Composition: Each 1 ml contains 5.45 mg Moxifloxacin Hydrochloride (equivalent to 5 mg moxifloxacin).
Excipients:
Boric acid, Hydrochloric acid, Sodium hydroxide, Sodium chloride, Purified Water.
Mechanism of Action:
Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and topoisomerase IV required for bacterial DNA replication, repair, and recombination.
Pharmacokinetic Properties:
Following topical ocular administration of moxifloxacin, moxifloxacin was absorbed into the systemic circulation. Plasma concentrations of moxifloxacin were measured in 21 male and female subjects who received bilateral topical ocular doses of the medicinal product 3 times a day for 4 days. The mean steady-state Cmax and AUC were 2.7 ng/ml and 41.9 ng•hr/ml, respectively. These exposure values are approximately 1,600 and 1,200 times lower than the mean Cmax and AUC reported after therapeutic 400 mg oral doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.
Indications:
Topical treatment of purulent bacterial conjunctivitis, caused by susceptible strains.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Contraindications:
Hypersensitivity to the active substance, to other quinolones, or to any of the Excipients.
Posology and Method of Administration:
Adults including the elderly (≥ 65 years): The dose is one drop in the affected eye(s) 3 times a day.
The infection normally improves within 5 days and treatment should then be continued for a further 2-3 days. If no improvement is observed within 5 days of initiating therapy, the diagnosis and/or treatment should be reconsidered.
The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection.
Pediatric patient: No dosage adjustment is necessary.
Use in hepatic and renal impairment: No dosage adjustment is necessary.
Method of administration: For ocular use only. Not for injection. Moxifloxacin (5mg/ml)eye drops, solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye.To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
Warnings and Precautions:
In patients receiving systemically administered quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the medicinal product. Serious acute hypersensitivity reactions to moxifloxacin or any other product ingredient may require immediate emergency treatment. Oxygen and airway management should be administered where clinically indicated. As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.
The medicinal product is not recommended for the treatment of Chlamydia trachomatis in patients less than 2 years of age as it has not been evaluated in such patients. Patients older than 2 years of age with eye infections caused by Chlamydia trachomitis should receive appropriate systemic treatment.
Side Effects:
- Blood and lymphatic system disorders: hemoglobin decreased.
- Immune system disorders: Hypersensitivity.
- Nervous system disorders.
- Eye disorders :(eye pain, eye irritation) punctate keratitis, dry eye, conjunctival haemorrhage, ocular hyperaemia, eye pruritus, eyelid oedema, ocular discomfort, corneal epithelium defect, corneal disorder, conjunctivitis,blepharitis, eye swelling, conjunctival oedema, vision blurred, visual acuity reduced, asthenopia, erythema of eyelid, endophthalmitis, ulcerative keratitis, corneal erosion, corneal abrasion, intraocular pressure increased, corneal opacity, corneal infiltrates, corneal deposits, eye allergy, keratitis, corneal oedema, photophobia, eyelid oedema, lacrimation increased, eye discharge, foreign body sensation in eyes.
- Cardiac disorders: palpitations.
- Respiratory, thoracic and mediastinal disorders: nasal discomfort, pharyngolaryngeal pain, sensation of foreign body (throat) dyspnea
- Gastrointestinal disorders: dysgeusia, vomiting, nausea.
- Hepatobiliary disorders: alanine amino transferase increased, gamma-glutamyl transferase increased.
- Skin and subcutaneous tissue disorders: erythema, rash, pruritus, urticaria.
Drug Interactions:
No specific interaction studies have been performed with moxifloxacin (5mg/ml) eye drops, solution. Given the low systemic concentration of moxifloxacin following topical ocular administration of the medicinal product, drug interactions are unlikely to occur.
Pregnancy:
There are no adequate and well-controlled studies with moxifloxacin in pregnant women. However, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin is negligible. The medicinal product can be used during pregnancy.
Breast Feeding:
It is unknown whether moxifloxacin/metabolites are excreted in human milk. Animal studies have shown excretion of low levels in breast milk after oral administration of moxifloxacin. However, at therapeutic doses of moxifloxacin no effects on the suckling child are anticipated. The medicinal product can be used during breast-feeding.
Overdose:
The limited holding capacity of the conjunctival sac for ophthalmic products practically precludes any overdosing of the medicinal product. The total amount of moxifloxacin in a single container is too small to induce adverse effects after accidental ingestion.