Nystafung ( Tablets - Oral Suspension )

Treatment of non-eesophageal mucus membrane gastrointestinal candidosis, The prevention and treatment of candidal infections of the oral cavity, oesophagus and intestinal tract. the suspension also provides effective prophylaxis

Therabeutic Group : Anti-Fungal
Licensers : Oshar pharma
Chemical Composition : Nystatin

Composition

Each 1 ml of oral suspension contains: Nystatin 100000 I.U

Excipients: alcohol ( 1% v/v), carboxymethylcellulose sodium, flavor, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, and sucrose (50% w/v). May also contain citric acid , purefied water , banana flavor

 

Usage

Indications:

Nystatin- Film-Coated Tablets: Treatment of non-eesophageal mucus membrane gastrointestinal candidosis.

Nystatin-Oral Suspension: The prevention and treatment of candidal infections of the oral cavity, oesophagus and intestinal tract. The suspension also provides effective prophylaxis against oral candidosis in those born of mothers with vaginal candidosis.

Contraindications:

Nystatin is contraindicated in patients with a history of hypersensitivity to any of product components.

 

Side Effects

Side Effects:

Nausea, vomiting, diarrhea, and gastrointestinal upset have occasionally been reported after oral use of Nystatin.

Oral irritation or sensitisation may occur.

Rashes, including urticaria, have occurred and Stevens-Johnson syndrome has been reported rarely.

 

Properties

Mechanism of action:

Nystatin 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.

 

Dosage

Dosage and Administration:

  • Nystatin -Film-Coated Tablets:

For adults, one or two tablets 3times daily. Treatment should generally be continued for at least 48hours after clinical cure to prevent relapse.

  • Nystatin- Oral Suspension:

Oral Candidiasis

Infants (1 month to 2 years):

1ml should be dropped into the mouth four times a day.

Children ( 2 years) and adults:

For the treatment of denture sores, and oral infections in children (≥ 2 years) and adults caused by candidas albicans. 1ml of the suspension should be dropped into the mouth four times daily; it should be kept in contact with the affected areas as long as possible.

Intestinal candidiasis

Infants (1 month to 2 years):

1ml should be dropped into the mouth four times a day.

Adults:

For the treatment of intestinal candidosis 5ml of the suspension should be dropped into the mouth four times daily.

Paediatric population ( 2 years):

1ml should be dropped into the mouth four times a day.

For prophylaxis a total daily dosage of 1 million units has been found to suppress the overgrowth of candidas albicans in patients receiving broad-spectrum antibiotic therapy.

For prophylaxis in the newborn the suggested dose is 1ml once daily.

The longer the suspension is kept in contact with the affected area in the mouth before swallowing, the greater will be its effect.

Administration should be continued for 48 hours after clinical cure to prevent relapse.

Overdoses:

Oral doses of nystatin in excess of 5 million units daily have caused nausea and gastrointestinal upset.

 

Drug interactions

Drug and Food Interactions:

No interactions have been reported.

 

precautions and precautions

Precautions:

Nystatin oral preparations should not be used for treatment of systemic mycoses.

Discontinue treatment if sensitization or irritation is reported during use.

Use in pregnancy and Lactation:

Nystatin preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

 

Package

STORAGE: store at 20 – 25 º C , avoid freezing

PACKAGE : Carton Pack containing 30  ml or 60 ml glass bottle of oral suspension with plastic dropps