Instructions for Tamveler eye drops 5 mg/ml dropper bottle 5 ml
Composition
active ingredient: moxifloxacin;
1 ml of solution contains 5 mg of moxifloxacin (as moxifloxacin hydrochloride);
excipients: sodium chloride, boric acid, sodium hydroxide, water for injection.
Dosage form
Eye drops.
Main physicochemical properties: transparent greenish-yellow solution, free from foreign particles.
Pharmacotherapeutic group
Means used in ophthalmology. Antibacterial agents. ATX code S01A E07.
Pharmacological properties
Pharmacodynamics
Mechanism of action
Moxifloxacin, a fourth-generation fluoroquinolone, inhibits DNA gyrase and topoisomerase IV, which are essential for bacterial DNA replication, repair, and recombination.
Mechanism of resistance
Resistance to fluoroquinolones, including moxifloxacin, usually occurs due to chromosomal mutations in the genes encoding DNA gyrase and topoisomerase IV. In Gram-negative bacteria, resistance to moxifloxacin can occur due to mutations in the mar (multidrug resistance) and qnr (quinolone resistance) system genes. Cross-resistance with beta-lactams, macrolides and aminoglycosides is unlikely due to differences in the mode of action.
Limit values
The European Committee on Antibiotic Susceptibility Testing (EUCAST) has established the following minimum inhibitory concentration (MIC) breakpoints (mg/L):
| Microorganisms | Sensitivity | Resistance |
| Staphylococcus strains | ≤ 0.5 mg/l | > 1 mg/l |
| Streptococcus A, B, C, G | ≤ 0.5 mg/l | > 1 mg/l |
| Streptococcus pneumoniae | ≤ 0.5 mg/l | > 0.5 mg/l |
| Haemophilus influenzae | ≤ 0.5 mg/l | > 0.5 mg/l |
| Moraxella catarrhalis | ≤ 0.5 mg/l | > 0.5 mg/l |
| Enterobacteriaceae | ≤ 0.5 mg/l | > 1 mg/l |
| Non-species-specific strains | ≤ 0.5 mg/l | > 1 mg/l |
In vitro breakpoints are used to predict the clinical efficacy of moxifloxacin when administered systemically. These breakpoints may not be acceptable when the drug is administered topically to the eye, as higher concentrations are used with topical administration and local physical/chemical conditions may affect the activity of the drug at the site of administration.
Sensitivity
The prevalence of acquired resistance may vary geographically and over time for the relevant strains of microorganisms, so it is desirable to have local information on the resistance of microorganisms, especially when treating severe infections.
If necessary, specialist advice should be sought if the local prevalence of resistance is such that the activity of moxifloxacin, at least against some types of infections, is questionable.
Susceptible strains
Aerobic Gram-positive microorganisms
Corynebacterium strains, including Corynebacterium diphtheriae
Staphylococcus aureus (methicillin-susceptible)
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus viridans group
Aerobic Gram-negative microorganisms
Enterobacter cloacae
Haemophilus influenzae
Klebsiella oxytoca
Moraxella catarrhalis
Serratia marcescens
Anaerobic microorganisms
Proprionibacterium acnes
Other microorganisms
Chlamydia trachomatis
Conditionally resistant strains
Aerobic Gram-positive microorganisms
Staphylococcus aureus (methicillin-resistant)
Staphylococcus, coagulase-negative strains (methicillin-resistant)
Aerobic Gram-negative microorganisms
Neisseria gonorrhoeae
Other microorganisms
Missing
Resistant microorganisms
Aerobic Gram-negative microorganisms
Pseudomonas aeruginosa
Other microorganisms
Missing
Pharmacokinetics
After topical application, moxifloxacin was absorbed into the systemic circulation. Plasma concentrations of moxifloxacin were measured in 21 male and female subjects who received topical instillation of the drug into both eyes 3 times daily for 4 days. The mean steady-state plasma Cmax and AUC values were 2.7 ng/ml and 41.9 ng h/ml, respectively. These values are approximately 1600 and 1200 times lower than the mean Cmax and AUC values reported after oral administration of therapeutic doses of moxifloxacin of 400 mg. The plasma half-life of moxifloxacin was 13 hours.
Indication
Topical treatment of bacterial conjunctivitis caused by moxifloxacin-sensitive strains of bacteria.
For information on the appropriate use of antibacterial agents, see official guidelines.
Contraindication
Hypersensitivity to the active substance, other quinolones or to any of the components of the drug.
Interaction with other medicinal products and other types of interactions
No drug interaction studies have been conducted. Drug interactions are unlikely since moxifloxacin has low systemic concentrations following topical ophthalmic administration.
If several topical ophthalmic medicinal products are administered simultaneously, the interval between their applications should be at least 5 minutes. Eye ointments should be applied last.
Application features
For ophthalmic use only. Not for injection. Do not administer by subconjunctival injection or directly into the anterior chamber of the eye.
Serious, sometimes fatal, hypersensitivity (anaphylactic) reactions have been reported in patients receiving systemic quinolone therapy, sometimes after the first dose. Some reactions have been associated with cardiovascular failure, loss of consciousness, angioedema (including laryngeal, pharyngeal and facial swelling), airway obstruction, dyspnoea, urticaria and pruritus.
If an allergic reaction to moxifloxacin occurs, the drug should be discontinued. Serious acute hypersensitivity reactions to moxifloxacin or any component of this medicinal product may require emergency treatment. If clinically indicated, airway patency should be restored and oxygen therapy should be administered.
As with other antibiotics, prolonged use of the drug may result in overgrowth of non-susceptible microorganisms, including fungi. If superinfection occurs, the drug should be discontinued and alternative treatment should be instituted.
Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy, including moxifloxacin, especially in elderly patients and with concomitant use with corticosteroids. At the first signs of tendon inflammation, moxifloxacin eye drops should be discontinued.
It is not recommended to wear contact lenses during treatment of eye inflammation/infections.
The drug is not prescribed to children under 2 years of age for the treatment of eye diseases caused by Chlamydia trachomatis, as its effect has not been studied in this category of patients. Children over 2 years of age with eye diseases caused by Chlamydia trachomatis should receive appropriate systemic treatment. Newborns should receive appropriate systemic treatment in case of eye diseases caused by Chlamydia trachomatis or Neisseria gonorrhoeae.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug has no or negligible influence on the ability to drive or use machines. Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs during instillation, the patient should wait until the vision clears before driving or using machines.
Use during pregnancy or breastfeeding
Reproductive function
No studies have been conducted on the effects of moxifloxacin on human reproductive function when applied topically.
No adverse reactions on the reproductive function of men or women have been reported during the use of moxifloxacin eye drops.
Pregnancy
Since there are no adequate and well-controlled studies of the drug in pregnant women, the drug should not be used during pregnancy, except in cases where the expected benefit from the drug outweighs the potential risk to the fetus.
Breastfeeding period
It is not known whether moxifloxacin or its metabolites are excreted in human milk. Animal studies have shown low levels of oral excretion of moxifloxacin. Caution should be exercised when prescribing to lactating women.
Method of administration and doses
For ophthalmic use.
Adults, including elderly patients
Instill 1 drop into the affected eye(s) 3 times a day.
Usually the condition improves within 5 days, after which the treatment should be continued for another 2-3 days. If no improvement is observed within 5 days of treatment, you should consult a doctor for clarification of the diagnosis and/or treatment. The duration of treatment depends on the severity of the disease and the clinical and bacteriological picture of the course of the disease.
Children
There is no need for dose adjustment for this category of patients.
Patients with impaired liver and kidney function
There is no need for dose adjustment for this category of patients.
To prevent contamination of the dropper tip and contents of the bottle, care should be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip.
To prevent absorption of drops through the nasal mucosa, especially in newborns and children, it is recommended to pinch the nasolacrimal canal with your fingers for 2-3 minutes after applying the drops.
Not for injection. Do not administer by subconjunctival injection or directly into the anterior chamber of the eye.
Children
Moxifloxacin eye drops have been shown to be safe in children, including newborns. In patients under 18 years of age, adverse reactions such as eye irritation and eye pain have been observed.
Overdose
Given the characteristics of the drug, no toxic effect is expected in case of overdose when applying the drug to the eye or in case of accidental swallowing of the contents of one vial.
Adverse reactions
The most common side effects are eye pain and eye irritation.
The following adverse reactions have been observed with the use of moxifloxacin eye drops.
From the circulatory and lymphatic system: decreased hemoglobin level.
From the nervous system: headache, paresthesia, dizziness.
On the part of the organ of vision: eye pain, eye irritation, punctate keratitis, dry eye syndrome, conjunctival hemorrhage, conjunctival hyperemia, ocular hyperemia, ocular itching, abnormal eye sensitivity, eyelid edema, ocular discomfort, corneal epithelial defect, corneal disorder, corneal discoloration, conjunctivitis, blepharitis, eye swelling, eyelid pain, conjunctival edema, blurred vision, decreased visual acuity, asthenopia, eyelid disorder, eyelid erythema, ulcerative keratitis, keratitis, lacrimation increased, photophobia, ocular discharge.
Respiratory, thoracic and mediastinal disorders: nasal discomfort, pharyngolaryngeal pain, foreign body sensation (in the throat), dyspnea.
Gastrointestinal: dysgeusia, vomiting, nausea.
Liver and biliary tract disorders: increased alanine aminotransferase, increased gamma-glutamyltransferase.
On the part of the immune system: hypersensitivity.
Cardiac: palpitations.
Skin and subcutaneous tissue disorders: erythema, pruritus, rash, urticaria.
Serious, sometimes fatal, hypersensitivity (anaphylactic) reactions have been reported in patients receiving systemic quinolone therapy, sometimes after the first dose. Some reactions have been associated with cardiovascular failure, loss of consciousness, tinnitus, swelling of the throat or face, dyspnoea, urticaria and pruritus (see section 4.4).
Tendon inflammation and rupture may occur with systemic use of fluoroquinolones. Studies and post-marketing experience with systemic quinolones indicate that the risk of such ruptures may be increased in patients receiving corticosteroids, particularly in the elderly, and in patients with high tendon loads, including the Achilles tendon (see section 4.4).
Pediatric patients
For pediatric patients, including neonates, the type and severity of adverse reactions are similar to those seen in adult patients.
Expiration date
3 years.
Do not use after the expiry date stated on the packaging. Use no more than 4 weeks after first opening the bottle.
Storage conditions
There are no special storage conditions for the drug.
Keep out of reach of children.
Packaging
5 ml of eye drop solution in dropper bottles, closed with tamper-evident caps. 1 dropper bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
Pharmaten S.A.
Location of the manufacturer and its business address
Dervenakion 6, Pallini Attica 15351, Greece.
