WARNINGS
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
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.
Information For Patients
See PATIENT INFORMATION section.
Drug Interactions
See DRUG INTERACTIONS section.
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
Pregnancy Category C. 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®
Ophthalmic Ointment 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® Ophthalmic Ointment
is administered to a nursing mother.
Pediatric Use
Safety and effectiveness of CILOXAN 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
|
|
