Travoprost Ophthalmic Solution, 0.004% .04 mg/mL
Travoprost Ophthalmic Solution, 0.004% · SOLUTION/ DROPS · Mylan Pharmaceuticals Inc.
Travoprost ophthalmic solution is a prescription eye drop medication that belongs to a class of drugs called prostaglandin analogs, used to treat high eye pressure in glaucoma or ocular hypertension. It works by increasing the outflow of fluid from the eye to help lower intraocular pressure.
Key Facts
- Brand Name
- Travoprost Ophthalmic Solution, 0.004%
- Generic Name
- Travoprost Ophthalmic Solution, 0.004%
- NDC Code (Product)
0378-9651- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- .04 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA205050
- Drug Class
- Prostaglandin Analog [EPC]
- Marketing Start
- 12/18/2019
Recall History
No Recall HistoryFull 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, 0.004% used for?
Travoprost ophthalmic solution is a prescription eye drop medication that belongs to a class of drugs called prostaglandin analogs, used to treat high eye pressure in glaucoma or ocular hypertension. It works by increasing the outflow of fluid from the eye to help lower intraocular pressure.
Is Travoprost Ophthalmic Solution, 0.004% a controlled substance?
Travoprost Ophthalmic Solution, 0.004% is not classified as a controlled substance by the DEA.
What is the generic name for Travoprost Ophthalmic Solution, 0.004%?
The generic name for Travoprost Ophthalmic Solution, 0.004% is Travoprost Ophthalmic Solution, 0.004%. There are no other listed brand versions of Travoprost Ophthalmic Solution, 0.004%.
What is the NDC code for Travoprost Ophthalmic Solution, 0.004% .04 mg/mL?
The NDC (National Drug Code) for Travoprost Ophthalmic Solution, 0.004% .04 mg/mL is 0378-9651, listed by Mylan Pharmaceuticals Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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