Nystatin

1. Health Canada Product Monograph — Nystatin

• Nystatin oral suspension is used to prevent and treat fungal (candidal) infections of the mouth, esophagus, and intestines.
• Nystatin vaginal cream is used to treat vaginal yeast infections caused by Candida albicans.
• Nystatin topical cream and ointment are used to treat fungal skin infections caused by Candida species.
• Nystatin is also used to help prevent Candida overgrowth during treatment with antibiotics or corticosteroids.

• Human studies have not shown that oral nystatin causes harm to the developing baby.
• Nystatin is very poorly absorbed from the gastrointestinal tract, skin, or vaginal mucosa, so systemic exposure during pregnancy is minimal.
• Vaginal nystatin applicators should be used during pregnancy only on the advice of a physician.

• It is not known whether oral nystatin passes into breast milk, but no problems have been documented in nursing infants.
• Because nystatin is not meaningfully absorbed into the bloodstream, breastfeeding is generally considered compatible with nystatin use.

• No specific information is available on how age affects the response to nystatin in older adults, and no dose adjustment is expected to be needed based on age alone.

• Nystatin oral suspension is commonly used in infants and children for oral thrush and intestinal candidiasis, with dosing based on age.
• For infants with oral thrush, the medication is placed directly on the tongue and areas of infection using the calibrated dropper.
• Nystatin oral suspension is also commonly used, including off-label, in newborns and premature infants for oral thrush.

• For oral thrush and intestinal candidiasis in infants and children, the usual dose is 100,000 units given 3 to 4 times daily.
• For oral thrush and intestinal candidiasis in adults, the usual dose is 100,000 units given 4 times daily, and may be increased if needed.
• Oral suspension should be shaken well before use and, for mouth infections, held or swished in the mouth for as long as possible before swallowing.
• Vaginal cream is applied as one applicatorful daily, increased to every 12 hours for severe infections, generally continued for about 2 weeks and through menstruation if it occurs during treatment.
• Topical cream or ointment is applied liberally to the affected skin twice daily or as directed.
• Treatment with any nystatin formulation should generally continue for at least 48 hours after visible symptoms have resolved, to reduce the risk of relapse.
• When oral nystatin is used together with an antibacterial antibiotic to prevent Candida overgrowth, it should be continued for at least as long as the antibiotic course.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Significant systemic toxicity from nystatin overdose is unlikely because the drug is very poorly absorbed from the mouth, gut, skin, or vagina.
• Swallowing a large amount of oral nystatin suspension may cause nausea, vomiting, diarrhea, and stomach upset.
• There is no specific antidote for nystatin overdose; care is supportive.

• Nausea may occur, mainly with high oral doses.
• Vomiting may occur.
• Diarrhea may occur.
• Stomach pain or cramping may occur.
• Vaginal irritation, itching, or burning may occur with the vaginal cream.
• Mild skin irritation may occur at the site of topical cream or ointment application.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Allergic reactions, including hives and facial swelling, have been reported rarely.
• A fast heartbeat (tachycardia) has been reported rarely.
• Bronchospasm (wheezing or difficulty breathing) has been reported rarely.
• Generalized muscle pain (non-specific myalgia) has been reported rarely.
• Seek prompt medical attention for facial swelling, hives, difficulty breathing, or a racing heartbeat after using nystatin.

• Discontinue topical or vaginal nystatin if irritation or sensitization develops at the application site.
• Nystatin has little to no activity against bacteria, protozoa, or viruses, so it should not be relied on to treat infections caused by these organisms.
• Patients with dentures who have oral thrush may need to soak their dentures overnight in reconstituted nystatin suspension to fully clear the infection from the denture surface.
• Take measures to avoid reinfection during vaginal treatment, including avoiding unprotected intercourse until the infection has cleared.
• Nystatin vaginal cream may weaken latex condoms and diaphragms, so an alternative barrier method should be used during treatment.

• Contraindicated in patients with known hypersensitivity to nystatin or to any ingredient in the formulation.

• No clinically significant systemic drug interactions have been established for nystatin, largely because it is not meaningfully absorbed into the bloodstream from any of its formulations.
• Applying other topical or vaginal products at the same time and place as nystatin may dilute it and reduce its effectiveness, so applications should be spaced apart when possible.

• Nystatin oral suspension can be taken with or without food, and may be mixed with milk, formula, or a non-acidic food such as honey or jelly if this helps with administration, particularly in infants and children.

• Nystatin oral suspension is usually given several times a day at evenly spaced intervals and held in the mouth as long as possible before swallowing for mouth infections; vaginal cream is typically applied once daily, often at bedtime, and topical cream or ointment is applied to affected skin twice daily, regardless of meals.

• Store nystatin oral suspension, vaginal cream, topical cream, and topical ointment at room temperature, between 15°C and 30°C.
• Nystatin oral suspension should not be used more than 30 days after the bottle is first opened, and the bottle should be kept tightly closed and protected from light.

• Shake the oral suspension well before each use and, for mouth infections, keep it in the mouth as long as possible before swallowing.
• Complete the full course of treatment, generally continuing for about 48 hours after symptoms clear, to help prevent the infection from coming back.
• If using the vaginal cream, avoid unprotected intercourse during treatment to reduce the chance of reinfection, and continue treatment even during your period if needed.
• Denture wearers with oral thrush should ask their pharmacist about disinfecting dentures, since Candida can persist on denture surfaces.
• Contact a healthcare professional if you develop a rash, hives, facial swelling, or difficulty breathing after using this medicine.