Moxifloxacin Eye Drops IP 0.3 % w/v
COMPOSITION
Each ml contains:
Moxifloxacin Hydrochloride IP equ. to Moxifloxacin 5 mg
Water for Injections BP q.s.
DESCRIPTION
A clear, colourless to pale yellow colored solution.
PHARMACODYNAMIC
Pharmacotherapeutic group: Ophthalmological; anti-infectives, other anti-infectives.
ATC code: S01AE07
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 Moxifloxacin 0.5 % w/v eye drops, solution, moxifloxacin was absorbed into the systemic circulation. Plasma concentrations of moxifloxacin 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.
THERAPEUTIC INDICATION
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.
DOSAGE AND ADMINISTRATION
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.
Pediatric patients
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 0.5 % w/v 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.
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.
INSTRUCTION FOR USE
Apply MOXWELL Eye Drops in the following way:
- Wash your hands. Tilt your head back and look at the ceiling.
- Gently pull the lower eyelid down until there is a small pocket.
- Turn the bottle upside down and gently press the bottle to release drops into eyes that needs treatment.
- Let go of the lower lid, and close your eye for 30 seconds.
- To avoid contamination, do not let the tip of dropper touch your eye or anything else.
- Replace and tighten the cap straight after use.
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.
CONTRAINDICATION
It is contra-indicated in individuals who have shown hypersensitivity to Moxifloxacin, any of its excipients or any other quinolones.
WARNING AND PRECAUTIONS
- It is not for injection.
- Do not use the eye drop with contact lenses.
- Drug should be discontinued, if any allergic reaction occurs. Use this drug with caution in patient who have exhibited sensitivities to other quinolones antibacterial agents.
- It is not recommended for the treatment of chlamydia trachomatis in patient less than 2 year of age as it has not been evaluated.in such patient.
- As with other anti-infective, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.
- Patients should be monitored in case of prolonged use.
PREGNANCY AND LACTATION
Pregnancy
There are no or limited amount of data from the use of Moxifloxacin 0.5 % w/v eye drops, solution 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.
Lactation
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 0.5 % w/v eye drops, solution no effects on the suckling child are anticipated. The medicinal product can be used during breast-feeding.
DRUG INTERACTION
No specific interaction studies have been performed with Moxifloxacin 0.5 % w/v eye drops, solution. Given the low systemic concentration of moxifloxacin following topical ocular administration of the medicinal product, drug interactions are unlikely to occur.
ADVERSE EFFECTS
Eye irritation; ocular discomfort; taste disturbance; punctate keratitis; dry eye.
PRESENTATION
MOXWELL Eye Drops are supplied in 5 ml sterilized opaque plastic container with nozzle and cap
STORAGE AND OTHER INFORMATION
Store at temperature below 30 °C. Keep this medicine out of the sight and reach of children. Do not touch the dropper tip or other dispensing tip to any surface since this may contaminate the solution. Use the solution within one month after opening the container.
