Clinical Pharmacology Details


Bimatoprost


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Indications & Dose:

For the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of other intraocular pressure-lowering medications or insufficiently responsive (failed to achieve target lOP detemnined after multiple measurments overtime) to another intraocular pressure-lowering medication. 

Contraindications:

Patients with hypersensitivity to bimatoprost or any other ingredient of Bimatoprost.


DOSAGE & ADMINISTRATION: Recommended Dose: 1 drop in the affected eye(s) once daily in the evening. The dosage of Bimatoprost should not exceed once daily since it has been shown that more frequent administration may decrease the intraocular pressure-lowering effect. Reduction of the intraocular pressure starts approximately 4 hrs after the first administration with maximum effect reached within approximately 8-12hrs. Bimatoprost may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If> 1 topical ophthalmic drug is being used, the drugs should be administered at least 5 min apart.


OVERDOSAGE: No information is available on overdosage in humans. If overdose with Bimatoprost 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. This dose expressed as mg/m2 is at least 70 times higher than the accidental dose of 1 bottle of Bimatoprost for a 10-kg child. Ocular adverse events occurring in approximately 3-10% of patients, in descending order of incidence, included ocular dryness, visual disturbance, ocular burning, foreign body sensation, eye pain, pigmentation of the periocular skin, blepharitis, cataract, superficial punctate keratitis, eyelid erythema, ocular irritation and eyelash darkening. The following ocular adverse events reported in approximately 1-3% of patients, in descending order of incidence, included eye discharge. tearing, photophobia, allergic conjunctivitis. asthenopia, increases in iris pigmentation and conjunctival edema. In <1 % of patients, intraocular inflammation was reported as iritis. Systemic adverse events reported in approximately 10% of patients were infections (primarily colds and upper respiratory tract infections). The following systemic adverse events reported in approximately 1-5% of patients, in descending order of incidence, included headaches, abnormal liver function tests, asthenia and hirsutism. 

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