Travoprost Ophthalmic Solution USP, 0.004% Travoprost .04 mg/mL
Travoprost Ophthalmic Solution USP, 0.004% · SOLUTION/ DROPS · Alembic Pharmaceuticals Inc.
Travoprost ophthalmic solution is a prescription eye drop medication used to treat high eye pressure in glaucoma and ocular hypertension. It works as a prostaglandin analog to help increase fluid drainage from the eye.
Key Facts
- Brand Name
- Travoprost Ophthalmic Solution USP, 0.004% Travoprost
- Generic Name
- Travoprost Ophthalmic Solution USP, 0.004%
- NDC Code (Product)
62332-510- Manufacturer
- Alembic Pharmaceuticals Inc.
- Strength
- .04 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA210458
- Drug Class
- Prostaglandin Analog [EPC]
- Marketing Start
- 12/20/2019
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 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
2 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.
Contraindications
4 CONTRAINDICATIONS None
Adverse Reactions
6 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, d…
Frequently Asked Questions
What is Travoprost Ophthalmic Solution USP, 0.004% Travoprost used for?
Travoprost ophthalmic solution is a prescription eye drop medication used to treat high eye pressure in glaucoma and ocular hypertension. It works as a prostaglandin analog to help increase fluid drainage from the eye.
Is Travoprost Ophthalmic Solution USP, 0.004% Travoprost a controlled substance?
Travoprost Ophthalmic Solution USP, 0.004% Travoprost is not classified as a controlled substance by the DEA.
What is the generic name for Travoprost Ophthalmic Solution USP, 0.004% Travoprost?
The generic name for Travoprost Ophthalmic Solution USP, 0.004% Travoprost is Travoprost Ophthalmic Solution USP, 0.004%. There are no other listed brand versions of Travoprost Ophthalmic Solution USP, 0.004%.
What is the NDC code for Travoprost Ophthalmic Solution USP, 0.004% Travoprost .04 mg/mL?
The NDC (National Drug Code) for Travoprost Ophthalmic Solution USP, 0.004% Travoprost .04 mg/mL is 62332-510, listed by Alembic Pharmaceuticals Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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