NYSTATIN VAGINALINSERT, USP | Nystatin
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].
DURAMED PHARMACEUTICALS, INC.
Subsidiary of Barr Pharmaceuticals, Inc. B08-0705Pomona, New York 10970 R8-07 (V.2) 15001177
Store at 20° to 25°C (68° to 77°F)
[See USP Controlled
Corn starch, ethylcellulose,
polyethylene glycol, stearic acid
15 Vaginal Inserts
DURAMED PHARMACEUTICALS, INC.
Subsidiary of Barr Pharmaceuticals, Inc.
Pomona, New York 10970
Duramed Rx only
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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...
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...
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...
RATIONALE: Antifungal therapy with liposomal nystatin may reduce fever and neutropenia in patients undergoing treatment for hematologic cancer. It is not yet known whether liposomal nystat...
Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
To compare the efficacy, safety, and toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of o...
The aim of this study was to determine and compare the efficacy of treatment with fluconazole and nystatin in Brazilian women with vaginal Candida. In a population of 932 women, vaginal cultures were...
Nystatin is a topical antifungal agent. Its wide spectrum of action and low cost make it a treatment of choice. Though it is safe for external ear use, no study has proven its safety in cases of tympa...
Nystatin is commonly employed to treat fungal infections in the mouth. It is not absorbed via the stomach and it will therefore not treat fungal infections in any part of the body other than the mouth...
Gerodontology 2011; doi: 10.1111/j.1741-2358.2011.00544.x Comparison of therapeutic effect of aqueous extract of garlic and nystatin mouthwash in denture stomatitis Introduction: Denture stomatitis...
To develop more effective antifungal microparticulate therapeutic systems for the treatment of Candida vaginitis, microparticles containing nystatin were elaborated by emulsification/internal gelation...