Nystatin

Drug Approvals

Synonyms: Fungicidin; Nistatina; Nistatinas; Nisztatin; Nystatiini; Nystatin; Nystatinum

BAN: Nystatin

USAN: Nystatin

INN: Nystatin [rINN (en)]

INN: Nistatina [rINN (es)]

INN: Nystatine [rINN (fr)]

INN: Nystatinum [rINN (la)]

INN: Нистатин [rINN (ru)]

CAS: 1400-61-9

ATC code: A07AA02; D01AA01; G01AA01

Read code: y00qA [Mouth]; y013C [Skin]; y00Uh [Gynaecological Use]; y02UY; y08DQ [Systemic]

Pharmacopoeias

In Europe, International, Japan, US European Pharmacopoeia, 6th ed. (Nystatin).

An antifungal substance obtained by fermentation using certain strains of Streptomyces noursei. It contains mainly tetraenes, the principal component being nystatin A_:. The potency is not less than 4400 units/mg and not less than 5000 units/mg if intended for oral use, calculated with reference to the dried substance. It is a yellow or slightly brownish hygroscopic powder. Practically insoluble in water and in alcohol freely soluble in dimethylformamide and in dimethyl sulfoxide slightly soluble in methyl alcohol. Store in airtight containers. Protect from light.

The United States Pharmacopeia 31, 2008 (Nystatin).

A substance, or a mixture of two or more substances, produced by the growth of Streptomyces noursei (Streptomycetaceae). It has a potency of not less than 4400 units/mg, or, where intended for use in extemporaneous preparation of oral suspensions, not less than 5000 units/mg. A yellow to light tan, hygroscopic powder, with an odour suggestive of cereals it is affected by long exposure to light, heat, and air. Practically insoluble in water and in alcohol insoluble in chloroform and in ether freely soluble in dimethylformamide and in dimethyl sulfoxide slightly to sparingly soluble in methyl alcohol, in n-butyl alcohol, and in n-propyl alcohol. A 3% suspension in water has apH of 6.0 to 8.0. Store in airtight containers. Protect from light.

Adverse Effects

Nausea, vomiting, and diarrhoea have occasionally been reported after oral use of nystatin. Oral irritation or sensitisation may occur. Rashes, including urticaria, have occurred and Stevens-John son syndrome has been reported rarely. Irritation may occur rarely after the topical use of nystatin. Effects on the skin. Generalised pustular eruptions were reported in 3 patients after oral nystatin. Subsequent sensitivity testing revealed delayed (type IV) hypersensitivity to nystatin.

Precautions

Some intravaginal preparations of nystatin may damage latex contraceptives and additional contraceptive precautions may be necessary during treatment.

Antimicrobial Action

Nystatin is a polyene antifungal antibiotic that interferes with the permeability of the cell membrane of sensitive fungi by binding to sterols, chiefly ergosterol. Its main action is against Candida spp.

Pharmacokinetics

Nystatin is poorly absorbed from the gastrointestinal tract. It is not absorbed through the skin or mucous membranes when applied topically.

Uses and Administration

Nystatin is a polyene antifungal antibiotic used for the prophylaxis and treatment of candidiasis of the skin and mucous membranes. It has been used with antibacterials in various regimens to suppress the overgrowth of gastrointestinal flora and as part of selective decontamination regimens (see Intensive Care).

For the treatment of intestinal or oesophageal candidiasis, nystatin is given in oral doses of 500 000 or 1 000 000 units, as a tablet or capsule, 3 or 4 times daily. In infants and children a dosage of 100 000 units or more may be given 4 times daily, as an oral suspension.

For the treatment of lesions of the mouth, pastilles or a suspension may be given in a dosage of 100 000 units 4 times daily. Higher doses of, for example, 500 000 units 4 times daily, may be needed in immunocompromised patients (but see also Candidiasis, below). The formulation should be kept in contact with the affected area for as long as possible, and patients should avoid taking food or drink for one hour after a dose. In the USA, doses of 400 000 to 600 000 units 4 times daily of the suspension, or 200 000 to 400 000 units 4 or 5 times daily as lozenges, are used.

For prophylaxis of intestinal candidiasis in patients given broad-spectrum antibacterials, tablets to a total dose of 1 000 000 units daily may be given. A prophylactic dose for infants born to mothers with vaginal candidiasis is 100 000 units daily of the oral suspension.

For the treatment of vaginal infections, nystatin is given in a dosage of 100 000 to 200 000 units daily for 14 days or longer as pessaries or vaginal cream.

For cutaneous lesions, ointment, gel, cream, or dusting powder containing 100 000 units/g may be applied 2 to 4 times daily. A liposomal formulation of nystatin for parenteral use is under investigation.

Candidiasis

A systematic review of 14 studies (12 of prophylaxis, 2 of treatment) considered that nystatin could not be recommended for prophylaxis or treatment of Candida infections in patients with immunosuppression. In practice, fluconazole is usually preferred in such patients.

Preparations

Pharmacopoeias

British Pharmacopoeia 2008

• Nystatin Ointment
• Nystatin Oral Suspension
• Nystatin Pastilles
• Nystatin Pessaries
• Nystatin Tablets

The United States Pharmacopeia 31, 2008

• Nystatin and Triamcinolone Acetonide Cream
• Nystatin and Triamcinolone Acetonide Ointment
• Nystatin Cream
• Nystatin for Oral Suspension
• Nystatin Lotion
• Nystatin Lozenges
• Nystatin Ointment
• Nystatin Oral Suspension
• Nystatin Tablets
• Nystatin Topical Powder
• Nystatin Vaginal Suppositories
• Nystatin Vaginal Tablets
• Nystatin, Neomycin Sulfate, Gramicidin, and Triamcinolone Acetonide Cream
• Nystatin, Neomycin Sulfate, Gramicidin, and Triamcinolone Acetonide Ointment
• Oxytetracycline and Nystatin Capsules
• Oxytetracycline and Nystatin for Oral Suspension
• Tetracycline Hydrochloride and Nystatin Capsules

Proprietary Preparations

• Argentina: Candermil; Candidias; Dipni; Nicostatin; Neostatin; Nistagrand; Nistamed; Nistat
• Australia: Nycostatin; N-Statin; Nilstat
• Austria: Candio; Nycostatin; Nystaderm
• Belgium: Nilstat; Sterostatine
• Brazil: Albistin; Canclitrat; Hidrotiazida; Inofungin; Kandistat; Kolpazol; Micostal; Nicostalab; Nicostatin; Neo Nistatin; Neostatin; Nicostat; Nidazolin; Nistagen; Nistagyn; Nistanil; Nistatin; Nistaval; Nistax; Nistomic; Tricocet
• Canada: Canclistatin; Nycostatin; Nadostine; Nilstat; Nyaderm
• Chile: Nicostatin; Nistoral
• Czech Republic: Fungicidin
• Denmark: Nycostatin
• Finland: Nycostatin
• France: Nycostatine
• Germany: Adiclair; Biofanal; Candio; Lederlind; Noronal; Nykoderm Heilsalbe; NykoPosterine N; Nykundex; Nykundex mono; Nystaderm
• Greece: Nycostatin; Nystamysyn
• Hong Kong: Lystin; Nycostatin
• India: Nycostatin
• Ireland: Nycostatin
• Italy: Nycostatin
• Malaysia: Nikostat; Nycostatin; Uphastatin
• Mexico: Aponistan V; Bistatin V; Nibesan-S; Nicostatin; Nistan; Nistaquim; Nizin-V
• Norway: Nycostatin
• New Zealand: Nycostatin; Nilstat
• Philippines: Afunginal; Nycostatin
• Portugal: Mycostatin
• South Africa: Candacide; Canstat; Mycostatin; Nystacid
• Singapore: Mycostatin
• Spain: Mycostatin
• Sweden: Mycostatin
• Switzerland: Mycostatine
• Thailand: Lystin; Mycostatin
• Turkey: Fungostatin; Mikostatin
• United Arab Emirates: Mikostat
• United Kingdom (UK): Nystamont; Nystan
• United States (USA): Mycostatin; Nilstat; Nystop; Pedi-Dri
• Venezuela: Micostatin; Nistafesa; Romalina