Futsitalmik
Producer: Nycomed Austria GmbH (Nikomed Austria Gmbh) Austria
Code of automatic telephone exchange: S01AA13
Release form: Liquid dosage forms. Drops are eye.
General characteristics. Structure:
Active agent: The Fuzidovy acid micronized (in terms of acid anhydrous) – 10,00 mg (10,17 mg of fuzidovy acid are equivalent to a gemigidrat)
Excipients: Benzalkoiiya chloride of 0,11 mg, dinatrium эдетат 0,50 mg, Mannitolum of 50,00 mg, carbomer of 5,00 mg, sodium q.s hydroxide., water for injections to 1,0 g.
Description: viscous suspension of white or almost white color.
Pharmacological properties:
Pharmacodynamics. Fuzidovy acid concerns to group of Fusidinums, antimicrobic connections which mechanism of action is connected with disturbance of synthesis of protein in a bacterial cell. Blocking elongation of a factor of G, they prevent its linkng with ribosomes and guanozintrifosfaty that thus interrupts release of the energy necessary for synthesis of protein and leads to death of a bacterial cell.
Such microorganisms, the most often defiant eye infections as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae are sensitive to fuzidovy acid. Enterobacteriaciae and Pseudomonas are steady against effect of fuzidovy acid. There are no messages on cross resistance to fuzidovy acid.
Pharmacokinetics. The dosage form of the drug Futsitalmik® in the form of viscous eye provides with a drop long contact of drug with a conjunctiva and sufficient concentration of fuzidovy acid in the lacrimal liquid on condition of use two times a day. In 1, 3, 6 and 12 hours after use of a single dose of drug Futsitalmik average concentration of fuzidovy acid in the lacrimal liquid makes 15,7; 15,2; 10,5 and 5,6 mkg/ml, respectively. In intraocular liquid concentration of fuzidovy acid, equal 0,30 mkg/ml (after single use) and 0,8 mkg/ml (after repeated use), are reached within 1 hour after use and supported, at least, within 12 hours, at the same time fuzidovy acid in blood serum is not defined. Removal, generally happens to bile. Removal with urine makes less than 1% of a dose.
Indications to use:
Treatment of bacterial infections of the eyes (conjunctivitis, blepharitis, keratitis, dacryocystitis) caused by microorganisms, sensitive to drug.
Route of administration and doses:
For adults and children since 0 years on 1 drop in a conjunctival cavity of the affected eye 2 times a day within 7 days.
Features of use:
Prolonged use of antimicrobic drug can lead to development of the superinfection caused by microorganisms, resistant to this antimicrobic drug, including mushrooms.
The tuba needs to be closed after each use. It is not necessary to touch with a tuba tip an eye.
Therapy by Futsitalmik's drug has to be stopped in case of signs of hypersensitivity to drug.
It is not recommended to carry contact lenses during drug Futsitalmik® use. Microcrystals of fuzidovy acid can cause emergence of scratches on lenses or a cornea.
Influence on ability to manage vehicles and the equipment
At emergence of misting of sight after instillation it is necessary to refrain from control of vehicles and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions before its recovery.
Side effects:
Classification of the undesirable side reactions (USR) by development frequency: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); seldom (> 1/10 000, <1/1 000); very seldom (1/10 000, including separate messages).
The general
Disturbance from immune system
Frequency is unknown
Itch, periorbital hypostasis, rash, small tortoiseshell, Quincke's disease
Local
Disturbance from organs of sight
Often (≥ 1:100, <1:10)
Burning and itch in an eye, feeling of dryness and morbidity in an eye, short-term misting of sight, a conjunctival hyperemia, the century swelled
Sometimes: (≥ 1:1000, <1:100)
Dacryagogue
Seldom: (≥ 1:10000, <1:1000)
Exacerbation of conjunctivitis, swelled a transitional fold of a conjunctiva.
Interaction with other medicines:
Data on medicinal interaction are absent.
Contraindications:
Individual hypersensitivity to drug components.
Use during pregnancy and during breastfeeding
Drug Futsitalmik® use to destination of the attending physician is possible if the expected medical effect for mother exceeds risk of development of possible side effects in a fruit or the child.
Overdose:
About cases of overdose of drug it was not reported.
Storage conditions:
At a temperature not above 30 °C. To store in the place, unavailable to children. Period of validity 3 years. After opening of a tuba drug should be used within 1 month. Not to use after the expiry date specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Drops eye 1%. 5 g of drug in a tuba aluminum, laminated on both sides by polyethylene, with a polyethylene tip and with the screw-on polyethylene cover with control of the first opening; 1 tuba together with the application instruction in a cardboard pack.