Mycostatin

Mycostatin

nystatin

Manufacturer:

Taisho Pharmaceutical Indonesia
Full Prescribing Info
Contents
Nystatin.
Description
Mycostatin oral suspension ready-mixed contains nystatin 100,000 units and alcohol 1% per mL of pale yellow suspension pleasantly flavored with cherrymint. Nystatin is a polyene antibiotic that is obtained from Streptomyces noursei.
Action
Pharmacology: Mode of Action: Nystatin is fungistatic 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 sp. resulting in a change in membrane permeability and the subsequent leakage of intracellular components.
On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. Nystatin exhibits no activity against bacteria, protozoa or viruses.
Pharmacokinetics: Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool.
Indications/Uses
Treatment and prevention of candidiasis in the oral cavity.
Dosage/Direction for Use
Adults and Children: Dosage ranges of 1-6 mL (100,000-600,000 units nystatin) 4 times daily have been used.
Infants: Recommended Dose: 1 or 2 mL (100,000-200,000 units nystatin) 4 times daily.
Limited clinical studies in premature and low birth weight infants indicated that 1 mL administered 4 times daily is effective.
The dosage regimen for nystatin oral suspension should be continued for at least 48 hrs after symptoms have disappeared. If signs and symptoms worsen or persist (>14 days of treatment), the patient should be re-evaluated and alternate therapy considered.
Administration: The suspension should be retained in the mouth for as long as possible (eg, several minutes) before swallowing. In infants and young children, apply ½ of dose in each side of mouth.
Overdosage
Oral doses of nystatin in excess of 5 million units daily have caused nausea and gastrointestinal upset (see Pharmacology: Pharmacokinetics under Actions).
Contraindications
Hypersensitivity to any of the components of Mycostatin.
Special Precautions
General: Should not be used for the treatment of systemic mycoses.
If irritation or sensitization develops, treatment should be discontinued.
It is recommended that potassium hydroxide (KOH) smears, cultures, or other diagnostic methods be used to confirm the diagnosis of candidiasis and to rule out infection caused by other pathogens.
Information for the Patient: Patients taking Mycostatin should receive the following information and instructions: Use Mycostatin as directed. Mycostatin is not for any disorder other than that for which it was prescribed. Even if symptomatic relief occurs within the 1st few days of treatment, do not interrupt or discontinue Mycostatin until the prescribed course of treatment is completed. If symptoms of irritation develop, advise the physician promptly. Good oral hygiene is of importance, including the proper care (where applicable) of dentures.
Carcinogenicity, Mutagenicity & Impairment of Fertility: No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effect on male or female fertility.
Use in pregnancy: Animal reproduction studies have not been conducted with Mycostatin oral suspension. It is also not known whether Mycostatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Mycostatin oral suspension should be prescribed to pregnant women only if the potential benefit to the mother outweighs the potential risk to the fetus.
Use in lactation: It is not known whether nystatin is excreted in human milk. Though gastrointestinal absorption is insignificant, caution should be exercised when nystatin is prescribed to nursing women.
Use In Pregnancy & Lactation
Use in pregnancy: Animal reproduction studies have not been conducted with Mycostatin oral suspension. It is also not known whether Mycostatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Mycostatin oral suspension should be prescribed to pregnant women only if the potential benefit to the mother outweighs the potential risk to the fetus.
Use in lactation: It is not known whether nystatin is excreted in human milk. Though gastrointestinal absorption is insignificant, caution should be exercised when nystatin is prescribed to nursing women.
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-Johnson syndrome has been reported very rarely.
Storage
Store below 30°C.
Shelf-Life: 3 years.
MIMS Class
ATC Classification
A07AA02 - nystatin ; Belongs to the class of antibiotics. Used in the treatment of intestinal infections.
Presentation/Packing
Susp 100,000 units/mL x 12 mL x 1's. 100,000 units/mL x 30 mL x 1's.
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