Nystatin (Vaginal)
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VA CLASSIFICATION
Primary: GU302
Commonly used brand name(s): Mycostatin; Nadostine; Nilstat; Nyaderm.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Antifungal (vaginal)—
Indications
Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.
Accepted
Candidiasis, vulvovaginal (treatment)—Vaginal nystatin is indicated in the local treatment of vulvovaginal candidiasis caused by Candida albicans and other Candida species. {01}
[Candidiasis, oropharyngeal (treatment)]—Nystatin vaginal tablets are used as lozenges to treat oropharyngeal candidiasis since their slow dissolution rate provides prolonged oral contact.
—Not all species or strains of a particular organism may be susceptible to nystatin.
Unaccepted
Nystatin is not effective against Trichomonas vaginalis or Gardnerella vaginalis (Haemophilus vaginalis) {01}.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Source—
Derived from Streptomyces noursei {01}.
Chemical group—
Polyene antifungal.
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, which allows loss of essential cellular constituents. {01}
Precautions to Consider
Carcinogenicity/Mutagenicity
Long-term studies in animals have not been done to evaluate the carcinogenic or mutagenic potential of nystatin. {01}
Pregnancy/Reproduction
Fertility—
Long-term studies in animals have not been done to evaluate the effect of nystatin on fertility in females.
Pregnancy—
Studies in animals have not been done. However, studies in humans have not shown that nystatin causes adverse effects on the fetus.
FDA Pregnancy Category A. {01}
Breast-feeding
It is not known whether vaginal nystatin is distributed into breast milk. However, problems in humans have not been documented.
Pediatrics
No information is available on the relationship of age to the effects of vaginal nystatin in pediatric patients. {01}
Geriatrics
No information is available on the relationship of age to the effects of vaginal nystatin in geriatric patients.
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
Sensitivity to nystatin{01}
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
Incidence rare
Vaginal irritation not present before therapy (vaginal burning or itching){01}
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Nystatin (Vaginal) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Sensitivity to nystatin
Proper use of this medication
Reading patient instructions before using medication
Using applicator cautiously during pregnancy
Using medication during menstual periods if they start during treatment period
» Compliance with full course of therapy
» Proper dosing
Missed dose: Inserting as soon as possible; not inserting if almost time for next dose
» Proper storage
Precautions while using this medication
» Using hygienic measures to control sources of infection or reinfection
Checking with physician about douching or intercourse during therapy
Protection of clothing because of possible vaginal drainage
Side/adverse effects
Signs of potential side effects, especially vaginal irritation not present before therapy
General Dosing Information
Therapy for a period of 2 weeks is usually sufficient, but more prolonged treatment may be necessary. Treatment of resistent infections may be supplemented with oral products. {01}
To prevent thrush in the newborn, it is suggested that nystatin vaginal tablets be administered to pregnant patients with vulvovaginal candidiasis in a dosage of 100,000 to 200,000 Units daily for 3 to 6 weeks prior to delivery. {01}
Vaginal Dosage Forms
NYSTATIN VAGINAL CREAM
Usual adult and adolescent dose
Antifungal
Intravaginal, 1 (100,000-Unit) applicatorful one or two times a day for two weeks; or 1 (500,000-Unit) applicatorful once daily {01}.
Note: For severe infections, the dose of 500,000-Units of vaginal cream may be increased to every 12 hours.
Usual pediatric dose
Dosage has not been established.
Strength(s) usually available
U.S.—
Not commercially available.
Canada—
25,000 Units per gram (100,000 Units per applicatorful) (Rx) [Mycostatin{01}] [Nadostine{03}] [Nyaderm{04}]
100,000 Units per gram (500,000 Units per applicatorful) (Rx) [Nilstat{02}]
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. {05}
Auxiliary labeling:
• Continue medicine for full time of treatment.
• For vaginal use only.
Note: Include patient instructions when dispensing.
Explain administration technique.
NYSTATIN VAGINAL TABLETS USP
Usual adult and adolescent dose
Antifungal
Intravaginal, 100,000 Units one or two times a day for two weeks. {01} {02}
Usual pediatric dose
Dosage has not been established.
Strength(s) usually available
U.S.—
100,000 Units (Rx)[Generic]{06}
Canada—
100,000 Units (Rx) [Mycostatin{01}] [Nadostine{03}] [Nilstat{02}]
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. {05}
Note: Some manufacturers recommend storage in a refrigerator.
Auxiliary labeling:
• Continue medicine for full time of treatment.
• For vaginal use only.
• Refrigerate.
Note: Include patient instructions when dispensing.
Explain administration technique (for use as oral lozenge).
Revised: 08/11/1998
References
- Mycostatin vaginal cream and vaginal tablets product monograph (Squibb Canada—Canada), Rev 11/21/74, Rec 11/13/97.
- Nilstat (Lederle). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 1113.
- Nadostine (Nadeau). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 1065.
- Nyaderm (Taro). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 1199.
- United States pharmacopeia. National formulary. USP 23rd revision (January 1, 1995). NF 18th ed. (January 1, 1995). Rockville, MD: The United States Pharmacopeial Convention Inc, 1995. p. 1111.
- Nystatin (generic). Redbook 1998. Montvale, NJ: Medical Economics Company, 1998. p. 449-50.
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