TRAVOPROST OPHTHALMIC- travoprost ophthalmic solution solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Micro Labs Limited

प्रशासन का मार्ग:

OPHTHALMIC

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Travoprost ophthalmic solution 0.004% (ionic buffered solution) 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 ophthalmic solution 0.004% (ionic buffered solution) 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 pop

उत्पाद समीक्षा:

Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution) is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost, USP (0.04 mg/mL) supplied in 3 piece open nozzle container. Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution) is supplied as a 2.5 mL solution in a 5 mL and 5 mL solution in a 5 mL natural polypropylene container with a polypropylene open nozzle and an HDPE Turquoise color cap. NDC code: NDC 42571-130-27,               2.5 mL fill in 5 mL NDC 42571-130-21,               5 mL fill in 5 mL   Storage: Store at 2° to 25°C (36° to 77°F). After opening, travoprost ophthalmic solution USP, 0.004% (ionic buffered solution) can be used until the expiration date on the bottle.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

TRAVOPROST OPHTHALMIC - TRAVOPROST OPHTHALMIC SOLUTION SOLUTION
MICRO LABS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAVOPROST
OPHTHALMIC SOLUTION (IONIC BUFFERED SOLUTION) SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR TRAVOPROST OPHTHALMIC SOLUTION (IONIC BUFFERED
SOLUTION).
TRAVOPROST OPHTHALMIC SOLUTION (IONIC BUFFERED SOLUTION), FOR TOPICAL
OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Travoprost ophthalmic solution 0.004% (ionic buffered solution) is a
prostaglandin 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 travoprost 0.04 mg/mL. ( 3)
CONTRAINDICATIONS
None ( 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 reaction (30% to 50%) is conjunctival hyperemia. (
6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MICRO LABS USA, INC. AT
1-855-839-8195
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
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)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2022
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 Angle-closure, Inflammatory or Neovascular Glaucoma
5.6 Bacteri