Presentation

Brimodin Plus Sterile Eye Drops: Each ml contains Brimonidine Tartrate INN 2 mg and Timolol Maleate USP equivalent to Timolol 5 mg.

Description

Brimodin Plus is a combination preparation of selective alpha-2 adrenergic receptor agonist, brimonidine and a non-selective beta-adrenergic receptor inhibitor, timolol. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action. Brimonidine lowers IOP by reducing aqueous humor production and increasing uveoscleral outflow. Timolol also lowers IOP by reducing aqueous humor production.

Indications

Brimodin Plus is 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.

Dosage & Administration

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.

Safety and effectiveness in children below the age of 2 years have not been established.

Side Effects

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.

Precautions

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.

Use in Pregnancy & Lactation

Pregnancy: 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.

Lactation: 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.

Drug Interaction

Monoamine oxidase inhibitors may result in increased hypotension. Antihypertensives/cardiac glycosides may lower blood pressure. Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade. Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension. Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. Use with CNS depressants may result in an additive or potentiating effect. CYP2D6 inhibitors may potentiate systemic beta-blockade.

Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine.

Over Dose

No information is available on overdosage with this drops in humans.

Storage

Store in a cool & dry place, protected from light

Keep out of reach of children

Do not use more than 4 weeks after opening

Commercial Pack

Brimodin Plus Sterile Eye Drops: Each plastic dropper bottle contains 5 ml of sterile eye drops.