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Nystatin (Oral-Local)


VA CLASSIFICATION
Primary: AM700

Commonly used brand name(s): Mycostatin; Nadostine; Nilstat; Nystex; PMS Nystatin.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antifungal (oral-local)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Candidiasis, oropharyngeal (treatment)—Nystatin lozenges (pastilles), nystatin oral suspension, and nystatin for oral suspension are indicated in the local treatment of fungal infections of the oral cavity caused by Candida albicans and other Candida species. {10} {15}

[Candidiasis, oropharyngeal (prophylaxis)]—Nystatin oral suspension, lozenges (pastilles), and nystatin for oral suspension are used in the prophylaxis of oropharyngeal candidiasis. {01} {10}

—Not all species or strains of a particular organism may be susceptible to nystatin.

Unaccepted
Nystatin is not indicated in the treatment of systemic fungal infections since it is not absorbed from the gastrointestinal tract.

USP medical experts do not recommend nystatin oral tablets for any indication. {05}


Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Binds to sterols in the fungal cell membrane, resulting in the cell membrane's inability to function as a selective barrier, thus allowing loss of essential cellular constituents. {15}

Absorption:

Not absorbed from the gastrointestinal tract. {15}

Saliva concentrations

Saliva concentrations of nystatin are maintained above those required in vitro to inhibit the growth of clinically significant Candida species for approximately 2 hours after the start of oral dissolution of 2 nystatin lozenges (400,000 units). {04}

Elimination:
    Fecal. Orally administered nystatin is excreted almost entirely as unchanged drug. {15}


Precautions to Consider

Carcinogenicity/Mutagenicity

Studies have not been done to evaluate the carcinogenic or mutagenic potential of nystatin. {04}

Pregnancy/Reproduction
Fertility—
Studies have not been done to evaluate the effect of nystatin on fertility in either males or females. {04}

Pregnancy—
Studies in humans have not shown that nystatin causes adverse effects on the fetus. {02}

Breast-feeding

It is not known whether oral nystatin is excreted in breast milk. However, problems in humans have not been documented.

Pediatrics

Use of nystatin lozenges is not recommended in infants and children up to 5 years of age since this age group may not be capable of using the lozenges or tablets safely. However, no pediatrics-specific problems have been documented to date with nystatin oral suspension. {04}


Geriatrics


No information is available on the relationship of age to the effects of oral nystatin in geriatric patients.


Dental

Patients with full or partial dentures who have symptomatic oral candidiasis may need to soak their dentures nightly in reconstituted nystatin for oral suspension to eliminate Candida species from the dentures. In rare cases when this does not eliminate the fungus, it may be necessary to have new dentures made. {05}

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Intolerance to nystatin


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
    
Gastrointestinal disturbances (diarrhea; nausea or vomiting; stomach pain)





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Nystatin (Oral).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Intolerance to nystatin





Use in children—Nystatin lozenges or tablets are not recommended in infants and children up to 5 years of age since this age group may not be capable of using the lozenges or tablets safely


Proper use of this medication
Proper administration technique for dry powder, lozenges, and oral suspension

» Compliance with full course of therapy

» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling doses

» Proper storage


Side/adverse effects
Signs of potential side effects, especially gastrointestinal disturbance


General Dosing Information
The oral suspension should be administered by placing 1/2 of the dose in each side of the mouth. The patient should hold the suspension in the mouth or swish it throughout the mouth for as long as possible, then gargle and swallow. {05}

Lozenges (pastilles) should be allowed to dissolve slowly and completely in the mouth. They should not be chewed or swallowed whole. {04}

To prevent relapse, therapy should be continued for 48 hours after symptoms have disappeared and the cultures have returned to normal.


Oral Dosage Forms

NYSTATIN LOZENGES (PASTILLES)

Usual adult and adolescent dose
Candidiasis
Oral, as a lozenge dissolved slowly and completely in the mouth, 200,000 to 400,000 Units four or five times a day for up to fourteen days. {04}


Usual pediatric dose
Candidiasis
Infants and children up to 5 years of age: Use is not recommended since this age group may not be capable of using the lozenges safely. {04}

Children 5 years of age and over: See Usual adult and adolescent dose .


Strength(s) usually available
U.S.—


200,000 Units (Rx) [Mycostatin]

Canada—
Not commercially available.

Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Refrigerate.
   • Dissolve slowly in mouth.
   • Continue medicine for full time of treatment.


NYSTATIN ORAL SUSPENSION USP

Usual adult and adolescent dose
Candidiasis
Oral, 400,000 to 600,000 Units four times a day. {15}


Usual pediatric dose
Candidiasis
Premature and low-birth-weight infants: Oral, 100,000 Units four times a day. {15}

Older infants: Oral, 200,000 Units four times a day. {15}

Children: See Usual adult and adolescent dose.


Strength(s) usually available
U.S.—


100,000 Units per mL (Rx) [Mycostatin] [Nilstat] [Nystex][Generic]

Canada—


100,000 Units per mL (Rx) [Mycostatin] [Nadostine] [Nilstat] [PMS Nystatin]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.

Auxiliary labeling:
   • Shake well.
   • Continue medicine for full time of treatment.

Note: When dispensing, include a calibrated liquid-measuring device.



NYSTATIN FOR ORAL SUSPENSION USP

Usual adult and adolescent dose
See Nystatin Oral Suspension USP .

Usual pediatric dose
See Nystatin Oral Suspension USP .

Size(s) usually available:
U.S.—


50,000,000 Units (Rx)[Generic]


150,000,000 Units (Rx)[Generic]


500,000,000 Units (Rx)[Generic]


1,000,000,000 Units (Rx) [Nilstat][Generic]


2,000,000,000 Units (Rx) [Nilstat][Generic]


5,000,000,000 Units (Rx)[Generic]


10,000,000,000 Units (Rx)[Generic]

Canada—


1,000,000,000 Units (Rx) [Nilstat]


2,000,000,000 Units (Rx) [Nilstat]

Note: One-eighth (1/8) teaspoonful of nystatin for oral suspension is approximately equal to 500,000 units.


Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Preparation of dosage form:
Add 1/8 teaspoonful (approximately 500,000 Units) of dry powder to approximately 120 mL of water. Stir well. {13}

Stability:
After mixing, suspension should be used immediately since nystatin for oral suspension contains no preservatives.

Auxiliary labeling:
   • Dissolve in water immediately before taking.
   • Continue medicine for full time of treatment.

Note: Explain administration technique.



NYSTATIN TABLETS USP

Usual adult and adolescent dose
Candidiasis—
Oral, 500,000 to l,000,000 Units three times a day. {13}


Usual pediatric dose
Candidiasis
Infants and children up to 5 years of age: Use is not recommended since this age group may not be capable of using the tablet safely.

Children 5 years of age and over: Oral, 500,000 Units four times a day.


Strength(s) usually available
U.S.—


500,000 Units (Rx) [Mycostatin (film-coated)] [Nilstat (film-coated)][Generic]

Canada—


500,000 Units (Rx) [Mycostatin (film-coated)] [Nadostine (film-coated)] [Nilstat (film-coated)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container.

Auxiliary labeling:
   • Continue medicine for full time of treatment.



Revised: 04/14/1995



References
  1. Buchanan AG, et al. Nystatin prophylaxis of fungal colonization and infection in granulocytopenic patients: correlation of colonization and clinical outcome. Clin Invest Med 1985; 8(2): 139-47.
  1. PDR 1986, Mycostatin Oral Suspension (Squibb), p 1752.
  1. Package insert, Mycostatin Pastilles (Squibb), Rev 12/86, Rec 8/3/87.
  1. PDR 1988, Mycostatin Pastilles (Squibb), p 2060.
  1. Panel comments, Nystatin (Oral-Local), 12/23/86.
  1. USP DI 1989, VA Medication Classification System, p 2472.
  1. Redbook 1989, Mycostatin (Squibb), p 490.
  1. Redbook 1989, Nilstat (Lederle), p 508.
  1. Redbook 1989, Nystex (Savage), p 520.
  1. CPS 1988, Mycostatin (Squibb), p 581.
  1. CPS 1988, Nadostine (Nadeau), p 585.
  1. CPS 1988, Nilstat (Lederle), p 603.
  1. PDR 1989, Nilstat (Lederle), p 1138.
  1. Redbook 1989, Nystatin (various), pp 517-9.
  1. Package insert, Nystatin oral suspension (Pharmaderm), Rev 2/87, Rec 2/89.
  1. CPS 1992, PMS Nytatin (Pharmascience), p 894.
  1. Nystatin (Paddock). Red book 1994. Montvale, NJ: Medical Economics Data, 1994: 300.
  1. Nystatin (Millgood). Red book 1994. Montvale, NJ: Medical Economics Data, 1994: 299.
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