Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Travoprost ophthalmic solution USP, 0.004% (ionic buffered solution) is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL). Travoprost ophthalmic solution USP, 0.004% (ionic buffered solution) is supplied as a 2.5 mL solution and a 5 mL solution in a 5 mL screw neck bottle made with natural polypropylene, nozzle made with low density polyethylene and turquoise color screw cap made with high density polyethylene. Tamper evidence is provided with a tamper evident ring around the closure and neck area of the package. 2.5 mL fill ..........NDC 46708-625-02 5 mL fill...............NDC 46708-625-05 Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, Travoprost ophthalmic solution, 0.004% (ionic buffered solution) can be used until the expiration date on the bottle.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2.5 mL Bottle Label 2.5 mL Carton Label 5 mL Bottle Label 5 mL Carton Label travo-2-5-ml-bottle-ltd travo-2-5-ml-carton-ltd travo-5-ml-bottle-ltd travo-5-ml-carton-ltd
- 16 HOW SUPPLIED/STORAGE AND HANDLING Travoprost ophthalmic solution USP, 0.004% (ionic buffered solution) is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL). Travoprost ophthalmic solution USP, 0.004% (ionic buffered solution) is supplied as a 2.5 mL solution and a 5 mL solution in a 5 mL screw neck bottle made with natural polypropylene, nozzle made with low density polyethylene and turquoise color screw cap made with high density polyethylene. Tamper evidence is provided with a tamper evident ring around the closure and neck area of the package. 2.5 mL fill ..........NDC 46708-625-02 5 mL fill...............NDC 46708-625-05 Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, Travoprost ophthalmic solution, 0.004% (ionic buffered solution) can be used until the expiration date on the bottle.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2.5 mL Bottle Label 2.5 mL Carton Label 5 mL Bottle Label 5 mL Carton Label travo-2-5-ml-bottle-ltd travo-2-5-ml-carton-ltd travo-5-ml-bottle-ltd travo-5-ml-carton-ltd
Overview
Travoprost is a synthetic prostaglandin F analog. Its chemical name is [1R-[1α(Z),2β(1E,3R*),3α,5α]]-7-[3,5-Dihydroxy-2-[3-hydroxy-4-[3-(trifluoromethyl)phenoxy]-1-butenyl]cyclopentyl]-5-heptenoic acid, 1-methylethylester. It has a molecular formula of C 26 H 35 F 3 O 6 and a molecular weight of 500.55 g/mol. The chemical structure of travoprost is: Travoprost USP, is a clear, colorless, viscous oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is insoluble in water. Travoprost ophthalmic solution USP, 0.004% (ionic buffered solution) is supplied as clear, colorless sterile, buffered aqueous solution of travoprost, free from foreign visible particles with a pH of approximately 5.7 and an osmolality of approximately 290 mOsmol/kg. Travoprost ophthalmic solution USP, 0.004% (ionic buffered solution) contains Active : travoprost USP, 0.04 mg/mL; Inactives : polyoxyl 40 hydrogenated castor oil, boric acid, propylene glycol, sorbitol, zinc chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection, USP. Preserved in the bottle with an ionic buffered system. travo-structure
Indications & Usage
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. 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.
Dosage & Administration
The recommended dosage is one drop in the affected eye(s) once daily in the evening. Travoprost ophthalmic solution, 0.004% (ionic buffered solution)should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP lowering effect. Reduction of the IOP starts approximately 2 hours after the first administration with maximum effect reached after 12 hours. Travoprost ophthalmic solution, 0.004% (ionic buffered solution), may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart. One drop in the affected eye(s) once daily in the evening
Warnings & 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) 5.1 Pigmentation Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with travoprost ophthalmic solution, 0.004% (ionic buffered solution) can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. 5.2 Eyelash Changes Travoprost ophthalmic solution, 0.004% (ionic buffered solution) may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. 5.3 Intraocular Inflammation Travoprost ophthalmic solution, 0.004% (ionic buffered solution) should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. 5.4 Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. Travoprost ophthalmic solution, 0.004% (ionic buffered solution) should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. 5.5 Angle-closure, Inflammatory or Neovascular Glaucoma Travoprost ophthalmic solution, 0.004% (ionic buffered solution) has not been evaluated for the treatment of angle-closure, inflammatory or neovascular glaucoma. 5.6 Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. 5.7 Use with Contact Lenses Contact lenses should be removed prior to instillation of travoprost ophthalmic solution, 0.004% (ionic buffered solution) and may be reinserted 15 minutes following its administration.
Contraindications
None. None
Adverse Reactions
Most common adverse reaction (30% to 50%) is conjunctival hyperemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction observed in controlled clinical trials with travoprost ophthalmic solution 0.004% and travoprost ophthalmic solution, 0.004% (ionic buffered solution) was ocular hyperemia, which was reported in 30% to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5% to 10% in these clinical trials included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus. Ocular adverse reactions reported at an incidence of 1% to 4% in clinical trials with Travoprost ophthalmic solution, 0.004% or travoprost ophthalmic solution, 0.004% (ionic buffered solution) included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage, and tearing. Non-ocular adverse reactions reported at an incidence of 1% to 5% in these clinical studies were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence, and urinary tract infections. 6.2 Postmarketing Experience Additional adverse reactions have been identified during post approval use of travoprost ophthalmic solution, 0.004% or travoprost ophthalmic solution, 0.004% (ionic buffered solution) in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to travoprost ophthalmic solution or travoprost ophthalmic solution (ionic buffered solution), or a combination of these factors, include: arrhythmia, vomiting, epistaxis, tachycardia, and insomnia. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.
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