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Nystatin

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From Pharmacopedia
Nystatin
Mycostatin, Nystop, Nyamyc, Bio-Statin

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Summary
Common uses
Oropharyngeal candidiasis (oral suspension swish-and-swallow)0, Cutaneous candidiasis0, Vulvovaginal candidiasis0, Intestinal candidiasis (non-absorbable oral tablet)0
Pharmacy
Starting dose
Oral: 4-6 mL (400,000-600,000 units) suspension QID swish-and-swallow; topical: BID-QID; vaginal tablet 1 daily for 2 weeks
Preparations
100,000 units/mL oral suspension; 500,000 unit tablets; 100,000 units/g cream, ointment, powder; vaginal tablets
US FDA Max
Indication-specific
Pharmacology
Routes
Oral (topical action; minimal systemic absorption), topical, vaginal
Onset
Symptom relief within days
Duration
Hours per application
Half-life
Not meaningfully described (not systemically absorbed)[1]
Bioavailability
Essentially zero systemic absorption from oral or topical routes — the topical-action-only profile is the basis of its safety[1]
Pregnancy
Generally considered safe in pregnancy (no systemic absorption).[citation needed]
Legal status
Rx-only in US
Purported mechanism
Nystatin is a polyene antifungal that binds ergosterol in fungal cell membranes, forming transmembrane pores that disrupt ionic homeostasis and cause cell death; selectivity comes from preferential affinity for ergosterol (fungi) over cholesterol (mammalian membranes).0 Same mechanistic family as amphotericin B but with prohibitive systemic toxicity at therapeutic doses, hence restriction to topical and luminal-gut indications. No clinically meaningful resistance after decades of use[1].

References

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  1. 1.0 1.1 1.2 FDA Prescribing Information, nystatin oral suspension, current revision. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050425s055lbl.pdf