Adults, newborn infants (0-27 days), infants and toddlers (28 days to 23 months), children
(2-11 years) and adolescents (12 – 16 years)
OPTICIN is indicated for the treatment of corneal ulcers and superficial infections of the
eye and adnexa caused by susceptible strains of bacteria.
Consideration should be given to official guidance on the appropriate use of antibacterial
agents.

Adults, newborn infants (0-27 days), infants and toddlers (28 days to 23 months), children
(2-11 years) and adolescents (12 – 16 years)
Corneal Ulcers:
OPTICIN must be administered in the following intervals, even during night time:
On the first day, instill 2 drops into the affected eye every 15 minutes for the first six hours
and then 2 drops into the affected eye every 30 minutes for the remainder of the day.
On the second day, instill 2 drops in the affected eye hourly.

On the third through the fourteenth day, place two drops in the affected eye every 4 hours. If
the patient needs to be treated longer than 14 days, the dosing regimen is at the discretion of
the attending physician.
Superficial Ocular Infection:
The usual dose is one or two drops in the affected eye(s) four times a day. In severe
infections, the dosage for the first two days may be one or two drops every two hours during
waking hours.
For either indication a maximum duration of therapy of 21 days is recommended.
Children:
The safety and efficacy of OPTICIN in children under the age of 1 year has not been
established. The dosage in children above the age of 1 year is the same as for adults.

The clinical experience in children less than one year old, particularly in neonates is very
limited. The use of OPTICIN eye drops in neonates with ophthalmia neonatorum of
gonococcal or chalamydial origin is not recommended as it has not been evaluated in such
patients. Neonates with ophthalmia neonatorum should receive appropriate treatment for
their condition.
When using OPTICIN eye drops one should take into account the risk of rhinopharyngeal
passage which can contribute to the occurrence and the diffusion of bacterial resistance
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the
first dose, were observed in patients receiving treatment based on systematically
administered quinolones. Some reactions were accompanied by cardiovascular collapse, loss
of consciousness, tingling, pharyngeal or facial oedema, dyspnea, urticaria and itching. Only
a few patients had a history of hypersensitivity reactions.
Ciprofloxacin should be discontinued at the first appearance of skin rash or any other sign of
hypersensitivity.

As with all antibacterial preparations prolonged use may lead to overgrowth of nonsusceptible
bacterial strains or fungi. If superinfection occurs, appropriate therapy should be
initiated.
During therapy, soft contact lenses should not be worn.

Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin

As there are no controlled studies in pregnant women OPTICIN should be used during
pregnancy only if the potential benefit justifies the potential risk to the foetus.
Orally administered ciprofloxacin is excreted in the human milk. Excretion of ciprofloxacin
into human milk following topical ophthalmic administration has not been investigated.
Therefore, caution should be exercised when OPTICIN is administered to nursing mothers.

None known

Local burning and ocular discomfort may occur as well as itching, foreign body sensation, lid
margin crusting, crystals/scales, conjunctival hyperemia and bad taste following instillation.
Additionally, corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing,
photophobia, corneal infiltrates, nausea and decreased vision have been reported.
Hypersensitivity reactions cannot be excluded.
In patients with corneal ulcer and frequent administration of the drug, white precipitates have
been observed which resolved after continuous application of Opticin. The precipitate does not
preclude the continued use of Opticin nor does it adversely affect the clinical course of the ulcer
or the visual outcome. The onset of the precipitate was within 24 hours to 7 days after starting
therapy. Resolution of the precipitate varied from immediately to 13 days after therapy
commencing.
With locally applied fluoroquinolones (generalized) rash, toxic epidermolysis, dermatitis
exfoliative, Stevens-Johnson syndrome and urticaria occur very rarely.

In isolated cases blurred vision, decreased visual acuity and medication residue have been
observed with ophthalmic ciprofloxacin.
Pediatric population
Safety and effectiveness of Opticin 3mg/ml eye drops were determined in 230 children between
the ages of 0 and 12 years of age. No serious adverse drug reaction was reported in this group of
patients."
To reports any side effect(s):
Saudi Arabia
-The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

A topical overdose of OPTICIN may be flushed from the eye(s) with warm tap water.

Pharmacotherapeutic Group – Ophthalmologicals, Other Antiinfectives
ATC Code: S01A X13
Ciprofloxacin has cidal and inhibitory activities against bacteria which result from an
interference with DNA gyrase, an enzyme needed by the bacterium for the synthesis of
DNA. Thus, vital information from the bacterial chromosomes cannot be transcribed, which
causes a break-down of bacterial metabolism.
Ciprofloxacin has a very high in vitro activity against almost all gram negative
microorganisms including Pseudomonas aeruginosa. It is also effective against gram
positive bacteria, such as Staphylococci and Streptococci.
Anaerobes are in general less susceptible.

Resistance development against ciprofloxacin occurs infrequently. A plasmid-mediated
bacterial resistance does not appear to occur with the fluoroquinolone class of antibiotics.
The arthropathogenic potential of some quinolones in immature animals after oral
administration is recognised. Topical ocular administration of ciprofloxacin to immature
animals did not cause any arthropathy and there is no evidence that the ophthalmic dosage
form has any effect on the weight bearing points.

After topical ocular administration, ciprofloxacin is also absorbed systemically. Plasma
levels in volunteers ranged from nonquantifiable to 4.7 ng/mL (some 450-fold less than
levels observed following sample 250 mg oral administration).
There are no pharmacokinetic data available in respect of use in children.

Ciprofloxacin and other quinolones have been shown to cause arthropathy in immature
animals of most species tested following oral administration. The degree of cartilage
involvement was found to be dependent on age, species and dosage. With 30 mg/kg
ciprofloxacin the effect on the joint was minimal.
A one month topical ocular study with ciprofloxacin 3mg/ml eye drops, solution in
immature beagle dogs did not demonstrate any articular lesions. Likewise there is no
evidence that the ophthalmic dosage form has any effect on the weight bearing points.

Benzalkonium chloride
Sodium Acetate
Mannitol
Disodium Edetate
Water for injection
Acetic acid 6N

Hydrochloric acid 1N or NaOH 1N

Incompatible with alkaline solutions.

Do not store above 30°C.

Primary packaging:
Immediate container : Bottle -10 ml LDPE opaque bottles
Cap- HDPE white round shaped with locking ring
Nozzle- LDPE white round nozzle
Secondary packaging:
Outer carton: 280g/m2 grammage paper, dimension 30 mm x 29 mm x 73 mm
Label: 20 mm x 73 mm , Self adhesive
Insert/Leaflet: 50-60 g/m2 paper both side printed.

Keep out of the reach of children, Discard after 30 days of opening