ACUVAIL® (ketorolac tromethamine ophthalmic solution) 0.45%
Important Information
INDICATION
ACUVAIL® ophthalmic solution is a nonsteroidal anti-inflammatory
indicated for the treatment of pain and inflammation following cataract surgery.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ACUVAIL® solution is contraindicated in patients with previously
demonstrated hypersensitivity to any of the ingredients in the formulation.
WARNINGS AND PRECAUTIONS
Delayed Healing: Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow
or delay healing. Topical corticosteroids are also known to slow or delay
healing. Concomitant use of topical NSAIDs and topical steroids may increase the
potential for healing problems.
Potential for Cross-Sensitivity: There is the potential for cross-sensitivity to
acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.
Increased Bleeding Time: With some NSAIDs, there exists the potential for
increased bleeding time due to interference with thrombocyte aggregation. There
have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may
cause increased bleeding of ocular tissues (including hyphemas) in conjunction
with ocular surgery.
Corneal Effects: Use of topical NSAIDs may result in keratitis. In some
susceptible patients, continued use of topical NSAIDs may result in epithelial
breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal
perforation. These events may be sight threatening.
Postmarketing experience with topical NSAIDs suggests that patients with
complicated ocular surgeries, corneal denervation, corneal epithelial defects,
diabetes mellitus, ocular surface diseases (eg, dry eye syndrome), rheumatoid
arthritis, or repeat ocular surgeries within a short period of time may be at
increased risk for corneal adverse events, which may become sight threatening.
Postmarketing experience with topical NSAIDs also suggests that use more than 1
day prior to surgery or use beyond 14 days postsurgery may increase patient risk
for the occurrence and severity of corneal adverse events.
ACUVAIL® should not be administered while wearing contact lenses.
ADVERSE REACTIONS
The most common adverse events were reported in 1% to 6% of patients and
included increased intraocular pressure, conjunctival hyperemia and/or
hemorrhage, corneal edema, ocular pain, headache, tearing, and vision blurred.
Some of these events may be the consequence of the cataract surgical procedure.
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ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% or
0.15% Important Information
INDICATIONS AND USAGE
ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% or
0.15% is an alpha-adrenergic receptor agonist indicated for the reduction of
elevated intraocular pressure (IOP) in patients with open-angle glaucoma or
ocular hypertension.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Neonates and Infants (under the age of 2 years): ALPHAGAN® P is
contraindicated in neonates and infants (under the age of 2 years).
Hypersensitivity Reactions: ALPHAGAN® P is contraindicated in
patients who have exhibited a hypersensitivity reaction to any component of this
medication in the past.
WARNINGS AND PRECAUTIONS
Potentiation of Vascular Insufficiency: ALPHAGAN® P may
potentiate syndromes associated with vascular insufficiency.
ALPHAGAN® P should be used with caution in patients with
depression, cerebral or coronary insufficiency, Raynaud’s phenomenon,
orthostatic hypotension, or thromboangiitis obliterans.
Severe Cardiovascular Disease: Although brimonidine tartrate ophthalmic solution
had minimal effect on the blood pressure of patients in clinical studies,
caution should be exercised in treating patients with severe cardiovascular
disease.
Contamination of Topical Ophthalmic Products After Use: 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.
DRUG INTERACTIONS
Antihypertensives/Cardiac Glycosides: Because ALPHAGAN® P may
reduce blood pressure, caution in using drugs such as antihypertensives and/or
cardiac glycosides with ALPHAGAN® P is advised.
CNS Depressants: Although specific drug interaction studies have not been
conducted with ALPHAGAN® P, the possibility of an additive or
potentiating effect with CNS depressants (alcohol, barbiturates, opiates,
sedatives, or anesthetics) should be considered.
Tricyclic Antidepressants: Tricyclic antidepressants have been reported to blunt
the hypotensive effect of systemic clonidine. It is not known whether the
concurrent use of these agents with ALPHAGAN® P in humans can
lead to resulting interference with the IOP-lowering effect. Caution is advised
in patients taking tricyclic antidepressants, which can affect the metabolism
and uptake of circulating amines.
Monoamine Oxidase Inhibitors: Monoamine oxidase (MAO) inhibitors may
theoretically interfere with the metabolism of brimonidine and potentially
result in an increased systemic side effect such as hypotension. Caution is
advised in patients taking MAO inhibitors, which can affect the metabolism and
uptake of circulating amines.
ADVERSE REACTIONS
Adverse reactions occurring in approximately 10% to 20% of the subjects
receiving brimonidine ophthalmic solution (0.1% to 0.2%) included: allergic
conjunctivitis, conjunctival hyperemia, and eye pruritus. Adverse reactions
occurring in approximately 5% to 9% included: burning sensation, conjunctival
folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual
disturbance.
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ALPHAGAN® P.
COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic
solution) 0.2%/0.5% Important Information
INDICATION
COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic
solution) 0.2%/0.5% is approved for reducing elevated intraocular pressure (IOP)
in patients with glaucoma who require additional or adjunctive IOP-lowering
therapy. COMBIGAN® lowers IOP slightly less than taking both
brimonidine tartrate three times a day and timolol maleate two times a day.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
COMBIGAN® ophthalmic solution should not be used by patients who
have or ever had a reactive airway disease including bronchial asthma, chronic
bronchitis, emphysema, slow heartbeat, impaired conduction of the heart, heart
failure, or impaired pumping of the heart. COMBIGAN® should not
be used in patients aged 2 years and younger, or by patients with
hypersensitivity to any ingredient in this product.
WARNINGS AND PRECAUTIONS
Severe respiratory reactions and cardiac reactions, including death due to
difficulty breathing and rarely death in association with cardiac failure, have
been reported in patients with asthma. Additionally, ophthalmic beta-blockers
may impair compensatory tachycardia and increase risk of hypotension.
Stimulation of the nervous system may be essential in individuals with
diminished heart-pumping ability. In patients without a history of cardiac
failure, continued use of beta-blocking agents over a period of time can, in
some cases, lead to cardiac failure. Patients with mild or moderate chronic
bronchitis, emphysema, or asthma should not take COMBIGAN®
ophthalmic solution. COMBIGAN® may worsen symptoms associated
with poor circulation. COMBIGAN® patients who have allergies may
experience stronger allergy symptoms than they would without
COMBIGAN® ophthalmic solution. Patients may experience muscle
weakness or fatigue. COMBIGAN® may mask hypoglycemic symptoms in
patients with diabetes mellitus. COMBIGAN® may mask certain
clinical signs of hyperthyroidism, such as rapid heartbeat. Patients with
overactive thyroid who withdraw too abruptly from COMBIGAN® may
experience severe hyperthyroid symptoms. Ocular hypersensitivity reactions have
been reported with brimonidine tartrate ophthalmic solutions 0.2%, with some
reported to be associated with an increase in intraocular pressure. There have
been reports of bacterial keratitis associated with the use of multiple-dose
containers of topical ophthalmic products. Beta-adrenergic receptor blockade
impairs the ability of the heart to respond to general anesthesia in surgical
procedures, and some patients have experienced protracted severe hypotension
during anesthesia. In patients undergoing elective surgery, gradual withdrawal
of beta-adrenergic receptor blocking agents may be recommended.
ADVERSE REACTIONS
The most common adverse reactions, occurring in approximately 5% to 15% of
patients, included allergic inflammation of the eye, abnormally large lymph
follicles in the mucous membrane lining the inner surface of the eyelid and the
exposed surface of the eyeball (also called the conjunctiva), eye redness,
severe itching of the eyes, and burning and stinging of the eyes.
DRUG INTERACTIONS
Blood pressure drugs and drugs that are used to stimulate the heart in cases of
heart failure (also called cardiac glycosides) may lower blood pressure. Using
COMBIGAN® ophthalmic solution together with beta-blocker drugs,
either orally or intravenously, may interrupt beta-receptor activity
(beta-blockade) within the body. Oral or intravenous calcium channel blockers
that prevent calcium from entering the cells of the heart and blood vessels
(calcium antagonists) may cause disturbances in the passage of blood through the
heart and/or abnormally low blood pressure. Drugs that significantly decrease
fluids of the adrenal gland may produce low blood pressure and/or a noticeably
slow heartbeat rate below 60 beats per minute. Using COMBIGAN®
with central nervous system depressants may result in an increased effect. Using
COMBIGAN® with digitalis, a cardiac stimulant, may have added
effects in prolonging the time it takes for blood to pass through the heart.
CYP2D6 inhibitors may enhance the effect of beta-blockade within the body.
Tricyclic antidepressants may reduce the ability of clonidine to lower blood
pressure. Monoamine oxidase inhibitors (a type of antidepressant drug) may
result in low blood pressure.
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COMBIGAN®.
LASTACAFT® (alcaftadine ophthalmic solution) 0.25% Important
Information
APPROVED USE
LASTACAFT® (alcaftadine ophthalmic solution) 0.25% is a
prescription medicine approved for the prevention of itching associated with eye
allergies.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
LASTACAFT® is contraindicated in patients with hypersensitivity
to any component in the product.
WARNINGS AND PRECAUTIONS
To minimize eye injury and contaminating the dropper tip of the bottle and
solution, do not touch your eyelids or the areas around your eyes with the
dropper tip. Keep bottle tightly closed when not in use.
Do not wear a contact lens if your eye is red.
LASTACAFT® should not be used to treat contact lens-related
irritation.
Remove contact lenses before putting LASTACAFT® in your eyes. The
preservative in LASTACAFT® may be absorbed by soft contact
lenses. Lenses may be put back in your eye 10 minutes after using
LASTACAFT®.
SIDE EFFECTS
The most common eye-related side effects that were reported in less than 4% of
LASTACAFT® treated eyes were eye irritation, burning and/or
stinging in the eyes after use, eye redness, and eye itching.
The most common non–eye-related side effects that were reported in less than 3%
of patients with LASTACAFT® treated eyes were inflammation of the
nose and the upper part of the throat and headache. Some of these side effects
were similar to the symptoms of eye allergies.
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You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088
.
LUMIGAN® (bimatoprost ophthalmic solution) 0.01% Important
Information
INDICATION
LUMIGAN® (bimatoprost ophthalmic solution) 0.01% is used for the
reduction of high eye pressure, also called intraocular pressure (IOP), in
people with open‐angle glaucoma or ocular hypertension.
IMPORTANT SAFETY INFORMATION
Do not use LUMIGAN® 0.01% if you are allergic to any of the
ingredients.
LUMIGAN® (bimatoprost ophthalmic solution) 0.01% can cause
increased brown coloring of the iris, which may be permanent.
LUMIGAN® 0.01% can cause darkening of the eyelid skin and
eyelashes, which may be reversible after treatment is stopped. The long‐term
effects of increased dark coloring are not known.
LUMIGAN® 0.01% may slowly increase the growth and thickness of
eyelashes, which are usually reversible after treatment is stopped.
Prostaglandin analogs, including bimatoprost, have been reported to cause
inflammation inside the eye. Also, treatment with LUMIGAN® 0.01%
may make existing inflammation worse.
Macular edema (swelling of the macula), including cystoid macular edema, has been
reported during treatment with bimatoprost ophthalmic solution.
LUMIGAN® 0.01% should be used with caution in patients without a
natural lens, in patients with a torn posterior lens capsule who have an
artificial lens implant, or in patients with known risk factors for macular
edema.
Avoid allowing the tip of the dispensing bottle to touch the eye, anything around
the eye, fingers, or any other surface to avoid contamination by common bacteria
known to cause eye infections. Using contaminated solutions can cause serious
damage to the eye and loss of vision.
If you have eye surgery, eye trauma or infection, or develop any eye reactions,
immediately consult with your physician about continuing the use of
LUMIGAN® 0.01%.
LUMIGAN® 0.01% contains an ingredient that may be absorbed by and
cause discoloration of soft contact lenses. If you wear contact lenses, remove
them before using LUMIGAN® 0.01%. Then wait 15 minutes after
using LUMIGAN® 0.01% before you put your contacts back into your
eyes. The most common side effect is eye redness. Other side effects include
growth of eyelashes and itchy eyes.
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LUMIGAN®.
OZURDEX® (dexamethasone intravitreal implant) 0.7 mg Important
Information
APPROVED USES
OZURDEX® (dexamethasone intravitreal implant) is a
prescription medicine that is an implant injected into the eye (vitreous)
and used:
- To treat adults with diabetic macular edema
-
To treat adults with swelling of the macula (macular edema)
following branch retinal vein occlusion (BRVO) or central
retinal wvein occlusion (CRVO)
-
To treat adults with noninfectious inflammation of the uvea
(uveitis) affecting the back segment of the eye
IMPORTANT SAFETY INFORMATION
WHEN NOT TO USE OZURDEX®
OZURDEX® should not be used if you have any
infections in or around the eyes, including most viral diseases of
the cornea and conjunctiva, including active herpes viral infection
of the eye, vaccinia, varicella, mycobacterial infections, and
fungal diseases.
OZURDEX® should not be used if you have glaucoma that
has progressed to a cup-to-disc ratio of greater than 0.8.
OZURDEX® should not be used if you have a posterior
lens capsule that is torn or ruptured.
OZURDEX® should not be used if you are allergic to any
of its ingredients.
WARNINGS AND PRECAUTIONS
Injections into the vitreous in the eye, including those with
OZURDEX®, are associated with serious eye infection
(endophthalmitis), eye inflammation, increased eye pressure, and
retinal detachments. Your eye doctor should monitor you regularly
after the injection.
Use of corticosteroids including OZURDEX® may produce
posterior subcapsular cataracts, increased eye pressure, glaucoma,
and may increase the establishment of secondary eye infections due
to bacteria, fungi, or viruses. Let your doctor know if you have a
history of ocular herpes simplex as corticosteroids are not
recommended in these patients.
COMMON SIDE EFFECTS IN DIABETIC MACULAR EDEMA
The most common side effects reported in patients with diabetic
macular edema include: cataract, increased eye pressure,
conjunctival blood spot, reduced vision, inflammation of the
conjunctiva, specks that float in the field of vision, swelling of
the conjunctiva, dry eye, vitreous detachment, vitreous opacities,
retinal aneurysm, foreign body sensation, corneal erosion,
inflammation of the cornea, anterior chamber inflammation, retinal
tear, drooping eyelid, high blood pressure, and bronchitis.
COMMON SIDE EFFECTS IN RETINAL VEIN OCCLUSION AND UVEITIS
The most common side effects reported in patients for retinal vein
occlusion and uveitis include: increased eye pressure, conjunctival
blood spot, eye pain, eye redness, ocular hypertension, cataract,
vitreous detachment, and headache.
PATIENT COUNSELING INFORMATION
After repeated injections with OZURDEX®, a cataract
may occur. If this occurs, your vision will decrease and you will
need an operation to remove the cataract and restore your vision.
You may develop increased eye pressure with OZURDEX®
that will need to be managed with eye drops, and rarely, with
surgery.
In the days following injection with OZURDEX®, you may
be at risk for potential complications including in particular, but
not limited to, the development of serious eye infection or
increased eye pressure. If your eye becomes red, sensitive to light,
painful, or develops a change in vision, you should seek immediate
care from your eye doctor. You may experience temporary visual
blurring after receiving an injection and should not drive or use
machinery until your vision has resolved.
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OZURDEX®.
PRED FORTE® (prednisolone acetate ophthalmic suspension, USP) 1%
sterile Important Information
INDICATIONS AND USAGE
PRED FORTE® is indicated for the treatment of steroid-responsive
inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior
segment of the globe.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
PRED FORTE® suspension is contraindicated in acute untreated
purulent ocular infections, in most viral diseases of the cornea and conjunctiva
including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia,
and varicella, and also in mycobacterial infection of the eye and fungal
diseases of ocular structures.
PRED FORTE® suspension is also contraindicated in individuals with
known or suspected hypersensitivity to any of the ingredients of this
preparation and to other corticosteroids.
WARNINGS
Prolonged use of corticosteroids may result in posterior subcapsular cataract
formation and may increase intraocular pressure in susceptible individuals,
resulting in glaucoma with damage to the optic nerve, defects in visual acuity
and fields of vision. Prolonged use may also suppress the host immune response
and thus increase the hazard of secondary ocular infections.
If this product is used for 10 days or longer, intraocular pressure should be
routinely monitored even though it may be difficult in children and
uncooperative patients. Steroids should be used with caution in the presence of
glaucoma. Intraocular pressure should be checked frequently.
Various ocular diseases and long-term use of topical corticosteroids have been
known to cause corneal and scleral thinning. Use of topical corticosteroids in
the presence of thin corneal or scleral tissue may lead to perforation.
Acute purulent infections of the eye may be masked or activity enhanced by the
presence of corticosteroid medication.
The use of steroids after cataract surgery may delay healing and increase the
incidence of bleb formation.
Use of ocular steroids may prolong the course and may exacerbate the severity of
many viral infections of the eye (including herpes simplex). Employment of a
corticosteroid medication in the treatment of patients with a history of herpes
simplex requires great caution; frequent slit lamp microscopy is recommended.
PRED FORTE® suspension contains sodium bisulfite, a sulfite that
may cause allergic-type reactions, including anaphylactic symptoms and
life-threatening or less severe asthmatic episodes in certain susceptible
people. The overall prevalence of sulfite sensitivity in the general population
is unknown and probably low. Sulfite sensitivity is seen more frequently in
asthmatic than in non-asthmatic people.
PRECAUTIONS
General: The initial prescription and renewal of the medication order beyond 20
milliliters of PRED FORTE® suspension should be made by a
physician only after examination of the patient with the aid of magnification,
such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining.
If signs and symptoms fail to improve after 2 days, the patient should be
re-evaluated.
As fungal infections of the cornea are particularly prone to develop
coincidentally with long-term local corticosteroid applications, fungal invasion
should be suspected in any persistent corneal ulceration where a corticosteroid
has been used or is in use. Fungal cultures should be taken when appropriate.
Information for Patients: Advise patients that if eye inflammation or pain
persists longer than 48 hours or becomes aggravated, they should consult a
physician.
Advise patients that to prevent eye injury or contamination, care should be taken
to avoid touching the bottle tip to eyelids or to any other surface. The use of
this bottle by more than one person may spread infection. Keep bottle tightly
closed when not in use. Keep out of the reach of children.
Advise patients that PRED FORTE® suspension contains benzalkonium
chloride, which may be absorbed by soft contact lenses. Contact lenses should be
removed prior to application of PRED FORTE® and may be reinserted
15 minutes following its administration.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been
conducted in animals or in humans to evaluate the potential of these effects.
Pregnancy: Prednisolone has been shown to be teratogenic in mice when given in
doses 1-10 times the human dose. Dexamethasone, hydrocortisone, and prednisolone
were ocularly applied to both eyes of pregnant mice five times per day on days
10 through 13 of gestation. A significant increase in the incidence of cleft
palate was observed in the fetuses of the treated mice. There are no adequate
well-controlled studies in pregnant women. Prednisolone should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus.
Nursing Mothers: It is not known whether topical ophthalmic administration of
corticosteroids could result in sufficient systemic absorption to produce
detectable quantities in breast milk. Systemically administered corticosteroids
appear in human milk and could suppress growth, interfere with endogenous
corticosteroid production, or cause other untoward effects. Because of the
potential for serious adverse reactions in nursing infants from prednisolone, 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: The safety and effectiveness in pediatric patients have been
established. Use in pediatric patients is supported by evidence from adequate
and well-controlled studies of prednisolone acetate ophthalmic suspension in
adults with additional data in pediatric patients.
Geriatric Use: No overall differences in safety or effectiveness have been
observed between elderly and younger patients.
ADVERSE REACTIONS
The following adverse reactions have been identified during use of PRED
FORTE®. Because reactions are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate
their frequency or establish a causal relationship to drug exposure.
Adverse reactions include elevation of intraocular pressure (IOP) with possible
development of glaucoma and infrequent optic nerve damage, posterior subcapsular
cataract formation, and delayed wound healing.
The development of secondary ocular infection (bacterial, fungal, and viral) has
occurred. Fungal and viral infections of the cornea are particularly prone to
develop coincidentally with long-term applications of steroids. The possibility
of fungal invasion should be considered in any persistent corneal ulceration
where steroid treatment has been used (see PRECAUTIONS).
Other adverse reactions reported with the use of prednisolone acetate ophthalmic
suspension include: allergic reactions; dysgeusia; eye pain; foreign body
sensation; headache; pruritus; rash; transient burning and stinging upon
instillation and other minor symptoms of ocular irritation; urticaria; and
visual disturbance (blurry vision).
Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia,
loss of accommodation and ptosis have occasionally been reported following local
use of corticosteroids. Corticosteroid-containing preparations have also been
reported to cause acute anterior uveitis and perforation of the globe.
Please click here for the full Product Information for PRED
FORTE®.
RESTASIS® and RESTASIS MULTIDOSE® 0.05% Important
Information
APPROVED USE
RESTASIS® and RESTASIS MULTIDOSE® Ophthalmic
Emulsion help increase your eyes’ natural ability to produce tears, which may be
reduced by inflammation due to Chronic Dry Eye. RESTASIS® and
RESTASIS MULTIDOSE® did not increase tear production in patients
using anti-inflammatory eye drops or tear duct plugs.
IMPORTANT SAFETY INFORMATION
Do not use RESTASIS® and RESTASIS MULTIDOSE®
Ophthalmic Emulsion if you are allergic to any of the ingredients. Be careful
not to touch the container tip to your eye or other surfaces, to help avoid eye
injury and contamination. RESTASIS® and RESTASIS
MULTIDOSE® should not be used while wearing contact lenses. If
contact lenses are worn, they should be removed prior to use of
RESTASIS® and RESTASIS MULTIDOSE® and may be
reinserted after 15 minutes.
The most common side effect is a temporary burning sensation. Other side effects
include eye redness, discharge, watery eyes, eye pain, foreign body sensation,
itching, stinging, and blurred vision.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088
.
TRUETEAR® Important Information
INDICATION
TrueTear® provides a temporary increase in tear production during
neurostimulation to improve dry eye symptoms in adult patients with severe dry
eye symptoms.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Do not prescribe TrueTear® to patients with a cardiac demand
pacemaker, implanted or wearable defibrillator, or other implanted metallic or
electronic device within head or neck; a known hypersensitivity to the hydrogel
device material; or chronic or recurrent nosebleeds, or bleeding
disorder/condition that can lead to increased bleeding.
WARNINGS
Do not apply stimulation around electronic monitoring equipment (eg, cardiac
monitors, ECG alarms), in the bath/shower, while driving, operating machinery,
during activity in which sneezing/watery eyes may cause risk, areas other than
the nose, within 3 feet of shortwave or microwave therapy equipment, around
flammable anesthetics mixture (air, oxygen or nitrous oxide). Persistent use on
irritated nasal tissue may cause injury. The device is limited only to the
improvement in dry eye symptoms, as the safety and effectiveness for neither the
treatment of dry eye disease nor use for periods longer than 6 months has been
established. Safety not established in pregnancy, patients under 22 years of
age, patients with nasal or sinus surgery (including nasal cautery) or
significant trauma; severe nasal airway obstruction or vascularized polyp;
active, severe systemic or chronic seasonal allergies; rhinitis or sinusitis
requiring treatment; untreated nasal infection; and disabling arthritis,
neuropathy, severe dexterity impairment or limited motor coordination. Use only
manufacturer’s supplied accessories.
PRECAUTIONS
Consult patients to discontinue use if pain, discomfort or numbness in the nose
persists after adjusting for high levels/long sessions; to remove studs, nose
rings, or other nose jewelry before use; to not use prescription eye medications
or nasal sprays 30 minutes before or after using TrueTear®.
Suspected or diagnosed heart disease patients should follow doctor’s
precautions. Keep away from children. Clean as directed. Failure to replace the
tip as directed will cause the device to not work properly.
ADVERSE EVENTS
Nasal pain, discomfort or burning (10.3%); transient electrical discomfort
(5.2%); nosebleed (5.2%); nasal congestion (3.1%); headaches (2.1%); trace
blood, dot heme in nostril (2.1%); facial pain (2.1%); sore eye (1.0%); sinus
pain (1.0%); periorbital pain (1.0%); runny nose (1.0%); nasal ulcers (1.0%);
and light-headedness (1.0%).
Caution: Federal law restricts this device to sale by or on the order of a
licensed physician. Proper patient training on use of the device is required before
home use. For the full Directions for Use, please visit
www.allergan.com/truetear/usa.htm
or call 1-800-678-1605. Please call
1-800-433-8871
to report an adverse event.
XEN® Gel Stent Important Information
INDICATIONS
The XEN® Glaucoma Treatment System (XEN® 45 Gel
Stent preloaded into a XEN® Injector) is indicated for the
management of refractory glaucomas, including cases where previous surgical
treatment has failed, cases of primary open-angle glaucoma, and
pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive
to maximum tolerated medical therapy.
IMPORTANT SAFETY INFORMATION
WHO SHOULD NOT RECEIVE THE XEN® GLAUCOMA TREATMENT SYSTEM?
This surgical treatment should not be used if you currently have any of the
following: angle-closure glaucoma where the drainage angle of the eye has not
been surgically opened; a glaucoma drainage device previously implanted or
scarring and pathologies of the conjunctiva (the clear membrane covering the
white outer layer of the eye) in the area needed for this implant; eye
inflammation (such as inflammation of the eyelids, conjunctiva, cornea, or
uvea); abnormal formation of new blood vessels on the iris (the colored part of
the eye) surface; artificial lens implanted in the anterior chamber (the space
between your cornea, the outer transparent part of the eye, and the iris);
silicone oil in your eye; and vitreous (the transparent jelly-like tissue that
is found behind the lens) present in the anterior chamber.
WHAT WARNINGS SHOULD I BE AWARE OF?
XEN® Gel Stent complications may include buildup of fluid between
the choroid (inner layer of blood vessels) and the sclera (white outer layer of
the eyeball), blood in the eye, very low eye pressure, implant moving to another
part of the eye, implant exposure, wound leak, need for additional surgical
intervention, and other eye surgery complications. The safety and effectiveness
of the XEN® Gel Stent in neovascular, congenital, and infantile
glaucoma has not been established. After the XEN® Gel Stent
procedure, to help avoid the possibility of implant damage, avoid rubbing or
pressing your fingers on the eye in the area where the XEN® Gel
Stent was implanted.
WHAT PRECAUTIONS SHOULD I BE AWARE OF?
Before surgery, your doctor will check that the device and injector are not
damaged. During surgery, your doctor will stop the procedure if he or she
observes increased resistance during implantation and will use a new
XEN® system. After surgery, your doctor should check and manage
your eye pressure appropriately. The safety and effectiveness of implanting more
than one XEN® Gel Stent in an eye has not been studied.
WHAT ARE POSSIBLE SIDE EFFECTS?
The most common side effects after surgery include reduction of vision, eye
pressure becoming too low, an increase in eye pressure, and need for an
additional surgical procedure in the eye to release scar tissue (needling)
around the implant under the conjunctiva. Talk to your doctor about other
possible side effects.
Caution: Federal law restricts this device to sale by or on the order of a
licensed physician. For the full Directions for Use, please visit
www.allergan.com/xen/usa.htm
or call 1-800-678-1605. Please call
1-800-433-8871
to report an adverse event.
ZYMAXID® (gatifloxacin ophthalmic solution) 0.5% Important
Information
INDICATION
ZYMAXID® is indicated for the treatment of bacterial
conjunctivitis caused by susceptible strains of the following organisms:
Aerobic gram-positive bacteria: Staphylococcus aureus, Staphylococcus
epidermidis, Streptococcus mitis group*, Streptococcus oralis*, Streptococcus
pneumoniae.
Aerobic gram-negative bacteria: Haemophilus influenzae.
*Efficacy for these organisms were studied in fewer than 10 infections.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ZYMAXID® is contraindicated in patients with a history of
hypersensitivity to gatifloxacin, to other quinolones, or to any of the
components in this medication.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Some patients receiving topical ophthalmic gatifloxacin
experienced hypersensitivity reactions including anaphylactic reactions,
angioedema (including pharyngeal, laryngeal, or facial edema), dyspnea,
urticaria, and itching, even following a single dose. Rare cases of
Stevens-Johnson Syndrome were reported in association with topical ophthalmic
gatifloxacin use. If an allergic reaction to gatifloxacin occurs, discontinue
the drug.
Growth of Resistant Organisms with Prolonged Use: Prolonged use of
ZYMAXID® may result in overgrowth of nonsusceptible organisms,
including fungi. If superinfection occurs, discontinue use and institute
alternative therapy. Whenever clinical judgment dictates, examine the patient
with the aid of magnification, such as slit lamp biomicroscopy and where
appropriate, fluorescein staining.
Corneal Endothelial Cell Injury: ZYMAXID® is for topical
ophthalmic use. ZYMAXID® may cause corneal endothelial cell
injury if introduced directly into the anterior chamber of the eye.
ADVERSE REACTIONS
In clinical studies of patients with bacterial conjunctivitis treated with
ZYMAXID® (N=717), the most frequently reported adverse reactions
occurring in ≥ 1 % of patients were: worsening of the conjunctivitis, eye
irritation, dysgeusia, and eye pain.
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