Nystatin

Oral suspension treats candidiasis of the oral cavity. Swallowed tablets treat non-esophageal gastrointestinal mucosal candidiasis. Cream, ointment and topical powder treat cutaneous/mucocutaneous infections caused by susceptible Candida; they are not for systemic, oral, intravaginal or ophthalmic use. Selected products have FDA Prescription status; package records do not establish stock.

IDSA’s 2016 guideline includes nystatin suspension as an alternative for mild oropharyngeal candidiasis. Moderate/severe oral disease needs a different plan; esophageal candidiasis requires systemic antifungal therapy. Skin labels’ laboratory activity statements are not an indication to treat every fungal rash or presumed dermatophyte infection.

Selected concentration: 100,000 units/mL. Give half the dose to each side of the mouth; retain as long as possible before swallowing. Shake well and measure with the calibrated device.

Suspension label: continue at least 48 hours after perioral symptoms disappear and cultures demonstrate Candida eradication. IDSA mild-oropharyngeal guidance: 4–6 mL of 100,000 units/mL four times daily for 7–14 days, separately identified from the label. Tablets: one or two 500,000-unit tablets three times daily (500,000–1,000,000 units per dose); continue at least 48 hours after clinical cure. Tablets are for the gastrointestinal indication, not a substitute oral-contact formulation or esophageal treatment.

Adults and pediatric patients, neonates and older: cream or ointment applied liberally to affected areas twice daily or as directed until healing is complete. Powder: apply to candidal lesions two or three times daily until healed; the selected label favors powder for very moist lesions. For Candida infection of feet, powder can also be applied to footwear. This does not authorize powder for nonspecific athlete’s foot or oral ingestion.

Follow the exact prescription and complete the directed course even after early symptom relief. Keep skin products at the specified skin site; do not interchange units/mL suspension with units/g skin products. No standard systemic, renal/hepatic percentage adjustment or universal maximum is provided. Obtain product-specific missed-dose advice; avoid making up extra doses.

History of hypersensitivity to nystatin or any component of the selected formulation. Excipient composition varies; a tolerated oral product does not establish tolerance of every cream, ointment or powder.

Selected current oral and dermatologic nystatin labels have no boxed warning. Infection-site restrictions and allergy/irritation precautions remain applicable. These labels do not establish safety of systemic or injected nystatin.

Oral treatment can cause irritation, nausea, vomiting, diarrhea or gastrointestinal upset. Rare reports include urticaria, severe skin reactions, bronchospasm, facial swelling and tachycardia; stop and seek urgent care for severe allergy/skin symptoms. Skin products can cause burning, itching, rash, eczema or application pain. Oral doses above five million units/day have produced nausea/GI upset; this overdose observation is not a recommended maximum. For significant accidental ingestion or overdose seek poison-center/medical advice rather than assume topical products are safe to swallow.

Selected single-ingredient labels do not provide a clinically established systemic drug-interaction table or routine interaction-driven dose algorithm. Review other antifungals, site products and excipient allergies with the pharmacist; do not mix preparations or replace a corticosteroid-containing combination with plain nystatin without a new plan. Minimal absorption supports a local role, but occasional oral systemic levels in renal insufficiency require clinical judgment.

Suspension gives infant and child dosing, with limited lower-dose premature/low-birth-weight data. Selected topical labels establish pediatric safety/effectiveness from birth through age 16 and give neonatal-and-older application directions. The tablet label does not provide a distinct pediatric regimen; do not extrapolate adult tablets to neonates. Cream studies included too few patients ≥65 to establish differential response; greater sensitivity remains possible.

Oral absorption is usually insignificant, but significant plasma levels may occasionally occur in renal insufficiency. Skin absorption from intact skin/mucosa is not demonstrated in these labels. No quantified renal or hepatic adjustment is supplied; do not invent a creatinine-clearance table or assume severe organ disease has been fully studied. Local treatment still requires appropriate diagnosis and response assessment.

Selected oral labels reserve use in pregnancy for clear need; topical labels call for benefit exceeding potential fetal risk. Reproduction data are limited/absent. Some current labels retain historical Category C wording; this is not a modern quantitative safety rating. Milk excretion is unknown in the selected labels, which advise caution in nursing patients. Assess product/site, maternal need and infant exposure individually.

Nystatin binds fungal membrane sterols, alters permeability and permits intracellular contents to leak. It is fungistatic/fungicidal in vitro against susceptible yeasts; activity and resistance vary by organism. It has no appreciable antibacterial, antiviral or antiprotozoal activity. Oral GI absorption is insignificant and most dose passes unchanged in stool; intact-skin/mucosal absorption is not shown for skin products. No numeric systemic Tmax, protein binding or half-life is established for these regimens.

Follow lesions/symptoms, oral intake when relevant, tolerance and hypersensitivity. Persistent or recurrent disease warrants diagnostic reassessment, adherence/contact-time review and consideration of other infection sites rather than dose escalation alone. Skin labels recommend KOH smears/cultures or other tests initially and repetition with poor response. No routine therapeutic drug-level or laboratory-toxicity monitoring schedule is prescribed.

Shake suspension, verify units/mL, split across both sides of the mouth and retain before swallowing. Observe infant feeding delay and the prescribed duration. Keep powder/cream/ointment out of mouth, eyes and vagina; use only for the diagnosed site. Report irritation, allergy or lack of improvement. Painful swallowing, systemic illness or inability to eat/drink requires clinical assessment because local nystatin may be inadequate. Store securely, especially non-child-resistant unit-dose cups.

PAI oral suspension: ready-to-use light creamy-yellow cherry/peppermint preparation, 100,000 units/mL; 60 mL bottle with calibrated dropper NDC 0121-0868-02. Other listed supplies include 473 mL bottles and 5 mL unit-dose cups. Check the actual package and dose device.

Selected suspension: 100,000 units/mL. Avet film-coated tablets: 500,000 units, round brown, HP51. Selected cream, ointment and Nystop powder: 100,000 units/g; skin vehicles/package sizes differ. This profile excludes nystatin/corticosteroid combinations, veterinary products, unverified compounded preparations, vaginal products and historical pastilles as executable current U.S. regimens.

PAI suspension: 20–25°C, avoid freezing. Avet tablets: 20–25°C. Torrent cream/ointment: 20–25°C, excursions 15–30°C; cream also specifies avoid freezing. Nystop powder: 15–30°C, avoid excessive heat at 40°C. Follow actual container/expiry, keep away from children and do not reuse expired or contaminated product.