Indication
LUMIGAN® 0.01% (bimatoprost ophthalmic solution) is indicated
for the reduction of elevated intraocular pressure in patients with open-angle glaucoma
or ocular hypertension.
Important Safety Information
Warnings and Precautions
Pigmentation
Bimatoprost 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. Pigmentation is expected to
increase as long as bimatoprost is administered. After discontinuation of bimatoprost,
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 long-term effects of increased pigmentation are not known.
Iris color change may not be noticeable for several months to years.
Intraocular Inflammation
LUMIGAN® 0.01% should be used with caution in patients
with active intraocular inflammation (eg, uveitis) because the inflammation may
be exacerbated.
Macular Edema
Macular edema, including cystoid macular edema, has been reported during treatment
with bimatoprost ophthalmic solution. LUMIGAN® 0.01% should
be used with caution in aphakic patients, in pseudophakic patients with a torn posterior
lens capsule, or in patients with known risk factors for macular edema.
Angle-Closure, Inflammatory, or Neovascular Glaucoma
LUMIGAN® 0.01% has not been evaluated for the treatment
of angle-closure, inflammatory, or neovascular glaucoma.
Use With Contact Lenses
Contact lenses should be removed prior to instillation of LUMIGAN®
0.01% and may be reinserted 15 minutes following its administration.
Adverse Reactions
In clinical studies with bimatoprost ophthalmic solution (0.01%), the most
common adverse event was conjunctival hyperemia (range 25%-45%). Approximately
0.5% to 3% of patients discontinued therapy due to conjunctival hyperemia with 0.01%
bimatoprost ophthalmic solution. Other common events (> 10%) included growth
of eyelashes and ocular pruritus.
USE IN SPECIFIC POPULATIONS
Pediatric Use
Use in pediatric patients below the age of 16 years is not recommended because of
potential safety concerns related to increased pigmentation following long-term
chronic use.
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