Description
Trade name:
Tymer
Compound:
Each 1 ml of solution contains:
Gatifloxacin 3 mg
Auxiliary components:
Benzalkonium chloride, sodium chloride, disodium EDTA, hydrochloric acid, sodium hydroxide, water for injection.
Properties:
The antibacterial action of gatifloxacin is due to the inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an enzyme involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme that plays a key role in the separation of chromosomal DNA during bacterial cell division.
The mechanism of action of fluoroquinolones, including gatifloxacin, differs from the mechanism of action of antibacterial drugs of the aminoglycoside, macrolide and tetracycline groups, so gatifloxacin may be active against pathogenic bacteria that are resistant to the antibiotics listed above, and they, in turn, may be active against pathogenic bacteria resistant to gatifloxacin. Cross-resistance between gatifloxacin and the antibiotics listed above has not been established.
In vitro studies have demonstrated that resistance to gatifloxacin develops as a result of multistep mutations and occurs at a frequency of 1×107-1×1010.
Gatifloxacin is active against most of the bacterial strains listed below, both in vitro and in clinical use.
Aerobic gram-positive bacteria: Corynebacterium propinquum, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis, Streptococcus pneumoniae.
Aerobic gram-negative bacteria: Haemophilus influenzae.
Indications:
Treatment of bacterial conjunctivitis caused by pathogens sensitive to the drug:
Aerobic gram-positive bacteria: Corynebacterium propinquum, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis, Streptococcus pneumoniae.
Aerobic gram-negative bacteria: Haemophilus influenzae.
Method of administration and dosage:
On the 1st and 2nd day, instill 1 drop into the affected eye every 2 hours, up to 8 times a day.
From the 3rd to the 7th day, instill 1 drop up to 4 times a day.
Contraindications:
Hypersensitivity to gatifloxacin, other quinolones, and other components of the drug.
Precautions:
Long-term (more than 28 days) use of Timer, like other antibacterial drugs, may lead to the growth of microorganisms insensitive to it, as well as fungi. If superinfection occurs, the drug should be discontinued and alternative therapy prescribed.
During treatment with Timer, wearing contact lenses is not recommended due to the presence of benzalkonium chloride in the composition.
Use with caution in patients receiving systemic quinolone drugs, including gatifloxacin. Serious and sometimes fatal hypersensitivity reactions (anaphylactic reactions) have been reported in this category of patients, sometimes after the first administration of the drug. Some reactions have included cardiovascular collapse, loss of consciousness, angioedema (including swelling of the larynx, pharynx, or face), airway obstruction, dyspnea, pruritus, and urticaria;
in patients with a history of allergic reactions to other topical preparations containing gatifloxacin. There are extremely rare reports of Stevens-Johnson syndrome developing after topical use of gatifloxacin. At the first sign of allergic reactions, the drug should be discontinued immediately.
Use during pregnancy and breastfeeding:
Due to the lack of adequate and strictly controlled studies in pregnant women, Timer should be used with caution during pregnancy, and only if the expected benefit to the mother outweighs the potential risk to the fetus. It has been confirmed that with local application of gatifloxacin in the form of eye drops, its systemic concentration in blood plasma is low, so no effect on children who are breastfed is expected.
However, when prescribing the drug during lactation, breastfeeding should be discontinued for the duration of treatment due to the fact that the excretion of the drug into breast milk with local application has not been studied.
Side effects:
From the side of the organ of vision:
Common: conjunctival irritation, increased lacrimation, keratitis, papillary conjunctivitis, chemosis, conjunctival haemorrhage, dry mucous membrane of the eye (dry eye syndrome), eye discharge, eye irritation, eye pain, eyelid oedema, eye redness, decreased visual acuity.
From the nervous system:
Common: headache.
From the side of metabolism and nutrition:
Common: changes in taste sensation.
The following adverse reactions have been reported with Timer during the post-marketing period (frequency unknown):
From the organ of vision: blepharitis, hyperemia of the eyes and conjunctiva, blurred vision, itching in the eye area, swelling in the eye area (including swelling of the cornea and conjunctiva), eye irritation, eye pain.
From the digestive system: nausea.
From the immune system: hypersensitivity, anaphylactic reactions and angioedema (including swelling of the larynx, mouth and face).
From the respiratory system, chest organs and mediastinum: dyspnea.
From the skin and subcutaneous tissues: itching (including generalized itching), rash, urticaria.
Storage method:
Store at temperatures not exceeding 30 degrees.
Once opened, use within 30 days.
Package:
The cardboard box contains a 5 ml dropper bottle and paper instructions.
