Composition, form of production and packaging
Eye drops 1 ml
gatifloxacin 3 mg
5 ml - a bottle-droppers (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
Gatifloxacin - 8-methoxy fluoroquinolone with substitution of 3-methylpiperazinyl at the C7 position. The antibacterial effect of gatifloxation is due to 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 the division of a bacterial cell.
The mechanism of action of fluoroquinolones, including gatifloxacin, differs from the mechanism of action of antibacterial drugs of the group of aminoglycosides, macrolides and tetracyclines, therefore gatifloxacin can be active against pathogenic bacteria that are resistant to the antibiotics listed above, and they, in turn, can be active against pathogenic bacteria resistant to gatifloxacin. There is no cross-resistance between gatifloxanin and the antibiotics listed above.
In vitro studies demonstrated that resistance to gatifloxacin develops as a result of multistage mutations and occurs at a frequency of 1 Г— 10 7 -1 Г— 10 10 .
Gatifloxacin is active against most of the following bacterial strains, 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.
After the installation of 0.3% eye drops of gatifloxacin, the concentration of gatifloxacin in the blood plasma remains below the threshold of analytical determination (5 ng / ml).
- treatment of bacterial conjunctivitis caused by drug-susceptible pathogens.
Locally. The drug is instilled during the waking period.
The 1st and 2nd days are instilled by 1 drop into the affected eye every 2 hours, up to 8 times a day.
From 3 to 7 days instilled in 1 drop to 4 times a day.
When using the drug, the development of the following adverse reactions with the indicated frequency of development is possible: very often (> 10%), often (> 1%, <10%), infrequently (> 0.1%, <1%); rarely (> 0.01%, <0.1%), very rarely (<0.01%).
From the side of the organ of vision
Often: irritation of the conjunctiva, increased lacrimation, keratitis, papillary conjunctivitis, chemosis. hemorrhage in the conjunctiva, dry eye mucosa (dry eye syndrome), discharge from the eyes, eye irritation, eye pain, eyelid edema, redness of the eyes, decreased visual acuity.
From the nervous system
From the side of metabolism and nutrition
Often: a change in taste
In the postmarketing period, there were reports of the following undesirable reactions of Zimar (frequency not known).
From the side of the organ of vision: blepharitis, hyperemia of the eyes and conjunctiva, impaired vision, itching in the eye area, edema in the eye area (including corneal edema and conjunctiva), eye irritation, eye pain. From the side of the digestive system: nausea.
From the immune system: hypersensitivity, anaphylactic reactions and angioedema (including laryngeal edema, oral cavity and face).
On the part of the respiratory system, the organs of the thorax and the mediastinum: dyspnoea.
From the skin and subcutaneous tissues: itching (including generalized itching), rash, hives.
- hypersensitivity to gatifloxacin, other quinolones, as well as other components of the drug;
- Children's age up to 1 year.
- in patients receiving preparations of a quinolone series of systemic action, including gatifloxacin. In this category of patients, severe hypersensitivity reactions (anaphylactic reactions), and in some cases with fatal outcome, are noted, in some cases after the first administration of the drug. Individual reactions were accompanied by cardiovascular insufficiency, loss of consciousness, angioedema (including laryngeal edema, pharynx or face), airway obstruction, dyspnea, pruritus and urticaria;
- Pregnancy and the period of breastfeeding;
- in patients with a history of allergic reactions to other topical preparations containing gatifloxacin. There is very little information about the development of Stephen-Johnson syndrome after topical application of gatifloxacin. At the first signs of allergic reactions should immediately stop taking the drug.
PREGNANCY AND LACTATION
Due to the lack of adequate and strictly controlled studies in pregnant women, Zimar during pregnancy should be used with caution, and only if the expected benefit to the mother exceeds the potential risk to the fetus. It has been confirmed that with topical application of gatifloxacin in the form of eye drops, its systemic concentration in the blood plasma is low, therefore it is not supposed to affect children who are breastfed.
Nevertheless, with the appointment of Zimar during lactation, breastfeeding should be stopped for the period of treatment because the excretion of the drug into breast milk was not studied locally.
APPLICATION FOR CHILDREN
Contraindicated for children under 1 year.
Long-term (more than 28 days) use of Zimar as well as other antibacterial drugs can lead to growth of insensitive microorganisms, as well as fungi. If there is a superinfection, the drug should be discontinued and an alternative therapy should be prescribed.
During treatment with Zimar, contact lenses are not recommended. Zimar is not used for injections, including for subconjunctival injections, do not inject the drug into the anterior chamber of the eye. Do not allow the tip of the dropper bottle to come in contact with the eye mucosa, skin of hands and any surfaces.
Shelf life of the drug after the first opening of the bottle-dropper is 28 days.
Impact on the ability to manage vehicles and mechanisms
During the installation of the drug, short-term blurring of vision is possible, therefore, it is necessary to refrain from driving vehicles and performing activities requiring an increased concentration of attention and speed of psychomotor reactions, until vision is restored.
There is a theoretical possibility of an overdose of Zimar drug when instilled in the eye. In this case, it is possible to remove the excess of the drug from the eye / eyes by washing with warm running water.
Studies to study the interaction of the drug Zimar was not conducted. Due to the low concentration of gatifloxacin (<5 ng / ml) in blood plasma after topical application, systemic drug interactions are unlikely.
TERMS OF RELEASE FROM PHARMACY
TERMS AND CONDITIONS OF STORAGE
At a temperature of no higher than 25 В° C. Keep out of the reach of children. Shelf life - 2 years.