NYST® COLLUTORY POWDER

FORMULA:

For 1 sachet
Nystatin 25000 IU
Excipients (Sorbitol, Vanillin) s.q.f 1 sachet

PHARMACODYNAMICS:

Nystatin is a polyene antibiotic obtained from Streptomyces noursei, yellow powder, very slightly soluble in water. The fungal growth inhibitionor annihilation of Nystatin dependson its concentration and sensitivity of the fungus. The most sensitive fungus is yeast, especially Candida albicans. Nystatin exhibits no appreciable activity against bacteria, protozoa, or virus.

Nystatin acts by binding to sterols in the cell membrane of fungi, with a resultant change in permeability and function of membrane, allowing leakage of potassium and other essential intracellular components. Nystatin is well tolerated even with prolonged therapy and rarely causes resistance.When Candida become resistant on treatment with Nystatin,they simultaneously become cross resistant to other polyene antifungals.Symptoms of candidiasis will decrease within 24 to 72 hours.

Nystatin is used for multiple infection of gastrointestinal candidiasis during antibiotic treatment. This medicine is administered topically, not to be used for the treatment of systemic candidiasis.

PHARMACOKINETICS:

Nystatin is poorly absorbed from the gastrointestinal tract. It is not absorbed through the skin or mucous membranes when applied topically. Most orally administered Nystatin is passed unchanged in the stool.

INDICATIONS:

Prevention and treatment of candidiasis: oral thrush, stomatitis, papillary atrophy,pharyngitis caused by Candida albicans.

DOSAGE AND ADMINISTRATION:

Infants under 1 month of age: take half a sachet each time, twice a day.

Children from 1 month to under 18 years: take 1 sachet each time, twice a day.

Adults from 18 years and older: take 2 sachets each time, twice a day.

Or follow doctor’s instructions.

Add one dose to a small glass with one teaspoon of cooled-boiled water, stir to disperse evenly, wrap around one finger with sterilized gauze, apply to the tongue, throat, etc where fungi grow. Within 20 minutes after taking this medicine, do not eat or drink. It is designed for extemporaneous preparation of a single dose at a time. Swallowing this medicine has no effect on patient’s health.

CONTRAINDICATIONS:

This medicine should be avoided if you have a known history of hypersensitivity to Nystatin or any ingredients of the medicine.

PRECAUTIONS:

If any hypersensitivity reactions occur, discontinue your treatment immediately and take an appropriate healthcare.

Patients with rare genetic disorder of fructose intolerance should not take this medicine.

PREGNANT WOMEN AND LACTATING WOMEN:

Pregnancy: It is not known whether Nystatin can cause fetal harm when administered to a pregnant woman. Nystatin should be given to a pregnant woman only if clearly needed.

Lactation: It is not known whether Nystatin is excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

DRIVING AND OPERATING MACHINERY ABILITY:

No effect.

UNDESIRABLE EFFECTS:

Nystatin is virtually non-toxic and hypoallergenic and well tolerated in all age groups, including debilitated infants, and even with prolonged therapy.

Less common: Urticaria or external rash.

Rarely: Local irritation. Steven – Johnson syndrome.

Inform the doctor immediately if any undesirable effect occurs while using this medicine.

DRUG INTERACTIONS:

Nystatin will lose its effect against Candida albicans if it is used concomitantly with Riboflavin phosphate.

OVERDOSE AND TREATMENT:

Gastric lavage should be used, use gastrointestinal cleanser and appropriate supportive treatment.

DOSAGE FORM AND PRESENTATION:

Powder.

Box of 10 sachets x 1 g powder.

SHELF LIFE:

36 months from manufacturing date.