SIMBRINZA EYE DROPS 5ML

Indications

Approved Uses

Reduction of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension

Dosage & Administration

Dosing by Condition

Open-angle glaucoma / Ocular hypertension: One drop instilled into the affected eye(s) three times daily (approximately every 8 hours)

Initial Dose

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

Maintenance Dose

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

Maximum Dose

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

Children's Dosage

Not recommended for children under 2 years; safety and efficacy not established in pediatric patients.

Dose Adjustment Notes

Not recommended in severe renal impairment (CrCl <30 mL/min) or hyperchloremic acidosis; use caution in mild to moderate renal impairment and hepatic impairment. When used with other topical ophthalmic agents, separate administration by at least 5 minutes.

How to Take

Shake well before each use. Instill 1 drop in the affected eye(s) as prescribed (commonly 3 times daily). Avoid touching the dropper tip. After instillation, close the eye and apply nasolacrimal occlusion (press inner corner) for 1-2 minutes to reduce systemic absorption. Remove contact lenses before use and wait at least 15 minutes before reinserting. If using other ophthalmic products, separate by at least 5 minutes (apply eye ointments last).

How to Prepare

Shake well before each use to resuspend the suspension.

Side Effects

Common Side Effects

Common: blurred vision, ocular irritation/burning, ocular hyperemia/redness, eye allergy/itching, dysgeusia (bitter/abnormal taste), dry mouth, and headache.

Side Effect Frequency

Very common (≥10%): blurred vision, dysgeusia. Common (1-10%): ocular irritation (including eye pain/pruritus), conjunctival hyperemia, dry eye, foreign body sensation, eye discharge, headache, somnolence. Uncommon (<1%): allergic conjunctivitis/eyelid edema, corneal disorders (e.g., erosion/staining), dry mouth, dizziness, nausea, depression, hypotension/bradycardia.

Safety & Warnings

Contraindications

Hypersensitivity to brinzolamide, brimonidine, or any excipient (including sulfonamide hypersensitivity); concomitant MAO inhibitor therapy; severe renal impairment (CrCl <30 mL/min) and/or hyperchloremic acidosis; neonates and infants <2 years.

Warnings & Precautions

Sulfonamide hypersensitivity may occur; not recommended in severe renal impairment (CrCl <30 mL/min) or hyperchloremic acidosis; may cause systemic effects including hypotension, bradycardia, and CNS depression-use caution in patients with cardiovascular disease, cerebrovascular disease, depression, Raynaud’s phenomenon, or orthostatic hypotension; risk of corneal edema and erosion, particularly in patients with low endothelial cell counts.

Age Restriction

Contraindicated in children <2 years; safety and efficacy not established in pediatric patients.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Contraindicated with MAO inhibitors within 14 days. Use caution with antidepressants (e.g., MAOIs, TCAs), CNS depressants, antihypertensives, beta-blockers, cardiac glycosides, other IOP-lowering agents, oral carbonic anhydrase inhibitors.

Interaction Severity

Contraindicated: MAO inhibitors. Moderate: CNS depressants (additive sedation), antihypertensives/cardiac glycosides (additive hypotension/bradycardia), TCAs (may reduce brimonidine effect), other IOP-lowering agents.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Contraindicated

Children

Not recommended for children under 2 years; safety and efficacy not established in pediatric patients.

Elderly

Standard adult dosing. No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Kidney Impairment

Not recommended in severe renal impairment (CrCl <30 mL/min) or hyperchloremic acidosis; use caution in mild to moderate renal impairment.

Liver Impairment

No established dose adjustment; use with caution in hepatic impairment.

Storage & Patient Advice

Storage Conditions

Store below 25°C; protect from light. Discard 28 days after opening.

Preparation Instructions

Shake well before each use to resuspend the suspension.

Missed Dose

Use the missed dose as soon as remembered unless it is close to the next scheduled dose; if close, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not discontinue without prescriber advice; stopping may lead to loss of IOP control.

Overdose

Ocular overdose: rinse/flush the eye(s) with water or saline. Oral ingestion/systemic overdose: may cause CNS depression (somnolence), bradycardia, hypotension, and respiratory depression-seek urgent medical care; treat supportively with airway and cardiovascular monitoring.

Patient Counseling

Shake well; instill as directed without touching the tip; remove contact lenses and reinsert after 15 minutes; use nasolacrimal occlusion for 1-2 minutes; separate other eye drops by ≥5 minutes; expect possible transient blurred vision and bitter taste; use caution with driving until vision clears and with sedating medicines; report allergy/eye swelling or significant systemic symptoms (dizziness, slow pulse, faintness). Store below 30°C and discard about 4 weeks after opening.

Monitoring Requirements

Monitor intraocular pressure and optic nerve/visual fields per glaucoma care standards; monitor for ocular hypersensitivity. In at-risk patients, consider monitoring systemic effects (blood pressure/heart rate, CNS depression) and renal function if clinically indicated.

Pharmacology

Mechanism of Action

Brinzolamide inhibits carbonic anhydrase II in the ciliary processes, reducing aqueous humor formation; brimonidine (alpha-2 agonist) lowers IOP by decreasing aqueous humor production and increasing uveoscleral outflow.

Onset of Action

IOP reduction generally begins within about 1 hour, with peak effect around 2-3 hours after dosing.

Duration of Effect

Clinically, IOP-lowering effect is sustained for roughly 8-12 hours, supporting TID dosing.

Half-Life

Brinzolamide: terminal half-life ~111 days in erythrocytes (due to carbonic anhydrase binding); Brimonidine tartrate: plasma half-life ~2-3 hours.

Bioavailability

Systemic absorption can occur via nasolacrimal drainage; brinzolamide shows low systemic levels but accumulates in red blood cells; brimonidine has measurable systemic exposure after ocular dosing (reduced by nasolacrimal occlusion).

Metabolism

Brinzolamide: absorbed systemically, distributes into RBCs, metabolite N-desethyl brinzolamide formed and accumulates in RBCs; Brimonidine: extensive hepatic metabolism primarily by aldehyde oxidase.

Excretion

Brinzolamide (and metabolites) is eliminated primarily via the kidney; brimonidine and its metabolites are also primarily renally excreted.

Protein Binding

Brinzolamide: ~60% protein binding; Brimonidine: ~29% protein binding.

Product Information

Available Dosage Forms

Eye drops, suspension (ophthalmic suspension).

Composition per Dose

Each 1ml of suspension contains: 10mg Brinzolamide and 2mg Brimonidine Tartrate.

OTC Alternatives

No OTC alternative

Target Organ

Eye

Preservative Free

No

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