Indication: COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% is approved for reducing elevated intraocular pressure (IOP) in patients with
glaucoma who require additional or adjunctive IOP-lowering therapy. COMBIGAN® lowers IOP slightly less than taking both brimonidine tartrate three times a day and timolol maleate two times a day.
IMPORTANT SAFETY INFORMATION
Contraindications: COMBIGAN® ophthalmic solution should not be used by patients who have or ever had a reactive airway disease including bronchial asthma, chronic bronchitis, emphysema, slow heartbeat, impaired conduction of the heart, heart failure, or impaired pumping of the heart. COMBIGAN® should not be used in patients aged 2 years and younger, or by patients with hypersensitivity to any ingredient in this product.
Warnings and Precautions: Severe respiratory reactions and cardiac reactions, including death due to difficulty breathing and rarely death in association with cardiac failure, have been reported in patients with asthma. Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension. Stimulation of the nervous system may be essential in individuals with diminished heart-pumping ability. In patients without a history of cardiac failure, continued use of beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. Patients with mild or moderate chronic bronchitis, emphysema, or asthma should not take COMBIGAN® ophthalmic solution. COMBIGAN® may worsen symptoms associated with poor circulation. COMBIGAN® patients who have allergies may experience stronger allergy symptoms than they would without COMBIGAN® ophthalmic solution. Patients may experience muscle weakness or fatigue. COMBIGAN® may mask hypoglycemic symptoms in patients with diabetes mellitus. COMBIGAN® may mask certain clinical signs of hyperthyroidism, such as rapid heartbeat. Patients with overactive thyroid who withdraw too abruptly from COMBIGAN® may experience severe hyperthyroid symptoms. Ocular hypersensitivity reactions have been reported with brimonidine tartrate ophthalmic solutions 0.2%, with some reported to be associated with an increase in intraocular pressure. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to general anesthesia in surgical procedures, and some patients have experienced protracted severe hypotension during anesthesia. In patients undergoing elective surgery, gradual withdrawal of beta-adrenergic receptor blocking agents may be recommended.
Adverse reactions: The most common adverse reactions, occurring in approximately 5% to 15% of patients, included allergic inflammation of the eye, abnormally large lymph follicles in the
mucous membrane lining the inner surface of the eyelid and the exposed surface of the eyeball (also called the conjunctiva), eye redness, severe itching of the eyes, and burning and stinging of the eyes.
Drug interactions: Blood pressure drugs and drugs that are used to stimulate the heart in cases of heart failure (also called cardiac glycosides) may lower blood pressure. Using COMBIGAN®
ophthalmic solution together with beta-blocker drugs, either orally or intravenously, may interrupt beta-receptor activity (beta-blockade) within the body. Oral or intravenous calcium channel blockers that prevent calcium from entering the cells of the heart and blood vessels (calcium antagonists) may cause disturbances in the passage of blood through the heart and/or abnormally low blood pressure. Drugs that significantly decrease fluids of the adrenal gland may produce low blood pressure and/or a noticeably slow heartbeat rate below 60 beats per minute. Using COMBIGAN® with central nervous system depressants may result in an increased effect. Using COMBIGAN® with digitalis, a cardiac stimulant, may have added effects in prolonging the time it takes for blood to pass through the heart. CYP2D6 inhibitors may enhance the effect of beta-blockade within the body. Tricyclic antidepressants may reduce the ability of clonidine to lower blood pressure. Monoamine oxidase inhibitors (a type of antidepressant drug) may result in low blood pressure.
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