Vigamox, eye drops 0.5% 5 ml

Vigamox eye drops is a broad-spectrum antibacterial drug (group of fluoroquinolones) for local use in ophthalmology. The drug shows bactericidal activity against a large number of bacteria including staphylococci, streptococci, Escherichia coli, diphtheria pathogens, salmonella, mycoplasmas, chlamydia, gonococci, spirochetes, Klebsiella, including strains of microorganisms resistant to 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 ampicillin-insensitive strains); Haemophilus parainfluenzae; Klebsiella spp.

Other microorganisms: Chlamydia trachomatis.

Moxifloxacin works 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 group 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 in small amounts into the systemic bloodstream; penetration into breast milk is possible, but the possibility of systemic action of the drug when used as directed is negligible.

Vigamox eye drops have a fast and prolonged therapeutic effect: the drug starts working 10-15 minutes after application and the duration of bactericidal effect is 6-8 hours.

Pharmacokinetics

When applied topically there is systemic absorption of moxifloxacin: Cmax is 2.7 ng/ml, AUC value is 45 ng×h/ml. These values are approximately 1600 and 1000 times lower than the Cmax and AUC after a therapeutic dose of moxifloxacin 400 mg by oral administration. T1/2 of moxifloxacin from plasma is about 13 hours.

Indications

Active ingredient

Composition

1 ml – moxifloxacin 5 µg.

Associated substances:

Sodium chloride,

boric acid,

hydrochloric acid and/or sodium hydroxide (for pH adjustment),

purified water.

How to take, the dosage

Topically.

At least 5 days improvement usually occurs and treatment should be continued for 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 treatment prescribed should be raised. The duration of treatment depends on the severity of the condition and the clinical and bacteriological course of the disease.

Special Instructions

In patients who have used systemic quinolone drugs, severe and in some cases fatal hypersensitivity reactions (anaphylaxis) have been observed, sometimes immediately after the first dose (!).

Some reactions have been accompanied by collapse, loss of consciousness, Quincke’s edema (including laryngeal and/or facial edema), airway obstruction, shortness of breath, urticaria and skin itching. Resuscitation measures may be necessary if the above conditions occur.

Prolonged use of an antibiotic may lead to overgrowth of non-susceptible microorganisms, including fungi. If superinfection occurs, the drug should be withdrawn and adequate therapy administered.

Do not touch the tip of the dropper bottle with any surface in order to avoid contamination of the bottle and its contents. The bottle should be closed after each use.

Impact on driving and operating machinery

After using the drug, there may be a temporary decrease in visual acuity, and until it is restored, it is not recommended to drive a vehicle and engage in activities requiring increased attention and reaction.

Contraindications

Hypersensitivity to any of the components of the drug or to other quinolones.

Children and adolescents under 1 year of age. Pregnancy. Lactation (period of breastfeeding).

Side effects

Topical. 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 – corneal epithelium defect, pitting keratitis, subconjunctival hemorrhage, conjunctivitis, ocular edema, eye discomfort, blurred vision, decreased visual acuity, erythema of eyelids, unusual sensations in the eye.

Systemic. In 1-10% of cases, dysgeusia. In 0.1-1% of cases – headache, paresthesia, decreased blood hemoglobin, feeling of discomfort in the nose, pharyngolaryngeal pain, feeling of a foreign body in the throat, vomiting, increased ALT and GGT levels.

Postmarketing experience (frequency unknown):

Local: Endophthalmitis, ulcerative keratitis, corneal erosion, corneal defect formation, increased intraocular pressure, corneal opacity, corneal infiltrates, corneal deposits, allergic eye reactions, keratitis, corneal edema, photophobia, blepharitis, eyelid edema, increased tear production, eye discharge, feeling of foreign body in eye.

Systemic: palpitations, dizziness, shortness of breath, nausea, erythema, rash, itching of the skin, hypersensitivity.

The occurrence of an allergic reaction requires withdrawal of the drug!

In patients who have used systemic quinolone drugs, including moxifloxacin, hypersensitivity reactions (anaphylaxis) have been observed, including immediately after the first dose – collapse, loss of consciousness, Quincke’s edema, airway obstruction, shortness of breath, skin itching, rash.

Overdose

If you get too much product in your eyes, it is recommended to rinse your eyes with warm water.

Pregnancy use

Contraindicated:

There is no sufficient experience of using the drug during pregnancy and lactation.

The use of the drug in pregnancy (FDA Category C) is only possible if the expected therapeutic benefit to the mother outweighs the potential risk to the fetus and the baby.

Vigamox may pass into the breast milk, therefore breastfeeding should be stopped during treatment with the drug.

Theratogenicity

In preclinical animal studies, moxifloxacin had no teratogenic effect at doses of 500 mg/kg/day (which is approximately 21,700 times the recommended daily dose for humans). However, some decrease in fetal body weight and delayed development of the musculoskeletal system were observed. At the 100 mg/kg/day dose, there was an increased incidence of decreased neonatal growth.

Similarities