Composition

Each 1 ml or 1 g contains:
Ciprofloxacin (as hydrochloride) .............................
3 mg
Inactive ingredients:
CIPROCIN Sterile Ophthalmic Solution: Benzalkonium chloride, disodium edetate, mannitol, acetic acid glacial, sodium acetate anhydrous, sodium hydroxide or hydrochloric acid, water for injection.

CIPROCIN Sterile Eye Ointment: Anhydrous lanolin, chlorobutanol, yellow soft paraffin.


Therapeutic Indications

Adults, Newborn infants (0-27 days), Infants and toddlers (28 days to 23 months), Children (2-11 years) and Adolescents (12-16 years):
CIPROCIN Sterile Ophthalmic Solution is indicated for the treatment of corneal ulcers and superficial infections of the eye and adnexa caused by susceptible strains of bacteria.

Adults and Children 1 year and above:
CIPROCIN Sterile Eye Ointment is indicated for the treatment of the following infections when known or suspected to be caused by ciprofloxacin-susceptible bacteria:
Corneal ulcers.

Conjunctivitis.

Blepharitis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.


Dosage and Administration

CIPROCIN Sterile Ophthalmic Solution:
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:
Ciprocin must be administered in the following intervals, even during night time:
On the first day, instill 2 drops into the affected eye(s) every 15 minutes for the first six hours and then 2 drops into the affected eye(s) every 30 minutes for the remainder of the day.

On the second day, instill 2 drops in the affected eye(s) hourly.

On the third through the fourteenth day, place two drops in the affected eye(s) 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 Infections:
The usual dose is 1 or 2 drops in the affected eye(s) four times a day.

In severe infections, the dosage for the first two days may be 1 or 2 drops every two hours during waking hours.

For either indication a maximum duration of therapy of 21 days is recommended.

The dosage in children above the age of 1 year is the same as for adults.

Children:
Safety and effectiveness of ciprofloxacin 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.

Use in renal and hepatic impairment: No studies have been performed using ciprofloxacin eye drops in patients with kidney or liver problems.

CIPROCIN Sterile Eye Ointment:
Adults and Children 1 year and above:
The recommended dosage regimens for adults (including the elderly) and children over the age of one year of age are as follows:
Corneal ulcers:

1.25 cm ointment ribbon applied into the conjunctival sac every 1-2 hours around the clock for two days, then every 4 hours for a further 12 days.
The dosing may be extended at the discretion of the physician.

Bacterial conjunctivitis (and Blepharitis):

1.25 cm ointment ribbon applied into the conjunctival sac (or on the lid margin, respectively) three times daily for two days, then twice daily for a further five days.
The dosing may be extended at the discretion of the physician.

Use in elderly:
Clinical studies have indicated dosage modifications are not required for the elderly.

Use in children:
Clinical studies have indicated that dosage modifications are not required for children.

There is no experience in children less than 1 year old.

Use in hepatic and renal impairment:
No studies have been performed in patients with kidney or liver problems