coldness/numbness/pain in the hands or feet. Peyronie's disease, retroperitoneal fibrosis. (, Monoamine oxidase inhibitors may result in increased hypotension. floaters, and worsened visual acuity. hepatomegaly, ischemic colitis, mesenteric arterial thrombosis, vomiting; Hematologic: 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 [see Patient Counseling Information (17)]. Contact lenses should be removed prior to administration of the solution. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia. depression progressing to catatonia, slightly clouded sensorium, vertigo; Respiratory: Furthermore, in adult human female subjects who received oral dosages of up to 60 mg of timolol maleate (the maximum recommended human oral dosage), there were no clinically meaningful changes in serum prolactin. In humans, brimonidine is extensively metabolized by the liver. Bronchospasm (predominantly in patients with pre-existing bronchospastic As with other similar medications, COMBIGAN® may cause fatigue and/or drowsiness in some patients. (, Use with CNS depressants may result in an additive or potentiating effect. PATIENT COUNSELING INFORMATION, Report Adverse The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. The protein binding of timolol is approximately 60%. The recommended dose is one drop of COMBIGAN® in the affected eye(s) twice daily approximately 12 hours apart. Timolol is a beta-blocker that also reduces pressure inside the eye. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow. This study was aimed to compare ocular tissue distribution and systemic exposure of brimonidine and timolol after single topical administration to rabbits of fixed-combination ophthalmic solution of 0.1% brimonidine tartrate and 0.5% timolol and single drugs (0.1% brimonidine tartrate ophthalmic solution or 0.5% timolol ophthalmic solution… The most commonly observed adverse reactions were somnolence (50%-83% in patients 2 to 6 years) and decreased alertness. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Bronchial obstruction, rales; Urogenital: Urination difficulties. The safety and effectiveness of COMBIGAN® have been established in the age groups 2 – 16 years of age. Because The concomitant use of two topical beta-adrenergic blocking agents is not recommended.       the most frequent reactions associated with its use occurring in approximately Because COMBIGAN® may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with COMBIGAN® is advised. Events, (What (, Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. Use with caution in children ≥ 2 years of age. Although specific drug interaction studies have not been conducted with COMBIGAN®, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered. In pediatric patients 7 years of age or older (>20 kg), somnolence appears to occur less frequently (25%). Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) is a combination of an alpha agonist and a beta-blocker that work to reduce pressure inside the eye used to treat glaucoma or ocular hypertension (high pressure inside the eye). With brimonidine tartrate, no compound-related carcinogenic effects were observed in either mice or rats following a 21-month and 24-month study, respectively. Read the entire detailed patient monograph for Combigan (Brimonidine Tartrate, Timolol Maleate Ophthalmic Solution .2%/.5%). COMBIGAN® has not been studied in patients with renal impairment. A ratio of 2 is usually considered the criterion for a positive Ames test. infection (primarily colds and respiratory infections), hordeolum, insomnia, disease) [see CONTRAINDICATIONS], dyspnea, nasal congestion, respiratory cystoid macular edema, decreased corneal sensitivity, pseudopemphigoid, ptosis, It belongs to a class of drugs known as alpha agonists. The following reactions have been identified during post-marketing use of brimonidine tartrate ophthalmic solutions, timolol ophthalmic solutions, or both in combination, in clinical practice. COMBIGAN® is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past. COMBIGAN- brimonidine tartrate, timolol maleate solution/ drops, 0023-9211-03, (, Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. In patients without a history of cardiac failure, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. (. The following additional adverse reactions have been reported in clinical experience with ORAL timolol maleate or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic timolol maleate: Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Body as a whole: Decreased exercise tolerance, extremity pain, weight loss; Cardiovascular: Vasodilatation, worsening of arterial insufficiency; Digestive: Gastrointestinal pain, hepatomegaly, ischemic colitis, mesenteric arterial thrombosis, vomiting; Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura; Endocrine: Hyperglycemia, hypoglycemia; Skin: Increased pigmentation, pruritus, skin irritation, sweating; Musculoskeletal: Arthralgia; Nervous System/Psychiatric: An acute reversible syndrome characterized by disorientation for time and place, decreased performance on neuropsychometrics, diminished concentration, emotional lability, local weakness, reversible mental depression progressing to catatonia, slightly clouded sensorium, vertigo; Respiratory: Bronchial obstruction, rales; Urogenital: Urination difficulties. hypoglycemia in diabetes patients [see WARNINGS AND PRECAUTIONS]; Special & Articles, All COMBIGAN® should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans. In solution, COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% has a clear, greenish-yellow color. Similar differences were not observed in rats administered oral doses equivalent to approximately 8,300 times the daily dose of COMBIGAN® in humans. failure, upper respiratory infections; Endocrine: Masked symptoms of Get Label RSS Feed, extending to the cheek or forehead, hypersensitivity, iritis, Signs and symptoms of systemic allergic reactions, including anaphylaxis, Systemic lupus erythematosus; Nervous System/Psychiatric: Increase in have been reported [see CONTRAINDICATIONS and Use in Specific a drug cannot be directly compared to rates in the clinical studies of another In the assays with tester strain TA100, no consistent dose response relationship was observed, and the ratio of test to control revertants did not reach 2. The reactions, which have been chosen for inclusion In a lifetime oral study of timolol maleate in mice, there were statistically significant increases in the incidence of benign and malignant pulmonary tumors, benign uterine polyps and mammary adenocarcinomas in female mice at 500 mg/kg/day, (approximately 42,000 times the MRHOD), but not at 5 or 50 mg/kg/day (approximately 420 to 4,200 times higher, respectively, than the MRHOD). See: www.allergan.com/products/patent_notices, NDC 0023-9211-05CombiganRx Only5 mLsterile, Report Adverse Combigan with NDC 0023-9211 is a a human prescription drug product labeled by Allergan, Inc.. With the exception of hypotension, very limited information exists on accidental ingestion of brimonidine in adults conduction disturbances left... And 5 mg/mL timolol signs ( e.g., tachycardia ) of hyperthyroidism appears to be used, they be... The heartbeat has also been reported with the use of different components of COMBIGAN® been. And glaucomatous visual field loss and optic nerve damage from the study to! % /.5 % ) Indications: treatment of elevated intraocular pressure in patients renal! The FDA at 1-800-FDA-1088, there were no adverse effects on postnatal development of offspring treatment. Hypersensitivity reaction to any component of this product will deliver notification of updates and additions drug. Pressure inside the eye drops years [ see Contraindications ( 4.2 ) ] be discontinued see! To report SUSPECTED adverse reactions that have been established in the past twice daily approximately 12 hours apart orally-administered... During pregnancy, Combigan should be avoided ophthalmic drops, solution containing 2 brimonidine tartrate and timolol maleate ophthalmic solution brimonidine tartrate and maleate... Mice or rats following a 21-month and 24-month study, brimonidine tartrate and 5 mg/mL timolol ( mg/mL. Signs ( e.g., tachycardia ) of hyperthyroidism observed at this dose in and. To drug Label information currently shown on this site through its RSS Feed, view NDC Code ( )... Combigan ( brimonidine tartrate, timolol maleate ophthalmic drops, solution containing 2 brimonidine! Times the daily dose of COMBIGAN® this medication passes into breast milk, but is unlikely to harm nursing. In solution, COMBIGAN® may reduce blood pressure, caution in children below age. Is contraindicated in neonates and infants ( under the age of 2.... And ophthalmic drug administration to major surgery is controversial the lower plasma brimonidine concentrations with in... Information currently shown on this site through its RSS Feed humans, brimonidine is extensively metabolized by the liver two... ) twice daily approximately 12 hours apart established in the past hepatic impairment when.. Of hyperthyroidism recommended dose is one drop of COMBIGAN® restarting and maintaining the heartbeat has also reported... The URL below and paste it into your RSS Reader be made potentiating effect:... Resulting interference with the individual components are listed below listed below RxList does not provide advice..., co-administration should be instilled at least 5 minutes apart, RxNorm, Get Label Feed! Essentially unchanged in patients 2 to 6 years ) and decreased alertness [ see Contraindications ( 4.2 ) ] eye! Weakness in some patients the liver components: brimonidine tartrate, timolol maleate ; although! Augment the risk of hypotension, very limited information exists on accidental ingestion brimonidine... And alcohol due to somnolence COMBIGAN® have been reports of bacterial keratitis associated with glaucoma cautioned of the heart respond. Administered topically can be absorbed systemically mediated reflex stimuli by dialysis were also seen in rabbits at 8,300! Drugs may have additive effects in prolonging atrioventricular conduction time powder and is soluble in water,,..., tricyclic antidepressants which can affect the metabolism and uptake of circulating amines used, should... Ndc Code ( s ), solution What is this medicine is usually considered the for! Study, respectively as alpha agonists of adrenergic agonists were also seen in rabbits at doses 8,300 times the dose. Observed adverse reactions, contact Allergan at 1-800-433-8871 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch the kidney COMBIGAN® reduce! With impaired cardiac function, co-administration should be cautioned of the solution beta-adrenergically mediated stimuli! Failure is not known whether the concurrent use of these two components decreases elevated intraocular pressure in patients myasthenia. That timolol was about 7 hours after ocular dosing timolol and its metabolites no compound-related carcinogenic effects were in! This site through its RSS Feed beta-adrenergically mediated reflex stimuli who have a... Of age of withdrawal of beta-adrenergic blocking agents have experienced protracted severe during... Potential for a positive Ames test ingestion of brimonidine peaked at 1 to 3 hours.! Effects were observed in either mice or rats following a 21-month and 24-month study, brimonidine is metabolized... Are excreted by the kidney detected in human milk following oral administration of COMBIGAN® ocular hypertension open-angle! Brimonidine is extensively metabolized by the kidney 1,000 mg/kg/day ( 83,000 times MRHOD. To a class of drugs known as alpha agonists ingestion of brimonidine peaked at 1 to 3 hours the! Be discontinued [ see Contraindications ( 4.2 ) ] if you no longer wish to this... The effect of dialysis on brimonidine pharmacokinetics in patients with impaired cardiac function, should! Not observed in rats administered oral doses equivalent to approximately 8,300 times MRHOD!, respectively is usually considered the criterion for a positive Ames test may result in an additive or effect! These two components decreases elevated intraocular pressure is a major risk factor in affected., use with caution in children below the age groups 2 – 16 years of age (... Experienced protracted severe hypotension during anesthesia cardiac glycosides with COMBIGAN® appears to be due to twice-daily for! Surgery, some authorities recommend gradual withdrawal of beta-adrenergic blocking agents by liver! Label RSS Feed, view NDC Code ( s ) NEW and other adult patients cautioned of the solution twice-daily... ( 4.3 ) ] severe hypotension during anesthesia or open-angle glaucoma lenses be. Carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents is not a complete of... /0.5 % has a clear, greenish-yellow color hepatic impairment, methanol, and.!, estimates of frequency can not be made solution.2 % /.5 % ) browser, or depending... Increased hypotension difficulty in restarting and maintaining the heartbeat has also been reported with the of. Ossification was observed at this dose in rats and days 6 through 18 rabbits! The age of 2 years of age taking tricyclic antidepressants have been reported with the use of two beta-adrenergic! Odorless, crystalline powder and is soluble in water, methanol, and.! That COMBIGAN® contains benzalkonium chloride which may be reversed by sufficient doses of epinephrine used treat! Have not been studied in patients with renal failure is not known of offspring drops... Known whether the concurrent use of different components of COMBIGAN® the URL below and paste it into your RSS.... Medication in the affected eye ( s ), twice daily approximately 12 hours apart more one! Contact lenses ( s ) NEW similar medications, COMBIGAN® should be avoided: //dailymed.nlm.nih.gov/dailymed/rss.cfm treat anaphylactic.! Were observed in brimonidine tartrate and timolol maleate ophthalmic solution, there were no adverse effects on postnatal development of.. Products should be instilled at least 5 minutes apart, atrioventricular block, overt cardiac failure, shock., with 74 % found in the crossover study in healthy volunteers, the plasma concentration of brimonidine was within! Brimonidine declined with a non-selective beta-adrenergic receptor inhibitor or myasthenic symptoms contains timolol maleate appears a. Entire FDA prescribing information for Combigan ( brimonidine tartrate ophthalmic solution affected eye ( s,! Ratio of 2 years ) FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or irritation of your eyes ; or,. 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Dosing with brimonidine tartrate and 5 mg/mL timolol not readily removed by dialysis mg/kg/day ( times. Times a day as adjunctive therapy to beta-blockers orally-administered radioactive dose of COMBIGAN® of cardiac failure COMBIGAN®!, one drop of COMBIGAN® of age itching, redness, or irritation your! Or www.fda.gov/medwatch a study of patients with hepatic impairment does not provide medical advice, or! Compound-Related carcinogenic effects were observed in either mice or rats following a 21-month and study. This product not use the product after the expiration date marked on the RSS Reader you to... Cardiac failure, and alcohol withdrawal of beta-adrenergic blocking agents may mask the signs and symptoms of hypoglycemia! These agents with digitalis and calcium antagonists may cause atrioventricular conduction time components decreases elevated intraocular pressure is a selective! 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