Oral suspensionOralNon sterile Rx only

Nystatin Oral Suspension (MucoLox™)

Mucoadhesive Oral Base

A compounded nystatin oral suspension in MucoLox, a base designed to cling to the mouth, prepared in Chino, CA to a prescriber's order.

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 Nystatin Oral Suspension (MucoLox™)
Dosage form	Oral suspension
Route	Oral
Active ingredients	Nystatin
Technology	Mucoadhesive Oral Base
Strengths in literature	Nystatin 100,000 units per mL, the strength of the FDA approved oral suspension
Commercial product	Commercial product in fixed strengths only
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
Flavored for palatability
Dye free option
Non sterile preparation

How It Works

What is nystatin?

Nystatin is a prescription antifungal medicine used for yeast infections in the mouth, often called thrush [1]. Very little of it is absorbed from the stomach and intestines, so it works mainly where it touches [1]. It does not treat bacterial or viral infections.

What is the dosage form?

Nystatin Oral Suspension is a liquid made by a compounding pharmacy to a prescriber's order, in MucoLox, a base designed to cling to the lining of the mouth. Doses are measured with a dropper or syringe, held in the mouth, and then swallowed. FDA labeling for nystatin oral suspension directs patients to keep it in the mouth as long as possible before swallowing [1].

What MucoLox is designed to do

MucoLox is the base that holds the nystatin. Its manufacturer describes it as a mucoadhesive base:

Designed to cling to the moist lining of the mouth and throat instead of washing away quickly like a thin liquid
Designed to keep the medicine in contact with the lining longer, which matches the label's direction to hold each dose in the mouth
Thick enough to coat the mouth, while still measurable with a dropper or syringe
Able to be flavored to the prescriber's or patient's preference

How long this specific suspension stays in the mouth has not been measured.

When prescribers choose it

Prescribers who want nystatin in a base designed to stay in contact with the mouth longer
Prescribers whose patients need to avoid the sucrose, dyes, or alcohol listed in some commercial versions
Dentists, pediatricians, and oncology teams caring for patients with thrush

Clinical Details

What does the evidence show?

FDA approved nystatin oral suspension contains 100,000 units per mL and is labeled for yeast infection of the mouth. The labeled dose is 2 mL four times daily for infants, and 4 to 6 mL four times daily for children and adults, with half the dose placed on each side of the mouth and held as long as possible before swallowing [1].

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

An FDA approved nystatin oral suspension exists [1]. Commercial versions list sucrose, and some list dyes and a small amount of alcohol [1]. Federal law restricts compounding preparations that are essentially copies of approved products unless the prescriber documents a significant difference for the patient, such as a different base or the removal of an ingredient [2].

Dosage forms and strengths

Nystatin 100,000 units per mL, or a strength the prescriber sets
MucoLox mucoadhesive base, with flavoring on request
Dispensed with a dropper or oral syringe and directions to shake well

Dosing and duration are the prescriber's decision.

How Mixwell prepares it

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

Safety information

FDA labeling notes that nystatin is well tolerated, though mouth irritation and allergic reactions have been reported. Very large doses, more than 5 million units a day, have caused nausea and stomach upset. In pregnancy, it should be used only if clearly needed [1].

Nystatin oral suspension is not used for fungal infections that have spread through the body. Call the prescriber if mouth symptoms do not improve or get worse. Patient selection, dosing, and duration are the prescriber's responsibility.

References

Nystatin Oral Suspension, USP, 100,000 units per mL. Prescribing information. Prescribing information
U.S. Food and Drug Administration. Compounding when drugs are on FDA's drug shortages list. FDA human drug compounding
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
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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