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ALPHAGAN® Indications and Important Safety 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
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.
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 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.
Combigan® Indication and Important Safety 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 reactive airway disease including 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; cardiogenic shock; in neonates and infants (aged 2 years and younger); 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 and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with systemic or ophthalmic administration of timolol maleate). Ophthalmic beta‐blockers may impair compensatory tachycardia and increase risk of hypotension.
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 in diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Carefully manage patients who 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 either orally or intravenously 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 effects such as hypotension. Use caution in patients taking MAO inhibitors, which can affect the metabolism and uptake of circulating amines.
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
LUMIGAN® 0.01% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients.
WARNINGS AND PRECAUTIONS
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.
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.
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, 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.
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.
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
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.
Indications and Usage
Diabetic Macular Edema
Diabetic Macular Edema
OZURDEX® (dexamethasone intravitreal implant) is a corticosteroid indicated for the treatment of diabetic macular edema.
Retinal Vein Occlusion
OZURDEX® is a corticosteroid indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Posterior Segment Uveitis
OZURDEX® is indicated for the treatment of noninfectious uveitis affecting the posterior segment of the eye.
Dosage and Administration
FOR OPHTHALMIC INTRAVITREAL INJECTION. The intravitreal injection procedure should be carried out under controlled aseptic conditions. Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.
IMPORTANT SAFETY INFORMATION
Ocular or Periocular Infections: OZURDEX® (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
Glaucoma: OZURDEX® is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8.
Torn or Ruptured Posterior Lens Capsule: OZURDEX® is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for OZURDEX® use.
Hypersensitivity: OZURDEX® is contraindicated in patients with known hypersensitivity to any components of this product.
Warnings and Precautions
Intravitreal Injection-related Effects: Intravitreal injections, including those with OZURDEX®, have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored regularly following the injection.
Steroid-related Effects: Use of corticosteroids including OZURDEX® may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.
Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.
Diabetic Macular Edema
Diabetic Macular Edema
Ocular adverse reactions reported by greater than or equal to 1% of patients in the two combined 3-year clinical trials following injection of OZURDEX® for diabetic macular edema include: cataract (68%), conjunctival hemorrhage (23%), visual acuity reduced (9%), conjunctivitis (6%), vitreous floaters (5%), conjunctival edema (5%), dry eye (5%), vitreous detachment (4%), vitreous opacities (3%), retinal aneurysm (3%), foreign body sensation (2%), corneal erosion (2%), keratitis (2%), anterior chamber inflammation (2%), retinal tear (2%), eyelid ptosis (2%). Non-ocular adverse reactions reported by greater than or equal to 5% of patients include: hypertension (13%) and bronchitis (5%).
Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 28% of OZURDEX® patients versus 4% of sham patients. 42% of the patients who received OZURDEX® were subsequently treated with IOP-lowering medications during the study versus 10% of sham patients.
The increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles (at the end of the 6-month period).
Cataracts and Cataract Surgery: The incidence of cataract development in patients who had a phakic study eye was higher in the OZURDEX® group (68%) compared with Sham (21%). The median time of cataract being reported as an adverse event was approximately 15 months in the OZURDEX® group and 12 months in the Sham group. Among these patients, 61% of OZURDEX® subjects versus 8% of sham-controlled subjects underwent cataract surgery, generally between Month 18 and Month 39 (Median Month 21 for OZURDEX® group and 20 for Sham) of the studies.
Retinal Vein Occlusion and Posterior Segment Uveitis
Adverse reactions reported by greater than 2% of patients in the first 6 months following injection of OZURDEX® for retinal vein occlusion and posterior segment uveitis include: intraocular pressure increased (25%), conjunctival hemorrhage (22%), eye pain (8%), conjunctival hyperemia (7%), ocular hypertension (5%), cataract (5%), vitreous detachment (2%), and headache (4%).
Increased IOP with OZURDEX® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of the patients who received OZURDEX® required surgical procedures for management of elevated IOP.
RESTASIS® 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
RESTASIS® is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, individuals prescribed RESTASIS® should not touch the vial tip to their eye or other surfaces.
Use With Contact Lenses: RESTASIS® 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® ophthalmic emulsion.
In clinical trials, the most common adverse reaction following the use of RESTASIS® 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).
TrueTear™ Indication and Important Safety Information
TrueTear™ provides a temporary increase in tear production during neurostimulation in adult patients.
Important Safety Information
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.
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 oxygen). 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.
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.
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.
XEN® Indications and Important Safety Information
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
XEN® Gel Stent is contraindicated in angle-closure glaucoma where angle has not been surgically opened, previous glaucoma shunt/valve or conjunctival scarring/pathologies in the target quadrant, active inflammation, active iris neovascularization, anterior chamber intraocular lens, intraocular silicone oil, and vitreous in the anterior chamber.
XEN® Gel Stent complications may include choroidal effusion, hyphema, hypotony, implant migration, implant exposure, wound leak, need for secondary surgical intervention, and intraocular surgery complications. Safety and effectiveness in neovascular, congenital, and infantile glaucoma has not been established. Avoid digital pressure following implantation of the XEN® Gel Stent to avoid the potential for implant damage.
Examine the XEN® Gel Stent and XEN® Injector in the operating room prior to use. Monitor intraocular pressure (IOP) postoperatively and if not adequately maintained, manage appropriately. Stop the procedure immediately if increased resistance is observed during implantation and use a new XEN® system. Safety and effectiveness of more than a single implanted XEN® Gel Stent has not been studied.
The most common postoperative adverse events included best-corrected visual acuity loss of ≥ 2 lines (≤ 30 days 15.4%; > 30 days 10.8%; 12 months 6.2%), hypotony IOP < 6 mm Hg at any time (24.6%; no clinically significant consequences were associated, no cases of persistent hypotony, and no surgical intervention was required), IOP increase ≥ 10 mm Hg from baseline (21.5%), and needling procedure (32.3%).
Caution: Federal law restricts this device to sale by or on the order of a licensed physician. Please click here for the full Directions for Use. Please call 1-800-433-8871 to report an adverse event.