Lumigan Information
Lumigan (Bimatoprost) Indications And Usage
Lumigan (Bimatoprost) Dosage And Administration
The recommended dosage is one drop in the affected eye(s) once daily in the evening. 0.01% and 0.03% (bimatoprost ophthalmic solution) should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect.
Reduction of the intraocular pressure starts approximately 4 hours after the first administration with maximum effect reached within approximately 8 to 12 hours.
Lumigan (Bimatoprost) Dosage Forms And Strengths
Ophthalmic solution containing bimatoprost 0.1 mg/mL ( 0.01%) or containing bimatoprost 0.3 mg/mL ( 0.03%).
Lumigan (Bimatoprost) Contraindications
Lumigan (Bimatoprost) Warnings And Precautions
Bimatoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as bimatoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of bimatoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known.
Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with 0.01% and 0.03% (bimatoprost ophthalmic solution) can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. (see PATIENT COUNSELING INFORMATION, ).
Lumigan (Bimatoprost)
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Lumigan (Bimatoprost)
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Lumigan (Bimatoprost) Overdosage
No information is available on overdosage in humans. If overdose with 0.01% and 0.03% (bimatoprost ophthalmic solution) occurs, treatment should be symptomatic.
In oral (by gavage) mouse and rat studies, doses up to 100 mg/kg/day did not produce any toxicity. This dose expressed as mg/m is at least 70 times higher than the accidental dose of one bottle of 0.03% for a 10 kg child.
Lumigan (Bimatoprost) Description
Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. 0.01% and 0.03% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg.
Lumigan (Bimatoprost) Clinical Pharmacology
Absorption: After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily to both eyes of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and were below the lower limit of detection (0.025 ng/mL) in most subjects within 1.5 hours after dosing. Mean C and AUC values were similar on days 7 and 14 at approximately 0.08 ng/mL and 0.09 ng•hr/mL, respectively, indicating that steady state was reached during the first week of ocular dosing. There was no significant systemic drug accumulation over time.
Distribution: Bimatoprost is 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. Approximately 12% of bimatoprost remains unbound in human plasma.
Metabolism: Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing. Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites.
Elimination: Following an intravenous dose of radiolabeled bimatoprost (3.12 μg/kg) to six healthy subjects, the maximum blood concentration of unchanged drug was 12.2 ng/mL and decreased rapidly with an elimination half-life of approximately 45 minutes. The total blood clearance of bimatoprost was 1.5 L/hr/kg. Up to 67% of the administered dose was excreted in the urine while 25% of the dose was recovered in the feces.
Lumigan (Bimatoprost) Clinical Studies
In clinical studies of patients with open angle glaucoma or ocular hypertension with a mean baseline IOP of 26 mmHg, the IOP-lowering effect of 0.03% (bimatoprost ophthalmic solution) once daily (in the evening) was 7-8 mmHg.
In a 3 month clinical study of patients with open angle glaucoma or ocular hypertension with an average baseline IOP of 23.5 mmHg, the IOP-lowering effect of 0.01% once daily (in the evening) was up to 7.5 mmHg and was approximately 0.5 mmHg less effective than 0.03%. In this same study, 0.01% also had a similar overall safety profile compared with 0.03%. After 12 months of treatment, discontinuations were 8.1% for 0.01% and 13.4% for 0.03%.
Lumigan (Bimatoprost) How Supplied/storage And Handling
2.5 mL fill in a 5 mL container - NDC 0023-3205-035 mL fill in a 10 mL container - NDC 0023-3205-057.5 mL fill in a 10 mL container - NDC 0023-3205-08
2.5 mL fill in 5 mL container - NDC 0023-9187-035 mL fill in 10 mL container - NDC 0023-9187-057.5 mL fill in 10 mL container - NDC 0023-9187-07
Lumigan (Bimatoprost) Patient Counseling Information
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications.
© 2010 Allergan, Inc.Irvine, CA 92612® marks owned by Allergan, Inc.U.S. Patents 5,688,819 and 6,403,649
71807US12B
Lumigan (Bimatoprost)
Lumigan (Bimatoprost)
Lumigan (Bimatoprost)
Lumigan (Bimatoprost)
