Vigamox drops eye drops 0.5% 5ml
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Active ingredients
Moxifloxacin
Release form
Drops
Composition
Active ingredient: Moxifloxacin Auxiliary substances: sodium chloride, boric acid, hydrochloric acid and / or sodium hydroxide (to adjust pH), purified water. Concentration of active ingredient (mg): 5 mg
Pharmacological effect
Moxifloxacin - fluoroquinolone antibacterial drug of the fourth generation, 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 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 chromosomal DNA cleavage during bacterial cell division. There is no cross-resistance with macrolides, aminoglycosides, and tetracycline. The development of cross-resistance between the systemically applied 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 diphtheriae; Micrococcus luteus (including strains insensitive to erythromycin, gentamicin, tetracycline, and / or trimethoprim); Staphylococcus aureus (including strains not sensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim); Staphylococcus epidermidis (including strains that are insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprimum); Staphylococcus haemolyticus (including strains not sensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim); Staphylococcus hominis (including strains that are insensitive to methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and / or trimethoprim); Staphylococcus warneri (including strains insensitive to erythromycin); Streptococcus mitis (including strains that are not sensitive to penicillin, erythromycin, tetracycline, and / or trimethoprimus); Streptococcus pneumoniae (including strains not sensitive 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: Acinetobacler Iwoffii; Haemophilus influenzae (including ampicillin-insensitive strains); Haemophilus parainfluenzae; Klebsiella spp. Other microorganisms: Chlamydia trachomatis. Moxifloxacin acts 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, systemic absorption of moxifloxacin occurs: Cmax is 2.7 ng / ml, the AUC value is 45 ng × h / ml. These values are about 1600 times and 1000 times less than Cmax and AUC after applying a therapeutic dose of moxifloxacin 400 mg orally. T1 / 2 moxifloxacin from plasma is about 13 hours.
Indications
Bacterial conjunctivitis caused by microorganisms sensitive to moxifloxacin.
Contraindications
Children and adolescents up to 1 year. Pregnancy. Lactation (breastfeeding period). Increased sensitivity to any of the components of the drug or to other quinolones.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
Sufficient experience on the use of the drug during pregnancy and lactation is not. The use of the drug during pregnancy (category C by the FDA) is possible only when the expected therapeutic effect for the mother outweighs the potential risk to the fetus and child. Vigamox may pass into breast milk, therefore, breastfeeding for the period of drug treatment should be discontinued. daily dose for humans). However, there was a slight decrease in fetal body weight and delayed development of the musculoskeletal system. Against the background of a dose of 100 mg / kg / day, an increase in the frequency of reducing the growth of newborns was noted.
Dosage and administration
Locally. Adults and children over 1 year old: instill 1 drop in the affected eye 3 times a day. Usually, the condition improves after 5 days and the treatment should be continued in the next 2-3 days. If the condition does not improve after 5 days, you should raise the question of the correctness of the diagnosis and / or 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 redness. In 0.1-1% of cases - a defect in the corneal epithelium, punctate keratitis, subconjunctival hemorrhage, conjunctivitis, swelling of the eye, a feeling of discomfort in the eyes, blurred vision, decreased visual acuity, erythema of the eyelids, unusual sensations in the eye.Systemic. In 1-10% of cases - dysgeusia. In 0.1-1% of cases - headache, paresthesia, decrease in blood hemoglobin, feeling of discomfort in the nose, pharyngolaryngeal pain, foreign body sensation in the throat, vomiting, increased ALT and GGT levels. Post-marketing experience (frequency unknown): Local: endophthalmitis , ulcerative keratitis, corneal erosion, formation of corneal defects, increased intraocular pressure, corneal clouding, corneal infiltrates, deposits on the cornea, allergic reactions of the eye, keratitis, corneal edema, photophobia, blepharitis, eyelid edema, increased lacrimation, edema eyes, a foreign body sensation in the eye. Systemic: palpitations, dizziness, shortness of breath, nausea, erythema, rash, skin itching, hypersensitivity. The appearance of an allergic reaction requires discontinuation of the drug! Patients who used the quinolone system drugs, including moxifloxacin, were observed hypersensitivity reactions (anaphylaxis), including immediately after taking the first dose, - collapse, loss of consciousness, angioedema, airway obstruction, shortness of breath, pruritus, rash.
Overdose
If an excessive amount of the drug gets into the eyes, it is recommended to wash the eyes with warm water.
Interaction with other drugs
Interaction locally assigned moxifloxacin with other drugs not izuchalos.Izvestny data for an oral dosage form of moxifloxacin not observed clinically significant drug interactions (unlike other drugs fluoroquinolone) with theophylline, warfarin, digoxin, oral contraceptives, probenicid, ranitidine and glibenclamide. In in vitro studies, moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, or CYP1A2 isoenzymes, which may indicate that moxifloxacin n does not change the pharmacokinetic properties of drugs metabolized by cytochrome P450 isoenzymes.
special instructions
Patients who used the quinolone systemic drugs experienced severe, in some cases, fatal hypersensitivity reactions (anaphylaxis) sometimes immediately after taking the first dose (!). Some reactions were accompanied by collapse, loss of consciousness, angioedema (including laryngeal edema and / or face) , airway obstruction, dyspnea, urticaria, and pruritus. In the event of the above condition may require resuscitation. Prolonged use of the antibiotic can lead to excessive growth of unresponsive microorganisms, including fungi. In case of superinfection, it is necessary to cancel the drug and prescribe adequate therapy. 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. Pediatric Vigamox can be used in pediatrics in children from 1 year in doses similar to adults. Effect on the ability to drive vehicles and control mechanisms. After using the drug, a temporary decrease in the clarity of visual perception is possible, and before its restoration it is not recommended to control car and engage in activities requiring increased attention and reaction.