Bimator 0.03%+0.5%

INDICATIONS

This preparation eye drops is indicated for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to mono-therapy.

PHARMACOLOGY

Bimatoprost is believed to lower intraocular pressure (IOP) in humans by increasing 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-occuring prostaglandin. Prostaglandins are a group of chemicals found in many places in the body. In the eye, they increase the drainage of the aqueous humour out of the eyeball. Bimatoprost is a synthetic compound related to one of the natural prostaglandins, and works by increasing the drainage of aqueous humour 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.Similar to propranolol and nadolol, timolol is a non-selective, beta-adrenergic receptor antagonist. Timolol does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane-stabilizing) activity, but does possess a relatively high degree of lipid solubility. 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.

DOSAGE & ADMINISTRATION

The recommended dose is one drop in the affected eye(s) once-daily.Pediatric Use: Safety and effectiveness in pediatric patients have not been established.Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

INTERACTION

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-arrhythmics and digitalis glycosides. Concomitant ocular medications should be administered at least 5 min apart from the instillations of this Eye Drops

SIDE EFFECTS

In clinical trials, Ocular hyperemia was reported in approximately 26% of patients. 5 to 10 % in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritis.

PREGNANCY & LACTATION

There are no adequate data from the use of the Bimatoprost / Timolol fixed combination in pregnant women. It should not be used during pregnancy unless clearly necessary. Animal studies showed Bimatoprost is excreted in rat’s milk. & Timolol is excreted in human milk. Therefore, Bimatoprost / Timolol should not be used during breastfeeding.

PRECAUTIONS & WARNINGS

Like other topically applied ophthalmic medicinal products, 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.

THERAPEUTIC CLASS

Other ophthalmic preparations

STORAGE CONDITIONS

Store below 25° C in a dry place protected from light. Keep out of reach of children. Solution can be used up to 28 days after first opening.