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.

For ocular use only. Not for injection. Moxifloxacin Hydrochloride 0.5% ophthalmic
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.
Pediatric 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.

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 edema), airway obstruction,
dyspnoea, urticaria, and itching.
If an allergic reaction to Moxifloxacin Hydrochloride 0.5% Ophthalmic Solution 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 Moxifloxacin Hydrochloride 0.5%
Ophthalmic Solution plasma concentrations of moxifloxacin are much lower than after
therapeutic oral doses of Moxifloxacin, however , caution should be exercised and
treatment with Moxifloxacin Hydrochloride 0.5% solution should be discontinued at the
first sign of tendon inflammation.

Data are very limited to establish efficacy and safety of Moxifloxacin Hydrochloride 0.5%
Ophthalmic Solution in the treatment of conjunctivitis in neonates. Therefore use of this
medicinal product to treat conjunctivitis in neonates is not recommended.
Moxifloxacin Hydrochloride 0.5% Ophthalmic Solution 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.

No specific interaction studies have been performed with Moxifloxacin Hydrochloride
0.5% Ophthalmic Solution. Given the low systemic concentration of moxifloxacin
following topical ocular administration of the medicinal product, drug interactions are
unlikely to occur.

Pregnancy Category C
Pregnancy
There are no adequate data from the use of Moxifloxacin Hydrochloride 0.5% Ophthalmic
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.
Breastfeeding
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 Hydrochloride 0.5%
Ophthalmic Solution no effects on the suckling child are anticipated. The medicinal
product can be used during breast-feeding.

Fertility
Studies have not been performed to evaluate the effect of ocular administration of
Moxifloxacin Hydrochloride 0.5% Ophthalmic Solution on fertility.

Moxifloxacin Hydrochloride 0.5% Ophthalmic Solution has no or negligible influence on
the ability to drive and use machines, however, as with any Ophthalmic Solution,
temporary blurred vision or other visual disturbances may affect the ability to drive or use
machines. If blurred vision occurs at instillation, the patient should wait until their vision
clears before driving or using machinery.

Summary of the safety profile

In clinical studies involving 2,252 patients, MOXIFLOXACIN HYDROCHLORIDE 0.5% OPHTHALMIC was administered up to 8 times a day, with over 1,900 of these patients receiving treatment 3 times daily. The overall safety population that received the medicinal product consisted of 1,389 patients from the United States and Canada, 586 patients from Japan and 277 patients from India. No serious ophthalmic or systemic undesirable effects related to the medicinal product were reported in any of the clinical studies. The most frequently reported treatment-related undesirable effects with the medicinal product were eye irritation and eye pain, occurring at an overall incidence of 1 to 2%. These reactions were mild in 96% of those patients who experienced them, with only 1 patient discontinuing therapy as a result.

Tabulated summary of adverse reactions

The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.

Description of selected adverse reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria and itching (see section 4.4).

Ruptures of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones. Studies and post marketing experience with systemic quinolones indicate that a risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including Achilles tendon (see section 4.4).

Paediatric population

In clinical trials, MOXIFLOXACIN HYDROCHLORIDE 0.5% OPHTHALMIC has shown to be safe in paediatric patients, including neonates. In patients under 18 years old, the two most frequent adverse reactions were eye irritation and eye pain, both occurring at an incidence rate of 0.9%.

Based on data from clinical trials involving paediatric patients, including neonates (see section 5.1), the type and severity of adverse reactions in the paediatric population are similar to those in adults.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is
important. It allows continued monitoring of benefit/risk balance of the medicinal product.
To report any side effects:
• Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
 Fax: +966-11-205-7662
 Call NPC at +966-11-2038222,
 Ext: 2317-2356-2353-2354-2334-2340.
 Toll free phone: 8002490000
 E-mail: npc.drug@sfda.gov.sa
 Website: www.sfda.gov.sa/npc
 Other GCC States:
Please contact the relevant competent authority.

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.

Pharmacotherapeutic group: Ophthalmologicals; anti-infective, other anti-infective, and ATC
code: S01A E07
Mode of Action:
Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and
topoisomerase IV required for bacterial DNA replication, repair, and recombination.
Resistance:
Resistance to fluoroquinolones, including moxifloxacin generally occurs by chromosomal
mutations in genes encoding DNA gyrase and topoisomerase IV. In Gram-negative bacteria,
moxifloxacin resistance can be due to mutations in mar (multiple antibiotic resistances) and the
qnr (quinolone resistance) gene systems. Resistance is also associated with expression of
bacteria efflux proteins and inactivating enzymes. Cross-resistance with beta-lactams,
macrolides and aminoglycosides is not expected due to differences in mode of action.
Susceptibility Testing Breakpoints
There are no pharmacological data correlated with clinical outcome for moxifloxacin
administered as a topical agent. As a result, the European Committee on Antimicrobial
Susceptibility Testing (EUCAST) suggests the following epidemiological cut-off values
(ECOFF mg/l) derived from MIC distribution curves to indicate susceptibility to topical
moxifloxacin:
Corynebacterium ND
Staphylococcus aureus 0.25 mg/l
Staphylococcus, coag-neg. 0.25 mg/l
Streptococcus pneumoniae 0.5 mg/l
Streptococcus pyogenes 0.5 mg/l
Streptococcus, viridans group 0.5 mg/l
Enterobacter spp. 0.25 mg/l
Haemophilus influenzae 0.125 mg/l
Klebsiella spp. 0.25 mg/l
Moraxella catarrhalis 0.25 mg/l
Morganella morganii 0.25 mg/l
Neisseria gonorrhoeae 0.032 mg/l
Pseudomonas aeruginosa 4 mg/l
Serratia marcescens 1 mg/l

The prevalence of acquired resistance may vary geographically and with time for selected
species and local information on resistance is desirable, particularly when treating severe
infections. As necessary, expert advice should be sought when the local prevalence of
resistance is such that the utility of moxifloxacin in at least some types of infections is
questionable.

Following topical ocular administration of Moxifloxacin Hydrochloride 0.5% Ophthalmic
Solution, 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 steadystate
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.

Effects in non-clinical studies were observed only at exposures considered sufficiently in
excess of the maximum human exposure following administration to the eye indicating
little relevance to clinical use.
As with other quinolones, moxifloxacin was also genotoxic in vitro in bacteria and
mammalian cells. As these effects can be traced to the interaction with bacterial gyrase and
in considerably higher concentrations to the interaction with topoisomerase II in
mammalian cells, a threshold level for genotoxicity can be assumed. In in -vivo tests, no
evidence of genotoxicity was found, despite high doses of moxifloxacin. The therapeutic
doses for human use therefore provide adequate safety margin. No indication of a
carcinogenic effect was observed in an initiation promotion model in rats.
Unlike other quinolones, moxifloxacin showed no phototoxic or photogenotoxic properties
in extensive in vitro and in vivo studies.

 Sodium Chloride
 Boric acid
 Hydrochloric Acid 1N and/or Sodium Hydroxide 1N (to adjust pH)
 Water for Injection

Not applicable.

 Do not store above 30°C
 Keep out of the reach and sight of children.

Carton Label and PIL

Any unused product or waste material should be disposed of in accordance with local
requirements.