Simbrinza Eye Drops

SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fixed combination of a carbonic anhydrase inhibitor and an alpha 2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. SIMBRINZA is a combination of brinzolamide, a carbonic anhydrase inhibitor, and brimonidine tartrate, an alpha adrenergic agonist, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. (1)

• The recommended dose is one drop of SIMBRINZA in the affected eye(s) three times daily
• Shake well before use
• SIMBRINZA ophthalmic suspension may be used concomitantly with other topical ophthalmic drug products to lower IOP
• If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart
• Shake well before use
• Instill one drop in the affected eye(s) three times daily
• If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart

Ophthalmic suspension containing 1% (10 mg/mL) brinzolamide and 0.2% (2 mg/mL) brimonidine tartrate. Ophthalmic suspension containing 1% (10 mg/mL) brinzolamide and 0.2% (2 mg/mL) brimonidine tartrate. (3)

• The individual component, brinzolamide, has been studied
• In pediatric glaucoma patients 4 weeks to 5 years of age
• The individual component, brimonidine tartrate, has been studied
• In pediatric patients 2 to 7 years old
• Somnolence (50-83%) and decreased alertness was seen in patients 2 to 6 years old
• SIMBRINZA ophthalmic suspension is contraindicated in children under the age of 2 years [see Contraindications ]

No overall differences in safety or effectiveness have been observed between elderly and adult patients.

• Sulfonamide Hypersensitivity Reactions Advise patients that if serious or unusual ocular or systemic reactions or signs of hypersensitivity occur, they should discontinue the use of the product and consult their physician immediately [see Warnings and Precautions and Adverse Reactions ]
• Temporary Blurred Vision Vision may be temporarily blurred following dosing with SIMBRINZA
• Care should be exercised in operating machinery or driving a motor vehicle [ see Adverse Reactions ]
• Effect on Ability to Drive and Use Machinery As with other drugs in this class, SIMBRINZA may cause fatigue and/or drowsiness in some patients. …

• Hypersensitivity to any component of this product
• Neonates and infants (under the age of two years)
• Hypersensitivity SIMBRINZA is contraindicated in patients who are hypersensitive to any component of this product
• Neonates and Infants (under the age of two years) SIMBRINZA is contraindicated in neonates and infants (under the age of two years ) [see Use in Specific Populations ]

Oral Carbonic Anhydrase Inhibitors (7.1) High-dose Salicylate Therapy (7.2) Central Nervous System Depressants (7.3) Antihypertensives/Cardiac Glycosides (7.4) Tricyclic Antidepressants (7.5) Monoamine Oxidase (MAO) Inhibitors (7.6) 7.1 Oral Carbonic Anhydrase Inhibitors There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and brinzolamide ophthalmic suspension 1%, a component of SIMBRINZA ophthalmic suspension. The concomitant administration of SIMBRINZA and oral carbonic anhydrase inhibitors is not recommended. …

Potential for sulfonamide hypersensitivity reactions because of the brinzolamide component (5.1) Potential for corneal endothelium cell loss (5.2) Severe renal impairment may limit the metabolism of the brinzolamide component (5.3) 5.1 Sulfonamide Hypersensitivity Reactions SIMBRINZA contains brinzolamide, a sulfonamide, and although administered topically is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration of SIMBRINZA. …

Most common adverse reactions occurring in approximately 3% to 5% of patients included blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, eye allergy. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Developmental toxicity studies with brinzolamide in rabbits at oral doses of 1, 3, and 6 mg/kg/day (20, 60, and 120 times the recommended human ophthalmic dose) produced maternal toxicity at 6 mg/kg/day and a significant increase in the number of fetal variations, such as accessory skull bones, which was only slightly higher than the historic value at 1 and 6 mg/kg. …

Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following an oral overdose of brinzolamide. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored. Very limited information exists on accidental ingestion of brimonidine in adults; the only adverse event reported to date has been hypotension. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.