BRIMO-P 0.1% EYE DROPS 5ML

Indications

Approved Uses

Lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Off-Label Uses

No routine/established off-label use should be recommended; proposed neuroprotection in glaucoma remains unproven and is not guideline-endorsed as an indication.

Dosage & Administration

Dosing by Condition

Open-angle glaucoma or ocular hypertension: Instill one drop in the affected eye(s) three times daily, approximately 8 hours apart.

Initial Dose

One drop in the affected eye(s) three times daily.

Maintenance Dose

1 drop in the affected eye(s) three times daily (every 8 hours)

Maximum Dose

1 drop in the affected eye(s) three times daily (approximately every 8 hours); do not exceed TID

Children's Dosage

Not recommended in children under 2 years. Appropriate studies have not demonstrated pediatric-specific problems that limit usefulness in children 2 years and older; however, somnolence and CNS depression reported; monitor closely.

How to Take

Ophthalmic use: wash hands; instill 1 drop into the conjunctival sac of the affected eye(s) as prescribed; avoid touching the dropper tip; close the eye and apply nasolacrimal occlusion (press inner canthus) for 1-2 minutes to reduce systemic absorption; if using other eye drops, separate by at least 5 minutes; remove contact lenses before use and wait at least 15 minutes before reinserting.

Side Effects

Common Side Effects

Oral dryness, ocular hyperemia (redness), burning and stinging, headache, blurred vision, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and eye pruritus (itching).

Side Effect Frequency

Most common: ocular hyperemia, allergic conjunctivitis, eye pruritus, burning sensation, oral dryness. Other common: hypertension, visual disturbance, conjunctival folliculosis, ocular allergic reaction. Less common: corneal erosion, etc. Postmarketing: somnolence in children, bradycardia, etc.

Safety & Warnings

Contraindications

Hypersensitivity to brimonidine tartrate/excipients; concomitant MAO inhibitor therapy; use in neonates/infants <2 years

Warnings & Precautions

Use caution in severe cardiovascular disease, cerebrovascular/coronary insufficiency, Raynaud’s, orthostatic hypotension, thromboangiitis obliterans, and depression; risk of CNS depression (greater in children) and avoid pediatric exposure; avoid with MAOIs; if preservative (e.g., benzalkonium chloride) present, remove contact lenses and reinsert after ~15 minutes; monitor for ocular allergic reactions

Age Restriction

Contraindicated in children under 2 years of age.

Drug Interactions

Drug Interactions

MAO inhibitors (contraindicated/avoid); CNS depressants (additive sedation/CNS depression); antihypertensives and cardiac glycosides (additive hypotension/bradycardia); tricyclic antidepressants (may reduce brimonidine effect); other IOP-lowering agents incl. topical beta-blockers (additive IOP-lowering and possible cardiovascular effects)

Interaction Severity

MAJOR: concomitant MAO inhibitors (and other drugs affecting adrenergic transmission) - avoid/contraindicated due to risk of enhanced systemic effects (e.g., hypotension/CNS depression). MODERATE: CNS depressants (additive sedation), antihypertensives/beta-blockers/cardiac glycosides (additive bradycardia/hypotension), tricyclic antidepressants (may reduce brimonidine’s IOP-lowering effect). MINOR: other topical ophthalmics-separate administration by ≥5 minutes.

Food Interaction

No restriction

Special Populations

Children

Not recommended in children under 2 years. Appropriate studies have not demonstrated pediatric-specific problems that limit usefulness in children 2 years and older; however, somnolence and CNS depression reported; monitor closely.

Kidney Impairment

No established dose adjustment; use with caution in severe renal impairment

Storage & Patient Advice

Missed Dose

Instill the missed dose as soon as remembered; if it is near the time of the next dose, skip the missed dose and resume the regular schedule; do not double doses.

Overdose

Ocular overdose: rinse/flush with water or saline; systemic/ingestion (especially children): CNS depression, hypotension, bradycardia, apnea/respiratory depression, hypothermia/coma-manage with supportive care (airway/ventilation, vitals monitoring) and urgent medical evaluation; no specific antidote

Patient Counseling

Use exactly as prescribed; wash hands and avoid touching the dropper tip; instill 1 drop and apply nasolacrimal occlusion for 1-2 minutes; if using other eye drops, wait ≥5 minutes between products; remove contact lenses and reinsert after ≥15 minutes; expect possible transient burning, blurred vision, dry mouth, fatigue/drowsiness-use caution with driving until effects are known and avoid alcohol/other sedatives if they worsen drowsiness; report persistent redness/itching/swelling or signs of allergy; store below 25°C (per SFDA) and follow local labeling for in-use discard time.

Monitoring Requirements

Monitor intraocular pressure and optic nerve/visual fields per glaucoma follow-up; monitor for ocular allergy (redness, itching, follicular conjunctivitis) and, in susceptible patients, systemic effects such as blood pressure/heart rate changes and excessive sedation.

Pharmacology

Mechanism of Action

A selective alpha-2 adrenergic agonist that lowers intraocular pressure by a dual mechanism: reducing aqueous humor production and increasing uveoscleral outflow.

Onset of Action

Onset of IOP reduction is typically within about 1 hour after instillation, with peak effect around 2 hours.

Duration of Effect

Intraocular pressure (IOP) lowering typically lasts about 12 hours after a dose; peak effect occurs around 2 hours.

Bioavailability

Systemic absorption can occur after ophthalmic dosing (via conjunctiva/nasolacrimal drainage), but plasma concentrations are generally low due to limited dose and first-pass metabolism after nasal/oral absorption.

Excretion

Primarily renal excretion of metabolites.

Product Information

Available Dosage Forms

Eye drops, solution (ophthalmic solution) only for this product (BRIMO-P 0.1% 5 mL).

Composition per Dose

Each 1 mL: Brimonidine tartrate 1 mg (0.1%)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Target Organ

Eye

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