The Fluoroquinolone Toxicity Research Foundation

 
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ADVERSE REACTIONS

Ophthalmic Use

The most frequently reported drug-related adverse reaction was
transient ocular burning or discomfort. Other reported reactions
include stinging, redness, itching, chemical
conjunctivitis/keratitis, periocular/facial edema, foreign body
sensation, photophobia, blurred vision, tearing, dryness, and eye
pain. Rare reports of dizziness have been received.

DRUG INTERACTIONS

Specific drug interaction studies have not been conducted with
OCUFLOX® ophthalmic solution. However, the systemic administration of
some quinolones has been shown to elevate plasma concentrations of
theophylline, interfere with the metabolism of caffeine, and 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

NOT FOR INJECTION.

OCUFLOX® solution should not be injected subconjunctivally, nor
should it be introduced directly into the anterior chamber of the
eye.

Serious and occasionally fatal hypersensitivity (anaphylactic)
reactions, some following the first dose, have been reported in
patients receiving systemic quinolones, including ofloxacin. Some
reactions were accompanied by cardiovascular collapse, loss of
consciousness, angioedema (including laryngeal, pharyngeal or facial
edema), airway obstruction, dyspnea, urticaria, and itching. A rare
occurrence of Stevens-Johnson syndrome, which progressed to toxic
epidermal necrolysis, has been reported in a patient who was
receiving topical ophthalmic ofloxacin. If an allergic reaction to
ofloxacin occurs, discontinue the drug. Serious acute
hypersensitivity reactions may require immediate emergency treatment.
Oxygen and airway management, including intubation should be
administered as clinically indicated.

PRECAUTIONS

General

As with other anti-infectives, prolonged use may result in overgrowth
of nonsusceptible organisms, including fungi. If superinfection
occurs discontinue use and institute alternative therapy. Whenever
clinical judgment dictates, the patient should be examined with the
aid of magnification, such as slit lamp biomicroscopy and where
appropriate, fluorescein staining. Ofloxacin should be discontinued
at the first appearance of a skin rash or any other sign of
hypersensitivity reaction.

The systemic administration of quinolones, including ofloxacin, has
led to lesions or erosions of the cartilage in weight-bearing joints
and other signs of arthropathy in immature animals of various
species. Ofloxacin, administered systemically at 10 mg/kg/day in
young dogs (equivalent to 110 times the maximum recommended daily
adult ophthalmic dose) has been associated with these types of
effects.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies to determine the carcinogenic potential of
ofloxacin have not been conducted.

Ofloxacin was not mutagenic in the Ames test, in vitro and in vivo
cytogenic assay, sister chromatid exchange assay (Chinese hamster and
human cell lines), unscheduled DNA synthesis (UDS) assay using human
fibroblasts, the dominant lethal assay, or mouse micronucleus assay.
Ofloxacin was positive in the UDS test using rat hepatocyte, and in
the mouse lymphoma assay.

In fertility studies in rats, ofloxacin did not affect male or female
fertility or morphological or reproductive performance at oral dosing
up to 360 mg/kg/day (equivalent to 4000 times the maximum recommended
daily ophthalmic dose).

Pregnancy

Teratogenic Effects: Pregnancy Category C: Ofloxacin has been shown
to have an embryocidal effect in rats and in rabbits when given in
doses of 810 mg/kg/day (equivalent to 9000 times the maximum
recommended daily ophthalmic dose) and 160 mg/kg/day (equivalent to
1800 times the maximum recommended daily ophthalmic dose). These
dosages resulted in decreased fetal body weight and increased fetal
mortality in rats and rabbits, respectively. Minor fetal skeletal
variations were reported in rats receiving doses of 810 mg/kg/day.
Ofloxacin has not been shown to be teratogenic at doses as high as
810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats
and rabbits, respectively.

Nonteratogenic Effects: Additional studies in rats with doses up to
360 mg/ kg/ day during late gestation showed no adverse effect on
late fetal development, labor, delivery, lactation, neonatal
viability, or growth of the newborn.

There are, however, no adequate and well-controlled studies in
pregnant women. OCUFLOX® solution should be used during pregnancy
only if the potential benefit justifies the potential risk to the
fetus.

Nursing Mothers

In nursing women a single 200 mg oral dose resulted in concentrations
of ofloxacin in milk which were similar to those found in plasma. It
is not known whether ofloxacin is excreted in human milk following
topical ophthalmic administration. Because of the potential for
serious adverse reactions from ofloxacin in nursing infants, a
decision should be made whether to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug
to the mother.

Pediatric Use

Safety and effectiveness in infants below the age of one year have
not been established. Quinolones, including ofloxacin, have been
shown to cause arthropathy in immature animals after oral
administration; however, topical ocular administration of ofloxacin
to immature animals has not shown any arthropathy. There is no
evidence that the ophthalmic dosage form of ofloxacin has any effect
on weight bearing joints.

CONTRAINDICATIONS

OCUFLOX® solution is contraindicated in patients with a history of
hypersensitivity to ofloxacin, to other quinolones, or to any of the
components in this medication.