Nystatin

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Candidal (monilial) infections of the oral cavity (sus)
• Candidal (monilial) infections of the vaginal cavity (vaginal tab)
• Adjuvant prophylaxis of secondary infections during antibiotic or corticosteroid therapy (vaginal tab)
• Local treatment of moniliasis caused by Candida albicans (oin,cre) 

Contraindications

Oral suspension, ointment, vaginal tablet

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment (tab)
• Hepatic impairment (tab)
• Elderly (tab)
• Systemic mycoses (sus)
• Diabetes mellitus (sus)
• Sodium controlled diet (sus)
• Fructose intolerance (sus)
• Glucose-galactose malabsorption (sus)
• Sucrase-isomaltase insufficiency (sus)

Forms avail. in SA and covered in this monograph: cre, oin, tab, sus

Dosages below include:

• General dosing range
• South African Standard Treatment Guideline indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Yeasts and yeast-like fungi, including Candida albicans

General dosing range
- Mild oropharyngeal candidiasis

• Oral (sus): 500 000 IU (5ml), retained in mouth for 3-5mins before swallowing, 6hrly

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Nystatin cream or ointment is an option for paronychia and cutaneous candidiasis

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Vaginal tablets are less effective for vulvovaginal candidiasis than other drug choices

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Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guideline indications and dosages

Oral candidiasis

• Oral (sus): 100 000 IU (1ml), 6hrly; after each meal; Treatment duration: 7 days; Continue for 48hrs after symptoms resolve
  (STG, PHC 2020)

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South African registered indications and dosages

Moniliasis by Candida albicans

• Topical (cre, oin): Apply small quantity to affected area(s), 12hrly; Treatment duration: Until healing is complete

Candida of the oral cavity

• Oral (sus): 100 000-200 000 IU (1-2ml), 6hrly; Treatment duration: Until 48hrs after symptoms resolve

- Severe infections

• Oral (sus): 400 000-600 000 IU (4-6ml), 6hrly; Treatment duration: Until 48hrs after symptoms resolve

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Retain in mouth for as long as possible before swallowing

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If significant regeneration or repair of the oral tissue has not occurred in 7 days, additional investigations into the etiology of the oral lesion is advised

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On administration by dropper, the suspension readily disperses throughout the mouth and is compatible with commonly used systemic antimicrobial agents

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Candida of the vaginal tract

• Vaginal (tab): 100 000-200 000 IU (1-2 tab), dly; Treatment duration: ≥2 weeks

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Continue treatment during menstruation

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Indications and dosages registered in other jurisdictions

Oral candidiasis
- For the treatment of denture sores and oral infections caused by candidas albicans

• Oral (sus): 100 000 IU (1ml), 6hrly; Treatment duration: Until 48hrs after symptoms resolve

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The longer the suspension is kept in contact with the affected area in the mouth before swallowing, the greater its effect

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Intestinal candidiasis
- The prevention and treatment of candidal infections of the intestinal tract

• Oral (sus): 500 000 IU (5ml), 6hrly; Treatment duration: Until 48hrs after symptoms resolve

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If signs and symptoms worsen or persist (beyond 14 days of treatment), the patient should be re-evaluated and alternate therapy considered

Paed. forms avail. in SA and covered in this monograph: cre, oin, tab, sus

Paed. dosages below include:

• General dosing range
• South African Standard Treatment Guideline indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Yeasts and yeast-like fungi, including Candida albicans

General dosing range
- Mild oropharyngeal candidiasis

Premature infants

• Oral (sus): 100 000 IU (1ml), 6hrly

Infants

• Oral (sus): 200 000 IU (2ml), 6hrly

Children and adolescents

• Oral (sus): 500 000 IU (5ml), 6hrly

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Infants and young children: Use dropper to place half of the dose in each side of mouth, avoid feeding for 5-10min

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Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guideline indications and dosages

Oral candidiasis (Thrush)

• Oral (sus): 100 000 IU (1ml), 4hrly
  (STG, Paed. 2017)
  OR
• Oral (sus): 100 000 IU (1ml), 6hrly after each meal/feed; Treatment duration: 7 days; Continue for 48hrs after symptoms resolve
  (STG, PHC 2020)

Opportunistic infections in children
- Recurrent oral candidiasis

• Oral (sus): 50 000 IU (0.5ml) after each feed; Treatment duration: Until 48hrs after symptoms resolve
  (STG, PHC 2020)

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South African registered indications and dosages

Candidal infections of the oral cavity

Infants

• Oral (sus): 100 000-200 000 IU (1-2ml), 6hrly

Children

• Oral (sus): See adult dosage

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The dose should be dropped in the mouth and retained before swallowing

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If significant regeneration or repair of the oral tissue has not occurred in 7 days, additional investigations into the etiology of the oral lesion is advised

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On administration by dropper, the suspension readily disperses throughout the mouth and is compatible with commonly used systemic antimicrobial agents

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Indications and dosages registered in other jurisdictions

Oral candidiasis
- The prevention and treatment of candidal infections of the oral cavity
- Prophylaxis against oral candidosis in those born of mothers with vaginal candidosis

Younger than 1 month

• Oral (sus): No information available

Between 1 month and 2 years

• Oral (sus): 100 000 IU (1ml), 6hrly; Treatment duration: Until 48hrs after symptoms resolve

2 years and older
- For the treatment of oral infections caused by candidas albicans

• Oral (sus): 100 000 IU (1ml), 6hrly; Treatment duration: Until 48hrs after symptoms resolve

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The suspension should be kept in contact with the affected areas as long as possible

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Intestinal candidiasis
- The prevention and treatment of candidal infections of the intestinal tract

Younger than 1 month

• Oral (sus): No information available

1 month and older

• Oral (sus): 100 000 IU (1ml), 6hrly; Treatment duration: Until 48hrs after symptoms resolve

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For prophylaxis in children ≥2 years, a total daily dosage of 1 million U has been found to suppress the overgrowth of candidas albicans in patients receiving broad-spectrum antibiotic therapy

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Prophylaxis against oral candidosis in those born of mothers with vaginal candidosis 

• Oral (sus): 100 000 IU (1ml), dly

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The longer the suspension is kept in contact with the affected area in the mouth before swallowing, the greater will be its effect

Pregnancy

• Caution (sus)
• Animal reproductive studies have not been conducted with nystatin
• It is not known whether nystatin can cause foetal harm when administered to a pregnant woman or can affect reproductive capacity; however, absorption of nystatin from the gastrointestinal tract is negligible
• Nystatin should be prescribed during pregnancy only if the potential benefits to be derived outweigh the possible risks involved
• No information available for topical or vaginal formulations

Breastfeeding

• Caution (sus)
• It is not known whether nystatin is excreted in human milk
• Although gastrointestinal absorption is insignificant, caution should be exercised when nystatin is prescribed for a breastfeeding woman
• No information available for topical or vaginal formulations

Renal Impairment

• No dose adjustment recommended (cre, oin, sus)
• Caution; no information available (tab) 

Hepatic Impairment

• No dose adjustment recommended (cre, oin, sus)
• Caution; no information available (tab)

Elderly

• No dose adjustment recommended (cre, oin, sus)
• Caution; no information available (tab)

Porphyria Information

• Not porphyrinogenic (NP) (cre, oin, sus)
• Not yet classified (NC) (tab)

Drugs in Sport

• Permitted - No warnings

Gastrointestinal Disorders

• Nausea and vomiting (large oral doses)
• Diarrhoea (large oral doses)
• Gastrointestinal distress (large oral doses)

Skin and Subcutaneous Tissue Disorders

• Irritation
• Allergic contact dermatitis
• Rash (large oral doses)
• Urticaria (large oral doses)
• Stevens-Johnson syndrome (large oral doses)

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity (large oral doses)
• Angioedema, including facial oedema (large oral doses)

None known 

None routine

Nystatin suspension - EML (Primary)

Nystatin cream, ointment, tablet - Non-EML

Nystatin is a mixture of antifungal polyenes produced by the growth of certain strains of Streptomyces noursei, or by any other means. It consists largely of Nystatin A. Nystatin has fungistatic and fungicidal activity which interferes with the permeability of the cell membrane of fungi by binding to sterols, mainly ergosterol.

Spectrum of activity: Yeasts and yeast-like fungi, including Candida albicans

Tablet 100 000 U

• Canstat vaginal tablet (Pharmacare)

Suspension (per ml) 100 000 U

• Candacide oral suspension (Be-Tabs) 
• Nystacid oral suspension (Pharmacare)

Cream (per g) 100 000 U

• Canstat (Pharmacare) originator

Ointment (per g) 100 000 U

• Nystacid (Pharmacare)