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PRO-BIMATOPROST RC 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: PRO-BIMATOPROST RC (bimatoprost ophthalmic solution) is indicated for: • the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension 1.1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment • The recommended dosage is one drop in the affected eye(s) once daily in the evening. The dosage of PRO-BIMATOPROST RC should not exceed once daily since it has been shown that more frequent administration of bimatoprost ophthalmic solution may lessen the intraocular pressure (IOP) lowering effect and increase the frequency and severity of adverse events.
See 7 WARNINGS AND PRECAUTIONS. 4 Administration Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures, to avoid eye injury and contamination of the solution.
PRO-BIMATOPROST RC 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 five (5) minutes apart. PRO-BIMATOPROST RC (Bimatoprost Ophthalmic Solution) Page 5 of 34 Contact lenses should be removed prior to instillation of PRO-BIMATOPROST RC and may be reinserted 15 minutes following its administration.
See 7 WARNINGS AND PRECAUTIONS. 5 Missed Dose Patients should be instructed to apply a single drop as soon as they remember, and then to return to their regular routine.
1 Adverse Reaction Overview In the 12-month multi-centre, double blind, active controlled clinical study with bimatoprost ophthalmic solution, most adverse events were ocular, mild, and not serious. 4% of patients treated). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
The data presented below are taken from a randomized, multicentre, double-blind, parallel- group clinical study, of 12 months duration, which was conducted in 560 patients with glaucoma or ocular hypertension. 0125% ophthalmic solutions administered once daily.
03% w/v. 01% w/v. 01% w/v had significantly fewer adverse events (all causality and treatment-related), and significantly fewer ocular adverse events. Patients experienced less severe macroscopic hyperaemia. 6%). 7%). 1%) Musculoskeletal and connective tissue disorders […]
4 Administration Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures, to avoid eye injury and contamination of the solution. PRO-BIMATOPROST RC 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 five (5) minutes apart. PRO-BIMATOPROST RC (Bimatoprost Ophthalmic Solution) Page 5 of 34 Contact lenses should be removed prior to instillation of PRO-BIMATOPROST RC and may be reinserted 15 minutes following its administration.
See 7 WARNINGS AND PRECAUTIONS. 5 Missed Dose Patients should be instructed to apply a single drop as soon as they remember, and then to return to their regular routine. 5 OVERDOSAGE No information is available on overdosage in humans.
If overdose with PRO-BIMATOPROST RC occurs, treatment should be symptomatic. In oral (by gavage) mouse and rat studies, doses up to 100 mg/kg/day did not produce any toxicity. 01% w/v. 02 % w/v as preservative, citric acid monohydrate, sodium chloride, sodium phosphate dibasic (heptahydrate) and water for injection.
Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
PRO-BIMATOPROST RC (Bimatoprost Ophthalmic Solution) Page 6 of 34 PRO-BIMATOPROST RC is supplied sterile in white opaque polypropylene bottles with translucent polypropylene droppers and turquoise opaque polypropylene caps in the following sizes: 3 mL and 5 mL.
5, and an osmolality of approximately 290 mOsmol/kg. 7 WARNINGS AND PRECAUTIONS 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).
PRO-BIMATOPROST RC is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The increased iris pigmentation may be permanent. Bimatoprost ophthalmic solution 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.
Pigmentation is expected to increase as long as bimatoprost ophthalmic solution is administered. 01% w/v. 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. PRO-BIMATOPROST RC (Bimatoprost Ophthalmic Solution) Page 7 of 34 There is the potential for hair growth to occur in areas where PRO-BIMATOPROST RC comes repeatedly in contact with the skin surface.
Thus, it is important to apply PRO-BIMATOPROST RC as instructed and to avoid it running onto the cheek or other skin areas. 03% w/v. Monitoring is required with frequent or prolonged use in dry eye patients or where the cornea is compromised.
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.
See Patient Medication Information. Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY. Driving and Operating Machinery 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 […]