COMPOSITION :
Nystatin Drops, each ml contains : 100,000 IU Nystatin.
DESCRIPTIONS :
Nystatin with Nystatin as active ingredient is available in suspension 100,000 IU/ml.
INDICATION :
Nystatin drops is indicated for the treatment of candidiasis in the oral cavity.
DOSAGE AND ADMINISTRATIONS :
- Infants : 1 – 2 ml (100,000 – 200,000 IU) 4 times daily (use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes).
- Premature and low birth weight infants : 1 ml (100,000 IU) 4 times daily.
- Children and adults : 1 – 6 ml (100,000 to 600,000 IU) 4 times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.
Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.
OVERDOSAGE :
An oral dose more than 5,000,000 IU a day can cause nausea and GI-upset.
CONTRAINDICATION :
Patient with a history hypersensitivity to Nystatin and any of its components.
WARNINGS AND PRECAUTIONS :
- General : Nystatin is not be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.
- Pregnancy : Use in pregnant woman only if clearly needed.
- Nursing mothers : Use with caution when nystatin is administered to a nursing woman.
- Advisable to do KOH smear, culture or others diagnose method to enforce the diagnose of candidiasis and not infection because of others pathogen.
ADVERSE REACTIONS :
- Nystatin is well tolerated. Oral irritation and sensitization have been reported (see WARNINGS AND PRECAUTIONS).
- Gastrointestinal : Diarrhea, nausea, vomiting, gastrointestinal disturbances, gastrointestinal distress.
- Dermatologic : Rash, including urticaria has been reported rarely. Steven-Johnson syndrome has been reported very rarely.
- Others : Tachycardia, bronchospasm, facial swelling and nonspecific myalgia have also been rarely reported.
PRESENTATION :
Nystatin Drops Box, 10 bottle @ 12 ml Reg. No. GKL1302347136A1
STORAGE :
STORE BELOW 25ºC AND DRY PLACE, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
