Bimatol Ophthalmic Solution
Bimatoprost 0.03% + Timolol 0.5% eye prep
0.03% + 0.5%
Eskayef Pharmaceuticals Ltd.
| Pack size | 5ml |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 650.00 AED |
Indications
Bimatol Ophthalmic Solution is used for:
Reduction of intra-ocular pressure in adult patients with, open-angle glaucoma, ocular hypertension
Adult Dose
Adult:
Eye drop: The recommended dose is one drop in the affected eye(s) once-daily.
Child Dose
Safety and effectiveness in pediatric patients have not been established.
Renal Dose
Administration
Contra Indications
It is contraindicated in patients with known hypersensitivity to any ingredient of this formulation.
Precautions
The active substances Timolol/Bimatoprost may be absorbed systemically. Due to the beta-adrenergic component, Timolol, the same types of cardiovascular, pulmonary, and other adverse reactions as seen with systemic beta-blockers may occur. Caution should be exercised in treating patients with severe or unstable and uncontrolled cardiovascular Disease.
Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid or periocular skin and increased brown iris pigmentation since these have been observed during treatment with Timolol/Bimatoprost. Increased iris pigmentation is likely to be permanent, and may lead to differences in appearance between the eyes if only one eye is treated.
After discontinuation of Timolol/Bimatoprost, pigmentation of the iris may be permanent. After 12 months of treatment with Timolol/Bimatoprost, the incidence of iris pigmentation was 0.2%. After 12 months of treatment with bimatoprost eye drops alone, the incidence was 1.5% and did not increase following 3 years of treatment. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
The long-term effects of increased iridial pigmentation are not known. Iris color changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years. Neither nevi nor freckles of the iris appear to be affected by treatment. Periorbital tissue pigmentation has been reported to be reversible in some patients.
Macular edema, including cystoid macular edema, has been reported with Timolol/Bimatoprost. Therefore, Timolol/Bimatoprost should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema (e.g. intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy).
Timolol/Bimatoprost should be used with caution in patients with active intraocular inflammation (e.g. uveitis) because the inflammation may be exacerbated.
Pregnancy-Lactation
Pregnancy
There are no adequate data from the use of the bimatoprost/timolol fixed combination in pregnant women. Timolol/Bimatoprost should not be used during pregnancy unless clearly necessary.
Bimatoprost
No adequate clinical data in exposed pregnancies are available. Animal studies have shown reproductive toxicity at high maternotoxic doses.
Timolol
Epidemiological studies have not revealed malformative effects but shown a risk for intra uterine growth retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If Timolol/Bimatoprost is administered until delivery, the neonate should be carefully monitored during the first days of life. Animal studies with timolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice.
Breast-feedingTimolol
Beta-blockers are excreted in breast milk. However, at therapeutic doses of timolol in eye drops it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant.
Bimatoprost
It is not known if bimatoprost is excreted in human breast milk but it is excreted in the milk of the lactating rat. Timolol/Bimatoprost should not be used by breastfeeding women.
Fertility
There are no data on the effects of Timolol/Bimatoprost on human fertility.
Interactions
There is a potential for bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers, guanethidine, beta-adrenergic blocking agents, parasympathomimetics, anti-arrhythmic and digitalis glycosides. Concomitant ocular medications should be administered at least 5 min apart from the instillation of this Eye Drops.
Adverse Effects
Side effects of Bimatoprost 0.03% + Timolol 0.5% eye prep :
26%
Ocular hyperemia
5-10%
Decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritis
Mechanism of Action
Bimatoprost is believed to lower intraocular pressure (IOP) in humans by increasing the outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Bimatoprost reduces the pressure in the eye by mimicking the action of a naturally occurring prostaglandin. Prostaglandins are a group of chemicals found in many places in the body. In the eye, they increase the drainage of the aqueous humor out of the eyeball.
Bimatoprost is a synthetic compound related to one of the natural prostaglandins and works by increasing the drainage of aqueous humor out of the eyeball. Bimatoprost may also lower the rate of aqueous formation in the eye. Both these effects decrease the pressure within the eye.
Timolol, when applied topically to the eye, has the action of reducing elevated, as well as normal, intraocular pressure, whether or not accompanied by glaucoma. Elevated intraocular pressure is a major risk factor in the pathogenesis of glaucomatous visual field loss and optic nerve damage.
Note
Bimatol 0.03% + 0.5% Ophthalmic Solution manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Bimatoprost 0.03% + Timolol 0.5% eye prep. Bimatol is availble in Bangladesh.
Farmaco BD drug index information on Bimatol Ophthalmic Solution is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.