Brinzolamide/brimonidine Tartrate (Simbrinza)

Trade Name : SIMBRINZA

Alcon Laboratories, Inc.

SUSPENSION/ DROPS

Strength 102 mg/mLmg/mL

BRINZOLAMIDE; BRIMONIDINE TARTRATE Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Brinzolamide/brimonidine Tartrate (Simbrinza) which is also known as SIMBRINZA and Manufactured by Alcon Laboratories, Inc.. It is available in strength of 10; 2 mg/mL; mg/mL per ml. Read more

Brinzolamide/brimonidine Tartrate (Simbrinza) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

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 fixed combination of a carbonic anhydrase inhibitor and an alpha 2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.u00a0n

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.
Shake well before use.u00a0 Instill one drop in the affected eye(s) three times daily. u00a0If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.u00a0n

Suspension containing 10 mg/mL brinzolamide and 2 mg/mL brimonidine tartrate.
Suspension containing 10 mg/mL brinzolamide and 2 mg/mL brimonidine tartrate.u00a0n

No data

Hypersensitivity to any component of this product. n
Neonates and infants (under the age of 2 years). n

No data

Potential for sulfonamide hypersensitivity reactions because of the brinzolamideu00a0component u00a0n
Potential for corneal endothelium cell loss n
Severe renal impairment may limit the metabolism of the brinzolamideu00a0component n

Most common adverse reactions occurring in approximately 3 to 5% of patients includedu00a0blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, eye allergy.u00a0n n n n

No data

Oral Carbonic Anhydrase Inhibitors n
High-dose Salicylate Therapy n
CNS Depressants n
Antihypertensives/Cardiac Glycosides n
Tricyclic Antidepressants n
Monoamine Oxidase Inhibitors n

No data

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. n 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.

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.u00a0n 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.n Brimonidine tartrate is described chemically as: 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. Its empirical formula of CHBrN u2013 CHO and its structural formula is:u00a0u00a0
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.u00a0u00a0n 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.n 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;u00a0propylene glycol, carbomer 974P, boric acid, mannitol, sodium chloride, tyloxapol and purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

No data

Brinzolamide caused urinary bladder tumors in female mice at oral doses of 10 mg/kg/day and in male rats at oral doses of 8 mg/kg/day in 2 year studies. Brinzolamide was not carcinogenic in male mice or female rats dosed orally for up to 2 years. The carcinogenicity appears secondary to kidney and urinary bladder toxicity. These levels of exposure cannot be achieved with topical ophthalmic dosing in humans.
The following tests for mutagenic potential of brinzolamide were negative: (1) mouse micronucleus assay; (2) sister chromatid exchange assay; and (3) Ames test. The mouse lymphoma forward mutation assay was negative in the absence of activation, but positive in the presence of microsomal activation. In this assay, there was no consistent dose-response relationship to the increased mutation frequency and cytotoxicity likely contributed to the high mutation frequency. Carbonic anhydrase inhibitors, as a class, are not mutagenic and the weight of evidence supports that brinzolamide is consistent with the class. In reproduction studies of brinzolamide in rats, there were no adverse effects on the fertility or reproductive capacity of males or females at doses up to 18 mg/kg/day (180 times the recommended human ophthalmic dose).u00a0n Brimonidine tartrate was not carcinogenic in either a 21-month mouse or 24-month rat study. In these studies, dietary administration of brimonidine tartrate at doses up to 2.5 mg/kg/day in mice and 1 mg/kg/day in rats resulted in plasma drug concentrations 80 and 120 times higher than the human plasma drug level at the recommended clinical dose, respectively. Brimonidine tartrate was not mutagenic or cytogenic in a series of and studies including the Ames test, chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells, a host-mediated assay and cytogenic studies in mice, and a dominant lethal assay. In reproductive studies performed in rats with oral doses of 0.66 mg brimonidine base/kg (approximately 100 times the plasma drug concentration level seen in humans following multiple ophthalmic doses), fertility was not impaired.

Two clinical trials of 3 months duration were conducted in patients with open-angle glaucoma or ocular hypertension to compare the IOP-lowering effect of SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% dosed three times daily to individually administered 1% brinzolamide three times daily and 0.2% brimonidine tartrate three times daily.u00a0 Mean IOP values at baseline are presented in Table 1.
The IOP-lowering effect of SIMBRINZA ophthalmic suspension was 1 to 3u00a0mmHg greater than monotherapy with either 1% brinzolamide or 0.2% brimonidine tartrate throughout the duration of the trials. Least Square Mean IOP (mmHg) and the results at Week 2, Week 6 and Month 3 for each study are provided in Table 2.
*Based on the Intent-to-Treat Population defined as all patients who received study drug and completed at least 1 on-therapy study visit.u00a0 **The estimates are based on least square means derived from a linear mixed model that accounts for correlated IOP measurements within patient; Treatment difference is SIMBRINZA minus individual component. CI=95% Confidence Interval
Figures 1 and 2 present the mean of individual subject IOP changes from baseline at Week 2, Week 6, and at Month 3 based on the observed data for the intent-to-treat population.
Figure 1.u00a0 Mean IOP Change from Baseline (Study 1)
Figure 2.u00a0 Mean IOP Change from Baseline (Study 2)

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 Handling
Store SIMBRINZA at 2 - 25u00b0C (36 - 77u00b0F).

No data

NDC 0065-4147-27 n n u00a0n n n n n n n n n n n n n n n n

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Brinzolamide/brimonidine Tartrate (Simbrinza)

Trade Name : SIMBRINZA

SUSPENSION/ DROPS

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Brinzolamide/brimonidine Tartrate (Simbrinza)

Trade Name : SIMBRINZA

SUSPENSION/ DROPS

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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