TRAVOPROST OPHTHALMIC SOLUTION, 0.004% solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRAVOPROST (UNII: WJ68R08KX9) (TRAVOPROST - UNII:WJ68R08KX9)

Available from:

Mylan Pharmaceuticals Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Travoprost ophthalmic solution (ionic buffered solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. None. Risk Summary There are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk. In animal reproduction studies, subcutaneous (SC) administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. Advise pregnant women of a potential risk to a fetus. Because animal reproductive studies are not always predictive of human response, travoprost should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth

Product summary:

Travoprost ophthalmic solution USP, (ionic buffered solution) 0.004% is a clear colorless, sterile, aqueous solution of travoprost, USP (0.04 mg/mL). Travoprost ophthalmic solution, USP (ionic buffered solution) is supplied as a 2.5 mL or 5 mL solution in a 5 mL natural colored low density polyethylene bottle with a turquoise, high density polyethylene, tamper evident screw cap and a low density polyethylene nozzle. 2.5 mL fill NDC 0378-9651-32 carton of one bottle 5 mL fill NDC 0378-9651-50 carton of one bottle Storage: Store at 2° to 25°C (36° to 77°F). After opening, travoprost ophthalmic solution, USP (ionic buffered solution) can be used until the expiration date on the bottle.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRAVOPROST OPHTHALMIC SOLUTION, 0.004%- TRAVOPROST OPHTHALMIC
SOLUTION, 0.004% SOLUTION/ DROPS
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAVOPROST
OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
TRAVOPROST OPHTHALMIC SOLUTION.
TRAVOPROST OPHTHALMIC SOLUTION (IONIC BUFFERED SOLUTION) 0.004%, FOR
TOPICAL OPHTHALMIC
USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Travoprost ophthalmic solution (ionic buffered solution) is a
prostaglandin analog indicated for the
reduction of elevated intraocular pressure (IOP) 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 travoprost 0.04 mg/mL (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most common adverse reaction (30% to 50%) is conjunctival hyperemia.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2020
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
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)
Use in pediatric patients below the age of 16 years is not recommended
because of potential safety
concerns related to increased pigmentation following long-term chronic
use. (8.4)
5.4 Macular Edema
5.5 Angle-closure, Inflammatory or Neovascular Glaucoma
5.6 Bacterial K