LATANOPROST solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LATANOPROST (UNII: 6Z5B6HVF6O) (LATANOPROST - UNII:6Z5B6HVF6O)

Available from:

Rebel Distributors Corp

INN (International Name):

LATANOPROST

Composition:

LATANOPROST 50 ug in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LATANOPROST- LATANOPROST SOLUTION/ DROPS
REBEL DISTRIBUTORS CORP
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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