TRAVOPROST OPHTHALMIC SOLUTION- travoprost solution/ drops

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Sandoz Inc

Spôsob podávania:

OPHTHALMIC

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Travoprost ophthalmic 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 ophthalmic 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 population, the estimated background risk of major birth defec

Prehľad produktov:

Travoprost ophthalmic solution is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL). Travoprost ophthalmic solution is supplied as a 2.5 mL solution in a 4 mL and a 5 mL solution in a 7.5 mL oval natural polypropylene dispenser bottle with a natural polypropylene dropper tip and a turquoise polypropylene or high density polyethylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the package. 2.5 mL fill           NDC 0781-6185-56 5 mL fill              NDC 0781-6185-75 Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, travoprost ophthalmic solution can be used until the expiration date on the bottle.

Stav Autorizácia:

New Drug Application Authorized Generic

Súhrn charakteristických

TRAVOPROST OPHTHALMIC SOLUTION- TRAVOPROST SOLUTION/ DROPS
SANDOZ INC
----------
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, FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Travoprost ophthalmic 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 SANDOZ INC., AT
1-800-525-8747 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: 4/2020
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
5.4 Macular Edema
5.5 Angle-closure, Inflammatory or Neovascular Glaucoma
5.6 Bacterial Keratitis
5.7 Use with Contact Lenses
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
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. Usuall