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brand lumigan 0.01% eye drops

Out of Stock Manufacturer ALLERGAN INC. 00023320505
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Uses

Ocular Hypertension and Glaucoma

Bimatoprost ophthalmic solution is used topically to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are intolerant of other IOP-lowering drugs or who have not responded adequately (i.e., failed to achieve target IOP as determined after multiple measurements over time) to another IOP-lowering drug. Safety and efficacy of bimatoprost have not been established for the treatment of angle-closure, inflammatory, or neovascular glaucoma.

Safety and efficacy of bimatoprost have been evaluated in 2 multicenter, randomized, double-blind studies that involved several hundred patients with open-angle glaucoma or ocular hypertension. In these studies, which included patients with a mean baseline IOP value of 26 mm Hg, topical application of bimatoprost 0.03% once daily reduced IOP by 7-8 mm Hg. Limited data indicate that bimatoprost 0.03% is at least as effective as latanoprost 0.005% in controlling diurnal IOP. Once daily administration of bimatoprost 0.03% appears to be more effective than twice daily administration of timolol 0.5% in reducing IOP in patients with open-angle glaucoma or ocular hypertension. In one comparative study in patients with mean baseline IOP of 26 mm Hg who received bimatoprost 0.03% once daily or timolol 0.5% twice daily, 64% of those who received bimatoprost had an IOP of less than 17 after 6 months of treatment compared with 37% of those who received timolol when IOP was measured at the time of peak timolol effect.

Dosage and Administration

General

Bimatoprost is applied topically to the eye as an ophthalmic solution. Care should be taken to avoid contamination of the solution container. (See Advice to Patients.)

If the patient is receiving more than one topical ophthalmic drug, the drugs should be administered at least 5 minutes apart.

The recommended dosage of bimatoprost for the treatment of open-angle glaucoma or ocular hypertension is one drop of a 0.03% solution in the affected eye(s) once daily in the evening. Bimatoprost solution 0.03% should not be administered more frequently than once daily since more frequent dosing may paradoxically diminish the IOP-lowering effect of the drug.

Special Populations

No special population dosage recommendations at this time.

Cautions

Contraindications

Known hypersensitivity to bimatoprost or any ingredient in the formulation.

Warnings/Precautions

Warnings

Ocular Effects

Increases in brown pigmentation of the iris and periorbital tissue (eyelid) or increased pigmentation and growth of eyelashes occurred in approximately 2 or 6% of patients, respectively, receiving the drug in clinical studies of up to 12 months' duration; these changes may be permanent. The increased pigmentation of the iris develops slowly and may not be evident until after several months to years of bimatoprost therapy. Long-term effects of these changes are unknown. Pending further accumulation of data, patients receiving bimatoprost should be examined regularly and, depending on the clinical situation, therapy may be discontinued if increased pigmentation persists. Eyelashes may become longer, thicker, more numerous, and darker. Patients expected to receive bimatoprost therapy in only one eye should be informed of the potential for a disparity between eyes in length, thickness, and/or number of eyelashes and that heterochromia between the eyes may occur.

General Precautions

Ocular Effects

Macular edema, including cystoid macular edema, has been reported during therapy with bimatoprost ophthalmic solution. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. Use with caution in patients with active intraocular inflammation (e.g., uveitis).

Specific Populations

Pregnancy

Category C.

Lactation

Bimatoprost is distributed in milk in animals. Caution if used in nursing women.

Pediatric Use

Safety and efficacy not established in children.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.

Renal and Hepatic Impairment

No studies have been performed in these patients; use with caution.

Common Adverse Effects

Conjunctival hyperemia, growth of eyelashes, and ocular pruritus occurred in approximately 15-45% of patients who received bimatoprost ophthalmic solution in clinical trials. Approximately 3% of patients discontinued therapy because of conjunctival hyperemia. Ocular dryness, visual disturbance, ocular burning, foreign body sensation, ocular pain, pigmentation of the periocular skin, blepharitis, cataract, superficial punctate keratitis, eyelid erythema, ocular irritation, and eyelash darkening have been reported in approximately 3-10% of patients who received bimatoprost ophthalmic solution in clinical trials. Adverse ocular effects reported in approximately 1-3% of patients include ocular discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, increases in iris pigmentation, and conjunctival edema.

Adverse systemic events reported in approximately 1-10% of patients include infection (primarily colds and upper respiratory tract infections), headache, abnormal liver function test results, asthenia, and hirsutism.

Drug Interactions

No formal drug interaction studies have been performed. The manufacturer states that pharmacokinetic interactions are unlikely.

Pharmacokinetics

Absorption

Bioavailability

Following once-daily topical ocular administration for 2 weeks, peak blood concentrations were attained within 10 minutes and were below the lower limit of detection within 1.5 hours. Steady-state blood levels were achieved during the first week of dosing.

Onset

Reduction in IOP generally occurs within 4 hours after topical application and peaks within 8-12 hours.

Distribution

Extent

Moderately distributed into body tissues with a steady-state volume of distribution of 0.67 L/kg. In human blood, bimatoprost resides mainly in the plasma.

Bimatoprost is distributed into milk in animals; it is not known whether the drug distributes into milk in humans.

Plasma Protein Binding

88%.

Elimination

Metabolism

Undergoes oxidation, N-deethylation, and glucuronidation to form various metabolites.

Elimination Route

Approximately 67% excreted in urine and 25% excreted in feces after IV administration.

Half-life

45 minutes after IV administration.

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