FUCITALMIK

Active material: Fusidic acid
When ATH: S01AA13
CCF: Antibiotics for topical use in ophthalmology
ICD-10 codes (testimony): H01.0, H04.3, H04.4, H10.2, H10.4, H10.5, H16
When CSF: 06.15.02
Manufacturer: LEO PHARMACEUTICAL PRODUCTS (Denmark)

Pharmaceutical form, composition and packaging

Eye drops in the form of a viscous suspension of white or nearly white.

1 g
fusidic acid micronized (based on the anhydrous acid)10 mg,
equivalent fusidic acid hemihydrate10.17 mg

Excipients: benzalkonium chloride, disodium эdetat, mannyt, carbomer 974R, Sodium hydroxide, Purified water.

5 g – aluminum tuba (1) with a plastic tip – packs cardboard.

 

Pharmacological action

Fusidic acid belongs to the group fuzidin-, antimicrobial compounds, mechanism of action which is associated with the violation of protein synthesis in the bacterial cell. By blocking the elongation factor G, they prevent it from binding to ribosomes and guanosine, that interrupts the release of energy, necessary for protein synthesis, and leads to the death of the bacterial cell.

It is active against Microorganisms, most commonly cause eye infections: Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae.

Enterobacteriaceae and Pseudomonas spp. resistant to fusidic acid.

 

Pharmacokinetics

The dosage form of the drug (Viscous Eye Drops) It provides prolonged contact with the conjunctiva and sufficient concentration of fusidic acid in the lachrymal fluid with the application of 2 times / day.

Through 1, 3, 6 and 12 hours after a single application Futsitalmika average concentration of fusidic acid in the tear fluid is 15.7; 15.2; 10.5 and 5.6 ug / ml, respectively. In the aqueous humor concentration of fusidic acid, equal 0.3 ug / ml (after a single application) and 0.8 ug / ml (after reapplying), It reached within 1 hours after administration and maintained, at least, during 12 no, wherein fusidic acid in serum is not determined.

 

Testimony

The treatment of bacterial eye infections, caused by sensitive microorganisms:

- Conjunctivitis;

- .Aloe;

- Keratit;

- Dakriocistit.

 

Dosage regimen

By 1 drop into the conjunctival sac of the affected eye 2 times / day for 7 days.

In the absence of positive dynamics within 7 days of the drug therapy should be reconsidered, using other drugs.

 

Side effect

On the part of the organ of vision: rarely – allergic reactions (a swelling of the conjunctiva follicles transition folds and urticaria); itch, burning, conjunctival hyperemia, soreness, lacrimation, swelling of the eyelids, worsening of conjunctivitis.

Futsitalmikom Therapy should be discontinued if signs of hypersensitivity to the drug.

 

Contraindications

- Hypersensitivity to the drug.

Preservative (benzalkonium chloride) It is a potential allergen.

 

Pregnancy and lactation

Enough experience with the drug during pregnancy and lactation (breast-feeding) no. Perhaps intended use PCP, if the expected therapeutic effect is greater than the risk of possible side effects.

 

Cautions

Tube should be closed after each use. Do not touch the tip of the tube to the eye.

Do not wear contact lenses during application Futsitalmika, because its components can cause blurred lenses.

 

Overdose

Data on drug overdose missing.

 

Drug Interactions

Data on drug interactions are absent.

 

Conditions of supply of pharmacies

The drug is released under the prescription.

 

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.

After opening the bottle the drug should be used within 1 of the month.

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