LATANOPROST solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Latanoprost (UNII: 6Z5B6HVF6O) (Latanoprost - UNII:6Z5B6HVF6O)

Available from:

MWI

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. Teratogenic Effects: Pregnancy Category C. Reproduction studies have been performed in rats and rabbits. In rabbits, an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women. Latanoprost ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when latanoprost ophthalmic solution is administered to a nursing wom

Product summary:

Latanoprost Ophthalmic Solution, 0.005% is a clear, isotonic, buffered, preserved colorless solution of latanoprost 0.005% (50 mcg/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. NDC 13985-610-02     2.5 mL fill, 0.005% (50 mcg/mL) Storage: 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LATANOPROST- LATANOPROST SOLUTION/ DROPS
MWI
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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%
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Latanoprost ophthalmic solution is a prostaglandin F
analog 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 (≥4%) from clinical trials are blurred
vision, burning and stinging,
conjunctival hyperemia, foreign body sensation, itching, increased
pigmentation of the iris, punctate
keratitis, and upper respiratory tract
infection/nasopharyngitis/influenza. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AKORN, INC. AT
1-800-932-5676 OR FDA AT
1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
_In vitro_ studies have shown that precipitation occurs when eye drops
containing thimerosal are mixed with
latanoprost ophthalmic solution. If such drugs are used, they should
be administered at least 5 minutes
apart. (7)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS