Signigensef - instructions for use, reviews, analogs and formulations (eye drops 0.5%, injections in ampoules for antibiotic injection) of the drug for the treatment of conjunctivitis, blepharitis and other eye infections in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Signtsef. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of antibiotics Signtsef in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Signtsef in the presence of existing structural analogues.Use for the treatment of conjunctivitis, blepharitis, keratitis and other eye infections in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Signtsef - an antibacterial preparation of a group of fluoroquinolones for topical application in ophthalmology and as injections.

Levofloxacin (the active ingredient of Signtsef) is the L-isomer of the racemic drug substance ofloxacin. The antibacterial activity of Ofloxacin is mainly related to the L-isomer. As an antibacterial drug of the fluoroquinolones class, Levofloxacin blocks the DNA-gyrase and topoisomerase 4, disrupts the supercoiling and cross-linking of DNA gaps, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and bacterial membranes.

It is active against Enterococcus faecalis (enterococci), Staphylococcus aureus (Staphylococcus aureus), Staphylococcus epidermidis, Streptococcus pneumoniae (Streptococcus), Streptococcus pyogenes and Streptococcus agalactiae, Viridans group streptococci, Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii, Escherichia coli (E. Hemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Chlamydia pneumoniae (chlamydia), Chlamydia trachomatis, Mycoplasma pneumoniae (mycoplasma), Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii, Morganella morganii, Proteus vulg aris, Providencia rettgeri, Providcncia stuartii, Serratia marcescens, Clostridium perfringens, Neisseria gonorrhoeae.

The maximum concentration of levofloxacin,achieved with 0.5% eye drops, is more than 100 times greater than the minimum inhibitory concentration of levofloxacin for sensitive microorganisms.

Composition

Levofloxacin (in the form of hemihydrate) + auxiliary substances.

Pharmacokinetics

Eye drops

After instillation into the eye, levofloxacin is well preserved in the lacrimal film. The concentration of levofloxacin in the lacrimal fluid after a single dose (1 drop) quickly reaches high values ​​and is held at a level above the MIC for the most sensitive eye pathogens (less than or equal to 2 μg / ml) for at least 6 hours. In studies on healthy volunteers, it was shown that the average concentrations of levofloxacin in the tear film, measured at 4 and 6 hours after topical application, were 17.0 μg / ml and 6.6 μg / ml, respectively. In five out of six subjects, levofloxacin concentrations were 2 μg / ml and higher 4 hours after instillation. In four out of six subjects, this concentration was preserved 6 hours after instillation.

The average concentration of levofloxacin in the blood plasma after 1 h after application is from 0.86 ng / ml on the first day to 2.05 ng / ml.The maximum concentration of levofloxacin in the plasma, equal to 2.25 ng / ml, was detected on the fourth day after two days of the drug every 2 hours up to 8 times a day. The maximum concentrations of levofloxacin reached on day 15 are more than 1000 times lower than those concentrations observed after oral doses of levofloxacin.

Injections

When taken orally absorbed from the gastrointestinal tract quickly and almost completely. Food intake has little effect on the speed and completeness of absorption. Bioavailability is 99%. Binding to plasma proteins - 30-40%. It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, polymorphonuclear leukocytes, alveolar macrophages. In the liver, a small portion is oxidized and / or deacetylated. Kidney clearance is 70% of the total clearance. It is excreted from the body mainly by the kidneys through glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites.

Indications

Eye drops:

• treatment of infections of the adnexa of the eye and anterior segment of the eye caused by the flora sensitive to levofloxacin;
• prevention of complications after surgical and laser operations on the eye.

Injections:

• infection of the lower respiratory tract (chronic bronchitis, pneumonia), ENT organs (sinusitis, otitis media), urinary tract and kidneys (including acute pyelonephritis), genital organs (including urogenital chlamydia), skin and soft tissues (festering atheromas, abscess, boils).

Forms of release

Eye drops 0.5%.

Solution for infusions (injections in ampoules for injections).

Instructions for use and how to use them

Eye Drops

Adults and children aged 1 year and older are instilled in the affected eye 1-2 drops every 2 hours up to 8 times a day during the waking period during the first 2 days, then 4 times a day from the 3rd to the 5th day. The duration of treatment is an average of 5 days.

Ampoules

Apply inside or intravenously.

With sinusitis - inside, 500 mg once a day; with exacerbation of chronic bronchitis - 250-500 mg once a day. With pneumonia - inside, 250-500 mg 1-2 times a day (500-1000 mg per day); in / in - 500 mg 1-2 times a day. For infections of the urinary tract - inside, 250 mg once a day or IV in the same dose. With infections of the skin and soft tissues, 250-500 mg orally 1-2 times a day or IV, 500 mg twice a day.After iv introduction in a few days, you can switch to oral administration at the same dose.

In case of kidney diseases, the dose is reduced in accordance with the degree of disruption of the function: with KK = 20-50 ml / min - 125-250 mg 1-2 times a day, with KK = 10-19 ml / min - 125 mg once every 12 -48 hours, with CC less than 10 ml / min - 125 mg after 24 or 48 hours. The duration of treatment is 7-10 (up to 14) days.

Side effect

• reduction of visual acuity and appearance of mucosal strands;
• blepharitis;
• papillary sprains on the conjunctiva;
• swelling of the eyelids;
• unpleasant sensations in the eye;
• burning and itching in the eye;
• deterioration of vision;
• pain in the eye;
• hyperemia of the conjunctiva;
• mucous discharge;
• follicle disease of the conjunctiva;
• dry eye syndrome;
• erythema eyelids;
• contact dermatitis;
• photophobia;
• rhinitis;
• nausea, vomiting;
• diarrhea;
• anorexia;
• abdominal pain;
• pseudomembranous enterocolitis;
• increased activity of hepatic transaminases;
• hepatitis;
• dysbiosis;
• a decrease in blood pressure;
• vascular collapse;
• tachycardia;
• hypoglycemia (increased appetite, sweating, trembling);
• headache;
• dizziness;
• weakness;
• drowsiness;
• insomnia;
• paresthesia;
• anxiety;
• fear;
• hallucinations;
• confusion of consciousness;
• depression;
• motor disorders;
• convulsions;
• arthralgia;
• myalgia;
• rupture of tendons;
• muscle weakness;
• tendonitis;
• eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia;
• photosensitization;
• itching;
• swelling of the skin and mucous membranes;
• malignant exudative erythema (Stevens-Johnson syndrome);
• toxic epidermal necrolysis (Lyell's syndrome);
• hives;
• bronchospasm;
• suffocation;
• anaphylactic shock;
• allergic pneumonitis;
• vasculitis;
• aggravation of porphyria;
• rhabdomyolysis;
• persistent fever;
• development of superinfection.

Contraindications

• pregnancy;
• lactation period (breastfeeding);
• children under 1 year (for eye drops), children and adolescents under 18 years (for injections);
• epilepsy;
• the defeat of the tendons during the previous treatment with quinolones;
• hypersensitivity to any of the components of the drug or to other quinolones.

Application in pregnancy and lactation

Contraindicated use of the drug Signtsef during pregnancy and during breastfeeding.

Use in children

The drug in the form of injections is contraindicated in children and adolescents under 18 years.

Eye drops are contraindicated in children under the age of 1 year (in newborns are not used). Caution should be given to the drug in the form of drops to children and adolescents under the age of 18 years.

Application in elderly patients

With caution appoint levofloxacin to elderly patients (high probability of concomitant decrease in kidney function).

special instructions

Eye drops Signtsef can not be administered subconjunctivally and into the anterior chamber of the eye.

With the simultaneous use of other ophthalmic agents, the interval between instillations should be at least 15 minutes.

Drops should not be used during the wearing of hydrophilic (soft) contact lenses, due to the presence in the drops of the preservative benzalkonium chloride, which can be absorbed by contact lenses and adversely affect the eye tissues, and cause a change in the color of the contact lenses.

To avoid contamination of the tip of the dropper and solution, do not touch the eye when digging.

After normalizing the temperature, it is recommended to continue treatment for at least 48-78 hours. The duration of intravenous infusion of 500 mg (100 ml of infusion solution) should be at least 60 minutes.During treatment, sun and artificial UV irradiation should be avoided to avoid damage to the skin (photosensitivity). When there are signs of tendonitis, levofloxacin is immediately withdrawn. It should be borne in mind that the development of seizures is possible in patients with a history of brain injury (stroke, severe trauma), with the insufficiency of glucose-6-phosphate dehydrogenase - the risk of hemolysis.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment with injectable forms of the drug, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Drug Interactions

Special studies on the interaction of eye drops Signtsef was not conducted.

Since Cmax levofloxacin in plasma after instillation in the eye is at least 1000 times lower than after ingestion in standard doses, interaction with other drugs characteristic of systemic use is clinically insignificant.

Levofloxacin increases the half-life of cyclosporine.

The effect of levofloxacin reduces drugs that depress intestinal motility, sucralfate, magnesium and aluminum-containing antacids and iron salts (a break between intake of at least 2 hours is necessary).

With the simultaneous use of non-steroidal anti-inflammatory drugs (NSAIDs), theophylline increases convulsive readiness, glucocorticosteroids (GCS) - increase the risk of rupture of tendons.

Cimetidine and drugs that block tubular secretion, slow the withdrawal of levofloxacin.

The solution of levofloxacin for intravenous administration is compatible with 0.9% sodium chloride solution, 5% Dextrose solution, 2.5% Ringer's solution with dextrose, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).

A solution of levofloxacin for intravenous administration should not be mixed with Heparin and solutions that have an alkaline reaction.

Analogues of the drug Signtsef

Structural analogs for the active substance:

• Ashlyov;
• Glevo;
• Ivacin;
• L Optic Rompharm;
• Lebel;
• Levoxime;
• Levot P;
• Levostar;
• Levotech;
• Levoflox;
• Levofloxabol;
• Levofloxacin;
• Leobeg;
• Leflobact;
• Leflobact Forte;
• Lefokcin;
• Luffy;
• Matlevo;
• Oftakwix;
• Remedy;
• Roflox Scan;
• Tavanik;
• Tanflomed;
• Flexine;
• Floracid;
• Hayleflex;
• Ecology;
• Eleflox.

Analogues on the curative effect (remedies for the treatment of conjunctivitis):

• Arthromax;
• Berberil N;
• Bronal;
• Vitabakt;
• Garamycin;
• Gentamicin;
• Hydrocortisone;
• Histalong;
• Dexamethasone;
• Zanotsin;
• Zindolin 250;
• Ilozon;
• Innolier;
• Colbiocin;
• Levomycetin;
• Liprokhin;
• Maxidex;
• Maxitrol;
• Midrim;
• Naklof;
• Okatsin;
• Okostistin;
• Okulokhel;
• Ofloxacin;
• Plivasept;
• Poludan;
• Prenatsid;
• Sofradex;
• Sulfacil sodium;
• Tebridex;
• Tobrex;
• Totatsef;
• Uniflox;
• Floxal;
• Furagin;
• Furacilin;
• Fucitalmic;
• Cefetrexyl;
• Cephezole;
• Ceftidine;
• Ciloxane;
• Ciprobay;
• Ciprosan;
• Ciprofloxacin;
• Cifloxinal;
• Chibroxin;
• Hermitsed.

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