Product Description.:
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei.
Nystatin Oral Suspension for oral administration contains 100,000 USP Nystatin Units per mL.
Inactive ingredients: Alcohol (≤ 1% v/v), D&C Yellow #10, dibasic sodium phosphate, edetate calcium disodium, flavors, glycerin, magnesium aluminum silicate, methylparaben (0.18%) and propylparaben (0.03%) added as preservatives, purified water, sucrose (50% w/v).
INDICATIONS AND USAGE
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
CONTRAINDICATIONS
The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
PRECAUTIONS
General
This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.
Pregnancy
Teratogenic Effects
Category C: Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.
