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IZBA is a brand name for Travoprost, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General FOR OPHTHALMIC USE ONLY. Patients should remove contact lenses prior to administration of IZBA*; lenses may be reinserted 15 minutes following administration. Carcinogenesis and Mutagenesis See Toxicology section for animal data.
Dependence/Tolerance No evidence of drug abuse, withdrawal or rebound phenomena has been identified with the use of travoprost in clinical trials. Driving and Using Machinery The instillation of IZBA* may cause temporary blurred vision and other visual disturbances, which may affect the ability to drive or use machines.
If blurred vision occurs after instillation, the patient should be advised to wait until vision clears before driving or using machinery. Ophthalmologic IZBA* may gradually change eye colour, increasing the amount of brown pigmentation in the iris by increasing the number of melanosomes (pigment granules) in melanocytes.
The long term effects on the melanocytes and any consequences of potential injury to the melanocytes and/or deposition of pigment granules to other areas of the eye are currently unknown. Typically the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish.
The change in iris colour occurs slowly and may not be noticeable for months to years. In clinical trials, iris pigmentation was detected as early as 3 months. , blue-brown, gray-brown, yellow-brown and green- brown; however, it has also been observed in patients with brown eyes.
These changes may be permanent. Patients should be informed of the possibility of iris colour change. Patients who receive treatment in only one eye may experience increased brown pigmentation of the iris, periorbital and/or eyelid tissue, and eyelashes in the treated eye.
They may also experience disparity between the eyes in length, thickness, and/or number of eyelashes. These changes in pigmentation and lash growth may be permanent. 004%). IZBA* may gradually change eyelashes in the treated eye; these changes include increased length, thickness, pigmentation, and/or number of lashes.
During long-term clinical trials, eyelash photographs taken periodically during the studies, revealed an overall incidence of eyelash changes of 61%. 8%. Changes in eyelashes may be noticed as early as one and a half months after initiation IZBA* Product monograph Page 5 of 36 of treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Travoprost in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The mechanism of eyelash changes and their long term consequence are currently unknown. There is no experience with IZBA* in inflammatory ocular conditions, or in neovascular or angle-closure glaucoma. IZBA* should be used with caution in patients with active intraocular inflammation (iritis/uveitis), as well as patients with predisposing risk factors for uveitis.
Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin F2α analogues. These reports have mainly occurred in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
IZBA* should be used with caution in these patients. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the epithelial surface.
73m2. No clinically relevant changes in hematology, blood chemistry, urinalysis laboratory data or plasma concentrations of free acid were observed in patients with impaired (mild, moderate, or severe) hepatic or renal function. No dosage adjustment is necessary in patients with hepatic or renal impairment.
Sexual Function/Reproduction There are no data on the effects of IZBA* on human fertility.
Special Populations Pregnant Women:
No adequate and well-controlled studies have been performed in pregnant women. Travoprost, like all FP agonists, may interfere with the maintenance of pregnancy and should not be used by women during pregnancy or by women attempting to become pregnant.
Travoprost was teratogenic in rats. Travoprost administered intravenously to pregnant rats from gestation days 6-17 at a dose of 10 μg/kg/day, induced a slight increase in the incidence of skeletal malformations such as fused sternebrae, domed head and hydrocephaly.
04 μg/kg/day). 3 μg/kg/day. Since prostaglandins are biologically active and may be absorbed through the skin, women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid IZBA* Product monograph Page 6 of 36 direct exposure to the contents of the bottle.
In case of accidental contact with the contents of the bottle, thoroughly cleanse the exposed area with soap and water immediately.
Nursing Women:
A study in lactating rats demonstrated that radiolabeled travoprost and/or its metabolites were excreted in milk. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be […]