国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
LATANOPROST (UNII: 6Z5B6HVF6O) (LATANOPROST - UNII:6Z5B6HVF6O)
Rebel Distributors Corp
LATANOPROST
LATANOPROST 50 ug in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
Latanoprost Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredients in this product.
Latanoprost Ophthalmic Solution is a clear, isotonic, buffered, preserved colorless solution of latanoprost 0.005% (50 μg/mL). It is supplied as a 2.5 mL solution in a 4 mL low density polyethylene bottle with a low density polyethylene dropper tip, and a turquoise high density polypropylene screw cap. 2.5 mL NDC 21695-986-25 Protect from light. Store unopened bottle(s) under refrigeration at 2° to 8°C (36° to 46°F). During shipment to the patient, the bottle may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 8 days. Once a bottle is opened for use, it may be stored at room temperature up to 25°C (77°F) for 6 weeks. Rx only MANUFACTURER INFORMATION Bausch & Lomb Incorporated Tampa, Florida 33637 ©Bausch & Lomb Incorporated Revised November 2010 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Abbreviated New Drug Application
LATANOPROST- LATANOPROST SOLUTION/ DROPS REBEL DISTRIBUTORS CORP ---------- LATANOPROST OPHTHALMIC SOLUTION 0.005% (50 UG/ML) DESCRIPTION Latanoprost is a prostaglandin F2α analogue. Its chemical name is isopropyl-(Z)- 7[(1R,2R,3R,5S)3,5- dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C H O and its chemical structure is: Latanoprost is a colorless to slightly yellow oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol and octanol. It is practically insoluble in water. Latanoprost Ophthalmic Solution is supplied as a sterile, isotonic, buffered aqueous solution of latanoprost with a pH of approximately 6.7 and an osmolality of approximately 267 mOsmol/kg. Each mL of Latanoprost Ophthalmic Solution contains 50 micrograms of latanoprost. Benzalkonium chloride, 0.02% is added as a preservative. The inactive ingredients are: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous and water for injection. One drop contains approximately 1.5 μg of latanoprost. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Latanoprost is a prostanoid selective FP receptor agonist that is believed to reduce the intraocular pressure (IOP) by increasing the outflow of aqueous humor. Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. PHARMACOKINETICS /PHARMACODYNAMICS Absorption: Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. Studies in man indicate that the peak concentration in the aqueous humor is reached about two hours after topical administration. Distribution: The distribution volume in humans is 0.16 ± 0.02 L/kg. The acid of latanoprost can be measured in aqueous humor dur 完全なドキュメントを読む