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

Pharmacodynamics:Moxifloxacin - fluoroquinolone antibacterial drug of the IV generation, has a bactericidal effect. It is active against a wide range of gram-positive and gram-negative microorganisms, anaerobic, acid-fast and atypical bacteria.

The mechanism of action is associated with the inhibition of topoisomerase II (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 involved in the cleavage of chromosomal DNA during the division of a bacterial cell.

There is no cross-resistance with macrolides, aminoglycosides and tetracyclines. It was reported about the development of cross-resistance between the systemically used moxifloxacin and other fluoroquinolones.

Moxifloxacin is active against most strains of microorganisms (both in vitro and in vivo):

Gram-positive bacteria:

Corynebacterium spp., Including Corynebacterium diphtheriae;

Micrococcus luteus (including strains not susceptible to erythromycin, gentamicin, tetracycline and / or trimethoprim);

Staphylococcus aureus (including strains insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim);

Staphylococcus epidermidis (including strains insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline, and / or trimethoprim); Staphylococcus haemolyticus (including strains insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline, and / or trimethoprim); Staphylococcus hominis (including strains insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim); Staphylococcus warneri (including strains, insensitive to erythromycin); Streptococcus mitis (including strains that are insensitive to penicillin, erythromycin, tetracycline, and / or trimethoprim);

Streptococcus pneumoniae (including strains that are insensitive to penicillin, erythromycin, gentamicin, tetracycline, and / or trimethoprim);

Streptococcus group of viridans (including strains, insensitive to penicillin, erythromycin, tetracycline and / or trimethoprim).

Gram-negative bacteria:

Acinetobacter Iwojfii; Haemophilus influenzae (including strains not susceptible to ampicillin); Haemophilus parainfluenzae; Klebsiella spp.

Other microorganisms:

Chlamydia trachomatis

Moxifloxacin acts in vitro against most of the below listed microorganisms, but the clinical significance of this data is not known:

Gram-positive bacteria:

Listeria monocytogenes; Staphylococcus saprophyticus; Streptococcus agalactiae; Streptococcus mitis; Streptococcus pyogenes; Streptococcus group C, G, F;

Gram-negative bacteria:

Acinetobacter baumannii; Acinetobacter calcoaceticus; Citrobacter freundii; Citrobacter koseri; Enterobacter aerogenes; Enterobacter cloacae; Escherichia coli; Klebsiella oxytoca; Klebsiella pneumoniae; Moraxella catarrhalis; Morganella morganii; Neisseria gonorrhoeae; Proteus mirabilis; Proteus vulgaris; Pseudomonas stutzeri;

Anaerobic microorganisms:

Clostridiumperfringens; Fusobacterium spp .; Prevotella spp .; Propionibacterium acnes.

Other organisms:

Chlamydia pneumoniae; Legionella pneumophila; Mycobacterium avium; Mycobacterium marinum; Mycoplasma pneumoniae.

Pharmacokinetics:When topical application occurs systemic absorption of moxifloxacin: the maximum concentration of moxifloxacin in plasma (C_max) is 2.7 ng / ml, the AUC value is 45 ng * h / ml. These values are about 1600 times and 1000 times smaller than C_max and AUC after administration of a therapeutic dose of moxifloxacin 400 mg orally. Half-life T_1/2 moxifloxacin from plasma is about 13 hours.

Indications:Bacterial conjunctivitis caused by microflora-sensitive moxifloxacin.

Contraindications:Hypersensitivity to any of the components of the drug or to other quinolones, the period of breastfeeding, children under 1 year.

Pregnancy and lactation:Sufficient experience in the use of the drug during pregnancy and during lactation there. The use of the drug during pregnancy and during lactation is possible if the expected therapeutic effect exceeds the potential risk to the fetus and the baby.

Studies in animals have shown that after oral administration of moxifloxacin with breast milk, small amounts of substance are excreted. However, if therapeutic doses are observed, the development of adverse reactions in infants is not expected.

Teratogenicity

In pre-clinical animal studies moxifloxacin did not have a teratogenic effect in doses of 500 mg / kg / day (which is approximately 21,700 times higher than the recommended daily dose for humans). However, there was a slight decrease in fetal weight and a delay in the development of the musculoskeletal system.Against the background of a dose of 100 mg / kg / day there was an increase in the frequency of decrease in the growth of newborns.

Use in children.

Vigamox® can be used in pediatrics in children from 1 year in doses similar to adults.

Dosing and Administration:Locally. Adults and children older than 1 year instilled 1 drop in the affected eye 3 times a day. Usually, the condition improves after 5 days and treatment should be continued in the next 2-3 days. If the condition does not improve after 5 days, the question of the correctness of the diagnosis and / or the prescribed treatment should be raised. The duration of treatment depends on the severity of the condition and the clinical and bacteriological course of the disease.

Side effects:During the clinical trials of the drug Vigamox®, the following adverse reactions were reported, which were classified according to the criteria: very often (≥ 1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1,000 to <1/100), rarely (from ≥1 / 10,000 to <1/1000). very rarely (<1/10 000). In each group, the frequency of development of adverse reactions are presented in descending order of their severity.

Violations of the blood and lymphatic system

Rarely: a decrease in the level of hemoglobin.

Disturbances from the nervous system

Infrequently: a headache.

Rarely: paresthesia.

Disturbances on the part of the organ of sight

Often: pain, irritation in the eyes.

Infrequent: spot keratitis, dry eye syndrome, conjunctival hemorrhage, eye hyperemia, itching in the eyes, eyelid swelling, a feeling of discomfort in the eyes.

Rarely: defects in the corneal epithelium, corneal disorders, conjunctivitis, blepharitis, eye swelling, conjunctival edema, blurred vision, decreased visual acuity, asthenopia, erythema of the eyelids.

Disturbances from the respiratory system, chest and mediastinal organs

Rarely: sensation of discomfort in the nose, pharyngolaryngeal pain, foreign body sensation (in the throat).

Disorders from the gastrointestinal tract

Not often: dysgeusia.

Rarely: vomiting.

Disturbances from the liver and bile ducts

Rarely: increased levels of alanine aminotransferase and gamma glutamyltransferase.

Post-marketing experience (frequency unknown):

Immune system disorders

Hypersensitivity.

Disturbances from the nervous system

Dizziness.

Disturbances on the part of the organ of sight

ulcerative keratitis, keratitis, increased lacrimation, photophobia, discharge from the eyes.

Heart Disease

a feeling of palpitations.

Disturbances from the respiratory system, chest and mediastinal organs

Dispno.

Disorders from the gastrointestinal tract

Nausea.

Disturbances from the skin and subcutaneous tissues

erythema, pruritus, rash, hives.

Overdose:If eye contact is excessive, it is recommended to wash eyes with warm water.

Interaction:The interaction of locally prescribed moxifloxacin with other drugs has not been studied.

Data are known for the oral dosage form of moxifloxacin: no clinically significant drug interactions (unlike other fluoroquinolone formulations) with theophylline, warfarin, digoxin, oral contraceptives, probenicid, ranitidine and glibenclamide have been observed.

In studies by vitro moxifloxacin Does not inhibit isoenzymes CYP3A4, CYP2D6, CYP2C9 or CYP1A2, which may indicate that moxifloxacin does not change the pharmacokinetic properties of drugs metabolized by cytochrome P450 isoenzymes.

Special instructions:Only for ophthalmic use. Not for injection. Do not administer the drug subconjunctivalally or directly into the anterior chamber of the eye.

There have been reports of the development of serious and, in some cases, fatal hypersensitive (anaphylactic) reactions in patients taking quinolones systematically; in some patients, the development of the reaction was observed even after the administration of the first dose. Some reactions were accompanied by cardiovascular failure, loss of consciousness, Quinck's edema (including laryngeal edema, pharynx or face swelling), airway obstruction, dyspnoea, urticaria and itching.

When developing an allergic reaction to the drug Vigamox® should stop using the drug. In the case of severe acute hypersensitivity reactions to moxifloxacin, it may be necessary to provide first aid. Devices for the resumption of oxygen supply and the restoration of airway patency are applied only for clinical indications.

Prolonged use of antibiotic can lead to excessive growth of non-susceptible microorganisms, including fungi.In case of superinfection, it is necessary to stop the use of the drug and to prescribe adequate therapy.

Systemic use of fluoroquinolones, including moxifloxacin, can lead to inflammation and rupture of tendons, especially in elderly patients and those taking corticosteroids at the same time. Thus, when the first symptoms of inflammation of the tendons appear, stop taking the drug.

Data on the efficacy and safety of the drug Vigamox® for the treatment of neonatal conjunctivitis are limited. Therefore, the use of the drug for the treatment of neonatal conjunctivitis is not recommended.

Vigamox® is not recommended for the prophylaxis or empirical therapy of conjunctivitis, including gonococcal ophthalmia of newborns, due to the fluoride-resistance of gonococci Neisseria gononhoeae. Patients with ocular infections caused by gonococci Neisseria gonorrhoeae should receive appropriate systemic treatment. Vigamox® is not recommended for the treatment of eye infections caused by Chlamidia Irachomitis in patients younger than 2 years of age, since no relevant studies have been conducted.

Patients over the age of 2 years with eye infections caused by Chlamidia irachomitis should receive appropriate systemic treatment. Newborns with ophthalmic neonates should receive appropriate treatment based on their condition, for example, systemic treatment in cases caused by gonorrhea Chlamidia Irachomitis or Neisseria gonorrhoeae. Patients are not recommended to wear contact lenses if they have signs of infectious diseases of the anterior segment of the eyeball.

Do not touch the tip of the dropper bottle to any surface to avoid contamination of the vial and its contents.

The bottle must be closed after each use.

Effect on the ability to drive transp. cf. and fur:After application of the drug, a temporary decrease in the clarity of visual perception is possible, and before its restoration it is not recommended to drive and engage in activities requiring increased attention and reaction.

Form release / dosage:Eye drops 0.5%.

Packaging:To 5 ml in a plastic bottle-dropper "Droptainer ™".

1 bottle is placed together with instructions for use in a cardboard box.

Storage conditions:Store at a temperature of 2 to 25 ° C.

Keep out of the reach of children.

Shelf life:2 years.

Do not use after the expiry date printed on the package!

Terms of leave from pharmacies:On prescription

Registration number:LSR-003706/10

Date of registration:04.05.2010 / 14.07.2015

Expiration Date:Unlimited

The owner of the registration certificate:ALKON PHARMACEUTICS, LLC ALKON PHARMACEUTICS, LLC Russia

Manufacturer: & nbsp

ALCON-COUVREUR, n.v. s.a. Belgium

Representation: & nbspALKON PHARMACEUTICS LLCALKON PHARMACEUTICS LLCRussia

Information update date: & nbsp11.01.2017

Illustrated instructions

Instructions

Vigamox® (Vigamox)