Anti-Glaucoma

BRIMOEYE-T

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BRIMOEYE-T

Anti-Glaucoma


Brimonidine Tartrate & Timolol Maleate Ophthalmic Solution

COMPOSITION
Each ml contains: Brimonidine Tartrate IP 0.2% w/v, Timolol Maleate IP equivalent to Timolol 0.5% w/v, Sterile Aqueous buffered vehicle q.s

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INTRODUCTION
BRIMOEYE-T (Brimonidine Tartrate & Timolol Maleate Ophthalmic Solution) 0.2% w/v & 0.5% w/v respectively, sterile, is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent).
5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24 (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (salt); MW=432.50 as the maleate salt In solution, BRIMOEYE-T (Brimonidine Tartrate & Timolol Maleate ophthalmic solution) 0.2% w/v & 0.5% w/v respectively has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine Tartrate appears as an off-white, or white to pale-yellow powder and is soluble in both water (1.5 mg/ml) and in the product vehicle (3 mg/ml) at pH 7.2. Timolol Maleate appears as a white, odorless, crystalline powder and is soluble in water, methanol, and alcohol. Each ml of BRIMOEYE-T contains the active ingredients Brimonidine Tartrate 0.2% w/v and Timolol Maleate 0.5% w/v in sterile aqueous buffered vehicle.

INDICATIONS
BRIMOEYE-T (Brimonidine Tartrate & Timolol Maleate Ophthalmic Solution) 0.2% w/v & 0.5% w/v respectively is an alpha-adrenergic receptor agonists with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of BRIMOEYE-T dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% w/v Timolol Maleate ophthalmic solution dosed twice a day and 0.2% w/v Brimonidine Tartrate ophthalmic solution dosed three times per day.

DIRECTIONS
BRIMOEYE-T dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% w/v Timolol Maleate ophthalmic solution dosed twice a day and 0.2% w/v Brimonidine Tartrate ophthalmic solution dosed three times per day.

WARNINGS
Potentiation of Respiratory Reactions Including Asthma : BRIMOEYE-T contains Timolol Maleate; and although administered topically can be absorbed systemically. Therefore, the same types of
adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. Ocular hypersensitivity reactions have been reported with Brimonidine Tartrate ophthalmic solutions 0.2% w/v, with some reported to be associated with an increase in intraocular pressure.
Impairment of Beta-adrenergically Mediated Reflexes During Surgery : The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have experienced protracted severe hypertension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported. For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta adrenergic receptor blocking agents. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists

SIDE EFFECTS
Clinical Studies Experience : Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. BRIMOEYE-T, the most frequent reactions associated with its use occurring in approximately 5% to 15% of the patients included: allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging. The following adverse reactions were reported in 1% to 5% of patients: asthenia, blepharitis, corneal erosion, depression, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, eyelid pruritus, foreign body sensation, headache, hypertension, oral dryness, somnolence, superficial punctate keratitis, and visual disturbance. Other adverse reactions that have been reported with the individual components are listed below.
Brimonidine Tartrate (0.1%-0.2%) : Abnormal taste, allergic reaction, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, fatigue, flu syndrome, follicular conjunctivitis, gastrointestinal disorder, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), hordeolum, insomnia, keratitis, lid disorder, nasal dryness, ocular allergic reaction, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, taste perversion, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity.
Timolol (Ocular Administration) :
Body as a whole: chest pain; Cardiovascular: Arrhythmia, bradycardia, cardiac arrest, cardiac failure, cerebral ischemia, cerebral vascular accident, claudication, cold hands and feet, edema, heart block, palpitation, pulmonary edema, Raynaud’s phenomenon, syncope, and worsening of angina pectoris; Digestive: Anorexia, diarrhea, nausea;
Immunologic: Systemic lupus erythematosus;
Nervous System/Psychiatric: Increase in signs and symptoms of myasthenia gravis, insomnia, nightmares, paresthesia, behavioral changes and psychic disturbances including confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss;
Skin: Alopecia, psoriasiform rash or exacerbation of psoriasis;
Hypersensitivity: Signs and symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria, and generalized and localized rash;
Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), dyspnea, nasal congestion, respiratory failure;
Endocrine: Masked symptoms of hypoglycemia in diabetes patients
Special Senses: Diplopia, choroidal detachment following filtration surgery,cystoid macular edema, decreased corneal sensitivity, pseudopemphigoid, ptosis, refractive changes, tinnitus;
Urogenital: Decreased libido, impotence, Peyronie’s disease, retroperitoneal fibrosis.

PACKING
BRIMOEYE-T is supplied in 5ml and 10ml plastic dropper vials which are specially designed to avoid contamination due to non sterile air or other causes.

Storage :
Store at a temperature not exceeding 30°C and protect from light.

Medicine :
Keep out of reach of children.
Use the solution within one month after opening the container.
For external use only.

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