Tymer solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible
strains of the following organisms:
Aerobic Gram-Positive Bacteria:
Cornyebacterium propinquum*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mitis*
Streptococcus pneumoniae
Aerobic Gram-Negative Bacteria:
Haemophilus influenzae
* Efficacy for this organism was studied in fewer than 10 infections

The recommended dosage regimen for the treatment of bacterial conjunctivitis is:
Days 1 and 2: Instil one drop every two hours in the affected eye(s) while awake, up to 8
times daily.
Days 3 through 7: Instil one drop up to four times daily while awake.

NOT FOR INJECTION.
Tymer solution should not be injected subconjunctivally, nor should it be introduced directly
into the anterior chamber of the eye.
In patients receiving systemic quinolones, including gatifloxacin, serious and occasionally
fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been
reported. Some reactions were accompanied by cardiovascular collapse, loss of
consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway
obstruction, dyspnea, urticaria, and itching. If an allergic reaction to gatifloxacin occurs,
discontinue the drug. Serious acute hypersensitivity reactions may require immediate
emergency treatment. Oxygen and airway management should be administered as clinically
indicated.
PRECAUTIONS
General: As with other anti-infectives, prolonged use may result in overgrowth of
nonsusceptible organisms, including fungi. If superinfection occurs discontinue use and
institute alternative therapy. Whenever clinical judgment dictates, the patient should be
examined with the aid of magnification, such as slit lamp biomicroscopy and, where
appropriate, fluorescein staining.
Patients should be advised not to wear contact lenses if they have signs and symptoms of
bacterial conjunctivitis.

Information for Patients: Avoid contaminating the applicator tip with material from the
eye, fingers or other source.
Systemic quinolones, including gatifloxacin, have been associated with hypersensitivity
reactions, even following a single dose. Discontinue use immediately and contact your
physician at the first sign of a rash or allergic reaction.

Specific drug interaction studies have not been conducted with Tymer ophthalmic solution.
However, the systemic administration of some quinolones has been shown to elevate plasma
concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the
effects of the oral anticoagulant warfarin and its derivatives, and has been associated with
transient elevations in serum creatinine in patients receiving systemic cyclosporine
concomitantly.

There were no teratogenic effects observed in rats or rabbits following oral gatifloxacin
doses up to 50 mg/kg/day (approximately 1000-fold higher than the maximum
recommended ophthalmic dose). However, skeletal/craniofacial malformations or delayed
ossification, atrial enlargement, and reduced fetal weight were observed in fetuses from rats
given ≥150 mg/kg/day (approximately 3000-fold higher than the maximum recommended
ophthalmic dose). In a perinatal/postnatal study, increased late postimplantation loss and
neonatal/perinatal mortalities were observed at 200 mg/kg/day (approximately 4500 times
the maximum recommended ophthalmic dose).
Because there are no adequate and well-controlled studies in pregnant women, TYMER
solution should be used during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Nursing Mothers: Gatifloxacin is excreted in the breast milk of rats. It is not known
whether this drug is excreted in human milk. Because many drugs are excreted in human
milk, caution should be exercised when gatifloxacin is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in infants below the age of one year have not been
established. Geriatric use: No overall differences in safety or effectiveness have been
observed between elderly and younger patients.

As with any eye drops, 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.

None known

Flush from the eye(s) with warm tap water

Pharmacotherapeutic group: Ophthalmologicals; anti infectives, other anti-infectives, ATC
code: S01A X21
Mode of Action:
Gatifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and
topoisomerase IV required for bacterial DNA replication, repair, and recombination
In a randomised double-blind, multicentre clinical trial, where patients were dosed for 5 days,
Gatifloxacin solution was superior to its vehicle on day 5 – 7 in patients with conjunctivitis
and positive conjunctival cultures. Clinical outcomes for the trial demonstrated clinical cure of
77% (40/52) for the Gatifloxacin treated group versus 58% (28/48) for the placebo treated
group. Microbiological outcomes for the same clinical trial demonstrated a statistically
superior eradication rate for causative pathogens of 92% (48/52) for Gatifloxacin vs. 72%
(34/48) for placebo. Please note that microbiological eradication does not always correlate
with clinical outcome in anti-infective trials.

Gatifloxacin ophthalmic solution 0.3% or 0.5% was administered to one eye of 6 healthy male
subjects each in an escalated dosing regimen starting with a single 2 drop dose, then 2 drops 4
times daily for 7 days and finally 2 drops 8 times daily for 3 days. At all time points, serum
Gatifloxacin levels were below the lower limit of quantification (5 ng/mL) in all subjects.

Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl substituent at C7. The
antibacterial action of gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV.
DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of
bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of
chromosomal DNA during bacterial cell division.
Resistance to gatifloxacin in vitro develops via multiple-step mutations. Resistance to gatifloxacin
in vitro occurs at a general frequency of between 1 x 10-7 to 10-10.
Gatifloxacin has been shown to be active against most strains of the following organisms both in
vitro and clinically, in conjunctival infections as described in the INDICATIONS section. In vitro
activity does not necessarily imply in vivo activity.
Aerobes, Gram-Positive
Corynebacterium propinquum*, Staphylococcus aureus (variable sensitivity), Staphylococcus epide
Streptococcus mitis*, Streptococcus pneumoniae.
Aerobes, Gram-Negative Haemophilus influenza.
* Efficacy for this organism was studied in fewer than 10 infections.
The following in vitro data are available, but their clinical significance in ophthalmic infections is
unknown. The safety and effectiveness of TYMER in treating ophthalmic infections due to the
following organisms have not been established in adequate and well-controlled clinical trials.
The following organisms are considered susceptible when evaluated using systemic breakpoints.
However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has
not been established. The following list of organisms is provided as guidance only in assessing the
potential treatment of conjunctival infections. Gatifloxacin exhibits in vitro minimal inhibitory
concentrations (MICs) of 2μg/ml or less (systemic susceptible breakpoint) against most (≥ 90%)
strains of the following ocular pathogens.

Aerobes, Gram-Positive:
Listeria monocytogenes
Staphylococcus saprophyticus
Streptococcus agalactiae
Streptococcus pyogenes
Streptococcus viridans Group
Streptococcus Groups C, F, G
Aerobes, Gram-Negative:
Acinetobacter lwoffii
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli
Citrobacter freundii
Citrobacter koseri
Haemophilus parainfluenzae
Klebsiella oxytoca
Klebsiella pneumoniae
Moraxella catarrhalis
Morganella morganii
Neisseria gonorrhoeae
Neisseria meningitides
Proteus mirabilis
Proteus vulgaris
Serratia marcescens
Vibrio cholerae
Yersinia enterocolitica

Other Microorganisms:
Chlamydia pneumoniae
Legionella pneumophila
Mycobacterium marinum
Mycobacterium fortuitum
Mycoplasma pneumoniae
Anaerobic Microorganisms:
Bacteroides fragilis
Clostridium perfringens

Because clinical studies are conducted under widely varying conditions, adverse reaction rates
observed in the clinical studies of a drug cannot be directly compared to rates in the clinical
studies of another drug and may not reflect the rates observed in practice.
In clinical studies of patients with bacterial conjunctivitis treated with Tymer (N=717), the
most frequently reported adverse reactions occurring in ≥ 1 % of patients were: worsening of
the conjunctivitis, eye irritation, dysgeusia, and eye pain.
Additional adverse reactions reported with other formulations of gatifloxacin ophthalmic
solution in other clinical studies included chemosis, conjunctival hemorrhage, dry eye, eye
discharge, eyelid edema, headache, increased lacrimation, keratitis, red eye, papillary
conjunctivitis, and reduced visual acuity.

Benzalkonium Chloride
Sodium Chloride
Edetate Disodium (EDTA)
Hydrochloric Acid 1N or Sodium Hydroxide 1N
Water for injection

None known.

Do not store above 30°C. Discard after 30 days of opening.

5 ml of the Tymer 0.3 % Eye Drop is filled in a pre-sterilized 10 ml white High Density
Polyethylene (HDPE) bottle with a pre-sterilized LDPE dropper and High Density
Polyethylene (HDPE) pre-sterilized.

There is no special requirement for disposal. Any unused product or waste material should
be disposed of in accordance with local requirements.