Moxayz

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MOKSAYZ (MOXIEYES)

Composition:

Active substance: moxifloxacin;

1 ml of solution contains moxifloxacin hydrochloride 5.45 mg, equivalent to 5 mg of moxifloxacin;

Excipients: sodium chloride, boric acid, sodium hydroxide, hydrochloric acid concentrated, water for injections.

Pharmaceutical form. Eye drops.

Main physicochemical characteristics: transparent yellow solution, free from visible foreign particles.

Pharmacotherapeutic group. Agents used in ophthalmology. Antibacterial agents. ATC code S01AE07.

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, generally arises through chromosomal mutations in genes encoding DNA gyrase and topoisomerase IV. In Gram-negative bacteria, resistance to moxifloxacin may also occur due to mutations in the mar (multiple antibiotic resistance) and qnr (quinolone resistance) gene systems. Cross-resistance with beta-lactams, macrolides, and aminoglycosides is unlikely due to differences in mechanisms of action.

Breakpoints

The European Committee on Antimicrobial Susceptibility Testing (EUCAST) has established the following minimum inhibitory concentration (MIC) breakpoints (mg/L):

The in vitro breakpoints are used to predict the clinical efficacy of moxifloxacin when administered systemically. These breakpoints may not be appropriate when the medicinal product is applied topically to the eye, as higher concentrations are used with topical administration and local physical/chemical conditions may influence the drug's activity at the site of application.

Susceptibility

The prevalence of acquired resistance among relevant microorganisms may vary geographically and over time; therefore, local information on microbial resistance is desirable, especially when treating severe infections.

If local resistance prevalence renders the activity of moxifloxacin at least questionable against certain types of infections, expert advice should be sought.

Preclinical safety data

During preclinical studies, effects following topical ocular administration were observed only when the drug was administered at doses significantly exceeding the maximum human dose, indicating minimal relevance to clinical use.

As with other quinolones, moxifloxacin was shown to be genotoxic in vitro in bacterial and mammalian cells. A threshold level for genotoxicity can be assumed, since these effects may occur at considerably higher concentrations due to interaction with bacterial gyrase and mammalian topoisomerase II. However, in in vivo studies, despite high doses of moxifloxacin, no evidence of genotoxicity was found. Thus, therapeutic doses in humans provide an adequate safety margin. No signs of carcinogenic effects were observed in preclinical studies in rats.

In contrast to other quinolones, moxifloxacin showed no phototoxic or photo-genotoxic properties during extensive in vitro and in vivo investigations.

Pharmacokinetics.

After topical administration of Moxiaiz eye drops, moxifloxacin was absorbed into the systemic circulation. The plasma concentration of moxifloxacin was measured in 21 subjects—men and women—who received the medication instilled locally into both eyes three times daily for 4 days. The mean peak plasma concentration (Cmax) and the area under the concentration-time curve (AUC) in plasma were 2.7 ng/mL and 41.9 ng·h/mL, respectively. These values are approximately 1600 and 1200 times lower, respectively, than the mean Cmax and AUC values reported after oral administration of therapeutic doses of moxifloxacin (400 mg). The elimination half-life of moxifloxacin in plasma is 13 hours.

Clinical characteristics.

Indications.

Local treatment of bacterial conjunctivitis caused by bacterial strains sensitive to moxifloxacin. For information on the appropriate use of antibacterial agents, see official guidelines.

Contraindications.

Hypersensitivity to the active substance, other quinolones, or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

No interaction studies with other medicinal products have been conducted. Interaction with other medicinal products is unlikely due to low systemic concentrations of moxifloxacin following topical ophthalmic administration. If several topical ophthalmic medicinal products are prescribed simultaneously, the interval between their administration should be at least 5 minutes. Ophthalmic ointment should be administered last.

Special precautions for use.

• For ophthalmic use only. Not for injection. Subconjunctival injection or direct injection into the anterior chamber of the eye with Moxiayz is contraindicated.
• In patients receiving systemic therapy with quinolones, severe, sometimes fatal, hypersensitivity reactions (anaphylactic reactions) have been reported, occasionally after the first dose. Some of these reactions were accompanied by cardiovascular collapse, loss of consciousness, angioneurotic edema (including laryngeal, pharyngeal, and facial edema), airway obstruction, dyspnea, urticaria, and pruritus.
• If an allergic reaction to Moxiayz eye drops occurs, the drug should be discontinued immediately. 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 administered.
• As with other antibiotics, prolonged use of Moxiayz eye drops may result in overgrowth of non-susceptible microorganisms, including fungi. If superinfection occurs, treatment should be discontinued and appropriate therapy initiated.
• With systemic therapy using fluoroquinolones, including moxifloxacin, tendon inflammation and tendon rupture may occur, particularly in elderly patients and in those receiving concomitant corticosteroid therapy. Treatment with Moxiayz eye drops should be discontinued at the first sign of tendon inflammation.
• Wearing contact lenses is not recommended during treatment of eye inflammation/infection.
• The drug is not indicated for children under 2 years of age for the treatment of eye diseases caused by Chlamydia trachomatis, as its efficacy has not been studied in this patient population. Children aged 2 years and older with eye diseases caused by Chlamydia trachomatis should receive appropriate systemic therapy. Newborns should receive appropriate systemic therapy in case of eye infections caused by Chlamydia trachomatis or Neisseria gonorrhoeae.

Use during pregnancy or breastfeeding.

Reproductive function

Studies on the effect of Moxiayz on human reproductive function following topical administration have not been conducted.

No adverse effects on the reproductive function of men or women have been reported during use of Moxiayz eye drops.

Pregnancy

Since adequate and well-controlled studies of the use of the drug in pregnant women have not been conducted, Moxiayz should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

Period of breastfeeding

It is not known whether moxifloxacin or its metabolites are excreted in human breast milk. Animal studies have shown low levels of moxifloxacin excretion after oral administration. Moxiayz should be used with caution in breastfeeding women.

Ability to influence reaction rate while driving or operating machinery.

Moxiayz eye drops have no or negligible effect on the ability to drive or operate machinery. However, transient blurred vision or other visual disturbances may affect the ability to drive or operate machinery. If blurred vision occurs after instillation, patients should wait until vision clears before driving or operating machinery.

Method of Administration and Dosage

For ophthalmic use

Adults, including elderly patients

Instill 1 drop into the affected eye(s) 3 times daily.

Improvement is usually observed within 5 days; treatment should then be continued for an additional 2–3 days. If no improvement is observed after 5 days of treatment, consult a physician for reassessment of diagnosis and/or treatment. The duration of treatment depends on the severity of the condition and the clinical and bacteriological response.

Children

No dose adjustment is required for this patient group.

Patients with hepatic or renal impairment

No dose adjustment is required for this patient group.

To prevent contamination of the dropper tip and the contents of the bottle, care must be taken not to touch the eyelids, surrounding areas, or any other surfaces with the tip of the dropper bottle.

To minimize systemic absorption of the drops through the nasal mucosa, especially in newborns and children, occlusion of the nasolacrimal duct for 2–3 minutes after instillation is recommended.

Not for injection. Intracameral or subconjunctival injection of Moxiayz ophthalmic solution is strictly contraindicated.

Children

In clinical studies, Moxiayz ophthalmic solution was found to be safe when used in children, including newborns. In patients under 18 years of age, two adverse reactions were reported: eye irritation and eye pain (incidence – 0.9%). See also section "Special precautions for use".

Overdose

Due to the characteristics of the drug, no toxic effects are expected in case of overdose when administered into the eye or following accidental ingestion of the contents of one bottle.

Adverse reactions

During clinical studies, the most commonly reported adverse reactions were eye pain and ocular irritation, occurring in approximately 1–2% of patients.

The adverse reactions observed during clinical trials with the drug Moxiize are classified below by frequency: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), and very rare (<1/10000). Within each frequency group, adverse effects are listed in order of decreasing severity.

Additional adverse reactions have been identified during the post-marketing surveillance period. The frequency of their occurrence cannot be assessed. Within each organ system, adverse reactions are listed in order of decreasing severity.

In patients receiving systemic quinolone therapy, serious, sometimes fatal, hypersensitivity reactions (anaphylactic) have been observed, occasionally after administration of the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tinnitus, swelling of the throat or face, dyspnea, urticaria, and pruritus (see section "Special Instructions").

Tendon inflammation and tendon rupture may occur during systemic administration 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 elderly patients, and with high stress on tendons, including the Achilles tendon (see section "Special Instructions").

Shelf life. 3 years.

Storage period after first opening of the vial – 4 weeks.

Storage conditions.

Store in the original packaging, protected from light, at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

5 ml in a dropper vial, 1 dropper vial in a cardboard box.

Prescription status. Prescription only.

Manufacturer.

INDOCO REMEDIES LIMITED

INDOCO REMEDIES LIMITED

Manufacturer's address and location of manufacturing operations.

PLANT II, L-32, 33, 34 VERNAS INDUSTRIAL AREA, VERNAS, 403 722, INDIA

PLANT II, L-32, 33, 34 VERNA INDUSTRIAL AREA, VERNA, IN-403 722, INDIA

Marketing Authorization Holder.

M.Biotech Limited

M.Biotech Limited

Address of the Marketing Authorization Holder.

Gladstone House, 77-79 High Street, Egham TW20 9HY, Surrey, United Kingdom