Zimar - instructions for use, doses, side effects, contraindications

Active substanceGatifloxacinGatifloxacin

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Zimar®

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Allergen, Inc. USA

Dosage form: & nbspeye drops

Composition:

1 ml of the solution contains:

Active substance: gatifloxacin 3.0 mg;

Excipients: benzalkonium chloride 0.05 mg; disodium edetate dihydrate 0.1 mg, sodium chloride 8.6 mg, hydrochloric acid to pH 5.8-6.0, sodium hydroxide to pH 5.8-6.0, water to 1 ml.

Description:Transparent pale yellow solution.

Pharmacotherapeutic group:antimicrobial agent - fluoroquinolone.

ATX: & nbsp

J.01.M.A.16 Gatifloxacin

S.01.A.E.06 Gatifloxacin

Pharmacodynamics:

Gatifloxacin - 8-methoxy fluoroquinolone with substitution of 3-methylpiperazinyl at the C7 position. The antibacterial effect of gatifloxacin 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 gatifloxacin and the antibiotics listed above.

In studies in vitro demonstrated that resistance to gatifloxacin develops as a result of multistage mutation and occurs at a frequency of 1x 10⁷ - 1 x10¹⁰.

Gatifloxacin is active against most of the bacterial strains listed below, such as in vitro, and in clinical applications.

Aerobic Gram-positive bacteria:

Corynebacterium propinquum

Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus mitis

Streptococcus pneumoniae

Aerobic Gram-negative bacteria:

Haemophilus influenzae

Pharmacokinetics:

After instillation 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).

Indications:Treatment of bacterial conjunctivitis caused by drug-susceptible pathogens.

Contraindications:

- Hypersensitivity to gatifloxacin, other quinolones, as well as other components of the drug.

- Children up to 1 year.

Carefully:

- In patients receiving preparations of the 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 failure, loss of consciousness, angioedema (including laryngeal edema, pharynx or face swelling), airway obstruction, shortness of breath, itching and urticaria.

- Pregnancy and the period of breastfeeding

In patients who have a history of allergic reactions to other drugs for topical use, 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® in pregnancy should be used with caution, and only if the expected benefit for 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 discontinued for the period of treatment because the excretion of the drug into breast milk was not studied locally.

Dosing and Administration:

Locally. The drug is instilled during the waking period.

The first and second days are instilled by 1 drop into the affected eye every two hours, up to 8 times a day.

From the third to the seventh day, drop in 1 drop to 4 times a day.

Side effects:

When using the drug, the following adverse side effects may develop. reactions with a specified frequency of development - Often (>=10%), often (>=1%, <10%), infrequently (>=0,1%, <1%); rarely (>=0,01%, <0,1%), rarely (<0,01 %):

From the side of the organ of vision

Often: irritation of the conjunctiva, increased lacrimation, keratitis, papillary conjunctivitis, chemosis, conjunctival hemorrhage, 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

Often: headache

From the side of metabolism and nutrition

Often: change in taste

During the postmarketing period, the following adverse reactions of Zimar® were reported (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, swelling 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.

Overdose:There is a theoretical possibility of an overdose of Zimar® when applied to 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.

Interaction:

Studies to study the interaction of Zimar® have not been carried out.Due to the low concentration of gatifloxacin (<5 ng / ml) in blood plasma after topical application, systemic drug interactions are unlikely.

Special instructions:

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®, it is NOT recommended to wear contact lenses. Zimar® not applicable 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.

Effect on the ability to drive transp. cf. and fur:When instillation 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.

Form release / dosage:

Eye drops 0,3%.

Packaging:5 ml in a dropper of LDPE with a capacity of 10 ml, ukuporennoy cover of impact-resistant polystyrene, which is sealed with a shrinkable polymer film. 1 bottle-dropper along with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001525

Date of registration:16.02.2012

The owner of the registration certificate:Allergen, Inc.Allergen, Inc. USA

Manufacturer: & nbsp

ALLERGAN SALES, LLC Germany

Representation: & nbspAllergen of CIS SARL. LtdAllergen of CIS SARL. LtdRussia

Information update date: & nbsp19.08.2015

Illustrated instructions

Instructions

Zimar® (Zimar®)