TRAVOPROST OPHTHALMIC SOLUTION 0.00004 5 ML
Generic: Travoprost Ophthalmic Solution
TRAVOPROST OPHTHALMIC SOLUTION 0.00004 5 ML
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Identification
Travoprost Ophthalmic Solution
Travoprost Ophthalmic
Micro Labs Limited
HUMAN PRESCRIPTION DRUG
Administration
SOLUTION
OPHTHALMIC
ANDA203767
Active Ingredients
| Ingredient | Strength |
|---|---|
| TRAVOPROST | .04 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND 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 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 & Administration
2 DOSAGE AND 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. ( 2 )
Adverse Reactions
6 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 . 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 0.004% or travoprost ophthalmic solution 0.004% (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.
Information for Patients
17 PATIENT COUNSELING INFORMATION Potential for Pigmentation Advise the patient about the potential for increased brown pigmentation of the iris, which may be permanent. Inform the patient about the possibility of eyelid skin darkening, which may be reversible after discontinuation of travoprost ophthalmic solution 0.004% (ionic buffered solution) [see Warnings and Precautions (5.1) ] . Potential for Eyelash Changes Inform the patient about the possibility of eyelash and vellus hair changes in the treated eye during treatment with travoprost ophthalmic solution 0.004% (ionic buffered solution). These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment [see Warnings and Precautions (5.2) ] . Handling the Container Instruct the patient to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions (5.6) ] . When to Seek Physician Advice Advise the patient that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of travoprost ophthalmic solution 0.004% (ionic buffered solution) [see Warnings and Precautions ( 5.3 , 5.4 , 5.5 )] . 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 [see Warnings and Precautions (5.7) ] . Use with Other Ophthalmic Drugs If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes between applications. TIMOPTIC** is a registered trademark of Merck & Co., Inc. DROP-TAINER is a trademark of Alcon
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.