14:00 EDT 24th July 2014 | BioPortfolio

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Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei.

Nystatin Vaginal Inserts, USP are available as oval-shaped compressed inserts for intravaginal administration, each containing 100,000 units Nystatin, USP. Inactive ingredients include corn starch, ethylcellulose, anhydrous lactose, microcrystalline cellulose, polyethylene glycol and stearic acid.

Nystatin is both fungi-static and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Nystatin acts by binding to sterols in the cell membrane of sensitive fungi with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, trichomonads or viruses.

Nystatin is not absorbed from intact skin or mucous membranes.

Nystatin Vaginal Inserts, USP are effective for the local treatment of vulvovaginal candidiasis (moniliasis). The diagnosis should be confirmed, prior to therapy, by KOH smears and/or cultures. Other pathogens commonly associated with vulvovaginitis (Trichomonas and Haemophilus vaginalis) do not respond to nystatin and should be ruled out by appropriate laboratory methods.

This preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

Discontinue treatment if sensitization or irritation is reported during use.

The patient should be informed of symptoms of sensitization or irritation and told to report them promptly.

The patient should be warned against interruption or discontinuation of medication even during menstruation and even though symptomatic relief may occur within a few days.

The patient should be advised that adjunctive measures such as therapeutic douches are unnecessary and sometimes inadvisable, but cleansing douches may be used by nonpregnant women, if desired, for esthetic purposes.

If there is a lack of response to Nystatin Vaginal Inserts, USP, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy (see INDICATIONS AND USAGE).

Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenesis, or whether this medication affects fertility in females.

There have been no reports that use of Nystatin Vaginal Inserts by pregnant women increases the risk of fetal abnormalities or affects later growth, development and functional maturation of the child. Nevertheless, because the possibility of harm cannot be ruled out, Nystatin Vaginal Inserts should be used during pregnancy only if the physician considers it essential to the welfare of the patient.

Animal reproduction studies have not been conducted with Nystatin Vaginal Inserts.

Safety and effectiveness in pediatric patients have not been established.

Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even on prolonged administration. Rarely, irritation or sensitization may occur (see PRECAUTIONS).

The usual dosage is one insert (100,000 units nystatin) daily for two weeks.

The inserts should be deposited high in the vagina by means of the applicator. “Instructions for the Patient” are enclosed in each package.

Nystatin Vaginal Inserts, USP:

Pale yellow mottled oval-shaped, flat face, beveled insert (Debossed ODYSSEY on one side and 705 on the other) are available in packages of 15 individually foil wrapped inserts, with applicator and “Instructions for the Patient”.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].


Subsidiary of Barr Pharmaceuticals, Inc.               B08-0705Pomona, New York  10970                                    R8-07 (V.2)                                                                                15001177

IMAGE 0031559b-c668-492b-8a4e-551026ecaf2b-01.jpg

NDC 51285-534-22



Inserts, USP

100,000 Units

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled

Room Temperature].



Inactive ingredients:

Corn starch, ethylcellulose,

anhydrous lactose,

microcrystalline cellulose,

polyethylene glycol, stearic acid

15 Vaginal Inserts

with Applicator


Subsidiary of Barr Pharmaceuticals, Inc.

Pomona, New York 10970

Duramed Rx only


Duramed Pharmaceuticals Incorporated

Active Ingredients


Clinical Trials [14 Associated Clinical Trials listed on BioPortfolio]

A Study of Nystatin in HIV-Infected Patients

To evaluate the clinical toxicity, safety, and potential anti-HIV activity of intravenous nystatin in patients with HIV infection who have completed protocol FDA 103C. To evaluate the safe...

A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis

In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relative...

Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III o...

Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants

This study determines the effectiveness of oral nystatin as prophylaxis in order to prevent systemic fungal infection in very low birth weight preterm neonates. 47 participants received or...

Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers

Candida albicans is the most prevalent species in denture-related stomatitis (DS). There are several treatment options for this condition, including the use of antifungal agents such as ny...

PubMed Articles [12 Associated PubMed Articles listed on BioPortfolio]

Nystatin enhances the immune response against Candida albicans and protects the ultrastructure of the vaginal epithelium in a rat model of vulvovaginal candidiasis.

Vulvovaginal candidiasis (VVC) is a common infectious disease of the lower genital tract. Nystatin, a polyene fungicidal antibiotic, is used as a topical antifungal agent for VVC treatment. The aim of...

Interactions between Terpinen-4-ol and Nystatin on biofilm of Candida albicans and Candida tropicalis.

The aim of this study was to evaluate the antifungal activity of Terpinen-4-ol associated with nystatin, on single and mixed species biofilms formed by Candida albicans and Candida tropicalis, as well...

Galleria mellonella as a model system to study virulence potential of mucormycetes and evaluation of antifungal treatment.

Mucorales can cause cutaneous to deep-seated infections, mainly in the immunocompromised host, resulting in high mortality rates due to late and inefficient treatment. In this study, Galleria mellonel...

Amplitude-modulated cold atmospheric pressure plasma jet for treatment of oral candidiasis: In vivo study.

The aim of this study was to establish an effective and safe protocol for in vivo oral candidiasis treatment with atmospheric plasma jets. A novel amplitude-modulated cold atmospheric pressure plasma ...

Isolation of Candida auris from Ear of Otherwise Healthy Patient, Austria, 2018.

The emerging pathogen Candida auris is isolated mostly from hospitalized patients and often shows multidrug resistance. We report on the isolation of this yeast in Austria from an outpatient's auditor...

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