LATANOPROST solution/ drops

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

DIRECT RX

INN (Tên quốc tế):

LATANOPROST

Thành phần:

LATANOPROST 50 ug in 1 mL

Tuyến hành chính:

OPHTHALMIC

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Latanoprost Ophthalmic Solution, 0.005% 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.

Tóm tắt sản phẩm:

Latanoprost Ophthalmic Solution, 0.005% is a clear, isotonic, buffered, preserved colorless solution of latanoprost 0.005% (125 μg/2.5 mL). It is supplied as a 2.5 mL solution in a 5 mL clear low density polyethylene bottle with a clear low density polyethylene dropper tip, and a turquoise polyethylene screw cap. NDC17478-625-12 2.5 mL fill, 0.005% (125 μg/2.5 mL) Storage: Protect from light. Store unopened bottles) 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 Sterile Manufactured for: Akorm, Inc. Lake Forest, IL 60045

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

LATANOPROST- LATANOPROST SOLUTION/ DROPS
DIRECT RX
----------
LATANOPROST
Rx only
Sterile
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-heptenoatft
Its molecular formula is
C26H4O5 and its chemical structure is:
[Chemical Structure]
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, 0.005% 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, 0.005% 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.
Mechanism of Action
Latanoprost is a prostanoid selective FP receptor agonist that is
believed to reduce the intraocular
pressure (I0P) 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 Held 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.
Distributioin: The distribution volume in humans is 0.16 ± 0.02 L/kg.
The acid of latanoprost can be
measured in aqueous humor during the first 4 hours, and in pl