ALPHAGAN P 0.15% EYE DROPS 5ML

Indications

Approved Uses

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

Off-Label Uses

No well-established off-label uses for this ophthalmic brimonidine product in routine practice (neuroprotection remains investigational 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 (approximately every 8 hours)

Maximum Dose

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

Children's Dosage

Contraindicated in children under 2 years of age. Safety and effectiveness have not been established in pediatric patients. Somnolence is a common side effect in children aged 2-7 years.

Dose Adjustment Notes

No specific dosage adjustment is established for renal or hepatic impairment; use with caution in severe cardiovascular disease, depression, cerebral/coronary insufficiency, Raynaud’s/thromboangiitis, orthostatic hypotension, or severe renal/hepatic impairment.

How to Take

For ophthalmic use only: wash hands; remove contact lenses; tilt head back and pull down lower lid; instill 1 drop into affected eye(s) as prescribed; avoid touching dropper tip; close eye and perform nasolacrimal occlusion (press inner canthus) for 1-2 minutes; if using other ophthalmic products, separate by at least 5 minutes; wait at least 15 minutes before reinserting contact lenses.

Side Effects

Common Side Effects

Ocular hyperemia, burning and stinging sensation, conjunctival folliculosis, ocular pruritus, oral dryness, headache, ocular allergic reactions, blurred vision, foreign body sensation

Side Effect Frequency

Very common/common: ocular hyperemia/redness, burning/stinging, ocular pruritus, allergic conjunctivitis/follicular conjunctivitis, blurred vision/visual disturbance, dry mouth; common systemic: headache, fatigue/drowsiness. Less common/rare: hypotension, bradycardia, syncope, depression, nasal dryness.

Safety & Warnings

Contraindications

Hypersensitivity to brimonidine tartrate or any component; concomitant MAO inhibitor therapy; neonates/infants <2 years.

Warnings & Precautions

Avoid in neonates/infants <2 years; use caution in severe cardiovascular disease/cerebrovascular or coronary insufficiency, depression, Raynaud’s phenomenon, orthostatic hypotension, thromboangiitis obliterans, and in hepatic/renal impairment; may cause fatigue/drowsiness-caution with driving/machinery; discontinue if significant ocular allergy occurs; prevent contamination (do not touch dropper tip) and remove contact lenses if applicable per labeling.

Age Restriction

Contraindicated in children <2 years; safety/efficacy not established in pediatric patients <2 years and use in children (especially <7 years) is associated with higher risk of CNS depression-use only if clearly needed with close monitoring.

Driving Warning

May Cause Drowsiness

Drug Interactions

Food Interaction

No restriction

Special Populations

Pregnancy

Caution

Children

Contraindicated in children under 2 years of age. Safety and effectiveness have not been established in pediatric patients. Somnolence is a common side effect in children aged 2-7 years.

Elderly

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

Kidney Impairment

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

Liver Impairment

No established dose adjustment; use with caution in hepatic impairment (especially severe).

Storage & Patient Advice

Storage Conditions

Store below 25°C. Keep out of reach of children. Discard 28 days after first opening.

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.

Stopping the Medicine

Do not stop abruptly without consulting the prescriber; stopping may allow intraocular pressure (IOP) to rise and worsen glaucoma control.

Overdose

Ocular overdose: rinse/flush the eye(s) with water or saline; systemic overdose/accidental ingestion (notably in children) may cause CNS depression, somnolence/coma, apnea/respiratory depression, bradycardia, hypotension, hypothermia-treat with supportive care (airway/ventilation and cardiovascular monitoring) and seek urgent medical attention; no specific antidote.

Patient Counseling

Use exactly as prescribed (commonly 1 drop in affected eye(s) three times daily ~8 hours apart); demonstrate proper drop technique and avoid contaminating the tip; perform nasolacrimal occlusion for 1-2 minutes; remove contact lenses and wait ≥15 minutes before reinsertion; separate other eye drops by ≥5 minutes; may cause blurred vision, fatigue/drowsiness-use caution driving; seek care for signs of ocular allergy (redness/itching/swelling); keep out of reach of children (accidental ingestion can be serious).

Monitoring Requirements

Monitor intraocular pressure and optic nerve/visual fields per glaucoma follow-up; monitor for ocular allergy/irritation (e.g., follicular conjunctivitis); consider blood pressure/heart rate monitoring in susceptible patients (e.g., on antihypertensives, with bradycardia/hypotension risk) and monitor for CNS depression.

Pharmacology

Mechanism of Action

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

Duration of Effect

IOP-lowering effect lasts up to about 12 hours, with peak effect around 2 hours after instillation.

Metabolism

Extensively metabolized by the liver.

Excretion

Eliminated primarily via renal excretion of metabolites; most of an absorbed dose is recovered in urine (reported around three-quarters).

Product Information

Available Dosage Forms

Ophthalmic solution (eye drops)

Composition per Dose

Each mL: 1.5 mg brimonidine tartrate (0.15%); preserved with Purite (stabilized oxychloro complex) 0.005%

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Target Organ

Eye

Preservative Free

No

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