Nystatin
D07C - Corticosteroids, combinations with antibiotics
ATC A07AA02
Unknown
approved 1964
Oral
Topical
JFDA label: Rianest Oral Suspension
Mechanism of Action
Sequestering Agent of Ergosterol — Ergosterol sequestering agent
| Target | Action | Gene / class |
|---|---|---|
| Ergosterol efficacy | SEQUESTERING AGENT |
Indications
Approved
- Candidiasis — candidiasis
- Infections — infection
Off-label
- Bacteremia
- Burns
- Candidiasis, Oral
- Graft vs Host Disease
- HIV Infections
- Leukemia
- Lymphoma
- Multiple Myeloma
- Myelodysplastic Syndromes
- Myeloproliferative Disorders
- Pneumonia
- Stomatitis
- Stomatitis, Denture
- Tobacco Use Disorder
- Vaginosis, Bacterial
Class profile
| antifungalClass | Polyene |
|---|---|
| targetMolecule | Ergosterol (membrane disruption) |
| isFungicidal | 1 |
| spectrumCandida | S (topical/oral) |
| spectrumAspergillus | Not used systemically |
| spectrumCryptococcus | Not used systemically |
| spectrumDermatophytes | Limited |
| resistanceMechanisms | Ergosterol deficiency mutations (clinical resistance rare with topical use) |
| source | Pappas2016/Lass-Florl2011 |
Contraindications
Source: openFDA
- The preparation is contraindicated in patients with a history of hypersensitivity to any of its components. Absolute
Adverse Reactions
Very Common >10%Common 1–10%Uncommon 0.1–1%
Rare 0.01–0.1%Very Rare <0.01%Not Known
Skin and subcutaneous tissue disorders (3)
Not Known Eczema · Itching · Rash
General disorders and administration site conditions (1)
Not Known Burning
Dosing
Source: openFDA
2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. CHILDREN AND ADULTS: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing. Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans .
Pregnancy & Lactation
Pregnancy
Lactation
Caution
Hale L3
Nystatin is less effective than other topical agents for the treatment of thrush.
Monitoring
| Efficacy | Fungal culture and species identification; minimum inhibitory concentration (MIC) where available; clinical response (temperature, imaging for invasive fungal disease) |
|---|---|
| Toxicity | LFTs (hepatotoxicity — azoles in particular); renal function; ECG for QT prolongation (azoles); drug levels if available (itraconazole, voriconazole) |
| Clinical pearl | Voriconazole levels are highly variable due to CYP2C19 polymorphism — TDM recommended (target trough 2–5 mg/L). Check for drug interactions with CYP3A4 substrates. |
| Counseling | Report visual disturbances (voriconazole), jaundice, or rash. Take azoles with food or as directed to optimise absorption. |
Chemistry & Properties
| Formula | C47H75NO17 |
|---|---|
| Molecular weight | 926.1 g/mol |
| IUPAC name | (1S,15S,16R,17R,18S,19E,21E,25E,27E,29E,31E)-33-[(2S,3S,4S,5S,6R)-4-amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,4,7,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,25,27,29,31-hexaene-36-carboxylic acid |
| CAS | 1400-61-9 |
| PubChem CID | 6433272 |
| InChIKey | VQOXZBDYSJBXMA-RKEBNKJGSA-N |
| logP | -0.2 (XLogP -0.2) |
| Polar surface area | 320.0 Ų |
| H-bond acceptors / donors | 18 / 12 |
SMILES
CC1C=CC=CCCC=CC=CC=CC=CC(CC2C(C(CC(O2)(CC(C(CCC(CC(CC(CC(=O)OC(C(C1O)C)C)O)O)O)O)O)O)O)C(=O)O)OC3C(C(C(C(O3)C)O)N)OBiology & Pharmacokinetics
Pharmacokinetics predicted
| Bioavailability | 70.0% |
|---|---|
| Half-life | 4.191 h |
| Volume of distribution | 0.268 L/kg |
| Protein binding | 59.6% |
| BBB penetrant | No |
Enzyme interactions
| Enzyme | Role | Detail |
|---|---|---|
| CYP2C8 | Inhibitor | — |
Transporters
BCRP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)MRP2 (Inhibitor)OATP1B1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OATP1B3 (Inhibitor)OATP2B1 (Inhibitor)P-gp (Inhibitor)P-gp (Substrate)
Registered Products (16)
| Brand | Form / strength | Pack | Agent | Citizen (JOD) |
|---|---|---|---|---|
| Nystaform Oint | Ointment 1 g, 3 g, 1 g | 20 g tube | AL-Faiasel Drug Store | 0.930 |
| Nystatin Oral Suspension | Suspension 100000 IU | 30 ml | AL EIMAN DRUG STORE CO LLC | 1.030 |
| kenacin cream | Cream 100000 IU, 0.1 %, 0.025 %, 0.25 % | 15 g tube pack varies | MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN | 1.370 |
| kenacin oint | Ointment 100000 IU, 0.1 %, 0.025 %, 0.25 % | 15 g tube pack varies | MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN | 1.370 |
| Panderm Cream | Cream 10.000000 IU/100 g, 0.025 g/100 g, 0.25 g/100 g, 0.1 g/100 g | 15 g tube pack varies | Professional Drug Store | 1.420 |
| Kenaphil Cream | Cream 0.326 g/tube, 0.00375 g/tube, 0.055161 g/tube, 0.015 g/tube | 15 g tube | PHILADELPHIA PHAEMACEUTICALS.COMP/JORDAN | 1.510 |
| Mycophil Ointment | Ointment 100000 IU/g | 30 g tube | PHILADELPHIA PHAEMACEUTICALS.COMP/JORDAN | 1.650 |
| Rianest Oral Suspension | Suspension 100.000 IU/ml | 30 ml | Khoury Drug Store | 1.830 |
| Mycophil Susp. | Suspension 500000 Unit/5 ml | 30 ml | PHILADELPHIA PHAEMACEUTICALS.COMP/JORDAN | 1.840 |
| Mycosat oral suspention | Injection 100000 IU/ml | 30 ml pack varies | Amman Pharmaceutical Industries Co | 1.930 |
| Panderm Cream | Cream 10.000000 IU/100 g, 0.025 g/100 g, 0.25 g/100 g, 0.1 g/100 g | 30 g tube pack varies | Professional Drug Store | 2.480 |
| Polygynax 6 Vag. Cap. | Capsule 100000 IU, 35, 000 IU, 35, 000 IU | 6 cap | Quality Drug Store | 2.700 |
| Mycophil Susp. | Suspension 500000 Units/5 ml | 60 ml | PHILADELPHIA PHAEMACEUTICALS.COMP/JORDAN | 3.500 |
| Mycosat oral suspention | Injection 100000 IU/ml | 60 ml pack varies | Amman Pharmaceutical Industries Co | 3.500 |
| Topsym polyvalent oint. | Ointment 100.000 IU | 15 g tube | Nabulsi Drug Store | 4.520 |
| Polygynax 12 Ovules | Ovule 100000 IU, 35000 IU, 35000 IU | 12 | Quality Drug Store | 4.710 |