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Nystatin Ointment

TABLE OF CONTENTS

1. DESCRIPTION 7. WARNINGS AND PRECAUTIONS
2. INDICATIONS AND USAGE 8. ADVERSE REACTIONS
3. DOSAGE AND ADMINISTRATION 9. OVERDOSAGE
4. CONTRAINDICATIONS 10. DRUG INTERACTIONS
5. MICROBIOLOGY 11. PHARMACOKINETICS
6. USE IN SPECIFIC POPULATIONS 12. HOW SUPPLIED/STORAGE AND HANDLING

 

1. DESCRIPTION

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Its structural formula is:

Molecular formula: C47H75NO17- Molecular weight: 926.13

Nystatin ointment USP is for topical use only. It contains 100,000 USP Nystatin units per gram, in an ointment base of light mineral oil and white petrolatum.

2. INDICATIONS AND USAGE

Nystatin ointment USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

3. DOSAGE AND ADMINISTRATION

Nystatin Ointment USP should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder.

This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.

4. CONTRAINDICATIONS

Nystatin ointment USP is contraindicated in patients with a history of hypersensitivity to any of its components.

5. 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 levels 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.

6. USE IN SPECIFIC POPULATIONS

6.1 Usage in Pregnancy

Pregnancy 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.

6.2 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.

6.3 Pediatric Use

Safety and effectiveness have been established in the pediatric population from birth to 16 years (see DOSAGE AND ADMINISTRATION).

6.4 Geriatric Use

Clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

7. WARNINGS AND PRECAUTIONS

PRECAUTIONS

Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken.

This preparation is not for ophthalmic use.

8. ADVERSE REACTIONS

Nystatin Ointment USP is virtually non-toxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.

9. OVERDOSAGE

No overdosage information is available.

10. DRUG INTERACTIONS

No drug interaction information is available.

11. PHARMACOKINETICS

No pharmacokinetic information is available.

12. HOW SUPPLIED/STORAGE AND HANDLING

1) How Available:

a) Brand name: MYCOSTATIN (discontinued), by BRISTOL MYERS SQUIBB.

b) Generic drugs: Nystatin, by various manufacturers.

2) How Supplied:

Nystatin Ointment USP (100,000 USP Nystatin Units per gram) (by PERRIGO) is a yellow ointment available as follows:

15 g tube (NDC 45802-048-35)

30 g tube (NDC 45802-048-11)

3) Storage:

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

Rx only

Rev 08/09