Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Travoprost Ophthalmic Solution 0.004% is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL). Travoprost ophthalmic solution is supplied as a 2.5 mL 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 62332-510-25 5 mL fill NDC 62332-510-05 Storage Store at 2º to 25ºC (36º to 77ºF).; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL – Travoprost Ophthalmic Solution USP 0.004%, 2.5 mL Fill Container PRINCIPAL DISPLAY PANEL – Travoprost Ophthalmic Solution USP 0.004%, 2.5 mL Fill Carton PRINCIPAL DISPLAY PANEL – Travoprost Ophthalmic Solution USP 0.004%, 5.0 mL Fill Container PRINCIPAL DISPLAY PANEL – Travoprost Ophthalmic Solution USP 0.004%, 5.0 mL Fill Carton travo-2-5-mL-bottle travo-2-5-mL-carton travo-5-mL-bottle travo-5-mL-carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING Travoprost Ophthalmic Solution 0.004% is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL). Travoprost ophthalmic solution is supplied as a 2.5 mL 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 62332-510-25 5 mL fill NDC 62332-510-05 Storage Store at 2º to 25ºC (36º to 77ºF).
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL – Travoprost Ophthalmic Solution USP 0.004%, 2.5 mL Fill Container PRINCIPAL DISPLAY PANEL – Travoprost Ophthalmic Solution USP 0.004%, 2.5 mL Fill Carton PRINCIPAL DISPLAY PANEL – Travoprost Ophthalmic Solution USP 0.004%, 5.0 mL Fill Container PRINCIPAL DISPLAY PANEL – Travoprost Ophthalmic Solution USP 0.004%, 5.0 mL Fill Carton travo-2-5-mL-bottle travo-2-5-mL-carton travo-5-mL-bottle travo-5-mL-carton
Overview
Travoprost is a synthetic prostaglandin F analogue. Its chemical name is [1R-[1α(Z),2β(1E,3R*),3α,5α]]-7-[3,5Dihydroxy-2-[3-hydroxy-4-[3(trifluoromethyl)phenoxy]-1-butenyl]cyclopentyl]-5heptenoic acid, 1-methylethylester. It has a molecular formula of C 26 H 35 F 3 O 6 and a molecular weight of 500.55. The chemical structure of travoprost is: Travoprost is a clear, colorless and viscous oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is practically insoluble in water. Travoprost Ophthalmic Solution 0.004% is supplied as sterile, buffered aqueous solution of travoprost with a pH of approximately 6.0 and an osmolality of approximately 290 mOsmol/kg. Travoprost ophthalmic solution contains Active: travoprost 0.04 mg/mL; Preservative: benzalkonium chloride 0.015% w/v; Inactives: polyoxyl 40 hydrogenated castor oil, tromethamine, boric acid, mannitol, edetate disodium, sodium hydroxide and/or hydrochloric acid (to adjust pH)and water for injection. travoprost-structure
Indications & Usage
INDICATIONS & USAGE Travoprost Ophthalmic Solution USP, 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Travoprost Ophthalmic Solution USP, 0.004% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Dosage & Administration
DOSAGE & ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. Travoprost Ophthalmic Solution USP, 0.004% should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect. Reduction of the intraocular pressure starts approximately 2 hours after the first administration with maximum effect reached after 12 hours. Travoprost ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (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 can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. (see PATIENT COUNSELING INFORMATION, 17.1). 5.2 Eyelash Changes Travoprost ophthalmic 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 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 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 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 (see PATIENT COUNSELING INFORMATION, 17.3). 5.7 Use with Contact Lenses Contact lenses should be removed prior to instillation of travoprost ophthalmic solution and may be reinserted 15 minutes following its administration.
Contraindications
None
Adverse Reactions
Most common adverse reaction (30% to 50%) is conjunctival hyperemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most common adverse reaction observed in controlled clinical studies with travoprost ophthalmic solution 0.004% 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 studies 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 studies with travoprost ophthalmic solution 0.004% 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. Nonocular 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. In post-marketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.
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