Lumigan Eye Drops

Lumigan Eye Drops is used for: Open-angle glaucoma, Ocular hypertension

Adult: Ophth Open-angle glaucoma; Ocular HTN As 0.03% solution: Instill 1 drop once nightly.

Apply nightly directly to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying applicators. Blot any excess solution beyond the eyelid margin. Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator.

Known hypersensitivity.

Concurrent administration of Bimatoprost and intraocular pressure (IOP)--lowering prostaglandin analogs in ocular hypertensive patients may decrease the IOP-lowering effect. Patients using these products concomitantly should be closely monitored for changes to their IOP. Pigmentation of the eyelids and iris may occur. Iris pigmentation is likely to be permanent. Bimatoprost contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.

Pregnancy Risk Summary There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryo-fetal development studies, the administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (AUC). These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. Because animal reproductive studies are not always predictive of human response Bimatoprost 0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on AUC). No abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. In an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). The NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). No abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC).

Side effects of Bimatoprost 0.03% Eye prep : >10% Conjunctival hyperemia (25-45%),Growth of eyelashes (15-45%),Ocular pruritus (15-45%) 1-10% Ocular dryness (3-10%),Visual disturbance (3-10%),Ocular burning (3-10%),Foreign body sensation (3-10%),Ocular pain (3-10%),Pigmentation of the periocular skin (3-10%),Blepharitis (3-10%),Cataract (3-10%),Superficial punctate keratitis (3-10%),Eyelid erythema (3-10%),Ocular irritation (3-10%),Eyelash darkening (3-10%),Ocular discharge (1-3%),Tearing (1-3%),Photophobia (1-3%),Allergic conjunctivitis (1-3%),Asthenopia (1-3%),Increases in iris pigmentation (1-3%),Conjunctival edema (1-3%) Frequency Not Defined Periorbital erythema,Eye swelling,Eyelids: burning sensation, edema, irritation, pruritus,Iris hyperpigmentation,Lacrimation increased,Madarosis and trichorrhexis,Periorbital and lid changes associated with a deepening of the eyelid sulcus,Rash (including macular, erythematous, and pruritic limited to the eyelids and periorbital region),Skin discoloration (periorbital),Blurred vision

Bimatoprost is a prostamide analogue with ocular hypotensive action. It is postulated to lower intraocular pressure by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes.

Lumigan 0.03% Eye Drops manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Bimatoprost 0.03% Eye prep. Lumigan is availble in Bangladesh. Farmaco BD drug index information on Lumigan Eye Drops is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.