidazole gel USP (topical), 0.75%. Prescribing information. DailyMed. DailyMed
  2. METROGEL (metronidazole) gel, 1%. Prescribing information. DailyMed. DailyMed
  3. Metronidazole topical cream, 0.75%. Prescribing information. DailyMed. DailyMed
  4. WO6 Anhydrous Topical Gel. Product information. PCCA. PCCA
  5. VersaBase Gel and VersaBase Cream. Product information. PCCA. VersaBase Gel PCCA base technologies
  6. XemaTop. Product information. PCCA. PCCA
  7. 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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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 Metronidazole / Niacinamide Topical

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 Metronidazole / Niacinamide Topicalfor practitioners across Southern California.

(909) 378-7301

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