TRAVOPROST OPHTHALMIC SOLUTION- travoprost solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data An embryo-fetal study was conducted in pregnant rats administered travoprost once daily by SC injection from gestation day (GD) 6 to 18, to target the period of organogenesis. At 10 mcg/kg (60 times the maximum recommended human ocular dose [MRHOD], based on estimated plasma Cmax ), travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly. Travoprost caused post-implantation loss at 10 mcg/kg. The no observed adverse effect level (NOAEL) for post-implantation loss was 3 mcg/kg (18 times the MRHOD, based on estimated plasma Cmax ). The maternal NOAEL was 10 mcg/kg. An embryo-fetal study was conducted in pregnant mice administered travoprost once daily by SC injection from GD 6 to 11, to target the period of organogenesis. At 1 mcg/kg (6 times the MRHOD, based on estimated plasma Cmax ), travoprost caused postimplantation loss and decreased fetal weight. The no observed adverse effect level (NOAEL) for malformations was 0.3 mcg/kg (2 times the MRHOD, based on estimated plasma Cmax ). The maternal NOAEL was 1 mcg/kg. Pre/postnatal studies were conducted in rats administered travoprost once daily by subcutaneous injection from GD 7 (early embryonic period) to postnatal Day 21 (end of lactation period). At doses of greater than or equal to 0.12 mcg/kg/day (0.7 times the MRHOD, based on estimated plasma Cmax ), adverse pregnancy outcomes (embryo-fetal lethality, abortion, and early delivery), low-birth weight and developmental delays were observed. The NOAEL for adverse pregnancy outcomes, low-birth weight and developmental delay was 0.1 mcg/kg (0.6 times the MHROD, based on estimated plasma Cmax ). The NOAEL for maternal toxicity was 0.72 mcg/kg (4 times the MHROD, based on estimated plasma Cmax ). Risk Summary There are no data on the effects of travoprost on the breastfed child or milk production. It is not known if travoprost is present in human milk following ophthalmic administration. A study in lactating rats demonstrated that radio-labeled travoprost and/or its metabolites were excreted in milk following subcutaneous administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for travoprost ophthalmic solution and any potential adverse effects on the breastfed child from travoprost ophthalmic solution. 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. No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. Travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in patients with renal impairment. No clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients.

Product summary:

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 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: 63629-8840-1) 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

TRAVOPROST OPHTHALMIC SOLUTION- TRAVOPROST SOLUTION/ DROPS
BRYANT RANCH PREPACK
----------
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: 1/2024
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
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)
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
8