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Drug Approvals

(British Approved Name, US Adopted Name, rINN)

INNs in other languages (French, Latin, Spanish):

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

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

UK: Nystamont Nystan

USA: Mycostatin Nilstat Nystop Pedi-Dri

Venezuela: Micostatin Nistafesa † Romalina

Multi-ingredient Preparations

The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed.

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