Nystatin Tablets 500 000 Units
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NYSTABS/Nystatin Tablets 500,000 Units
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Nystatin BP 525,000 Units (approximately 90.00 mg)
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Candidiasis
4.2 Posology and method of administration
Adults, including the Elderly:
1 tablet four times daily. This dose may be doubled. For prophylaxis a total daily dosage of 1 million units has been found to suppress the overgrowth of C. albicans in patients receiving broad-spectrum antibiotic therapy.
Administration should be continued for 48 hours after clinical cure to prevent relapse.
Children: Not recommended.
Route of administration: Oral
4.3 Contraindications
There are no known contra-indications to the use of Nystatin, except hypersensitivity to the ingredients in the product.
4.4 Special warnings and precautions for use
None stated
4.5 Interaction with other medicinal products and other forms of interaction
None stated
4.6 Pregnancy and lactation
None stated
4.7 Effects on ability to drive and use machines
None stated
4.8 Undesirable effects
Nausea, vomiting and diarrhoea have occasionally been reported with doses of Nystatin exceeding 4 to 5 million units daily. Non systemic effects or allergic reactions have been associated with its oral use.
4.9 Overdose
Since the absorption of Nystatin from the gastro-intestinal tract is negligible, overdosage causes no systemic toxicity.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Nystatin exerts its effect by interaction with cell walls and cell membranes. Sterols present in the cell membrane are necessary for this effect. It has both fungistatic and fungicidal effects.
5.2 Pharmacokinetic properties
Nystatin is an anti-fungal antibiotic active against Candida albicans and a wide range of yeast-like fungi.
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Pregelatinised maize starch, maize starch, lactose, sodium starch glycollate, magnesium stearate.
Shellac, povidone, talc, sucrose, E171, E124, E128 E110, E172.
6.2
Incompatibilities
None stated.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store in a cool, dry place in well closed containers.
Protect from light.
6.5 Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane/polythene inserts.
Pack sizes: 28 and 100.
6.6 Special precautions for disposal
Use as directed by the physician.
7 MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
Boumpoulinas 11, 3 rd Floor
NICOSIA
CYPRUS
PC. 1060
CYPRUS
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0072
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/11/2008
10 DATE OF REVISION OF THE TEXT
21/11/2008