Drugplain

Travatan Z .04 mg/mL

travoprost · SOLUTION/ DROPS · Novartis Pharmaceuticals Corporation

No Recall History
Plain English

Travatan Z is a solution/ drops containing travoprost at .04 mg/mL, taken ophthalmic. Manufactured by Novartis Pharmaceuticals Corporation.

Key Facts

Brand Name
Travatan Z
Generic Name
travoprost
NDC Code (Product)
0078-0946
Manufacturer
Novartis Pharmaceuticals Corporation
Strength
.04 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
NDA021994
Drug Class
Prostaglandin Analog [EPC]
Marketing Start
10/20/2006

Recall History

No Recall History

Side Effects Reported to FDA

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

treatment failure1,946 reports
drug ineffective534 reports
ocular hyperaemia493 reports
eye irritation481 reports
eye pain340 reports
intraocular pressure increased297 reports
hypersensitivity269 reports
fatigue263 reports
glaucoma256 reports
headache228 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE TRAVATAN Z ® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. TRAVATAN Z 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. TRAVATAN Z 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. TRAVATAN Z 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 Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 TRAVATAN and TRAVATAN Z 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 TRAVATAN or TRAVATAN Z, included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discolor

Frequently Asked Questions

What is Travatan Z used for?

Travatan Z contains travoprost. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Travatan Z a controlled substance?

Travatan Z is not classified as a controlled substance by the DEA.

What is the generic name for Travatan Z?

The generic name for Travatan Z is travoprost. There are 11 other brand versions of travoprost.

What is the NDC code for Travatan Z .04 mg/mL?

The NDC (National Drug Code) for Travatan Z .04 mg/mL is 0078-0946, listed by Novartis Pharmaceuticals Corporation.