Data Sheet

Mycostatin Oral

Nystatin

Presentation

Tablet: 500 000 units; chocolate brown, sugar coated

Suspension: 100 000 units/ml; contains sugar.

Uses

Actions

Nystatin is an antifungal antibiotic active against a wide range of yeasts and yeast-like fungi, including Candida albicans.

Microbiology

Nystatin is fungistatic and fungicidal in vitro against a variety of yeasts and yeast-like fungi..

Nystatin exhibits no activity against bacteria, protozoa, or viruses.

Pharmacokinetics

Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool^.

Indications

MYCOSTATIN (nystatin) suspension is used for the prevention and treatment of candidal infections of the oral cavity, oesophagus and intestinal tract. It provides effective prophylaxis against oral candidosis in those born of mothers with vaginal candidosis.

MYCOSTATIN (nystatin) tablets are used for intestinal candidosis. They may be used for the prophylaxis of candidal overgrowth during courses of broad-spectrum antibiotics.

Dosage And Administration

MYCOSTATIN (nystatin) oral suspension

Infants: The recommended dose is one or two mL (100,000 to 200,000 units nystatin) four times daily.

Limited clinical studies in premature and low birth weight infants indicate that one mL four times daily is effective.

Children and Adults: Dosage ranges of one to six mL (100,000 to 600,000 units nystatin) four times daily have been used.

The suspension should be retained in the mouth for as long as possible (e.g., several minutes) before swallowing. In infants and young children, apply one-half of dose in each side of mouth.

MYCOSTATIN (nystatin) oral tablets

The recommended dose is one or two tablets (500,000 or 1,000,000 units nystatin) three or four times daily.

The dosage regimen for both MYCOSTATIN (nystatin) for oral suspension & oral tablets should be continued for at least 48 hours after symptoms have disappeared. If signs and symptoms worsen or persist (beyond 14 days of treatment), the patient should be reevaluated, and alternate therapy considered

Elderly:

No specific recommendations or precautions.

Contraindications

Mycostatin (nystatin) oral tablets and suspension are contraindicated in patients with a history of hypersensitivity to any of their components.

Warnings And Precautions

Mycostatin Oral Suspension contains sugar.

General

MYCOSTATIN (nystatin) for oral suspension should not be used for the treatment of systemic mycoses.

If irritation or sensitization develops, treatment should be discontinued.

Information for the Patient

1. The patient should be instructed to use the medication as directed.
2. If symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue the medication until the course of treatment is completed.
3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.
4. When prescribing MYCOSTATIN (nystatin) oral suspension, advise the patient of the importance of good oral hygiene, including the proper care of dentures.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effect on male or female fertility.

Pregnancy

Category A

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Though gastrointestinal absorption is insignificant, caution should be exercised when nystatin is prescribed for a nursing woman.

Effect on ability to drive & use machines

No data has been established on the effect that nystatin has on the ability to drive & use machines, therefore it can only be assumed that it is safe or unlikely to produce an effect

Adverse Effects

Large oral doses have occasionally produced diarrhea, gastrointestinal distress, nausea and vomiting. Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Overdosage

Since the absorption of nystatin from the gastrointestinal tract is negligible, overdosage causes no systemic toxicity. However oral doses of nystatin in excess of 5 million units daily have caused nausea and gastrointestinal upset

Pharmaceutical Precautions

Suspension:

Shelf Life: 24 months from the date of manufacture

Store below 25°C

Do not freeze.

Shake well before use.

Tablets:

Shelf Life: 36 months from the date of manufacture

Store below 25°C

Dilution:

Not recommended as this may reduce therapeutic efficacy. If necessary, refer to the manufacturer.

Medicine Classification

Tablet:

Prescription Medicine

Suspension:

Restricted Medicine

Package Quantities

Tablet:

500 000 units 50s

Suspension:

100 000 units/ml, 24ml w/graduated dropper.

Further Information

Tablet:

Mycostatin (nystatin) tablets contains the following:

Core - Nystatin, lactose, corn starch, talc, magnesium stearate.

Coating - Castor oil, shellac lemon dewaxed, talc, povidone K30, sturcal L, sugar, light brown tablet powder & opaglos AG 7350 white.

Suspension

Mycostatin (nystatin) suspension contains nystatin, sugar,, glycerol, saccharin sodium, carmellose sodium, sodium phosphate dibasic, methyl hydroxybenzoate, propyl hydroxybenzoate, alcohol, flavour cherry, peppermint oil, cinnamaldehyde & purified water.

Chemical structure

C47H75NO17

Name And Address

Bristol-Myers Squibb (NZ) Company
Medicines Group
Simpson Grierson Building
92-96 Albert St
Auckland
New Zealand

Date Of Preparation

5^th May 2004