IBN SINA PHARMACEUTICALS LTD.
BRIMONIDINE TARTRATE + TIMOLOL MALEATE
This eye drops is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Drugs for miotics and glaucoma
Brimonidine is more selective for the 8-2 adrenoreceptor. It is thought that Brimonidine Tartrate lowers IOP by enhancing uveoscleral outflow and reducing aqueous humour formation. Timolol is a beta1 and 8-2 non-selective adrenergic receptor blocking agent. Timolol lowers IOP by reducing aqueous humour formation. The precise mechanism of action is not clearly established, predominant action may be related to reduced aqueous formation. However, in some studies a slight increase in outflow facility was also observed.
The recommended dose is one drop of this eye drops in the affected eye(s) twice daily approximately 12 hours apart. If more than one topical ophthalmic product is to be used, other eye drops should be instilled at least 5 minutes apart.
Specific drug interaction studies on this ophthalmic preparation have not been established
Contraindicated in patients with hypersensitivity to any component of this medication, in patients receiving monoamine oxidase (MAO) inhibitor therapy, bronchospasm, bronchial asthma or severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, cardiac failure or cardiogenic shock.
The most frequent reactions of this combination are allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, blepharitis, corneal erosion, epiphora, eye dryness, eye pain, eyelid edema, eyelid pruritus, headache, hypertension, superficial punctate keratitis, and visual disturbance
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Timolol has been detected in human milk following oral and ophthalmic drug administration. It is not known whether brimonidine passes into human breast milk. However, it has been shown to pass into the milk of nursing animals. Because of the potential for serious adverse reactions from this combination in nursing infants, 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.
No clinical data are available on overdose with this eye drops.
Like other topically applied ophthalmic agents, it may be absorbed systemically. Due to the presence of Timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur. Cautions should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular or pulmonary diseases.
Store in a cool & dry place, protected from light. Keep out of reach of children. Do not use more than 4 weeks after opening. It is desirable that the contents should not be used more than four weeks after first opening of the bottle.