MYCOSTATIN Oral suspension Ref.[49859] Active ingredients: Nystatin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Substipharm, 24 rue Erlanger, 75016 Paris, France

4.1. Therapeutic indications

The prevention and treatment of mycotic infections due to Candida albicans, affecting the oral cavity. Consideration should be given to official guidance on the appropriate use of antifungal agents.

4.2. Posology and method of administration

Posology

Neonates (from birth to 1 month)

Clinical studies of limited size in neonates, including preterm and babies of low weight at birth, indicate that 1 ml (100,000 U) three times daily is an effective regimen.

Infants (1 month to 2 years)

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

Children (over 2 years) and adults

Dosage ranges of one to six mL (100,000 to 600,000 units nystatin) four times daily have been used. It is recommended to keep the medication in contact with the affected areas as long as possible.

Older people

No specific dosage recommendations or precautions.

In the prevention and treatment of candidiasis, the dosage regimen for Mycostatin 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.

4.9. Overdose

Since the absorption of nystatin from the gastro-intestinal tract is negligible, overdosage or accidental ingestion causes no systemic toxicity. Oral doses of nystatin in excess of 5 million units daily have caused nausea and gastrointestinal upset.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Do not store above 25°C.

Do not freeze.

Store in the original container.

6.5. Nature and contents of container

30 ml Type III amber glass bottle with polypropylene cap, packed in a cardboard carton with a graduated, polyethylene dropper with natural rubber bulb.

6.6. Special precautions for disposal and other handling

Shake well before use.

Dilution is not recommended as this may reduce therapeutic efficacy.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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