Enystin

Enystin™
Nystatin

Composition :
Each ml oral suspension contains Nystatin ............... 100,000 units

Clinical pharmacology:
Pharmacokinetics :
Gastrointestinal absorption of Nystatin is insignificant. Most orally administered Nystatin is passed unchanged In the stool.

Mode of action :
Nystatin is fungi static and fungicidal in vitro against a variety of yeasts and yeast like fungi. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species resulting in a change In membrane permeability and the subsequent leakage of intracellular components.
On repeated sub culturing with increasing levels of Nystatin, Candida albicans does not develop resistant to Nystatin. Generally, resistance to Nystatin does not develop during therapy. Nystatin exhibits no activity against bacteria, protozoa or viruses.

Indications :
ENYSTIN (Nystatin) oral suspension is indicated for the treatment of candidiasis in the oral cavity.

Contraindications:
ENYSTIN (Nystatin) oral suspension is contraindicated in patients with history of hypersensitivity to any of its components.

Adverse reactions :
Nystatin is generally well tolerated by all age groups including debilitated infants, even on prolonged administration. Large oral doses have occasionally produced diarrhea, gastrointestinal distress, nausea and vomiting. Rash, including urticaria has been reported rarely. Stevens-Johnsons syndrome has been reported very rarely.

Precautions :
General
ENYSTIN oral suspension should not be used for the treatment of systemic mycoses.
If irritation or sensitization develops, treatment should be discontinued.
It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of candidiasis and to rule out infection caused other pathogens.

Information for the patient:
Patients taking ENYSTIN oral suspension should receive the following information and instructions:

1. The patients should be instructed to use the medications as directed. The medication is not for any disorder other than that for which it was prescribed.
2. Even 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 prescribed course of treatment is completed.
3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.
4. When prescribing ENYSTIN oral suspension, advise the patient of the importance of good oral hygiene, including the proper care (where applicable) of dentures.

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.

Presentation :
ENYSTIN oral suspension ready for use in 12 ml bottles. A dropper, calibrated at 0.5 ml, is provided. On simple administration by dropper, the suspension readily disperses throughout the mouth.

Dosage and administration :
ENYSTIN (Nystatin) oral suspension :
Infants, children and adults :
the recommended dose is 1 ml (100,000 units Nystatin) four times daily.
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.
The dosage regimen for Nystatin for oral suspension (Nystatin oral suspension) should be continued for at least 48 hours after symptoms have disappeared.

Packing :
Drops, Bottles 12 ml. Reg. No. : DKL0504424733A1

Storage:
Store in a cool dry place (15°-25°C).
Shake well before use.

ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER

PT DANKOS FARMA, JAKARTA-INDONESIA

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