Description
Latin name
Vigamox
Release form
eye drops.
Packaging
In a dropper bottle 5 ml drops. In the package 1 bottle.
Pharmacological action
Moxifloxacin is a fourth-generation fluoroquinolone antibacterial drug that has a bactericidal effect. It is active against a wide range of gram-positive and gram-negative microorganisms, anaerobic, acid-resistant 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 bacterial cell division.
There is no cross-resistance with macrolides, aminoglycosides, and tetracyclines. The development of cross-resistance between systemically used moxifloxacin and other fluoroquinolones has been reported.
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 / tetrimycin (tetramycyl to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim) Staphylococcus haemolyticus (including strains insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim) Staphyloc occus hominis (including strains insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim) Staphylococcus warneri (including strains insensitive to erythromycin) Streptococcus mitis (including strains,illino, erythromycin, tetracycline and / or trimethoprim).
Gram-negative bacteria: Acinetobacler Iwoffii Haemophilus influenzae (including ampicillin-insensitive strains) Haemophilus parainfluenzae Klebsiella spp.
Other microorganisms: Chlamydia trachomatis.
Moxifloxacin acts in vitro against most of the microorganisms listed below, but the clinical significance of these data is not known:
Gram-positive bacteria: Listeria monocytogenes Staphylococcus saprophyticus Streptococcus agalactiae Streptococcus mitis Streptococcus pyogenes Streptoclcus Fragcoccus group, Streptococcus gritcus Fragcoccus group 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 bacteria: 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 systemically absorbed: Cmax is 2.7 ng / ml, AUC is 45 ng h / ml. These values are approximately 1600 times and 1000 times smaller, than Cmax and AUC after applying a therapeutic dose of moxifloxacin 400 mg orally. T1 / 2 of moxifloxacin from plasma is approximately 13 hours.
Indications
Bacterial conjunctivitis caused by microorganisms sensitive to moxifloxacin.
Contraindications
Children and teenagers under 1 year.
Pregnancy.
Lactation (lactation period).
Hypersensitivity to any of the components of the drug or to other quinolones.
Use during pregnancy and lactation
There is no sufficient experience with the use of the drug during pregnancy and lactation.
The use of the drug during pregnancy (category C according to the FDA) is possible only if the expected therapeutic effect for the mother outweighs the potential risk to the fetus and the baby.
Vigamox may pass into breast milk, and therefore, breastfeeding for the period of treatment with the drug should be discontinued.
Teratogenicity
In preclinical studies in animals, moxifloxacin did not exert a teratogenic effect at doses of 500 mg / kg / day (which is approximately 21,700 times the recommended daily dose for humans). However, there was a slight decrease in fetal body weight and a delay in the development of the musculoskeletal system. Against the background of a dose of 100 mg / kg / day, an increase in the frequency of decrease in the growth of newborns was noted.
Composition
1 ml contains
Active substances: moxifloxacin hydrochloride 5.45 mg (equivalent to 5 mg moxifloxacin),
Excipients: sodium chloride, boric acid, hydrochloric acid and / or sodium hydroxide (to adjust pH), purified water.
Dosage and Administration
Topically.
Adults and children over 1 year of age: instill 1 drop in the affected eye 3 times a day.
Usually improvement occurs 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 should be raised about the correctness of the diagnosis and / or the prescribed treatment. The duration of treatment depends on the severity of the condition and the clinical and bacteriological course of the disease.
Side effects
Local. In 1-10% of cases – pain, irritation and itching in the eye, dry eye syndrome, conjunctival hyperemia, eye hyperemia. In 0.1-1% of cases – a defect in the corneal epithelium, point keratitis, subconjunctival hemorrhage, conjunctivitis, eye swelling, discomfort in the eyes, blurred vision, decreased visual acuity, erythema of the eyelids, unusual sensations in the eye.
system. In 1-10% of cases – dysgeusia. In 0.1-1% of cases – headache, paresthesia, decreased blood hemoglobin, discomfort in the nose, pharyngolaryngeal pain, foreign body sensation in the throat, vomiting, increased levels of ALT and GGT.
Post-marketing experience (frequency unknown):
Local: endophthalmitis, ulcerative keratitis, corneal erosion, formation of corneal defects, increased intraocular pressure, clouding of the cornea, corneal infiltrates, deposits on the cornea, allergic reactions of the eye, keratitis, phobitis, corneal edema, swelling of the eyelids, increased lacrimation, discharge from the eyes, a foreign body sensation in the eye.
Systemic: palpitations, dizziness, shortness of breath, nausea, erythema, rash, itching of the skin, hypersensitivity.
The occurrence of an allergic reaction requires discontinuation of the drug!
In patients using systemic quinolone drugs, including moxifloxacin, hypersensitivity reactions (anaphylaxis) were observed, including immediately after taking the first dose – collapse, loss of consciousness, Quincke’s edema, airway obstruction, shortness of breath, skin itching, rash.
Overdose
In case of contact with excess drug, it is recommended to rinse eyes with warm water.
Storage Conditions
Store at 2 to 25 ° C. Keep out of reach of children.
Shelf life
2 years. The opened bottle can be used no longer than 4 weeks.
Deystvuyushtee substance
Moxifloxacin
dosage form
eye drops
Possible product names
VIGAMOKS 0.5% 5ML GL. DROPS FL. / CAP.
VIGAMOX 0.5% 5ML FLAC / CAP GL DROPS
Vigamox 0.5% eye drops 5ml X1 M (R)
Vigamox eye drops 0.5%, 5 ml
Vigamox cap eye 0.5% vial 5 ml
Alkon, USA
