MOXIFUR 1ml

Moxifloxacin Ophthalmic Solution USP

THIS LEAFLET CONTAINS IMPORTANT PRODUCT USE AND SAFETY INFORMATION, PLEASE READ CAREFULLY AND RETAIN FOR FURTHER FUTURE REFERENCE.

DESCRIPTION:

Moxifur (Moxifloxacin Ophthalmic Solution USP) is a sterile 1 ml clear, pale yellow coloured, isotonic, preservative free ophthalmic solution.

COMPOSITION:

Each ML Contains:

Moxifloxacin Hydrochloride USP
• Eq. to Moxifloxacin 0.5% w/v
• Aqueous Buffered Vehicle q.s.

INDICATIONS:

Topical treatment of purulent bacterial conjunctivitis, caused by moxifloxacin susceptible strains. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

PHARMACOLOGICAL CLASSIFICATION:

Pharmacotherapeutic group: Ophthalmologicals; anti-infectives, other anti-infectives,

PHARMACODYNAMICS/ PHARMACOKINETICS:

Pharmacodynamics:

Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and topoisomerase IV required for bacterial DNA replication, repair, and recombination.

Pharmacokinetics:

Following topical ocular administration of Moxifur (Moxifloxacin Ophthalmic Solution USP), 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.

RECOMMENDED DOSE:

For ocular use only. Not for injection. Moxifur (Moxifloxacin Ophthalmic Solution USP), solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. Use in 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. Paediatric patients. No dosage adjustment is necessary. Use in hepatic and renal impairment No dosage adjustment is necessary. 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. In order to prevent the drops from being absorbed via the nasal mucosa, particularly in new-born infants or children, the nasolacrimal ducts should be held closed for 2 to 3 minutes with the fingers after administering the drops. After cap is removed, if tamper evident snap collar is loose, remove before using the product. If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart. Eye ointments should be administered last.

CONTRA-INDICATIONS:

Hypersensitivity to the active substance, to other quinolones,

WARNING AND PRECAUTION:

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 Moxifur (Moxifloxacin Ophthalmic Solution USP) 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. Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including moxifloxacin, particularly in older patients and those treated concurrently with corticosteroids. Following ophthalmic administration of Moxifur (Moxifloxacin Ophthalmic Solution USP) plasma concentrations of moxifloxacin are much lower than after therapeutic oral doses of moxifloxacin, however , caution should be exercised and treatment with Moxifur (Moxifloxacin Ophthalmic Solution USP) should be discontinued at the first sign of tendon inflammation.
Data are very limited to establish efficacy and safety of Moxifur (Moxifloxacin Ophthalmic Solution USP) in the treatment of conjunctivitis in neonates. Therefore use of this medicinal product to treat conjunctivitis in neonates is not recommended.
Moxifur (Moxifloxacin Ophthalmic Solution USP) should not be used for the prophylaxis or empiric treatment of gonococcal conjunctivitis, including gonococcal ophthalmia neonatorum, because of the prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae. Patients with eye infections caused by Neisseria gonorrhoeae should receive appropriate systemic treatment.
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.
Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition, e.g. systemic treatment in cases caused by Chlamydia trachomitis or Neisseria gonorrhoeae. Patients should be advised not to wear contact lenses if they have signs and symptoms of a bacterial ocular infection.

INTERACTIONS WITH OTHER MEDICAMENTS:

No specific interaction studies have been performed with Moxifur (Moxifloxacin Ophthalmic Solution USP). Given the low systemic concentration of moxifloxacin following topical ocular administration of the medicinal product, drug interactions are unlikely to occur.

OVERDOSE AND TREATMENT:

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.

STORAGE CONDITION:

Preserve in tight containers. Store between 2°C to 25°C.

SHELF LIFE:

24 Months.

HOW SUPPLIED:

Moxifur (Moxifloxacin Ophthalmic Solution USP) 1mL is available in sterile 2ml Glass vial with pouch pack.