LATANOPROST solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharma Holdings, Inc.

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 (IOP) in patients with open-angle glaucoma or ocular hypertension. Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. Risk Summary There are no adequate and well-controlled studies of Latanoprost Ophthalmic Solution administration in pregnant women to inform drug-associated risks. In animal reproduction studies, intravenous (IV) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see Data] . The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20% of clinically recognized pregnancies. Data Animal Data Embryofetal studies were conducted in pregnant rabb

Product summary:

Latanoprost Sterile Ophthalmic Solution is a clear, isotonic, buffered, preserved colorless solution of latanoprost 0.005% (50 mcg/mL). It is supplied as a 2.5 mL solution filled in a 5 mL translucent low density polyethylene bottle with insert cap assembly comprising of a turquoise colored, high density polyethylene screw cap over a low density polyethylene nozzle with tamper evident Low density polyethylene dust cover sealing the bottle cap. 2.5 mL fill, 0.005% (50 mcg/mL) : Package of 1 bottle :NDC 64980-516-25 Storage: Protect from light. Store unopened bottle(s) under refrigeration at 2°C to 8°C (36°F 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LATANOPROST - LATANOPROST SOLUTION
RISING PHARMA HOLDINGS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LATANOPROST
OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LATANOPROST OPHTHALMIC SOLUTION .
LATANOPROST OPHTHALMIC SOLUTION 0.005%, FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL:1996
INDICATIONS AND USAGE
Latanoprost Ophthalmic Solution is a prostaglandin F
analogue indicated for the reduction of elevated
intraocular pressure in patients with open-angle glaucoma or ocular
hypertension. (1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening. (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing 50 mcg/mL latanoprost (0.005%). (3)
CONTRAINDICATIONS
Known hypersensitivity to latanoprost, benzalkonium chloride, or any
other ingredients in this product. (4)
WARNINGS AND PRECAUTIONS
Pigmentation: pigmentation of the iris, periorbital tissue (eyelid)
and eyelashes can occur. Iris
pigmentation likely to be permanent. (5.1)
Eyelash Changes: gradual change to eyelashes including increased
length, thickness and number of
lashes. Usually reversible. (5.2)
ADVERSE REACTIONS
Most common adverse reactions (5-15%) from clinical trials are blurred
vision, burning and stinging,
conjunctival hyperemia, foreign body sensation, itching, increased
pigmentation of the iris and punctate
keratitis. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT RISING PHARMACEUTICALS,
INC AT 1-866-
562-4597 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._ (6)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Pigmentation
5.2 Eyelash Changes
5.3 Intraocular Inflammation
5.4 Macular Edema
5.5 Herpetic Keratitis
5.6 Bacterial Keratitis
5.7 Contact Lens Use
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
2α
6.1 Clin