Vigamox
Moxifloxacin is a IV generation fluoroquinolone antibacterial drug with a bactericidal effect. Shows activity against a wide range of gram-positive and gram-negative microorganisms, anaerobic, acid-fast and atypical bacteria.
The mechanism of action is associated with 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 bacterial cell division.
There is no cross-resistance with macrolides, aminoglycosides and tetracyclines. Cross-resistance has been reported between systemically administered 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 insensitive 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 insensitive to penicillin, erythromycin, tetracycline and/or trimethoprim); Streptococcus pneumoniae (including strains insensitive to penicillin, erythromycin, gentamicin, tetracycline and/or trimethoprim); Streptococcus viridans group (including strains insensitive to penicillin, erythromycin, tetracycline and/or trimethoprim).
Gram-negative bacteria: Acinetobacler Iwoffii; Haemophilus influenzae (including strains insensitive to ampicillin); Haemophilus parainfluenzae; Klebsiella spp.
Other microorganisms: Chlamydia trachomatis.
Moxifloxacin is active in vitro against most of the following microorganisms, but the clinical significance of these data is unknown:
Gram-positive bacteria: Listeria monocytogenes; Staphylococcus saprophyticus; Streptococcus agalactiae; Streptococcus mitis; Streptococcus pyogenes; Streptococcus groups C, G, F;
Gram-negative bacteria: Acinetobacler 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: Clostridium perfringens; Fusobacterium spp.; Prevotella spp.; Propionibacterium acnes.
Other organisms: Chlamydia pneumoniae; Legionella pneumophila; Mycobacterium avium; Mycobacterium marinum; Mycoplasma pneumoniae.
Pharmacokinetics
When applied topically, moxifloxacin is absorbed systemically: Cmax is 2.7 ng/ml, AUC value is 45 ng×h/ml. These values are approximately 1600 times and 1000 times less than the Cmax and AUC after a therapeutic dose of moxifloxacin 400 mg orally. T1/2 of moxifloxacin from plasma is about 13 hours.
Vigamox eye drops 0.5% 5ml (Novartis)
Vigamox eye drops are a broad-spectrum antibacterial drug (fluoroquinolone group) for topical use in ophthalmology. The drug exhibits a bactericidal effect against a large number of bacteria, including staphylococci, streptococci, E. coli, pathogens of diphtheria, salmonella, mycoplasma, chlamydia, gonococci, spirochetes, klebsiella, including strains of microorganisms resistant to the action of other groups of antibacterial drugs. 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 insensitive 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 insensitive to penicillin, erythromycin, tetracycline and/or trimethoprim); Streptococcus pneumoniae (including strains insensitive to penicillin, erythromycin, gentamicin, tetracycline and/or trimethoprim); Streptococcus viridans group (including strains insensitive to penicillin, erythromycin, tetracycline and/or trimethoprim). Gram-negative bacteria: Acinetobacler Iwoffii; Haemophilus influenzae (including strains insensitive to ampicillin); Haemophilus parainfluenzae; Klebsiella spp. Other microorganisms: Chlamydia trachomatis. Moxifloxacin is effective in vitro against most of the following microorganisms, but the clinical significance of these data is unknown: Gram-positive bacteria: Listeria monocytogenes; Staphylococcus saprophyticus; Streptococcus agalactiae; Streptococcus mitis; Streptococcus pyogenes; Streptococcus groups C, G, F; Gram-negative bacteria: Acinetobacler 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: Clostridium perfringens; Fusobacterium spp.; Prevotella spp.; Propionibacterium acnes. Other organisms: Chlamydia pneumoniae; Legionella pneumophila; Mycobacterium avium; Mycobacterium marinum; Mycoplasma pneumoniae. After instillation, it penetrates into the systemic bloodstream in small quantities, penetration into breast milk is possible, but the likelihood of a systemic effect of the drug when used according to the instructions is negligible. Vigamox eye drops have a rapid and long-lasting therapeutic effect: the drug begins to act 10 - 15 minutes after use , while the duration of the bactericidal effect is 6-8 hours. Pharmacokinetics When applied topically, moxifloxacin is systemically absorbed: Cmax is 2.7 ng/ml, AUC value is 45 ng×h/ml. These values are approximately 1600 times and 1000 times less than the Cmax and AUC after a therapeutic dose of moxifloxacin 400 mg orally. T1/2 of moxifloxacin from plasma is about 13 hours.
Instructions for use VIGAMOX® (VIGAMOX)
Patients receiving systemic quinolone drugs have experienced severe, sometimes fatal, hypersensitivity reactions (anaphylaxis), sometimes immediately after the first dose. Some reactions were accompanied by acute vascular insufficiency, loss of consciousness, angioedema (including swelling of the larynx, pharynx or face), airway obstruction, shortness of breath, urticaria and pruritus.
If an allergic reaction to Vigamox® occurs, you must stop using the drug. If an acute hypersensitivity reaction to moxifloxacin or other components occurs, resuscitation measures may be required. If clinically indicated, oxygen is used to restore airway patency.
As with other antibiotics, long-term use can lead to excessive growth of non-susceptible microorganisms, incl. mushrooms If superinfection occurs, the drug should be discontinued and alternative therapy should be prescribed.
With systemic use of fluoroquinolones, including moxifloxacin, inflammation and tendon rupture may develop, especially in elderly patients and patients receiving concurrent corticosteroids. Plasma concentrations of moxifloxacin after ophthalmic use of Vigamox® are much lower than after oral use of moxifloxacin in therapeutic doses, but caution must be exercised and treatment with Vigamox® should be discontinued at the first sign of tendon inflammation.
Patients should be warned not to wear contact lenses if they have signs and symptoms of a bacterial eye infection.
Use in pediatrics
There is limited data on the effectiveness and safety of Vigamox® in the treatment of conjunctivitis in newborns. Therefore, the drug is not recommended for the treatment of conjunctivitis in newborns.
Vigamox® eye drops should not be prescribed for the prophylaxis or as empirical treatment of gonoblennorrhea in newborns, due to the possibility of development of fluoroquinolone resistance in Neisseria gonorrhoeae. Patients with eye infection caused by Neisseria gonorrhoeae should receive appropriate systemic treatment.
It is not recommended to use the drug in the treatment of Chlamydia trachomatis in patients under 2 years of age, because the use of the drug in this case has not been studied. For patients over 2 years of age with eye infections caused by Chlamydia trachomatis, appropriate systemic treatment is prescribed.
For neonatal conjunctivitis, treatment appropriate to the condition is prescribed, that is, systemic treatment of diseases caused by Chlamydia trachomatis and Neisseria gonorrhoeae.
Impact on the ability to drive vehicles and machinery
Vigamox® does not affect or has an insignificant effect on the ability to drive a car and use machinery. As with any other eye drops, temporary blurred vision or other visual disturbances may affect your ability to drive or operate machinery. If visual impairment occurs after instillation, the patient must wait until vision is restored before driving or operating machinery.
Vigamox, 1 piece, 5 ml, 0.5%, eye drops
For ophthalmic use only. Not for injection. It is not allowed to administer the drug subconjunctivally or directly into the anterior chamber of the eye.
There have been reports of serious and in some cases fatal (anaphylactic) hypersensitivity reactions in patients systematically taking quinolones; In some patients, the development of a reaction was observed after the first dose. Some reactions have been accompanied by cardiovascular collapse, loss of consciousness, angioedema (including swelling of the larynx, pharynx or face), airway obstruction, dyspnea, urticaria and pruritus.
If an allergic reaction to Vigamox® develops, you should stop using the drug. Severe acute hypersensitivity reactions to moxifloxacin may require first aid. Devices to restore oxygen supply and restore airway patency are used only for clinical indications.
Long-term use of the drug can lead to excessive growth of non-susceptible microorganisms, incl. mushrooms In case of superinfection, it is necessary to stop using the drug and prescribe adequate therapy.
Systemic use of fluoroquinolones, including moxifloxacin, may lead to tendon inflammation and rupture, especially in elderly patients and those taking concomitant corticosteroids. Thus, when the first symptoms of tendon inflammation appear, you should stop taking the drug.
Data on the effectiveness and safety of Vigamox® for the treatment of conjunctivitis in newborns are limited. Therefore, the use of the drug for the treatment of conjunctivitis in newborns is not recommended.
Vigamox® is not recommended for the prevention or empirical treatment of conjunctivitis, incl. gonococcal ophthalmia of the newborn, due to fluoroquinolone resistance of gonococci ( Neisseria gonorrhoeae
).
Patients with eye infections caused by gonococci ( Neisseria gonorrhoeae
) should receive appropriate systemic treatment.
Vigamox® is not recommended for the treatment of eye infections caused by Chlamydia trachomatis
, in patients under 2 years of age, because
No relevant studies have been conducted. Patients over 2 years of age with eye infections caused by Chlamydia trachomatis
should receive appropriate systemic treatment.
Newborns with ophthalmia neonatorum should receive appropriate treatment based on their condition, such as systemic treatment in cases caused by gonococci ( Neisseria gonorrhoeae
) or
Chlamydia trachomatis
.
Patients are not recommended to wear contact lenses if they have signs of infectious diseases of the anterior segment of the eye.
Do not touch the tip of the dropper bottle to any surface to avoid contamination of the bottle and its contents.
The bottle must be closed after each use.
Use in children.
Vigamox® can be used in pediatrics in children from 1 year of age in doses similar to adults.
Influence on the ability to drive vehicles and operate machinery.
After using the drug, a temporary decrease in the clarity of visual perception is possible and until it is restored, it is not recommended to drive a car or engage in activities that require increased attention and reaction.
