NYSTATIN

Main information

  • Trade name:
  • NYSTATIN - nystatin ointment ointment
  • Composition:
  • Nystatin 100000 [USP'U] in 1 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NYSTATIN - nystatin ointment ointment
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida  albicans and other susceptible Candida species. Nystatin Ointment, USP is not indicated for systemic, oral, intravaginal or ophthalmic use. Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of their components.
  • Product summary:
  • Nystatin Ointment, USP (100, 000 USP Nystatin Units per gram) is a light yellow to yellow ointment available as follows: NDC 0713-0686-15   15 gram tube NDC 0713-0686-31   30 gram tube Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 8-0686GW2 Issued: 06/ 2017

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 0713-0686-15, 0713-0686-31
  • Last update:
  • 15-06-2019

Summary of Product characteristics: dosage, interactions, side effects

NYSTATIN - nystatin ointment ointment

G&W Laboratories, Inc.

----------

NYSTATIN OINTMENT, USP

100,000 USP Nystatin Units Per Gram

FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Rx Only

DESCRIPTION

Nystatin Ointment, USP is for dermatologic use. Nystatin Ointment, USP for topical use only, contains

100,000 USP nystatin units per gram, in a white petrolatum base.

Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei.

The structural formula is as follows:

Molecular Weight 926.13

Molecular Formula C

H NO

CLINICAL PHARMACOLOGY

Pharmacokinetics

Nystatin is not absorbed from intact skin or mucous membrane.

Microbiology

Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts

and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C.

pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes.

Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in

membrane permeability and the subsequent leakage of intracellular components. On repeated

subculturing with increasing concentrations of nystatin, Candida albicans does not develop resistance to

nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of

Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment

with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost

when the antibiotic is removed.

Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

INDICATIONS AND USAGE

Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections

caused by Candida albicans and other susceptible Candidaspecies.

Nystatin Ointment, USP is not indicated for systemic, oral, intravaginal or ophthalmic use.

CONTRAINDICATIONS

Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of their

components.

PRECAUTIONS

General

Nystatin Ointment should not be used for the treatment of systemic, oral, intravaginal or

ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken

as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to

confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by

other pathogens.

INFORMATION FOR THE PATIENT

Patients using these medications should receive the following information and instructions:

1. The patient should be instructed to use these medications as directed (including the replacement of

missed doses). These medications are not for any disorder other than that for which they are

prescribed.

2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be

advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.

3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

Laboratory Tests

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be

repeated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No

studies have been performed to determine the mutagenicity of nystatin or its effects on male or female

fertility.

Pregnancy: Teratogenic Effects

Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation.

It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or

can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant

woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is

prescribed for a nursing woman.

Pediatric Use

Safety and effectiveness have been established in the pediatric population from birth to 16 years.

SeeDOSAGE AND ADMINISTRATION

ADVERSE REACTIONS

The frequency of adverse events reported in patients using Nystatin Ointment preparations is less than

0.1%. The more common events that were reported include allergic reactions, burning, itching, rash,

eczema, and pain on application.

(See PRECAUTIONS: General.)

To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories, Inc. at 1-800-

922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

Nystatin Ointment

Adults and Pediatric Patients (Neonates and Older):

Apply liberally to affected areas twice daily or as indicated until healing is complete.

HOW SUPPLIED

Nystatin Ointment, USP (100,000 USP Nystatin Units per gram) is a light yellow to yellow ointment

available as follows:

NDC 0713-0686-15 15 gram tube

NDC 0713-0686-31 30 gram tube

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

Manufactured by:

G&W Laboratories, Inc.

111 Coolidge Street

South Plainfield, NJ 07080

8-0686GW2

Issued: 06/2017

PRINCIPAL DISPLAY PANEL

NYSTATIN

nystatin ointment ointment

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 713-0 6 8 6

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Nysta tin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E)

Nysta tin

10 0 0 0 0 [USP'U] in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Petro la tum (UNII: 4T6 H12BN9 U)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 713-0 6 8 6 -15

1 in 1 CARTON

0 7/30 /20 18

1

15 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:0 713-0 6 8 6 -31

1 in 1 CARTON

0 7/30 /20 18

2

30 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

G&W Laboratories, Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 9 114

10 /0 6 /20 17

Labeler -

G&W Laboratories, Inc. (001271188)

Registrant -

G&W Laboratories, Inc. (001271188)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

G&W Labo rato ries, Inc.

0 0 127118 8

ma nufa c ture (0 713-0 6 8 6 )

Revised: 10/2017