VISTITAN is a brand name for Bimatoprost, 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…
Verbatim from this product's HC label. Tap a section to expand.
General Bimatoprost ophthalmic solutions have been reported to cause changes to pigmented tissue. The changes include increased pigmentation and growth of eyelashes and increased pigmentation of the iris and periorbital tissue (eyelid).
The increased iris pigmentation may be permanent. 03% w/v may gradually change eye color, increasing the amount of brown pigment in the iris by increasing the number of melanosomes (pigment granules) in melanocytes. The long-term effects on the melanocytes and the consequences of potential injury to the melanocytes and/or deposition of pigment granules to other area of the eye are currently unknown.
The change in iris color occurs slowly and may not be noticeable for several months to years. 03% w/v is administered. 1% of patients treated for 6 months). Patients should be informed of the possibility of iris color change. In addition, patients who are expected to receive treatment in only one eye should be informed about the potential for increased brown pigmentation of the iris, periorbital tissue, and eyelashes in the treated eye and thus, heterochromia between the eyes.
They should be advised of the potential for a disparity between the eyes in length, thickness, and /or number of eyelashes. Typically the brown pigmentation around the pupil is expected to spread concentrically towards the periphery in affected eyes, but the entire iris or parts of it may also become more brownish.
Until more information about increased brown pigmentation is available, patients should be examined regularly and, depending on the clinical situation, treatment may be stopped if increased pigmentation ensues. The increase in brown iris pigment is not expected to progress further upon discontinuation of treatment, but the resultant color change may be permanent.
Neither nevi nor freckles of the iris are expected to be affected by treatment. 03% w/v comes repeatedly in contact with the skin surface. Thus, it is important to apply Vistitan as instructed and to avoid it running onto the cheek or other skin areas.
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 ocular epithelial surface.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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See Patient Medication Information. Carcinogenesis and Mutagenesis See Toxicology. 03% w/v has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients. Occupational Hazards Based on the pharmacodynamic profile, bimatoprost is not expected to influence a patient’s ability to drive or operate machinery.
As with any ocular medication, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery. g. uveitis). 03% w/v for elevated intraocular pressure (IOP). g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy).
03% w/v has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma. There is a potential for the IOP-lowering effect of prostaglandin analogs to be reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin analogs.
03% w/v studies in patients with glaucoma or ocular hypertension, it has been shown that more frequent exposure of the eye to more than one dose of bimatoprost daily may decrease the IOP-lowering effect. Patients using Vistitan with other prostaglandin analogs should be monitored for changes to their IOP.
The pivotal clinical studies included patients with pseudoexfoliative and pigmentary glaucoma, in numbers proportionate to the population. 03% w/v, however given the low absolute numbers of these patients enrolled no statistical significance can be concluded.
None of these patients dropped out due to lack of efficacy or adverse experiences. 03% w/v) contains the preservative benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Patients wearing soft (hydrophilic) contact lenses should be instructed to remove contact lenses prior to administration of Vistitan and wait at least 15 minutes following administration before reinserting soft contact lenses.
Vistitan Page 6 of 28 Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas. 03% w/v has not been studied in patients with renal impairment and should therefore be used with caution in such patients.
Sexual Function/Reproduction Bimatoprost did not impair fertility in male or female rats at doses of […]