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    • ACUVAIL® (ketorolac tromethamine ophthalmic solution) 0.45%
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    • COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2% / 0.5%
    • LASTACAFT® (alcaftadine ophthalmic solution) 0.25%
    • LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
    • OZURDEX® (dexamethasone intravitreal implant) 0.7 mg
    • PRED FORTE® (prednisolone acetate ophthalmic suspension, USP) 1%
    • REFRESH® BRAND (OTC)
    • RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%
    • RESTASIS MULTIDOSE® (Cyclosporine Ophthalmic Emulsion) 0.05%
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SEE FULL INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR ALL PRODUCTS BELOW.

INDICATION(S) AND IMPORTANT SAFETY INFORMATION

Click the links to go to each product's Indication(s) and Important Safety Information.

  • ACUVAIL® (ketorolac tromethamine ophthalmic solution) 0.45%
  • ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15%
  • COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%
  • LASTACAFT® (alcaftadine ophthalmic solution) 0.25%
  • LUMIGAN® (bimatoprost ophthalmic solution) 0.01%
  • OZURDEX® (dexamethasone intravitreal implant) 0.7 mg
  • PRED FORTE® (prednisolone acetate ophthalmic suspension, USP) 1%
  • RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%
  • RESTASIS MULTIDOSE® (cyclosporine ophthalmic emulsion) 0.05%
  • TRUETEAR®
  • XEN®
  • ZYMAXID® (gatifloxacin ophthalmic solution) 0.5%

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.

Please click here for full Product Information for ACUVAIL®.


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.

Please click here for full Product Information for 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.

Please click here for full Product Information for 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.

Please click here for full Product Information for LASTACAFT®.

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.

Please click here for the full Product Information for 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.

Please click here for the full Product Information for 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.

Please click here for the full Product Information for ZYMAXID®.

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AOT114246-v3 11/19

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