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standards of non-Merck sources.
Medication Safety Issues
Sound-alike/look-alike issues:
Nystatin may be confused with Nilstat®, Nitrostat®
Nilstat may be confused with Nitrostat®, nystatin
Pronunciation
(nye STAT in)
U.S. Brand Names
Generic Available
Yes: Cream, ointment, powder, suspension, tablet
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of susceptible cutaneous, mucocutaneous, and oral cavity fungal infections normally caused by the Candida species
Use: Dental
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
Drug Interactions
Saccharomyces boulardii: Antifungal Agents may diminish the therapeutic effect of Saccharomyces boulardii. Risk D: Consider therapy modification
Storage
Vaginal insert: Store in refrigerator. Protect from temperature extremes, moisture, and light.
Oral tablet, ointment, topical powder, and oral suspension: Store at controlled room temperature 15°C to 25°C (59°F to 77°F).
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
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
Dental Usual Dosing
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
Mucocutaneous infections: Children and Adults: Topical: Apply 2-3 times/day to affected areas; very moist topical lesions are treated best with powder
Administration: Oral
Suspension: Shake well before using. Should be swished about the mouth and retained in the mouth for as long as possible (several minutes) before swallowing.
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 tablet: 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 troche: 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 tablet: Wash hands before using. Lie down to insert high into vagina at bedtime.
Geriatric Considerations
For oral infections, patients who wear dentures must have them removed and cleaned in order to eliminate source of reinfection.
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
Nursing: Physical Assessment/Monitoring
Determine that cause of infection is fungal. Avoid skin contact when applying. Monitor therapeutic effectiveness, adverse reactions at beginning of therapy and periodically throughout therapy. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report.
Oncology: Emetic Potential
Low (10% to 30%)
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
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)
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, for prescription compounding: 1 billion units (190 g); 150 million units (30 g); 2 billion units (350 g); 50 million units (10 g); 500 million units (100 g)
Bio-Statin®: 2 billion units (30 g)
Powder for suspension, oral [preservative free]:
Paddock Nystatin™: 150 million units (30 g); 2 billion units (400 g); 50 million units (10 g); 500 million units (100 g) [sugar free]
Powder, topical:
Mycostatin®: 100,000 units/g (15 g) [contains talc]
Nyamyc™: 100,000 units/g (15 g, 30 g) [contains talc]
Nystop®: 100,000 units/g (15 g, 30 g, 60 g) [contains talc]
Pedi-Dri®: 100,000 units/g (56.7 g) [contains talc]
Suspension, oral: 100,000 units/mL (5 mL, 60 mL, 480 mL)
Tablet: 500,000 units
Tablet, vaginal: 100,000 units (15s) [packaged with applicator]
Pricing: U.S. (www.drugstore.com)
Cream (Nystatin)
100000 units/g (30): $12.99
Ointment (Nystatin)
100000 units/g (15): $12.99
Powder (Mycostatin)
100000 units/g (15): $36.99
Powder (Nystatin)
(1): $39.99
(30): $2699.58
Powder (Pedi-Dri)
100000 units/g (56.7): $93.80
Suspension (Nystatin)
100000 units/mL (180): $42.98
Tablets (Nystatin)
100000 unit (15): $68.19
500000 unit (60): $36.99
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.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2008
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