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Izba

"Glaucoma is a group of diseases that damage the optic nerve, a cable at the back of each eye that connects it to the brain. It affects more than 2.7 million people in the United States and more than 60 million worldwide. There are many forms of t"...

Izba

Izba Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Izba (travoprost) Ophthalmic Solution is a synthetic prostaglandin F2-alpha analog used for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Common side effects include eye redness, decreased visual acuity, eye discomfort, foreign body sensation, pain, and itching.

The recommended dosage of Izba is one drop in the affected eye(s) once daily in the evening. Izba may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Izba should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Izba (travoprost) Ophthalmic Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Izba FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

Different methodologies were used to collect adverse reactions during the development of travoprost. The most common adverse reaction observed in controlled clinical studies with travoprost 0.004% was ocular hyperemia. Ocular hyperemia was reported in 30 to 50% of patients by physician rating the severity of patient's post treatment ocular hyperemia compared to standardized reference photographs and/or patients who discontinued therapy due to ocular hyperemia.

In a 3 month clinical trial involving 442 patients exposed to IZBA (travoprost ophthalmic solution, 0.003%) and 422 control patients exposed to travoprost ophthalmic solution, 0.004%, the most common adverse drug reaction was ocular hyperemia. This was reported in 12% of patients treated with IZBA based on clinical observations and/or patient complaints. One patient (0.2%) discontinued treatment with IZBA due to ocular hyperemia. Rates observed in the control patients were comparable.

Ocular adverse reactions reported in clinical studies with travoprost ophthalmic solutions including IZBA at an incidence of 5% to 10% included decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritus. Ocular adverse reactions reported at an incidence of 1 to 4% included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage and tearing.

Nonocular adverse reactions reported at an incidence of 1 to 5% in these clinical studies were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections.

In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.

Read the entire FDA prescribing information for Izba (Travoprost Ophthalmic Solution) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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