Overdose
No information provided.
Contraindications
Nystatin topical preparations are contraindicated in patients with a history
of hypersensitivity to any of their components.
Undesirable effects
The frequency of adverse events reported in patients using Mycostatin (nystatin) ®
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.)
Pharmacokinetic properties
Nystatin is not absorbed from intact skin or mucous membrane.
Special warnings and precautions for use
WARNINGS
No information provided.
PRECAUTIONS
General
Nystatin, topical preparations 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.
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. (See DOSAGE AND ADMINISTRATION.)
Geriatric Use
Clinical studies with MYCOSTATIN (Nystatin) Cream and MYCOSTATIN (Nystatin) Topical Powder 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.
Dosage (Posology) and method of administration
Very moist lesions are best treated with the topical dusting powder.
MYCOSTATIN (nystatin) ® Cream
Adults and Pediatric Patients (Neonates and Older): Apply liberally
to affected areas twice daily or as indicated until healing is complete.
MYCOSTATIN (nystatin) ® Topical Powder
Adults and Pediatric Patients (Neonates and Older): Apply to candidal
lesions two or three times daily until healing is complete. For fungal infection
of the feet caused by Candida species, the powder should be dusted on the feet,
as well as, in all foot wear.
Interaction with other medicinal products and other forms of interaction
SIDE EFFECTS
The frequency of adverse events reported in patients using Mycostatin (nystatin) ®
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.)
DRUG INTERACTIONS
No information provided.