Trade Name: BRIMONIDINE TARTRATE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Somerset Therapeutics, LLC

Presentation: SOLUTION/ DROPS, HUMAN PRESCRIPTION DRUG

Strength: 2 mg/mL

Storage and handling

BRIMONIDINE TARTRATE Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Brimonidine tartrate ophthalmic solution 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • The IOP lowering efficacy of Brimonidine tartrate ophthalmic solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.
  • Brimonidine tartrate ophthalmic solution 0.2% is an alpha adrenergic agonist indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • The recommended dose is one drop of Brimonidine tartrate ophthalmic solution 0.2% in the affected eye(s) three times daily, approximately 8 hours apart.
  • Brimonidine tartrate ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.u00a0
  • One drop in the affected eye(s), three times daily, approximately 8 hours apart.
  • Solution containing 2 mg/mL brimonidine tartrate.
  • Solution containing 2 mg/mL brimonidine tartrate.
  • Neonates and infants (under the age of 2 years). ()
  • Potentiation of vascular insufficiency. ()
  • Most common adverse reactions occurring in approximately 10 to 30% of patients receiving brimonidine ophthalmic solution 0.2% included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. ()
  • No data
  • Antihypertensives/cardiac glycosides may lower blood pressure. ()
  • Use with CNS depressants may result in an additive or potentiating effect. ()
  • Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ()
  • Monoamine oxidase inhibitors may result in increased hypotension. ()
  • Use with caution in children u2265 2 years of age. ()
  • Very limited information exists on accidental ingestion of brimonidine in adults; the only adverse reaction reported to date has been hypotension. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine tartrate as part of medical treatment of congenital glaucoma or by accidental oral ingestion u00a0u00a0u00a0u00a0u00a0. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
  • Brimonidine tartrate ophthalmic solution 0.2%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (topical intraocular pressure lowering agent).
  • The structural formula of brimonidine tartrate is:
  • 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24
  • In solution, Brimonidine tartrate ophthalmic solution 0.2% has a clear, greenish-yellow color. It has an osmolality of 280 -330 mOsml/kg and a pH of 5.6 -6.6.
  • Each mL of Brimonidine tartrate ophthalmic solution contains the active ingredient brimonidine tartrate 0.2% (2 mg/mL) with the inactive ingredients benzalkonium chloride 0.005% (0.05 mg/mL) as a preservative; citric acid; polyvinyl alcohol; sodium chloride; sodium citrate; and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.
  • No data
  • No compound-related carcinogenic effects were observed in either mice or rats following a 21-month and 24-month study, respectively. In these studies, dietary administration of brimonidine tartrate at doses up to 2.5 mg/kg/day in mice and 1.0 mg/kg/day in rats achieved ~77 and 118 times, respectively, the plasma C drug concentration estimated in humans treated with one drop Brimonidine tartrate ophthalmic solution 0.2% into both eyes 2 times per dayn
  • Brimonidine tartrate was not mutagenic or clastogenic in a series of u00a0 and u00a0 studies including the Ames bacterial reversion test, chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells, and three u00a0 studies in CD-1 mice: a host-mediated assay, cytogenetic study, and dominant lethal assay.
  • A reproduction and fertility study in rats with brimonidine tartrate demonstrated no adverse effect on male or female fertility at oral doses up to 1 mg/kg, estimated as approximately 200 times the systemic exposure (AUC) following the maximum recommended human ophthalmic dose of Brimonidine tartrate ophthalmic solution 0.5%.
  • Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. Brimonidine tartrate has the action of lowering intraocular pressure with minimal effect on cardiovascular and pulmonary parameters.
  • In comparative clinical studies with timolol 0.5%, lasting up to one year, the IOP lowering effect of Brimonidine tartrate ophthalmic solution was approximately 4-6 mm Hg compared with approximately 6 mm Hg for timolol. In these studies, both patient groups were dosed BID; however, due to the duration of action of Brimonidine tartrate ophthalmic solution, it is recommended that Brimonidine tartrate ophthalmic solution be dosed TID. Eight percent of subjects were discontinued from studies due to inadequately controlled intraocular pressure, which in 30% of these patients occurred during the first month of therapy. Approximately 20% were discontinued due to adverse experiences.
  • Brimonidine tartrate ophthalmic solution 0.2% is supplied sterile, in white LDPE Bottle, White LDPE Nozzle with a Purple HDPE Cap in the following sizes:
  • 5 mL bottle in one carton u2013 NDC 70069--01
  • 10 mL bottle in one carton u2013 NDC 70069--01
  • 15 mL bottle in one carton u2013 NDC 70069--01
  • Storage:
  • Handlingn- then- Container
  • Instruct patients that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions u00a0u00a0u00a0u00a0. Always replace the cap after using. If solution changes color or becomes cloudy, do not use. Do not use the product after the expiration date marked on the bottle.
  • Whenn- ton- Seekn- Physiciann- Advice
  • Advise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose containern
  • Usen- withn- Contactn- Lenses
  • Advise patients that contact lenses should be removed prior to instillation of Brimonidine tartrate ophthalmic solution and may be reinserted 15 minutes following its administration.
  • Usen- withn- Othern- Ophthalmicn- Drugs
  • Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
  • Potentialn- forn- Decreasedn- Mentaln- Alertness
  • As with other similar medications, Brimonidine tartrate ophthalmic solution may cause fatigue and/or drowsiness in some patients. Caution patients who engage in hazardous activities of the potential for a decrease in mental alertness.
  • Manufactured for:
  • Somerset Therapeutics, LLC
  • Hollywood, FL 33024
  • Customer Care # 1-800-417-9175
  • Made in India
  • Code No.:KR/DRUGS/KTK/28/289/97
  • ST-BRM/P/02
  • 5 mL Container label
  • 5 mL Carton label
  • 10 mL Container label
  • 10 mL Carton label
  • 15 mL Container label
  • 15 mL Carton label

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) which is also known as BRIMONIDINE TARTRATE and Manufactured by Somerset Therapeutics, LLC. It is available in strength of 2 mg/mL.

BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) 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.

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