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Indication(s) and Important Safety Information

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

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 the full Prescribing Information for ALPHAGAN® P.

COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% Important Information

INDICATIONS AND USAGE: COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of COMBIGAN® dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: COMBIGAN® is contraindicated in patients with bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease; in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; in neonates and infants (under the age of 2 years); in patients with a hypersensitivity reaction to any component of COMBIGAN® in the past.

WARNINGS AND PRECAUTIONS: COMBIGAN® contains timolol maleate. COMBIGAN® is administered topically, but can be absorbed systemically. The adverse reactions with systemic administration of beta-adrenergic blocking agents may occur with topical use (eg, severe respiratory reactions including death due to bronchospasm in patients with asthma have been reported with systemic or ophthalmic administration of timolol maleate).

Sympathetic stimulation may be essential to support the circulation in patients with diminished myocardial contractility and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. In patients with no history of cardiac failure, continued depression of the myocardium with beta-blocking agents over time can lead to cardiac failure. Discontinue COMBIGAN® at the first sign or symptom of cardiac failure.

Patients with chronic obstructive pulmonary disease (eg, chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease should not receive beta-blocking agents, including COMBIGAN®.

COMBIGAN® may potentiate syndromes associated with vascular insufficiency. Use caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

Patients taking beta-blockers with a history of atopy or severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

Beta-adrenergic blockade can potentiate muscle weakness with myasthenic symptoms (eg, diplopia, ptosis, and generalized weakness). Although rare, timolol can increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.

Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia and clinical signs (eg, tachycardia) of hyperthyroidism. Use caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Carefully manage patients that may develop thyrotoxicosis to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.

Ocular hypersensitivity has occurred with brimonidine tartrate ophthalmic solutions 0.2% (eg, increase in IOP).

Some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents due to impairment of beta-adrenergically mediated reflexes during surgery. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists.

ADVERSE REACTIONS: The most frequent reactions with COMBIGAN® in about 5% to 15% of patients included: allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging.

DRUG INTERACTIONS: COMBIGAN® may reduce blood pressure. Use caution in patients on antihypertensives and/or cardiac glycosides.

Observe patients receiving a beta-adrenergic blocking agent orally and COMBIGAN® for additive effects of beta-blockade, both systemic and on intraocular pressure. Concomitant use of two topical beta-adrenergic blocking agents is not recommended.

Use caution in the co-administration of beta-adrenergic blocking agents (eg, COMBIGAN®) and oral or intravenous calcium antagonists due to possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. Avoid co-administration in patients with impaired cardiac function.

Observe patients closely when a beta-blocker is administered to patients receiving catecholamine-depleting drugs (eg, reserpine) due to possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension.

Specific drug interaction studies have not been conducted with COMBIGAN®, but consider the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics).

Concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.

Potentiated systemic beta-blockade (eg, decreased heart rate, depression) has been reported with combined use of CYP2D6 inhibitors (eg, quinidine, SSRIs) and timolol.

Tricyclic antidepressants (TCAs) can blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of TCAs with COMBIGAN® in humans can interfere with the IOP-lowering effect. Caution is advised in patients taking TCAs, which can affect the metabolism and uptake of circulating amines.

Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially increase systemic side effect such as hypotension. Use caution in patients taking MAO inhibitors, which can affect the metabolism and uptake of circulating amines.

Please click here for the full Prescribing Information for COMBIGAN®.

LASTACAFT® (alcaftadine ophthalmic solution) 0.25% Important Information

INDICATIONS AND USAGE
LASTACAFT® (alcaftadine ophthalmic solution) 0.25% is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.

MECHANISM OF ACTION
Alcaftadine is an H1 histamine receptor antagonist and inhibitor of the release of histamine from mast cells. Decreased chemotaxis and inhibition of eosinophil activation have also been demonstrated.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

Patients should be advised not to wear a contact lens if their eye is red.

LASTACAFT® should not be used to treat contact lens-related irritation.

Remove contact lenses prior to instillation of LASTACAFT®. The preservative in LASTACAFT®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of LASTACAFT®.

LASTACAFT® is for topical ophthalmic use only.

ADVERSE REACTIONS
The most frequent ocular adverse reactions, occurring in < 4% of LASTACAFT® treated eyes, were eye irritation, burning and/or stinging upon instillation, eye redness, and eye pruritus.

The most frequent non-ocular adverse reactions, occurring in < 3% of subjects with LASTACAFT® treated eyes, were nasopharyngitis, headache, and influenza. Some of these events were similar to the underlying disease being studied.

Please click here for the full Prescribing Information for LASTACAFT®.

LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information

Indication
LATISSE® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness.

Important Safety Information

Contraindications: LATISSE® is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients.

Warnings and Precautions: In patients using LUMIGAN® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure.

Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation, which is likely to be permanent.

Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients.

There is the potential for hair growth to occur in areas where LATISSE® solution comes in repeated contact with skin surfaces. Apply LATISSE® only to the skin of the upper eyelid margin at the base of the eyelashes.

LATISSE® solution should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may be exacerbated. LATISSE® 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.

Adverse Reactions: The most frequently reported adverse reactions were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema. These reactions occurred in less than 4% of patients.

Postmarketing Experience: The following adverse reactions have been identified during postapproval use of LATISSE®: dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and vision blurred.

Please click here for full Prescribing Information for LATISSE®.

LUMIGAN® (bimatoprost ophthalmic solution) 0.01% Important Information

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

CONTRAINDICATIONS
LUMIGAN® 0.01% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients.

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. While treatment with LUMIGAN® 0.01% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

Eyelash Changes
LUMIGAN® 0.01% may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.

Intraocular Inflammation
Prostaglandin analogs, including bimatoprost, have been reported to cause intraocular inflammation. In addition, because these products may exacerbate inflammation, caution should be used in patients with active intraocular inflammation (e.g., uveitis).

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.

Use with Contact Lenses
LUMIGAN® 0.01% contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft 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 a 12-month clinical study with bimatoprost ophthalmic solutions 0.01%, the most common adverse reaction was conjunctival hyperemia (31%). Approximately 1.6% of patients discontinued therapy due to conjunctival hyperemia. Other adverse drug reactions (reported in 1 to 4% of patients) with LUMIGAN® 0.01% in this study included conjunctival edema, conjunctival hemorrhage, eye irritation, eye pain, eye pruritus, erythema of eyelid, eyelids pruritus, growth of eyelashes, hypertrichosis, instillation site irritation, punctate keratitis, skin hyperpigmentation, vision blurred, and visual acuity reduced.

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.

Please click here for the full Prescribing Information for LUMIGAN®.

RESTASIS MULTIDOSE® 0.05% Important Information

Indications and Usage
RESTASIS MULTIDOSE® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Important Safety Information

Contraindications
RESTASIS MULTIDOSE® is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.

Warnings and Precautions
Potential for Eye Injury and Contamination: Be careful not to touch the bottle tip to your eye or other surfaces to avoid potential for eye injury and contamination.

Use With Contact Lenses: RESTASIS MULTIDOSE® should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS MULTIDOSE® ophthalmic emulsion.

Adverse Reactions
In clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic emulsion 0.05% was ocular burning (upon instillation)—17%. Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).

Please click here for full Prescribing Information for RESTASIS MULTIDOSE®.

TRUETEAR® Important Information

INDICATION
TrueTear® provides a temporary increase in tear production during neurostimulation in adult patients.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Do not prescribe TrueTear® to patients with a cardiac 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. Safety/effectiveness not established for longer than 6 months or for treating aqueous-deficient dry eye disease. 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.

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.

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. 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.

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 Prescribing Information for ZYMAXID®.

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