Expiration date: 07/2025
Composition and form of issue:
Eye drops 1g contains:
fusidic acid micronized (in terms of anhydrous acid) 10 mg
(equivalent to 10, 17 mg of the hemihydrate fusidic acid)
excipients: benzalkonium chloride disodium edetate mannit carbomer 974R sodium hydroxide purified water
in tubes of 5 grams in a cardboard bundle 1 tuba.
Description of dosage form:
Viscous suspension is white or almost white.
Pharmacokinetics:
Dosage form of Fucithalmic in the form of viscous eye drops delivers extended contact of the drug with the conjunctiva and sufficient concentration fusidic acid in the tear fluid for use 2 times a day. After 1, 3, 6 and 12 h after a single dose of Fucithalmic average concentration of fusidic acid in tear fluid is 15, 7 15, 2 10, 5 and 5, 6 µg/ml, respectively. In the intraocular fluid, the concentration of fusidic acid is equal to 0, 3 mg / ml (after a single application) and 0, 8 mg/ml (after repeated application), achieved within 1 h after application and maintained for at least 12 h, while fusidic acid in serum is not determined.
Description of the pharmacological action:
Fusidic acid belongs to the group of fuzidinu, antimicrobial compounds, mechanism of action which involves a violation of protein synthesis in the bacterial cell. Blocking factor g elongation, they prevent its binding to ribosomes and guanosine triphosphate, which interrupts the release of energy necessary for protein synthesis and leads to the death of the bacterial cell.
The following microorganisms are sensitive to fusidic acid, which most often cause eye infections: Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae.
Enterobacteriaceae and Pseudomonas are resistant to fusidic acid.
Indications:
Bacterial eye infections: conjunctivitis blepharitis keratitis dacryocystitis.
Contraindications:
Individual hypersensitivity to the components of the drug. Preservative (benzalkonium chloride) is a potential allergen.
Application for pregnancy and breastfeeding:
Sufficient experience on use of drug during pregnancy, breast-feeding there is no. It is possible to use according to the prescription of the attending physician, if the expected therapeutic effect exceeds the risk of possible side effects.
Side effect:
Rarely-allergic reactions in the form of edema of the transition folds of the conjunctiva and urticaria. Possible-itching, burning, conjunctival hyperemia, pain, lacrimation, edema, exacerbation of conjunctivitis.
Fucithalmic therapy should be discontinued in case of signs of hypersensitivity to the drug.
Drug interaction:
No data available.
Method of application and doses:
Conjunctival. 1 drop in the conjunctival cavity of the affected eye 2 times a day for 7 days.
In the absence of positive dynamics within 7 days of the drug should be reconsidered therapy, using other drugs.
Overdose:
No data available.
Special instruction:
The tube must be closed after each use. Do not touch the tip of the tube to the eye.
It is not recommended to wear contact lenses during the application of Fucithalmic, since its components can cause clouding of the lens.
Shelf life:
After opening, use the contents of the tube for 1 month.