brimonidine tartrate structure zofran

[label] In a clinical study of adult subjects with facial erythema of rosacea, brimonidine … Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling Brimonidine Tartrate Ophthalmic Solution to insert soft contact lenses.As with other drugs in this class, Brimonidine Tartrate Ophthalmic Solution may cause fatigue and/or drowsiness in some patients. In pediatric patients 7 years of age or older (>20kg), somnolence appears to occur less frequently (25%). Patients prescribed lOP-lowering medication should be routinely monitored for IOP.The preservative in Brimonidine Tartrate Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. 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 drug concentration estimated in humans treated with one drop of Brimonidine Tartrate Ophthalmic Solution into both eyes 3 times per day.Brimonidine tartrate was not mutagenic or cytogenic in a series of in vitro and in vivo studies including the Ames test, chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells, a host-mediated assay and cytogenic studies in mice and dominant lethal assay.Reproductive studies performed in rats with oral doses of 0.66 mg base/kg revealed no evidence of harm to the fetus due to Brimonidine Tartrate Ophthalmic Solution.Reproduction studies performed in rats with oral doses of 0.66 mg base/kg revealed no evidence of harm to the fetus due to Brimonidine Tartrate Ophthalmic Solution. Dosing at this level produced 100 times the plasma drug concentration level seen in humans following multiple ophthalmic doses.There are no adequate and well-controlled studies in pregnant women. The chemical name brimonidine tartrate is 5-bromo-6 (2-imidazolidinylideneamino) quinoxaline L-tartrate. 3 It is considered to be a third generation alpha-2 aadrenergic receptor agonist, since it displays preferential binding at alpha-2 adrenoceptors over alpha-1 receptors. The molecular formula is CBrimonidine Tartrate Ophthalmic Solution, 0.2% is a sterile ophthalmic solution.ACTIVE: Brimonidine Tartrate 2 mg (equivalent to 1.32 mg as brimonidine free base). Brimonidine readily penetrates the cornea following ocular administration [A178951] to reach pharmacologically active concentrations in the aqueous humor and ciliary body, the putative sites of its IOP-lowering activity. It has a peak ocular hypotensive effect occurring at two hours post-dosing. The most commonly observed adverse event was somnolence.

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. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.Brimonidine Tartrate Ophthalmic Solution, 0.2% is supplied in white opaque plastic dropper bottles as followss:KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDRENStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Carcinogenesis, mutagenesis, impairment of fertility:Pregnancy: Teratogenic Effects: Pregnancy Category B. Brimonidine Tartrate is the tartrate salt form of brimonidine, an imidazole derivative and a selective alpha-2 adrenergic receptor agonist. It has a peak ocular hypotensive effect occurring at two hours post-dosing. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.In a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years) the most commonly observed adverse events with brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50% - 83% in patients ages 2 to 6 years) and decreased alertness.
The molecular formula is C 11 H 10 BrN 5 •C 4 H 6 O 6 ; the structural formula is: Brimonidine Tartrate Ophthalmic Solution, 0.2% is a sterile ophthalmic solution. Treatment of an oral overdose includes supportive and symptomatic therapy; a patient airway should be maintained.The recommended dose is one drop of Brimonidine Tartrate Ophthalmic Solution 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.

It is not known whether the concurrent use of these agents with Brimonidine Tartrate Ophthalmic Solution in humans can lead to resulting interference with I0P lowering effect. Brimonidine is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.. Reference standards of Brimonidine API, and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below

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