Drugplain

Travoprost Ophthalmic Soluton .04 mg/mL

Travoprost · SOLUTION/ DROPS · Sagent Pharmaceuticals

No Recall History
Plain English

Travoprost Ophthalmic Soluton is a solution/ drops containing travoprost at .04 mg/mL, taken ophthalmic. Manufactured by Sagent Pharmaceuticals.

Key Facts

Brand Name
Travoprost Ophthalmic Soluton
Generic Name
Travoprost
NDC Code (Product)
25021-002
Manufacturer
Sagent Pharmaceuticals
Strength
.04 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
ANDA218159
Drug Class
Prostaglandin Analog [EPC]
Marketing Start
07/15/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

treatment failure890 reports
drug ineffective181 reports
eye irritation118 reports
fatigue110 reports
off label use106 reports
dyspnoea104 reports
dizziness98 reports
product dose omission issue98 reports
cough93 reports
diarrhoea92 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 Sagent Pharmaceuticals at 1-866-625-1618 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 and travoprost ophthalmic solution (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 or travoprost ophthalmic solution (ionic buffered solutio…

Frequently Asked Questions

What is Travoprost Ophthalmic Soluton used for?

Travoprost Ophthalmic Soluton contains Travoprost. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Travoprost Ophthalmic Soluton a controlled substance?

Travoprost Ophthalmic Soluton is not classified as a controlled substance by the DEA.

What is the generic name for Travoprost Ophthalmic Soluton?

The generic name for Travoprost Ophthalmic Soluton is Travoprost. There are 11 other brand versions of Travoprost.

What is the NDC code for Travoprost Ophthalmic Soluton .04 mg/mL?

The NDC (National Drug Code) for Travoprost Ophthalmic Soluton .04 mg/mL is 25021-002, listed by Sagent Pharmaceuticals.

Product NDC

25021-002

Package NDC

25021-002-02

Other Travoprost Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)