CILOXAN STERILE OPHTHALMIC OINTMENT 3 mgg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CIPROFLOXACIN HCl EQV CIPROFLOXACIN

Available from:

NOVARTIS (SINGAPORE) PTE LTD

ATC code:

S01AX13

Dosage:

3 mg/g

Pharmaceutical form:

OINTMENT

Composition:

CIPROFLOXACIN HCl EQV CIPROFLOXACIN 3 mg/g

Administration route:

OPHTHALMIC

Prescription type:

Prescription Only

Manufactured by:

s.a. ALCON-COUVREUR n.v

Authorization status:

ACTIVE

Authorization date:

2000-01-28

Patient Information leaflet

35769-B
CILOXAN
®
EYE OINTMENT
3 MG/G CIPROFLOXACINE
DESCRIPTION :
CILOXAN
®
Eye Ointment is a synthetic, sterile, multiple dose, antimicrobial for
topical ophthalmic use.
Ciprofloxacin is a fluoroquinolone antibacterial. It is available as
the monhydrochloride monohydrate salt of
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic
acid. Ciprofloxacin is a faint
to light yellow crystalline powder with a molecular weight of 385.8. 
Its empirical formula is C
17
H
18
FN
3
O
3
•HCl•H
2
O
and its chemical structure is as follows : 
Ciprofloxacin differs from other quinolones in that it has a fluorine
atom at the 6-position, a piperazine
moiety at the 7-position, and a cyclopropyl ring at the 1-position.
EACH GRAM OF CILOXAN EYE OINTMENT CONTAINS : 
ACTIVE : Ciprofloxacin Hydrochloride monohydrate 3.5 mg equivalent
to 3 mg base. 
INACTIVES : Liquid Paraffin, White Soft Paraffin.
CLINICAL PHARMACOLOGY :
SYSTEMIC ABSORPTION : A systemic absorption study was performed in
which CILOXAN Ophthalmic Solution
was administered in each eye every two hours while awake for two days
followed by every four hours while
awake for an additional 5 days. The maximum reported plasma
concentration of ciprofloxacin was less
than 5 ng/ml. The mean concentration was usually less than 2.5 ng/ml.
Ointment mean concentration levels
have not been determined but are expected to be similar.
MICROBIOLOGY : Ciprofloxacin has _in vitro _activity against a
wide range of gram-negative and gram-positive
organisms. The bactericidal action of ciprofloxacin results from
interference with the enzyme DNA gyrase
which is needed for the synthesis of bacterial DNA.
Ciprofloxacin has been shown to be active against most strains of the
following organisms both _in vitro_
and in clinical infections (see INDICATIONS AND USAGE section).
GRAM-POSITIVE : 
_Staphylococcus aureus _(including methicillin-susceptible and
methicillin-resistant strains)
_Staphylococcus epidermidis_
_Streptococcus pneumoniae_
_Strep

Summary of Product characteristics

Ciloxan Mar.2022.SIN
Page 1 of 9
CILOXAN®
3 MG/G EYE OINTMENT (CIPROFLOXACIN)
1
TRADENAME(S)
CILOXAN
®
(ciprofloxacin) 3 mg/g Eye ointment
2
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Sterile eye ointment
White to off-white, homogeneous ointment
ACTIVE SUBSTANCES(S)
1 g of ointment contains 3.5 mg ciprofloxacin hydrochloride
monohydrate equivalent to 3 mg
ciprofloxacin base.
Ciprofloxacin is available as the monohydrochloride monohydrate salt
of 1-cyclopropyl-6-fluoro-1,4-
dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid.
Ciprofloxacin is a faint to light yellow
crystalline powder with a molecular weight of 385.8.
Its empirical formula is C
17
H
18
FN
3
O
3
•HCl•H
2
O and its chemical structure is as follows:
Ciprofloxacin differs from other quinolones in that it has a fluorine
atom at the 6-position, a piperazine
moiety at the 7-position, and a cyclopropyl ring at the 1-position.
EXCIPIENTS
Excipients: Mineral oil (alternative name: liquid paraffin), white
petrolatum (alternative name:
vaselinum album / white soft paraffin).
3
INDICATIONS
OCULAR USE:
•
Ciloxan Eye Ointment is a synthetic, sterile, multiple dose,
antimicrobial for topical ophthalmic
use. Ciprofloxacin is a fluoroquinolone antibacterial.
Ciloxan Eye Ointment is indicated for the treatment of bacterial
conjunctivitis caused by
susceptible strains of microorganisms listed below:
GRAM-POSITIVE:
Ciloxan Mar.2022.SIN
Page 2 of 9
_Staphylococcus aureus _
_Staphylococcus epidermidis _
_Streptococcus pneumoniae _
_Streptococcus Viridans Group_
GRAM-NEGATIVE:
_Haemophilus influenza _
4
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
Apply a 1/2” ointment ribbon into the conjunctival sac 3 times a day
on the first 2 days, then apply a 1/2”
ointment ribbon 2 times a day for the next 5 days.
SPECIAL POPULATIONS
RENAL AND HEPATIC IMPAIRMENT
No studies have been performed in patients with renal or hepatic
impairment.
PEDIATRIC PATIENTS
Safety and effectiveness of CILOXAN Eye Ointment in pediatric patients
below the age of two yea