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CILOXAN OPHTHALMIC OINTMENT

 * Generic Name: ciprofloxacin hcl ophthalmic ointment
 * Brand Name: Ciloxan Ophthalmic Ointment
 * Drug Class: Quinolones, Ophthalmic

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/11/2023

home drugs a-z list ciloxan ophthalmic ointment (ciprofloxacin hcl ophthalmic
ointment) drug

   
   
 * Related Drugs
   Cipro IV Cipro XR Proquin XR
   
   


DRUG SUMMARY

WHAT IS CILOXAN OPHTHALMIC OINTMENT?

Ciloxan (ciprofloxacin hcl) is a fluoroquinolone antibiotic used to treat eye
infections caused by bacteria, and is also used to treat an ulcer in the cornea
of the eye. Ciloxan is available in generic form.

WHAT ARE SIDE EFFECTS OF CILOXAN OPHTHALMIC OINTMENT?

Ciloxan Ophthalmic Ointment may cause serious side effects including:

 * hives,
 * difficulty breathing,
 * swelling of your face, lips, tongue, or throat,
 * severe burning, stinging, or irritation after using this medicine,
 * eye swelling,
 * redness,
 * severe discomfort of the eye, and
 * crusting or drainage from the eye

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Ciloxan include:

 * temporary stinging,
 * burning, or
 * irritation of the eyes for a minute or two when applied.

Other side effects of Ciloxan include:

 * blurred vision,
 * eye discomfort,
 * itching,
 * redness,
 * tearing,
 * dry eyes,
 * watery eyes,
 * feeling as if something is in your eye,
 * puffy eyelids,
 * a bad taste in your mouth after using the drops,
 * nausea,
 * sensitivity to light, and
 * a white-colored buildup in your eye (if you are being treated for corneal
   ulcer).

Tell your doctor if you have unlikely but serious side effects of Ciloxan
including:

 * staining of the eye, swelling in or around the eye, eye pain, or worsening
   vision.

Seek medical care or call 911 at once if you have the following serious side
effects:

 * Serious eye symptoms such as sudden vision loss, blurred vision, tunnel
   vision, eye pain or swelling, or seeing halos around lights;
 * Serious heart symptoms such as fast, irregular, or pounding heartbeats;
   fluttering in your chest; shortness of breath; and sudden dizziness,
   lightheadedness, or passing out;
 * Severe headache, confusion, slurred speech, arm or leg weakness, trouble
   walking, loss of coordination, feeling unsteady, very stiff muscles, high
   fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur.
Check with your physician for additional information about side effects.

DOSAGE FOR CILOXAN

Apply a 1/2" ribbon dose of Ciloxan into the conjunctival sac three times a day
on the first two days, then apply a 1/2" ribbon two times a day for the next
five days.

WHAT DRUGS, SUBSTANCES, OR SUPPLEMENTS INTERACT WITH CILOXAN OPHTHALMIC
OINTMENT?

It is not likely that other drugs you take orally or inject will have an effect
on Ciloxan used in the eyes. But many drugs can interact with each other. Tell
your doctor all other medications you use, especially: theophylline, blood
thinners, or cyclosporine used in the eyes or taken by mouth.

CILOXAN OPHTHALMIC OINTMENT DURING PREGNANCY AND BREASTFEEDING

Ciloxan should be used only when prescribed during pregnancy. It is unknown if
the medication in this product passes into breast milk. Consult your doctor
before breastfeeding.

ADDITIONAL INFORMATION

Our Ciloxan (ciprofloxacin hcl) Side Effects Drug Center provides a
comprehensive view of available drug information on the potential side effects
when taking this medication.


FDA DRUG INFORMATION

 * Drug Description
 * Indications & Dosage
 * Side Effects & Drug Interactions
 * Warnings & Precautions
 * Overdose & Contraindications
 * Clinical Pharmacology
 * Medication Guide


DESCRIPTION FOR CILOXAN OPHTHALMIC OINTMENT

CILOXAN® (ciprofloxacin ophthalmic ointment) is a synthetic, sterile, multiple
dose, antimicrobial for topical use. Ciprofloxacin is a fluoroquinolone
antibacterial. It is available as the monohydrochloride monohydrate salt of
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic
acid. Ciprofloxacin is a faint to light yellow crystalline powder with a
molecular weight of 385.82. Its empirical formula is C17H18FN3O3•HCl•H2O 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® (ciprofloxacin ophthalmic ointment) contains: Active:
ciprofloxacin HCl 3.33 mg equivalent to 3 mg base. Inactives: mineral oil, white
petrolatum.




USES FOR CILOXAN OPHTHALMIC OINTMENT

CILOXAN® (ciprofloxacin ophthalmic ointment) 0.3% is indicated for the treatment
of bacterial conjunctivitis caused by susceptible strains of the microorganisms
listed below:

GRAM-POSITIVE

Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus Viridans Group

GRAM-NEGATIVE

Haemophilus influenzae


DOSAGE FOR CILOXAN OPHTHALMIC OINTMENT

Apply a ½ inch ribbon into the conjunctival sac three times a day on the first
two days, then apply a ½ inch ribbon two times a day for the next five days.


HOW SUPPLIED

3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene
tip and white polyethylene cap.

3.5 g - NDC 0065-0654-35

STORAGE

Store at 2°C to 25°C (36°F-77°F).

Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134. Revised: Apr
2018


SIDE EFFECTS FOR CILOXAN OPHTHALMIC OINTMENT

The following adverse reactions (incidences) were reported in 2% of the patients
in clinical studies for CILOXAN® (ciprofloxacin ophthalmic ointment) 0.3%:
discomfort and keratopathy. Other reactions associated with ciprofloxacin
therapy occurring in less than 1% of patients included allergic reactions,
blurred vision, corneal staining, decreased visual acuity, dry eye, edema,
epitheliopathy, eye pain, foreign body sensation, hyperemia, irritation,
keratoconjunctivitis, lid erythema, lid margin hyperemia, photophobia, pruritus,
and tearing. Systemic adverse reactions related to ciprofloxacin therapy
occurred at an incidence below 1% and included dermatitis, nausea and taste
perversion.


DRUG INTERACTIONS FOR CILOXAN OPHTHALMIC OINTMENT

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


WARNINGS FOR CILOXAN OPHTHALMIC OINTMENT

FOR TOPICAL OPHTHALMIC USE ONLY.

NOT FOR INJECTION INTO THE EYE.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some
following the first dose, have been reported in patients receiving systemic
quinolone therapy. Some reactions were accompanied by cardiovascular collapse,
loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria,
and itching. Only a few patients had a history of hypersensitivity reactions.
Serious anaphylactic reactions require immediate emergency treatment with
epinephrine and other resuscitation measures, including oxygen, intravenous
fluids, intravenous antihistamines, corticosteroids, pressor amines and airway
management, as clinically indicated.


PRECAUTIONS FOR CILOXAN OPHTHALMIC OINTMENT

GENERAL

As with other antibacterial preparations, prolonged use of ciprofloxacin may
result in overgrowth of nonsusceptible organisms, including fungi. If
superinfection occurs, appropriate therapy should be initiated. Whenever
clinical judgment dictates, the patient should be examined with the aid of
magnification, such as slit lamp biomicroscopy and, where appropriate,
fluorescein staining. Ciprofloxacin should be discontinued at the first
appearance of a skin rash or any other sign of hypersensitivity reaction.
Ophthalmic ointments may retard corneal healing and cause visual blurring.
Patients should be advised not to wear contact lenses if they have signs and
symptoms of bacterial conjunctivitis.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Eight in vitro mutagenicity tests have been conducted with ciprofloxacin and the
test results are listed below:

 * Salmonella/Microsome Test (Negative)
 * E. coli DNA Repair Assay (Negative)
 * Mouse Lymphoma Cell Forward Mutation Assay (Positive)
 * Chinese Hamster V79 Cell HGPRT Test (Negative)
 * Syrian Hamster Embryo Cell Transformation Assay (Negative)
 * Saccharomyces cerevisiae Point Mutation Assay (Negative)
 * Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay
   (Negative)
 * Rat Hepatocyte DNA Repair Assay (Positive)

Thus, two of the eight tests were positive, but the results of the following
three in vivo test systems gave negative results:

 * Rat Hepatocyte DNA Repair Assay
 * Micronucleus Test (Mice)
 * Dominant Lethal Test (Mice)

Long-term carcinogenicity studies in mice and rats have been completed. After
daily oral dosing for up to two years, there is no evidence that ciprofloxacin
had any carcinogenic or tumorigenic effects in these species.

PREGNANCY

Reproduction studies have been performed in rats and mice at doses up to six
times the usual daily human oral dose and have revealed no evidence of impaired
fertility or harm to the fetus due to ciprofloxacin. In rabbits, as with most
antimicrobial agents, ciprofloxacin (30 and 100 mg/kg orally) produced
gastrointestinal disturbances resulting in maternal weight loss and an increased
incidence of abortion. No teratogenicity was observed at either dose. After
intravenous administration, at doses up to 20 mg/kg, no maternal toxicity was
produced and no embryotoxicity or teratogenicity was observed. There are no
adequate and well controlled studies in pregnant women. CILOXAN® (ciprofloxacin
ophthalmic ointment) 0.3% should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.

NURSING MOTHERS

It is not known whether topically applied ciprofloxacin is excreted in human
milk. However, it is known that orally administered ciprofloxacin is excreted in
the milk of lactating rats and oral ciprofloxacin has been reported in human
breast milk after a single 500 mg dose. Caution should be exercised when
CILOXAN® (ciprofloxacin ophthalmic ointment) 0.3% is administered to a nursing
mother.

PEDIATRIC USE

Safety and effectiveness of CILOXAN® (ciprofloxacin ophthalmic ointment) 0.3% in
pediatric patients below the age of two years have not been established.
Although ciprofloxacin and other quinolones may cause arthropathy in immature
Beagle dogs after oral administration, 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
joints.

GERIATRIC USE

No overall clinical differences in safety or effectiveness have been observed
between the elderly and other adult patients.


OVERDOSE INFORMATION FOR CILOXAN OPHTHALMIC OINTMENT

No Information Provided


CONTRAINDICATIONS FOR CILOXAN OPHTHALMIC OINTMENT

A history of hypersensitivity to ciprofloxacin or any other component of the
medication is a contraindication to its use. A history of hypersensitivity to
other quinolones may also contraindicate the use of ciprofloxacin.


CLINICAL PHARMACOLOGY FOR CILOXAN OPHTHALMIC OINTMENT

SYSTEMIC ABSORPTION

Absorption studies in humans with the ciprofloxacin ointment have not been
conducted, however, based on studies with ciprofloxacin solution, 0.3%, mean
maximal concentrations are expected to be less than 2.5 ng/mL.

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
microorganisms both in vitro and in clinical infections (see INDICATIONS
section).

AEROBIC GRAM-POSITIVE MICROORGANISMS

Staphylococcus aureus (methicillin-susceptible strains)
Staphylococcus epidermidis (methicillin-susceptible strains)
Streptococcus pneumoniae
Streptococcus Viridans Group

AEROBIC GRAM-NEGATIVE MICROORGANISMS

Haemophilus influenzae

The following in vitro data are available; but their clinical significance in
ophthalmologic infections is unknown. The safety and effectiveness of
ciprofloxacin in treating conjunctivitis due to these microorganisms have not
been established in adequate and well controlled 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. Ciprofloxacin exhibits in
vitro minimal inhibitory concentrations (MIC’s) of 1 mcg/mL or less (systemic
susceptible breakpoint) against most (greater than or equal to 90%) strains of
the following ocular pathogens.

AEROBIC GRAM-POSITIVE MICROORGANISMS

Bacillus species
Corynebacterium species
Staphylococcus haemolyticus
Staphylococcus hominis

AEROBIC GRAM-NEGATIVE MICROORGANISMS

Acinetobacter calcoaceticus
Enterobacter aerogenes
Escherichia coli
Haemophilus parainfluenzae
Klebsielle pneumoniae
Moraxella catarrhalis
Neisseria gonorrhoeae
Proteus mirabilis
Pseudomonas aeruginosa
Serratia marcesens

Most strains of Burkholderia cepacia and some strains of Stenotrophomonas
maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria,
including Bacteroides fragilis and Clostridium difficile.

The minimal bactericidal concentration (MBC) generally does not exceed the
minimal inhibitory concentration (MIC) by more than a factor of 2. Resistance to
ciprofloxacin in vitro usually develops slowly (multiple-step mutation).
Ciprofloxacin does not cross-react with other antimicrobial agents such as
beta-lactams or aminoglycosides; therefore, organisms resistant to these drugs
may be susceptible to ciprofloxacin. Organisms resistant to ciprofloxacin may be
susceptible to beta-lactams or aminoglycosides.

CLINICAL STUDIES

In multi-center clinical trials, approximately 75% of the patients with signs
and symptoms of bacterial conjunctivitis and positive conjunctival cultures were
clinically cured and approximately 80% had presumed pathogens eradicated by the
end of treatment (Day 7).

ANIMAL PHARMACOLOGY

Ciprofloxacin and related drugs have been shown to cause arthropathy in immature
animals of most species tested following oral administration. However, a one
month topical ocular study using immature Beagle dogs did not demonstrate any
articular lesions.


PATIENT INFORMATION FOR CILOXAN OPHTHALMIC OINTMENT

Do not touch tip to any surface as this may contaminate the ointment.

Do not use the product if the imprinted carton seals have been damaged, or
removed.


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