CILOXAN STERILE OPHTHALMIC AND OTIC SOLUTION 0.3%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CIPROFLOXACIN HCl 3.5 MG/ML EQV CIPROFLOXACIN

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

S01AX13

Dosage:

3.5 mg/mL

Pharmaceutical form:

SOLUTION

Composition:

CIPROFLOXACIN HCl 3.5 MG/ML EQV CIPROFLOXACIN 0.3 % w/v

Administration route:

OPHTHALMIC, AURICULAR (OTIC)

Prescription type:

Prescription Only

Manufactured by:

S.A. ALCON-COUVREUR NV

Authorization status:

ACTIVE

Authorization date:

2002-05-14

Summary of Product characteristics

Ciloxan Mar 2022.SIN
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CILOXAN®
STERILE OPHTHALMIC AND OTIC
SOLUTION
(CIPROFLOXACIN 0.3
%
)
1
TRADENAME(S)
CILOXAN® Sterile Ophthalmic and Otic Solution 0.3%.
CILOXAN (ciprofloxacin hydrochloride solution), 0.3% as base
2
DESCRIPTION AND COMPOSITION
Eye/Ear drops, solution.
ACTIVE SUBSTANCE(S)
1 ml of solution contains 3.5 mg ciprofloxacin hydrochloride
monohydrate equivalent to 3 mg ciprofloxacin
base.
EXCIPIENTS
Excipient with known effect: 1 mL of solution contains 0.06 mg of
benzalkonium chloride.
Other excipients: disodium edetate, mannitol, acetic acid, sodium
acetate trihydrate, hydrochloric acid and
/ or sodium hydroxide for pH adjustment, and purified water.
3
INDICATIONS
OCULAR USE:
•
Ciloxan Eye drops is indicated for the treatment of corneal ulcers and
superficial infections of
the eye and its adnexa, caused by strains presumed or reported
susceptible to Ciprofloxacin, in
particular _ Pseudomonas _
_aeruginosa _ and
other
Gram-negative
bacteria
resistant
to
usual
tr
eatments.
OTIC USE:
•
Ciloxan
Ear drops is indicated for localized or diffuse otitis externa
accompanied by a strong
inflammatory reaction and of which the strains are susceptible to Cipr
o
floxacin.
4
DOSAGE REGIMEN AND ADMINISTRATION
EYE DROPS
DOSAGE REGIMEN
_ _
CORNEAL ULCERS
Ciloxan Eye drops must be administered at 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 6 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 into the affected eye(s) hourly.
Ciloxan Mar 2022.SIN
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•
On the third through the fourteenth day, place two drops into 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 BACTERIAL INFECTIONS OF THE EYE AND ADNEXA
•
For the first two days instill one or two drops into the conjunctival
sac of the infect