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SIMBRINZA

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Overview

What is SIMBRINZA?

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.  Brinzolamide is described chemically as: (R)-(+)-4-Ethylamino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno [3,2-e]-1,2-thiazine-6-sulfonamide-1,1- dioxide. Its empirical formula is CHNOS, and its structural formula is:

Brinzolamide has a molecular weight of 383.5. It is a white powder, which is insoluble in water, very soluble in methanol and soluble in ethanol. Brimonidine tartrate is described chemically as: 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Its empirical formula of CHBrN – CHO and its structural formula is:  

Brimonidine tartrate has a molecular weight of 442.2. It is a white to yellow powder that is soluble in water (34 mg/mL) at pH 6.5.   SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is supplied as a sterile, aqueous suspension which has been formulated to be readily suspended following shaking. It has a pH of approximately 6.5 and an osmolality of approximately 270 mOsm/kg. Each mL of SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% contains: brinzolamide 10 mg, brimonidine tartrate 2 mg (equivalent to 1.32 mg as brimonidine free base); benzalkonium chloride 0.03 mg; propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol and purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.



What does SIMBRINZA look like?



What are the available doses of SIMBRINZA?

Suspension containing 10 mg/mL brinzolamide and 2 mg/mL brimonidine tartrate. 

What should I talk to my health care provider before I take SIMBRINZA?

How should I use SIMBRINZA?

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.

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 intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.


What interacts with SIMBRINZA?

Sorry No Records found


What are the warnings of SIMBRINZA?

Sorry No Records found


What are the precautions of SIMBRINZA?

Sorry No Records found


What are the side effects of SIMBRINZA?

Sorry No records found


What should I look out for while using SIMBRINZA?

Hypersensitivity to any component of this product.

Neonates and infants (under the age of 2 years).


What might happen if I take too much SIMBRINZA?

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. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine as part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.


How should I store and handle SIMBRINZA?

Store original packages at room temperature; avoid excessive heat.SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is supplied in white low density polyethylene (LDPE) DROP-TAINER bottles with a natural LDPE dispensing-tip and light green polypropylene cap as follows:8 mL in a 10 mL bottle NDC 0065-4147-27 Storage and HandlingStore SIMBRINZA at 2 - 25°C (36 - 77°F).SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is supplied in white low density polyethylene (LDPE) DROP-TAINER bottles with a natural LDPE dispensing-tip and light green polypropylene cap as follows:8 mL in a 10 mL bottle NDC 0065-4147-27 Storage and HandlingStore SIMBRINZA at 2 - 25°C (36 - 77°F).SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is supplied in white low density polyethylene (LDPE) DROP-TAINER bottles with a natural LDPE dispensing-tip and light green polypropylene cap as follows:8 mL in a 10 mL bottle NDC 0065-4147-27 Storage and HandlingStore SIMBRINZA at 2 - 25°C (36 - 77°F).SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is supplied in white low density polyethylene (LDPE) DROP-TAINER bottles with a natural LDPE dispensing-tip and light green polypropylene cap as follows:8 mL in a 10 mL bottle NDC 0065-4147-27 Storage and HandlingStore SIMBRINZA at 2 - 25°C (36 - 77°F).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

SIMBRINZA is comprised of two components: brinzolamide (carbonic anhydrase inhibitor) and brimonidine tartrate (alpha 2 adrenergic receptor agonist).  Each of these two components decreases elevated intraocular pressure.  Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve damage and glaucomatous visual field loss.  The higher the level of intraocular pressure, the greater the likelihood of glaucomatous field loss and optic nerve damage.  Brinzolamide inhibits carbonic anhydrase in the ciliary processes of the eye to decrease aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport. Brinzolamide has a peak ocular hypotensive effect occurring at 2 to 3 hours post-dosing. 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. Brimonidine tartrate has a peak ocular hypotensive effect occurring at two hours post-dosing.  The result is a reduction in intraocular pressure (IOP).

Non-Clinical Toxicology
Hypersensitivity to any component of this product.

Neonates and infants (under the age of 2 years).

Plasma levels of anticonvulsant agents may become subtherapeutic during cisplatin therapy.

In a randomized trial in advanced ovarian cancer, response duration was adversely affected when pyridoxine was used in combination with altretamine (hexamethylmelamine) and cisplatin.

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. Fatalities have occurred due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitization may recur when a sulfonamide is re-administered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation. .

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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