Moxifur - instructions for use, dose, side effects, contraindications

Moxifloxacin is a fluoroquinolone antibacterial drug IV generation, has a bactericidal effect. It is active against a wide range of gram-positive and gram-negative microorganisms, anaerobic, acid-fast and atypical bacteria.

The mechanism of action is associated with the inhibition of topoisomerase II (DNA gyrase) and topoisomerases 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 the division of a bacterial cell.

There is no cross-resistance with macrolides, aminoglycosides and tetracyclines. It was reported about the development of cross-resistance between the systemically used moxifloxacin and other fluoroquinolones. Moxifloxacin is active against most strains of microorganisms (as in vitro, and in vivo).

Gram-positive bacteria:

Corynebacterium spp., including Corynebacterium diphtheria;

Micrococcus 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 that are insensitive to penicillin, erythromycin, tetracycline, and / or trimethoprim);

Streptococcus pneumoniae (including strains that are insensitive to penicillin, erythromycin, tetracycline, and / or trimethoprim);

Streptococcus groups viridans (including strains that are insensitive to penicillin, erythromycin, tetracycline, and / or trimethoprim).

Gram-negative bacteria:

Acinetobacter lwoffii;

Haemophilus influenzae (including strains not susceptible to ampicillin);

Haemophilus parainfluenzae; Klebsiella spp.

Other microorganisms:

Chlamydia trachomatis

Moxifloxacin is active in vitro against most of the below listed microorganisms, but the clinical significance of these data is unknown.

Gram-positive bacteria:

Listeria monocytogenes; Staphylococcus saprophyticus; Streptococcus agalactiae; Streptococcus pyogenes; Streptococcus groups C, G, F.

Gram-negative bacteria:

Acinetobacter baumannii; Acinetobacter calcoaceticus; Citrobacter freundii; Citrobacter koseri; Enterobacter aerogenes; Enterobacter cloacae; Escherichia coli; Klebsiella oxytoca; Klebsiella pneumonia; Moraxella catarrhalis; Morganella morganii; Neisseria gonorrhoeae; Proteus mirabilis; Proteus vulgaris; Pseudomonas stutzeri.

Anaerobic microorganisms:

Clostridium perfringens; Fusobacterium spp .; Prevotella spp .; Propionibacterium acnes.

Other microorganisms:

Chlamydia pneumonia; Legionella pneumophila; Mycobacterium avium; Mycobacterium marinum; Mycoplasma pneumonia.

Pharmacokinetics:

When topical application occurs systemic absorption of moxifloxacin: the maximum concentration of moxifloxacin in the blood plasma (C_max) is 2.7 ng / ml, the area under the concentration-time curve (AUC) - 45 ng / hr. These values are about 1600 times and 1000 times less than FROM_max and AUC after applying a therapeutic dose of moxifloxacin 400 mg orally. The half-life (T_1/2) of moxifloxacin from plasma is about 13 hours.

Indications:

Bacterial conjunctivitis caused by microflora-sensitive moxifloxacin.

Contraindications:Hypersensitivity to any of the components of the drug, other representatives of the quinolone series; the period of breastfeeding; children under 1 year.

Pregnancy and lactation:Sufficient experience in the use of the drug during pregnancy and during lactation there. The use of the drug in pregnancy is possible only if the expected benefit for the mother exceeds the potential risk to the fetus and the baby. Moxifloxacin can be excreted in breast milk, and therefore, breast-feeding for the period of drug treatment should be discontinued.

Dosing and Administration:

Locally. Adults and children older than 1 year instilled 1 drop in the affected eye 3 times a day. Usually, the condition improves after 5 days of therapy and treatment should be continued for the next 2-3 days. In the absence of therapeutic effect, it is recommended to revise the therapy. The duration of treatment depends on the severity of the patient's condition.

Side effects:

The frequency of the undesirable effects listed below was estimated as follows: from 0.1-1% - rarely and from 1-10% - often.

Local: often - pain, irritation and itching in the eye, dry eye syndrome, congestion hyperemia, eye hyperemia. Rarely - a defect of the epithelium of the cornea, pinpoint keratitis, subconjunctival hemorrhage, conjunctivitis, edema of the eye, a feeling of discomfort in the eyes, blurred vision, decreased visual acuity, erythema eyelids, unusual sensations in the eye.

System: often - dysgeusia.

Rarely - headache, paresthesia, decreased hemoglobin, a feeling of discomfort in the nose, sore throat, foreign body sensation in the throat, vomiting, increased activity of alanine aminotransferase and gamma-glutamyltransferase; allergic reactions (skin rash, itching, swelling of Quincke).

Overdose:

Cases of overdose were not noted, with topical application of the drug. If eye contact is excessive, it is recommended to wash eyes with warm water.

Interaction:

The possible interaction of moxifloxacin with topical application with other drugs has not been studied.

Data are known for another dosage form of moxifloxacin (for oral administration): no clinically significant interaction (unlike other fluoroquinolone series) with theophylline, warfarin,digoxin, oral contraceptives, probenicide, ranitidine and glibenclamide.

In studies in vitro moxifloxacin does not inhibit isoenzymes CYP3A4, CYP2D6, CYP2C9 or CYP1A2, which may indicate that moxifloxacin not changes the pharmacokinetic properties of drugs metabolized by isoenzymes of the cytochrome P450 system.

Special instructions:

Patients who use systemic preparations of the quinolone series may experience severe, in some cases, fatal reactions of hypersensitivity (anaphylaxis), sometimes immediately after taking the first dose. Some reactions may be accompanied by collapse, loss of consciousness, Quinck's edema (including laryngeal and / or face swelling), airway obstruction, dyspnoea, urticaria and skin pruritus. If these conditions occur, resuscitation may be required. Prolonged use of the drug may lead to excessive growth of non-susceptible microorganisms, including fungi. In case of superinfection, it is necessary to cancel the drug and prescribe the appropriate therapy.In the presence of symptoms of bacterial conjunctivitis, the patient should be advised not to wear contact lenses until they are completely cured.

It is unacceptable to touch the tip of the vial to any surfaces, in order to avoid infection of the eye and the contents of the vial. The bottle must be closed after each use.

Effect on the ability to drive transp. cf. and fur:

Use with caution when operating vehicles and other mechanisms (risk of developing visual impairment).

Form release / dosage:Eye drops 0.5%.

Packaging:

For 5 ml of the drug in an opaque polyethylene bottle with a nozzle-dropper and a white cap. 1 bottle with instructions for use in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001880

Date of registration:12.10.2012

Expiration Date:12.10.2017

The owner of the registration certificate:VARTAMAN PHARMA, LLC VARTAMAN PHARMA, LLC Russia

Manufacturer: & nbsp

APPASAMY OCULAR DEVICES (P) LTD.(PHARMA DIVISION) India

Information update date: & nbsp12.06.2018

Illustrated instructions

Instructions

Moxifur (Moxifur)