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Pronunciation:

(nye STAT in)

U.S. Brand Names:

Bio-Statin®; Mycostatin®; Nystat-Rx®; Nystop®; Pedi-Dri®

Generic Available:

Yes: Cream, ointment, powder, suspension, tablet

Canadian Brand Names:

Candistatin®; Mycostatin®; Nilstat; Nyaderm; PMS-Nystatin

Use:

Treatment of susceptible cutaneous, mucocutaneous, and oral cavity fungal infections normally caused by the Candida species

Pregnancy Risk Factor:

B/C (oral)

Lactation:

Does not enter breast milk/compatible (not absorbed orally)

Contraindications:

Hypersensitivity to nystatin or any component of the formulation

Adverse Reactions:

Frequency not defined: Dermatologic: Contact dermatitis, Stevens-Johnson syndrome

1% to 10%: Gastrointestinal: Nausea, vomiting, diarrhea, stomach pain

<1%: Hypersensitivity reactions

Overdosage/Toxicology:

Symptoms of overdose include nausea, vomiting, and diarrhea. Treatment is supportive.

Drug Interactions:

No data reported

Stability:

Keep vaginal inserts in refrigerator; protect from temperature extremes, moisture, and light

Mechanism of Action:

Binds to sterols in fungal cell membrane, changing the cell wall permeability allowing for leakage of cellular contents

Pharmacodynamics/Kinetics:

Onset of action: Symptomatic relief from candidiasis: 24-72 hours

Absorption: Topical: None through mucous membranes or intact skin; Oral: Poorly absorbed

Excretion: Feces (as unchanged drug)

Dosage:

Oral candidiasis:

Suspension (swish and swallow orally):

Premature infants: 100,000 units 4 times/day

Infants: 200,000 units 4 times/day or 100,000 units to each side of mouth 4 times/day

Children and Adults: 400,000-600,000 units 4 times/day

Troche: Children and Adults: 200,000-400,000 units 4-5 times/day

Powder for compounding: Children and Adults: ¹/8 teaspoon (500,000 units) to equal approximately ¹/2 cup of water; give 4 times/day

Mucocutaneous infections: Children and Adults: Topical: Apply 2-3 times/day to affected areas; very moist topical lesions are treated best with powder

Intestinal infections: Adults: Oral: 500,000-1,000,000 units every 8 hours

Vaginal infections: Adults: Vaginal tablets: Insert 1 tablet/day at bedtime for 2 weeks

Patient Education:

Take as directed. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Do not allow medication to come in contact with eyes. Report persistent nausea, vomiting, or diarrhea; or if condition being treated worsens or does not improve. Pregnancy precaution: Inform prescriber if you are pregnant.

Oral tablets: Swallow whole; do not crush or chew.

Oral suspension: Shake well before using. Remove dentures, clean mouth (do not replace dentures until after using medications). Swish suspension in mouth for several minutes before swallowing.

Oral troches: Remove dentures, clean mouth (do not replace dentures until after using medication). Allow troche to dissolve in mouth; do not chew or swallow whole.

Topical: Wash and dry area before applying (do not reuse towels without washing, apply clean clothing after use). Report unresolved burning, redness, or swelling in treated areas.

Vaginal tablets: Wash hands before using. Lie down to insert high into vagina at bedtime.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Oncology: Emetic Potential:

Low (10% to 30%)

Dosage Forms:

[DSC] = Discontinued product

Capsule (Bio-Statin®): 500,000 units, 1 million units

Cream: 100,000 units/g (15 g, 30 g)

Mycostatin®: 100,000 units/g (30 g)

Lozenge (Mycostatin®): 200,000 units [DSC]

Ointment, topical: 100,000 units/g (15 g, 30 g)

Powder, for prescription compounding: 50 million units (10 g); 150 million units (30 g); 500 million units (100 g); 2 billion units (400 g)

Nystat-Rx®: 50 million units (10 g); 150 million units (30 g); 500 million units (100 g); 1 billion units (190 g); 2 billion units (350 g)

Powder, topical:

Mycostatin®: 100,000 units/g (15 g)

Nystop®: 100,000 units/g (15 g, 30 g, 60 g)

Pedi-Dri®: 100,000 units/g (56.7 g)

Suspension, oral: 100,000 units/mL (5 mL, 60 mL, 480 mL)

Mycostatin® [DSC]: 100,000 units/mL (60 mL, 480 mL) [contains alcohol 1%; cherry-mint flavor]

Tablet: 500,000 units

Tablet, vaginal: 100,000 units (15s) [packaged with applicator]

International Brand Names:

Acronistina® (EC); Adiclair® (DE); Biofanal® (DE); Candacide® (ZA); Candermil® (AR); Candex® (BD); Candio-Hermal® (AT, DE, LU); Candistatin® (CA, DO); Candistin® (ID); Canstat® (BD, ZA); Dipni® (AR); Fefun® (BD); Fungicidin Leciva® (CZ); Fungistin® (BD); Kandistat® (BR); Kandistatin® (ID); Lederlind® (DE); Lystin® (HK, TH); Medley Nistatina® (BR); Micostatin® (AR, BR, CL, CO, MX); Mikostatin® (TR); Moronal® (DE); Multilind® (CH); Mycocin® (BD); Mycostatin® (AT, AU, CA, CH, CN, DK, ES, FI, ID, IE, IN, IT, NO, NZ, PT, SE, SG, TH, ZA); Mycostatine® (FR); Mycostatin Vaginal® (ES, ID, IE, IN); Mykoderm Heilsalbe® (DE); MykoPosterine N® (DE); Mykundex® (DE); Nadostine® (HK); Neostatin® (AR); Nilstat® (AU, BE); Nilstat (CA, LU, NZ); Nistagrand® (AR); Nistat® (AR); Nistatina® (AR, BR, EC, IT); Nistatina L.CH.® (CL); Nistatin® (BD); Nistatin Pliva® (HR); Nistatin (RO, SI); Nistoral® (CL); N-Stamicin® (RO); Nyaderm (CA); Nystacid® (ZA); Nystaderm® (AT, DE); Nystaform® (IE); Nystamont® (GB); Nystan® (GB); Nystanon® (BD); Nystat® (BD); Nystatin® (BG, GB, HU, IL, PL, RO, RU, YU); Nystatine® (BE, LU); Nystatine Plan® (CH); Nystatin Holsten® (DE); Nystatin Jenapharm® (DE); Nystatin Lederle® (AT, DE); Nystatin Stada® (DE); Nystatin YSP® (SG); Nystatyna® (PL); Nystin® (BD); Oranyst® (IL); Ornys® (BD); PMS-Nystatin (CA, SG); Qualistatina® (CR, GT, PA); Restatin® (CY); Stamicin® (RO)

References

Dismukes WE, Wade JS, Lee JY, et al, "A Randomized, Double-Blind Trial of Nystatin Therapy for the Candidiasis Hypersensitivity Syndrome,"N Engl J Med, 1990, 323(25):1717-23.

Epstein JB, Vickars L, Spinelli J, et al, "Efficacy of Chlorhexidine and Nystatin Rinses in Prevention of Oral Complications in Leukemia and Bone Marrow Transplantation,"Oral Surg Oral Med Oral Pathol, 1992, 73(6):682-9.

Meunier-Carpentier F, "Symposium on Infectious Complications of Neoplastic Disease (Part II). Chemoprophylaxis of Fungal Infections,"Am J Med, 1984, 76(4):652-6.

Poland JM, "Oral Thrush in the Oncologic Patient. Therapy Must Be Tailored,"Am J Hosp Care 1987, 4(5):30-2.

Wasilewski C Jr, "Allergic Contact Dermatitis From Nystatin,"Arch Dermatol, 1971, 104(4):437.

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