Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular HTN.
Elevated Intraocular Pressure
Open-Angle Glaucoma/Ocular HTN:
1 drop in affected eye(s) qd in pm
Max: Once-daily dosing
Space by at least 5 min if using >1 topical ophthalmic drug
Continue w/ the next dose as normal if 1 dose is missed
Sol: 0.005% [2.5mL]
May cause changes to pigmented tissues (eg, increased pigmentation of iris [may be permanent], periorbital tissue/eyelashes [may be reversible]); regularly examine patients who develop noticeably increased iris pigmentation. May gradually change eyelashes and vellus hair in the treated eye. Caution with a history of intraocular inflammation (iritis/uveitis). Macular edema, including cystoid macular edema, reported; caution in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or patients with known risk factors for macular edema. Reactivation of herpes simplex keratitis reported; caution with a history of herpetic keratitis. Avoid with active intraocular inflammation and in cases of active herpes simplex keratitis; inflammation may be exacerbated. Bacterial keratitis associated with the use of multiple-dose containers reported. Contact lenses should be removed prior to administration and may be reinserted 15 min after administration.
Foreign body sensation, punctate epithelial keratopathy, stinging, itching, burning, conjunctival hyperemia, blurred vision, increased iris pigmentation, excessive tearing, lid discomfort/pain, dry eye, eye pain, lid crusting, lid erythema, URTI/cold/flu.
Combined use of ≥2 prostaglandins or prostaglandin analogues is not recommended; administration of these prostaglandin drug products more than once daily may decrease the IOP-lowering effect or cause paradoxical IOP elevations. Precipitation occurs when mixed with eye drops containing thimerosal; if such drugs are used, they should be administered at least 5 min apart.
PREGNANCY AND LACTATION
Category C, caution in nursing.
MECHANISM OF ACTION
Prostaglandin analogue; prostanoid selective FP receptor agonist that is believed to reduce IOP by increasing outflow of aqueous humor.
Absorption: Absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the active acid form. Tmax=2 hrs (aqueous humor). Distribution: Vd=0.16L/kg. Metabolism: (Active acid) liver via fatty acid β-oxidation. Elimination: Urine (88% topical, 98% IV). (Active acid) T1/2=17 min (IV/topical).
Assess for hypersensitivity to drug or benzalkonium chloride, history of or active intraocular inflammation, history of herpetic keratitis, active herpes simplex keratitis, aphakia, pseudophakia with a torn posterior lens capsule, risk factors for macular edema, pregnancy/nursing status, and possible drug interactions.
Monitor for changes to pigmented tissues, eyelash changes, macular edema, herpetic/bacterial keratitis, and other adverse reactions.
Inform about the possibility of increased brown pigmentation of the iris, eyelid skin darkening, and eyelash and vellus hair changes in the treated eye. Instruct to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid contamination. Advise to immediately consult physician about the continued use of treatment if an intercurrent ocular condition (eg, trauma, infection) develops, if undergoing ocular surgery, or if any ocular reactions, particularly conjunctivitis and eyelid reactions, develop. Advise that contact lenses should be removed prior to administration and may be reinserted 15 min after administration. Instruct that if using >1 topical ophthalmic drug, to administer the drugs at least 5 min apart. Inform that if one dose is missed, treatment should continue with the next dose as normal.
Protect from light. Unopened: 2-8°C (36-46°F). During Shipment to Patient: Up to 40°C (104°F) for a period not exceeding 8 days. Opened: Room temperature up to 25°C (77°F) for 6 weeks.
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