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National Drug Formulary

PMS-NYSTATIN SUSPENSION 500,000 U/5 ML [SIN05499P]

Active ingredients: NYSTATIN

View product's general information
Last updated on 9 October 2026

Product Info

PMS-NYSTATIN SUSPENSION 500,000 U/5 ML

[SIN05499P]

Product information

Active Ingredient and Strength

NYSTATIN - 500,000 UNITS/5 ML

Dosage Form

SUSPENSION

Manufacturer and Country

PENDOPHARM - CANADA
HALO PHARMACEUTICAL CANADA INC. - CANADA

Registration Number

SIN05499P

Licence Holder

SYNMOSA BIOPHARMA PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

A07AA02

Prescription-only Medicines with Exemptions for Supply without Prescription

As an oral liquid preparation containing not more than 100,000 units per ml

  • Indication: Treatment of oral candidiasis

  • Maximum daily dose:

  • Infants and children 6 months and older: 400,000 units

  • Adults: 2.4 million units

  • Maximum supply: 2 weeks

  • Minimum age: 6 months

Indication

INDICATIONS
Prevention and treatment of candidal infections of the oral cavity and oesophagus, for intestinal candidasis and for protection against candidal overgrowth during antimicrobial or corticosteroid therapy.

Dosing

DOSAGE
Infants: Usual prophylactic and therapeutic dosage is 100,000 units 4 times daily, dropped into the side of the mouth and swallowed. Dosage may be increased if necessary.

For prophylaxis in the newborn, 100,000 units once daily may be given by dropper directly into the mouth.

Children and Adults:
Usual therapeutic dose is 100,000 units 4 times daily dropped into the mouth and held or swished throughout the mouth for some time before swallowing.

Contraindications

CONTRAINDICATIONS Hypersensitivity to nystatin or any components of pms-Nystatin Suspension. If irritation or sensitization occurs, pms-Nystatin Suspension should be discontinued.