Eye drops in the form of a clear solution of greenish-yellow color.
5 ml – polyethylene bottles with a capacity of 5 ml (1) with a dropper stopper – packs of cardboard.
Pharmacological action of
Bacterial conjunctivitis caused by microorganisms sensitive to moxifloxacin.
– children under 1 year of age
– individual hypersensitivity to the components of the drug
– hypersensitivity to antibiotics of the quinolone group.
Use during pregnancy and lactation
There is no sufficient experience with the drug during pregnancy and during breastfeeding. The use of the drug during pregnancy and during breastfeeding is possible when the expected therapeutic effect exceeds the potential risk to the fetus and baby.
Animal studies have shown that after taking moxifloxacin inside, a small amount of the substance is excreted in breast milk. However, with the use of the drug in therapeutic doses, the development of undesirable reactions in infants is not expected.
In preclinical studies on animals, moxifloxacin did not have teratogenic effects when applied at a dose of 500 mg / kg / day (which is about 21,700 times the recommended daily dose for humans), but there was a slight decrease in fetal weight and a delayed development of the musculoskeletal system. When used at a dose of 100 mg / kg / day, an increase in the frequency of decrease in the growth of newborns was noted.
A study of the effects of moxifloxacin on fertility when applied as instillations was not conducted.
1 ml moxifloxacin hydrochloride 5.45 mg, which corresponds to the content of moxifloxacin 5 mg
Excipients: boric acid – 3 mg, sodium chloride – 6.5 mg, hydrochloric acid solution 1M / sodium hydroxide solution 1M – up to pH 6.7-7.0, purified water – up to 1 ml.
Dosage and administration
The drug is intended for topical use only in ophthalmic practice. Not intended for use as subconjunctival injection or for administration to the anterior chamber of the eye.
When conducting treatment, the official recommendations for antibiotic therapy should be considered.
Adults (including elderly patients over 65) are prescribed 1 drop 3 times / day in the affected eye. Improvement occurs after 5 days of therapy, but treatment should be continued for another 2-3 days. In the absence of a therapeutic effect after 5 days of therapy, it is recommended to reconsider the diagnosis and choice of treatment tactics.
The duration of the course of therapy depends on the severity of the patientâs condition, clinical and bacteriological features of the infectious process.
In children, dosage adjustment is not required.
In patients with hepatic and renal failure, dose adjustment is not required.
To prevent microbial contamination of the tip of the dropper bottle and the drug, it is necessary to avoid contact with the eyelids, the skin of the peri-ocular area and other surfaces.
In order to prevent absorption of the drug through the nasal mucosa, it is necessary to squeeze the nasolacrimal canal with a finger for 2-3 minutes after instillation.
When using several topical preparations in ophthalmology, the interval between their use should be at least 5 minutes, eye ointments should be used last.
Side effects of
In clinical trials of moxifloxacin in a dosage form for use in ophthalmology, 2252 patients received the study drug 1 drop up to 8 times / essence, 1900 of which received moxifloxacin in the regimen of 1 drop 3 times / day. The population for safety assessment included 1389 patients in the USA and Canada, 586 patients in Japan and 277 patients in India. According to clinical studies, no serious adverse events have been received from both the organ of vision and the body as a whole. The most common adverse reactions associated with treatment, there were eye irritation and eye pain, the total frequency of occurrence of these phenomena ranged from 1% to 2%. In 96% of patients, the severity of these reactions was mild, while in one of the patients participating in the study, the severity of the adverse event led to the completion of participation in the study.
The following adverse reactions are classified according to the following gradation of frequency of occurrence: very often (> 1/10) often (> 1 / 100.1 / 1000.1 / 10 000,
From the hematopoietic system: rarely – decrease in hemoglobin.
Co side of the immune system: frequency unknown – hypersensitivity.
From the nervous system: infrequently – headache rarely – paresthesia frequency unknown – dizziness.
From the side of the organ of vision: often – eye pain, eye irritation infrequently – pinpoint keratitis, dry eye syndrome, subconjunctival hemorrhage, itching of the eyes, conjunctival injection, swelling of the eyelids, eye discomfort rarely – corneal epithelium defect, corneal disturbances, conjunctivitis, blepharitis, vision conjunctiva, decrease in fog , asthenopia, erythema of the eyelids frequency unknown – endophthalmitis, ulcerative keratitis, corneal erosion, increased intraocular pressure, corneal opacity, corneal edema, corneal infiltrates, corneal deposits, allergic other phenomena from the eyes, keratitis, corneal edema, photophobia, lacrimation, separated from the eyes, foreign body sensation in the eyes.
From the cardiovascular system: frequency unknown – sensation of palpitations.
From the respiratory system: rarely – discomfort in the nose, pain in the larynx and pharynx, foreign body sensation in the throat, frequency is unknown – shortness of breath.
From the digestive system: infrequently – dysgeusia rarely – vomiting, increased activity of aminotransferases and GGT frequency is unknown – nausea.
From the skin and subcutaneous fat: frequency unknown – erythema, rash, urticaria, pruritus.
Description of individual adverse reactions
There are reports of ruptures of tendons of the shoulder joint, arm joints, Achilles tendon, and other tendons that have led to a long period of disability or require surgical intervention. These phenomena were noted in patients receiving systemic therapy with fluoroquinolones. According to clinical studies and post-registration use, the risk of tendon ruptures during systemic therapy with fluoroquinolones may increase when corticosteroids are included in the treatment regimen, and elderly patients are at particular risk. Most often, lesions affect the tendons of the supporting joints, including Achilles tendon.
Use in children
In clinical trials involving children, including neonates, a safety profile of moxifloxacin in the form of instillations similar to the adult population was demonstrated. In patients under the age of 18 years, eye pain and eye irritation were most often observed, the frequency of occurrence was about 0.9%. According to the results of clinical studies in the pediatric population, there were no differences from the adult population in the profile of adverse events and their severity.
No specific studies of the interaction of the drug Maxiflox with other medicinal products have been performed. Due to the low systemic concentration, interaction with other drugs is unlikely after topical application in the form of instillations.
Due to the small capacity of the conjunctival cavity, the possibility of developing a local overdose when using medications in the form of instillations is practically absent. The total content of moxifloxacin in the preparation is too small for the development of undesirable phenomena by accidentally swallowing the contents of the vial.
The drug should be stored in its original packaging, out of the reach of children, at a temperature not exceeding 25 ° C.
After opening the vial, the drops should be used for 4 weeks.
C.O. Rompharm Company S.R.L., Romania