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Xalatan Warings and Precautions
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XALATAN Sterile Ophthalmic Solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes, and growth of eyelashes. Pigmentation is expected to increase as long as XALATAN is administered. After discontinuation of XALATAN, pigmentation of the iris is likely to be permanent while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The effects of increased pigmentation beyond 5 years are not known.
XALATAN Sterile Ophthalmic Solution may gradually increase the
of the iris. The eye color change is due to increased
melanin content in the stromal melanocytes of the iris rather than to an
increase in the number of melanocytes. This change may not be noticeable for
several months to years (see WARNINGS).
Typically, the brown pigmentation around the pupil spreads concentrically
towards the periphery of the iris and the entire iris or parts of the iris
become more brownish. Neither nevi nor freckles of the iris appear to be
affected by treatment. While treatment with XALATAN can be continued in patients
who develop noticeably increased iris pigmentation, these patients should be
During clinical trials, the increase in brown iris
pigment has not been shown to progress further upon discontinuation of
treatment, but the resultant color change may be permanent.
Eyelid skin darkening, which may be reversible, has been reported in
association with the use of XALATAN (see WARNINGS).
XALATAN may gradually change eyelashes and vellus hair in
the treated eye; these changes include increased length, thickness,
pigmentation, the number of lashes or hairs, and misdirected growth of
eyelashes. Eyelash changes are usually reversible upon discontinuation of
XALATAN should be used with caution in patients with a
history of intraocular inflammation (iritis/uveitis) and should generally not be
used in patients with active intraocular inflammation.
Macular edema, including cystoid macular edema, has been reported during
treatment with XALATAN. These reports have mainly occurred in aphakic patients,
in pseudophakic patients with a torn posterior lens capsule, or in patients with
known risk factors for macular edema. XALATAN should be used with caution in
patients who do not have an intact posterior capsule or who have known risk
factors for macular edema. There is
limited experience with XALATAN in the treatment of angle closure, inflammatory
or neovascular glaucoma.
There have been reports of bacterial keratitis associated
with the use of multiple-dose containers of topical ophthalmic products. These
containers had been inadvertently contaminated by patients who, in most cases,
had a concurrent corneal disease or a disruption of the ocular epithelial
surface (see PRECAUTIONS).
Contact lenses should be removed prior to the administration of XALATAN,
and may be reinserted 15 minutes after administration (see PRECAUTIONS).
for Patients (see WARNINGS
Patients should be advised about
the potential for increased brown pigmentation of the
iris, which may be permanent. Patients
should also be informed about the possibility of eyelid skin darkening, which
may be reversible after discontinuation of XALATAN.
Patients should also be informed of the possibility of
eyelash and vellus hair changes in the treated eye during treatment with
XALATAN. These changes may result in a disparity between eyes in length,
thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction
of eyelash growth. Eyelash changes are usually reversible upon discontinuation
Patients should be instructed to avoid allowing the tip
of the dispensing container to contact the eye or surrounding structures because
this could cause the tip to 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 solutions. Patients also should be advised that if they develop an
intercurrent ocular condition (e.g., trauma, or infection) or have ocular
surgery, they should immediately seek their physician’s advice concerning the
continued use of the multiple-dose container.
Patients should be advised that if they develop any ocular reactions,
particularly conjunctivitis and lid reactions, they should immediately seek
their physician’s advice. Patients
should also be advised that XALATAN contains benzalkonium chloride, which may be
absorbed by contact lenses. Contact lenses should be removed prior to
administration of the solution. Lenses may be reinserted 15 minutes following
administration of XALATAN.
If more than one topical ophthalmic drug is being used,
the drugs should be administered at least five (5) minutes apart.
Interactions: In vitro
studies have shown that precipitation occurs when eye drops
containing thimerosal are mixed with XALATAN. If such
drugs are used they should be administered at least five (5) minutes apart.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Latanoprost
was not mutagenic
in bacteria, in mouse lymphoma or in mouse micronucleus
Chromosome aberrations were observed in
with human lymphocytes. Latanoprost
was not carcinogenic in either mice or rats when administered by oral gavage at
doses of up to 170 µg/kg/day (approximately 2,800 times the recommended maximum
human dose) for up to 20 and 24 months, respectively.
vitro and in
vivo studies on unscheduled DNA
synthesis in rats were negative. Latanoprost
has not been found to have any effect on male or female fertility in animal
Pregnancy: Teratogenic Effects: Pregnancy
Reproduction studies have been performed in rats and
rabbits. In rabbits an incidence of 4 of 16 dams had no viable fetuses at a dose
that was approximately 80 times the maximum human dose, and the highest
nonembryocidal dose in rabbits was approximately 15 times the maximum human
dose. There are no adequate and well-controlled studies in pregnant women.
XALATAN should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
It is not known whether this drug or its metabolites are excreted in
human milk. Because many drugs are excreted in human
milk, caution should be exercised when XALATAN is administered to a nursing
Safety and effectiveness in pediatric patients have not been
No overall differences in safety or effectiveness have been observed
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