A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Chibroxin Warnings, Precautions, Pregnancy, Nursing, Abuse - Norfloxacin
Chibroxin Warnings, Precautions, Pregnancy, Nursing, Abuse - Norfloxacin
WARNINGS
NOT FOR INJECTION INTO THE EYE.
Serious and occasionally fatal hypersensitivity (anaphylactoid or 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 anaphylactoid or anaphylactic reactions require immediate
emergency treatment with epinephrine. Oxygen, intravenous steroids and airway
management, including intubation, should be administered as indicated.
PRECAUTIONS
General
As with other antibiotic preparations, prolonged use may result in overgrowth
of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate
measures 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.
There have been reports of bacterial keratitis associated with the use of multiple
dose containers of topical ophthalmic products. These containers have been inadvertently
contaminated by patients who, in most cases, had a concurrent corneal disease
or a disruption of the ocular epithelial surface. (See PRECAUTIONS
, Information
for Patients .)
Information For Patients
Patients should be instructed to avoid allowing the tip of the dispensing container
to contact the eye or surrounding structures.
Patients should also be instructed that ocular preparations, if handled improperly
or if the tip of the dispensing container contacts the eye or surrounding structures,
can become contaminated by common bacteria known to cause ocular infections.
Serious damage to the eye and subsequent loss of vision may result from using
contaminated preparations (see PRECAUTIONS
, General ). If redness, irritation,
swelling, or pain persists or becomes aggravated, the patient should be advised
to consult a physician.
Patients should also be advised that if they have ocular surgery or develop
an intercurrent ocular condition (e.g., trauma or infection), they should immediately
seek their physician's advice concerning the continued use of the present multidose
container.
Patients should be advised that norfloxacin may be associated with hypersensitivity
reactions, even following a single dose, and to discontinue the drug at the
first sign of a skin rash or other allergic reaction.
Patients should be advised not to wear contact lenses if they have signs and
symptoms of bacterial conjunctivitis.
Drug Interactions
Specific drug interaction studies have not been conducted with norfloxacin
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. Elevated serum levels of cyclosporine have been
reported with concomitant use of cyclosporine with norfloxacin. Therefore, cyclosporine
serum levels should be monitored and appropriate cyclosporine dosage adjustments
made when these drugs are used concomitantly.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No increase in neoplastic changes was observed with norfloxacin as compared
to controls in a study in rats, lasting up to 96 weeks at doses eight to nine
times the usual human oral dose***.
Norfloxacin was tested for mutagenic activity in a number of in vivo and
in vitro tests. Norfloxacin had no mutagenic effect in the dominant lethal
test in mice and did not cause chromosomal aberrations in hamsters or rats at
doses 30 to 60 times the usual oral dose***. Norfloxacin had no mutagenic activity
in vitro in the Ames microbial mutagen test, Chinese hamster fibroblasts
and V-79 mammalian cell assay. Although norfloxacin was weakly positive in the
Rec-assay for DNA repair, all other mutagenic assays were negative including
a more sensitive test (V-79).
Norfloxacin did not adversely affect the fertility of male and female mice
at oral doses up to 33 times the usual human oral dose***.
Pregnancy
Teratogenic Effects Pregnancy Category C. Norfloxacin has
been shown to produce embryonic loss in monkeys when given in doses 10 times
the maximum human oral dose*** (400 mg b.i.d.), with peak plasma levels that
are two to three times those obtained in humans. There has been no evidence
of a teratogenic effect in any of the animal species tested (rat, rabbit, mouse,
monkey) at 6 to 50 times the human oral dose. There are no adequate and well-controlled
studies in pregnant women. CHIBROXIN Ophthalmic Solution should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus.
Nursing Mothers
It is not known whether norfloxacin is excreted in human milk following ocular
administration. Because many drugs are excreted in human milk, and because of
the potential for serious adverse reactions in nursing infants from norfloxacin,
a decision should be made to discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to the mother (see ANIMAL PHARMACOLOGY
).
Pediatric Use
Safety and effectiveness in infants below the age of one year have not been
established.
Although quinolones including norfloxacin have been shown to cause arthropathy
in immature animals after oral administration, topical ocular administration
of other quinolones to immature animals has not shown any arthropathy and there
is no evidence that the ophthalmic dosage form of those quinolones has any effects
on the weight-bearing joints.
Geriatric Use
No overall differences in safety or effectiveness have been observed between
elderly and young patients.
***All factors are based on a standard patient weight of 50 kg. The usual oral
dose of norfloxacin is 800 mg daily. One drop of CHIBROXIN Ophthalmic Solution
0.3% contains about 1/6,666 of this dose (0.12 mg).
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