Travoprost Ophthalmic Solution .04 mg/mL
Travoprost Ophthalmic Solution · SOLUTION/ DROPS · Gland Pharma Limited
Travoprost Ophthalmic Solution is a solution/ drops containing travoprost ophthalmic solution at .04 mg/mL, taken ophthalmic. Manufactured by Gland Pharma Limited.
Key Facts
- Brand Name
- Travoprost Ophthalmic Solution
- Generic Name
- Travoprost Ophthalmic Solution
- NDC Code (Product)
68083-601- Manufacturer
- Gland Pharma Limited
- Strength
- .04 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA218159
- Drug Class
- Prostaglandin Analog [EPC]
- Marketing Start
- 07/12/2024
Recall History
Par Pharmaceutical, Inc.
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Mylan Pharmaceuticals Inc
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Golden State Medical Supply Inc.
Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Travoprost ophthalmic solution (ionic buffered solution) 0.004% 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. ( 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 (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 (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 )
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reaction (30% to 50%) is conjunctival hyperemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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% 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% included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry ey…
Frequently Asked Questions
What is Travoprost Ophthalmic Solution used for?
Travoprost Ophthalmic Solution contains Travoprost Ophthalmic Solution. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Travoprost Ophthalmic Solution a controlled substance?
Travoprost Ophthalmic Solution is not classified as a controlled substance by the DEA.
What is the generic name for Travoprost Ophthalmic Solution?
The generic name for Travoprost Ophthalmic Solution is Travoprost Ophthalmic Solution. There are 6 other brand versions of Travoprost Ophthalmic Solution.
What is the NDC code for Travoprost Ophthalmic Solution .04 mg/mL?
The NDC (National Drug Code) for Travoprost Ophthalmic Solution .04 mg/mL is 68083-601, listed by Gland Pharma Limited.