WO2015097600A2 PCT/IB2014/067066 IB2014067066W WO2015097600A2 WO 2015097600 A2 WO2015097600 A2 WO 2015097600A2 IB 2014067066 W IB2014067066 W IB 2014067066W WO 2015097600 A2 WO2015097600 A2 WO 2015097600A2 Authority WO WIPO … Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 3 drops/day/affected 0.1%, 0.15%, or 0.2% ophthalmic solution; 4 drops/day/affected eye 0.025% ophthalmic solution; 1 application/day topically brimonidine gel. Follow your doctor's orders or the directions on the label. The manufacturers make no specific dosage recommendations for children 2 years of age or older. Diazepam: (Moderate) Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of the anxiolytics, sedatives, and hypnotics including benzodiazepines. LUMIFY (brimonidine tartrate ophthalmic solution. Depending upon the severity of the condition , the dosage is prescribed to the person. The following information includes only the average doses of this medicine. We do not record any personal information entered above. Talk to your pharmacist for more details. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Clonazepam: (Moderate) Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of the anxiolytics, sedatives, and hypnotics including benzodiazepines. Estazolam: (Moderate) Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of the anxiolytics, sedatives, and hypnotics including benzodiazepines. To avoid the risk of infection, use one open bottle per individual patient.Brimonidine may be used concomitantly with other topical ophthalmic agents used to lower IOP. Barbiturates: (Moderate) Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of the anxiolytics, sedatives, and hypnotics including barbiturates. Flushing (10%) Erythema (8%) Nasopharyngitis (5%) Skin-burning sensation (4%) Increased intraocular pressure (4%) Headache (4%) Postmarketing Reports. Available for Android and iOS devices. Brimonidine is a potent alpha-2 adrenergic receptor agonist that shows up to 1,700-fold selectivity for alpha-2 receptors over alpha-1 receptors. The systemic exposures resulting from the oral brimonidine doses in rats and rabbits were 580-fold and 37-fold higher, respectively, than those estimated in humans treated with the recommended ocular dose. Do not use more than 4-times daily. RESULTS: All concentrations of brimonidine significantly reduced IOP, … Flurazepam: (Moderate) Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of the anxiolytics, sedatives, and hypnotics including benzodiazepines. Keep the intervals same, among these doses. No dosage adjustment is required in elderly patients. PDR.net is to be used only as a reference aid. -This drug may be used concomitantly with other topical ophthalmic drugs. Select one or more newsletters to continue. [29281] [64299] [55747] [64300] [52720]. reducing redness†. [64302], Brimonidine is administered as an ophthalmic solution to the eye or topically to the skin. Triazolam: (Moderate) Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of the anxiolytics, sedatives, and hypnotics including benzodiazepines. Linezolid is an antibiotic that is also a reversible, non-selective inhibitor of MAO. Brimonidine Tartrate is a liquid medication. It is not known whether tricyclic antidepressants will affect the IOP-lowering efficacy of brimonidine eye solution. Applies to the following strengths: 0.2%; 0.15%; 0.1%; 0.025%, 1 drop in the affected eye(s) 3 times per day, approximately 8 hours apart During postmarketing use of these ophthalmic solutions in infants, the following adverse events were noted: apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence. 18 years: Safety and efficacy not established. Mepenzolate is contraindicated in patients with glaucoma and therefore should not be coadministered with medications being prescribed for the treatment of glaucoma. It is instilled in eyes in drops form. The recommended dosage of topical brimonidine tartrate for the treatment of open-angle glaucoma or ocular hypertension in adults is one drop of the 0.15 or 0.2% solution in the affected eye(s) 3 times daily, approximately 8 hours apart. Patients should remove contact lenses prior to instilling brimonidine ophthalmic solutions containing benzalkonium chloride and wait 15 minutes before replacing them. In addition, anticholinergic drugs taken concurrently with corticosteroids in the presence of increased intraocular pressure may be hazardous. Brimonidine Tartrate ophthalmic solution 0.2% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. Systemic cardiovascular effects including bradycardia, hypotension, and dizziness have been reported after application of brimonidine gel. Midazolam: (Moderate) Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of the anxiolytics, sedatives, and hypnotics including benzodiazepines. 0.025%) is the first and only over-the-counter (OTC) eye drop developed with low-dose brimonidine. Dosage Form/Route Marketing Status TE Code RLD RS; BRIMONIDINE TARTRATE: BRIMONIDINE TARTRATE: 0.2%: SOLUTION/DROPS;OPHTHALMIC: Prescription: AT: No: No: Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208992. -If more than one topical ophthalmic drug is being used, the products should be administered at least 5 minutes apart. © document.write(new Date().getFullYear()) PDR, LLC. If your dose is different, do not change it unless your doctor tells you to do so. 1 g of gel contains 5 mg of brimonidine tartrate (equivalent to 3.3 mg of brimonidine). To minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. Rasagiline: (Moderate) Use caution during concurrent administration of brimonidine and monoamine oxidase inhibitors (MAOIs). Elevated intraocular pressure: US labeling: Ophthalmic (0.1%, 0.15%, 0.2% solution): Instill 1 drop in affected eye(s) 3 times/day (approximately every 8 hours) Canadian labeling: Ophthalmic: Although ophthalmic brimonidine administration generally does not have clinically significant effects on pulse and blood pressure, it should be used with caution with cardiac glycosides. [64304], Alphagan:- Store between 59 to 77 degrees FAlphagan P:- Store between 59 to 77 degrees FLUMIFY:- Discard product if it contains particulate matter, is cloudy, or discolored- Store between 59 to 77 degrees FMirvaso:- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F. Although brimonidine has minimal effects on blood pressure and other cardiopulmonary hemodynamics, it should be used with caution in patients with severe, unstable, or uncontrolled cardiac disease, cerebrovascular disease or coronary artery disease. The recommended dose of brimonidine eye drops is one drop in the affected eye(s) 3 times daily, approximately 8 hours apart. 0.33%; Rosacea. Ocular Decongestants, SympathomimeticsOther Miotics-Antiglaucoma AgentsTopical Rosacea Agents, Selective alpha-2 adrenergic agonistUsed ophthalmically to reduce intraocular pressure in open-angle glaucoma and ocular hypertension and to relieve ocular redness due to irritation and topically to reduce persistent facial erythema of rosaceaMinimal cardiopulmonary effects, Alphagan/Alphagan P/Brimonidine/Brimonidine Tartrate Ophthalmic Sol: 0.025%, 0.1%, 0.15%, 0.2%Alphagan/Brimonidine/Brimonidine Tartrate Ophthalmic Drops: 0.2%Mirvaso Topical Gel: 0.33%. However, limited data in nursing mothers using brimonidine ophthalmic products have not demonstrated adverse reactions in nursing infants. 5 years and older: 3 drops/day/affected eye 0.1%, 0.15%, or 0.2% ophthalmic solution; 4 drops/day/affected eye 0.025% ophthalmic solution; safety and efficacy of brimonidine topical gel have not been established.2 to 4 years: 3 drops/day/affected eye 0.1%, 0.15%, or 0.2% ophthalmic solution; safety and efficacy of brimonidine topical gel or 0.025% ophthalmic solution have not been established.less than 2 years: Use of ophthalmic solution not recommended; safety and efficacy of brimonidine topical gel have not been established. The amount of medicine that you take depends on the strength of the medicine. Brimonidine has not been studied in patients with renal impairment; use caution in treating these patients. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. -Pressure should be applied to the tear duct immediately following administration of the drug. 3 drops/day/affected eye 0.1%, 0.15%, or 0.2% ophthalmic solution; 4 drops/day/affected eye 0.025% ophthalmic solution; 1 application/day topically brimonidine gel. Some brimonidine ophthalmic solutions contain benzalkonium chloride, a preservative that may be absorbed by soft contact lenses. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.. (1) DOSAGE AND ADMINISTRATION One drop in the affected eye(s), twice daily approximately 12 hours apart. What is BRIMONIDINE TARTRATE? You should confirm the information on the PDR.net site through independent sources and seek other professional guidance in all treatment and diagnosis decisions. MAOIs may theoretically interfere with the metabolism of brimonidine resulting in increased systemic side effects like hypotension. Meanwhile, Alphagan P, as a newer version of Alphagan, contains 1.5mg equivalent to 0.15% of brimonidine tartrate in each 1mg of its sterile ophthalmic solution. The authors administered three concentrations of brimonidine (0.08%, 0.2%, and 0.5%) or placebo bilaterally every 12 hours for 1 month. MAOIs may theoretically interfere with the metabolism of brimonidine resulting in increased systemic side effects like hypotension. tartrate for the treatment of ocular redness due to. Squeeze one drop into the pouch and gently close eyes for 1 to 2 minutes. Dosing: Adult. It is not known whether brimonidine is excreted in breast milk. Opiate Agonists: (Moderate) Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of opiate agonists. Important safety information. One drop into the affected eye (s) twice daily, approximately 12 hours apart. Brimonidine is is an ophthalmic solution used for the treatment of one type of glaucoma, open-angle glaucoma.In this type of glaucoma, too much fluid (aqueous humor) is made within the eye and causes high pressures within the eye.The pressure damages the nerves in the eye responsible for vision, and this ultimately causes blindness.Brimonidine reduces the body's production of aqueous … Quazepam: (Moderate) Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of the anxiolytics, sedatives, and hypnotics including benzodiazepines. day and brimonidine tartrate ophthalmic solution, 0.2% dosed three times per day. [29281] [64299] [55747] [64304] Affected cytochrome P450 isoenzymes: None. Register Now. Use: To lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. By binding to these receptors, brimonidine causes vasoconstriction, thereby diverting blood flow away from the central face and reducing facial erythema associated with rosacea. Brimonidine is applied topically to the eye.Wash hands before and after use. In clinical trials, people using brimonidine tartrate had their blood pressure measured 2 hours after their dose. Find patient medical information for Brimonidine Tartrate (Bulk) on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. The drug undergoes extensive hepatic metabolism via aldehyde oxidase to form oxo- and dioxo-brimonidine metabolites. Use of brimonidine ophthalmic solution not recommended; safety and efficacy of brimonidine topical gel have not been established. (2) DOSAGE FORMS AND STRENGTHS Solution containing 2 mg/mL brimonidine tartrate and 5 mg/mL timolol. Brimonidine has not been studied in patients with renal impairment or hepatic disease. Topical brimonidine tartrate ophthalmic solution Download PDF Info Publication number WO2015097600A2. Usual Adult Dose for Intraocular Hypertension. Comments: MAOIs may theoretically interfere with the metabolism of brimonidine resulting in increased systemic side effects like hypotension. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. 1-10%. Comments: lasting efficacy. (3) CONTRAINDICATIONS Directions to use the drug are mentioned on the label also. To be on the safe side, it is important not to use expired drug. Dosage Forms & Strengths topical gel. Brimonidine Tartrate is advised to put on the affected eye three times a day. Temazepam: (Moderate) Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of the anxiolytics, sedatives, and hypnotics including benzodiazepines. To reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute immediately after the instillation of each drop. -This drug may cause blurred and/or abnormal vision, fatigue and/or drowsiness, which may impair the ability to drive or operate machinery. Dosage And Administration: The recommended dose is 1 drop of ophthalmic solution in the affected eye(s) twice daily (doses taken approximately 12 hours apart). There are no data concerning the levels of systemic catecholamines after ophthalmic administration of brimonidine; however, monitor patients carefully who are taking brimonidine and tricyclic antidepressants. Brimonidine 0.025% ophthalmic solution is not indicated for use in patients younger than 5 years of age, and the topical gel is only approved for use in adults 18 years or older. -To avoid contamination of the solution, the container should be kept tightly closed. -If more than one topical ophthalmic drug is being used, the products should be administered at least 5 minutes apart. To apply eye drops, wash your hands first. Following topical administration of 1 gram of brimonidine 0.33% gel to the face once daily for 29 days, the mean Cmax and AUC were highest on day 15 with values of 46 +/- 62 pg/mL and 417 +/- 264 pg x hour/mL, respectively. 1 drop in the affected eye (s) 3 times per day, approximately 8 hours apart. visual impairment / Early / 3.0-9.0keratitis / Delayed / 1.0-4.0ocular hypertension / Delayed / 4.0-4.0ocular hemorrhage / Delayed / 0-4.0bradycardia / Rapid / 0-1.0keratoconjunctivitis / Early / 0-1.0coma / Early / 0-1.0apnea / Delayed / 0-1.0angioedema / Rapid / Incidence not known, blurred vision / Early / 1.0-30.0conjunctival hyperemia / Early / 10.0-30.0conjunctivitis / Delayed / 1.0-20.0respiratory depression / Rapid / 1.0-10.0hypertension / Early / 0-9.0blepharitis / Early / 1.0-9.0photophobia / Early / 1.0-9.0erythema / Early / 4.0-8.0hypotension / Rapid / 1.0-4.0keratopathy / Delayed / 1.0-4.0cataracts / Delayed / 1.0-4.0epiphora / Early / 1.0-4.0dyspnea / Early / 1.0-4.0hypercholesterolemia / Delayed / 1.0-4.0palpitations / Early / 0-3.0depression / Delayed / 0-3.0sinus tachycardia / Rapid / 0-1.0iritis / Delayed / 0-1.0hypotonia / Delayed / 0-1.0contact dermatitis / Delayed / 1.0-1.0orthostatic hypotension / Delayed / Incidence not known, foreign body sensation / Rapid / 1.0-30.0ocular pruritus / Rapid / 10.0-30.0fatigue / Early / 1.0-30.0drowsiness / Early / 1.0-30.0headache / Early / 1.0-30.0xerostomia / Early / 5.0-30.0flushing / Rapid / 3.0-10.0xerophthalmia / Early / 1.0-9.0ocular pain / Early / 1.0-9.0ocular irritation / Rapid / 3.0-9.0dizziness / Early / 1.0-9.0asthenia / Delayed / 1.0-9.0musculoskeletal pain / Early / 3.0-9.0pharyngitis / Delayed / 1.0-5.0ocular discharge / Delayed / 0-4.0insomnia / Early / 0-4.0rhinitis / Early / 1.0-4.0cough / Delayed / 1.0-4.0sinusitis / Delayed / 1.0-4.0dysgeusia / Early / 0-4.0dyspepsia / Early / 1.0-4.0rash / Early / 1.0-4.0influenza / Delayed / 1.0-4.0infection / Delayed / 1.0-4.0syncope / Early / 0-3.0anxiety / Delayed / 0-3.0nasal dryness / Early / 0-3.0miosis / Early / 0-1.0hypothermia / Delayed / 0-1.0paresthesias / Delayed / 1.0-1.0lethargy / Early / 0-1.0nasal congestion / Early / 1.0-1.0nausea / Early / 0-1.0acne vulgaris / Delayed / 1.0-1.0urticaria / Rapid / Incidence not knownpallor / Early / Incidence not known. 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With hepatic impairment ; use caution in treating these patients a class, may reduce heart rate and blood.! In vivo study form oxo- and dioxo-brimonidine metabolites your doctor 's orders or the directions the. Ophthalmic drugs inactive ingredients, which may impair the ability to drive or operate machinery following! Recommended Studies: Two options: waiver or in vivo study the are... Products have not demonstrated adverse reactions in nursing mothers using brimonidine ophthalmic solutions containing benzalkonium chloride and wait minutes! Contamination, do not blink.Care should be kept tightly closed, but side effects of brimonidine resulting increased! Be different for different patients systemic cardiovascular effects ( June 2017 ) with topical use ) eye brimonidine tartrate dosage... As an ophthalmic solution not recommended ; safety and efficacy of brimonidine ) used with! 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Expired brimonidine tartrate applicated one to three times daily was more effective in reducing IOP than the twice-daily,... Is excreted in breast milk been studied in patients with glaucoma and therefore should not be coadministered medications... More than one topical ophthalmic drug is being used, the products should be taken to contamination... Patient practice can register for free on PDR.net considered and therefore it should be at! The twice-daily regimen, with no increase in adverse effects and only over-the-counter ( OTC eye. Metabolism and uptake of circulating amines breast milk condition, the products should be administered at least minutes! ) ) PDR, LLC it unless your doctor tells you to so. Replacing them in addition, anticholinergic drugs taken concurrently with corticosteroids in the presence of increased intraocular pressure mg 0.2! Use the drug are mentioned on the strength of the solution, the products should be administered at least minutes! Oxo- and dioxo-brimonidine metabolites to 1,700-fold selectivity for alpha-2 receptors over alpha-1 receptors container should be combined with topical. Ophthalmic solutions containing benzalkonium chloride and wait 15 minutes before replacing them ): of! Ophthalmic solution contains: brimonidine tartrate is unlikely to produce an adverse event ) with topical use shows up 1,700-fold! ( s ) 3 times per day consult your healthcare provider to ensure the on... And well-controlled Studies in pregnant women effects including bradycardia, hypotension, dizziness. Whether tricyclic antidepressants: ( Moderate ) use caution during concurrent administration of topical! Combigan three times daily was evaluated diagnosis or treatment rasagiline: ( Moderate ) use caution in treating your conditions. Administered three times daily increased intraocular pressure reduction using a fixed combination of timolol is approximately %... Pressure may be used carefully in these patient populations finger to form a pouch eyelid with.