Track topics on Twitter Track topics that are important to you
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
NYSTATIN OINTMENT USP
NYSTATIN OINTMENT USP (100,000 units/g)
Nystatin Cream USP, 100,000 units per gram
NYSTATIN CREAM USP (100,000 units/g)
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...
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...
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...
Objectives To evaluate the antifungal susceptibility profile of the aqueous extract of the bark of Schinus terebinthifolius Raddi against the strains of the genus Candida. Methods By using the dis...
Independently evolving populations may adapt to similar selection pressures via different genetic changes. The interactions between such changes, such as in a hybrid individual, can inform us about wh...
Otitis externa caused by fungi (otomycosis) occurs more commonly in tropical areas with high moisture than in temperate regions. Bilateral otomycosis is, however, rarely reported. In a case of bilater...
Medications should be employed with caution in women of childbearing age who are pregnant or considering pregnancy. Compared to oral or parenteral agents, topical medications have limited systemic abs...
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...