Medicinal Products

BIMATOPROST EG 03 mg / ml

Generic drug of the therapeutic class: Ophthalmology
active ingredients: Bimatoprost
laboratory: EG Labo

Eye drops in solution
box of 1 bottle of 3 ml
All forms

Indication

Reduction of elevated intraocular pressure in adult patients with chronic open-angle glaucoma or intraocular hypertonia (as monotherapy or in combination with beta-blockers).

Dosage BIMATOPROST EG 03 mg / ml eye drops in solution box of 1 vial of 3 ml

Reduction of elevated intraocular pressure in adult patients with chronic open-angle glaucoma or intraocular hypertonia (as monotherapy or in combination with beta-blockers).

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

BIMATOPROST EG 0.3 mg / ml, eye drops in solution is contraindicated in patients who have previously reported adverse reactions suspected to be related to benzalkonium chloride leading to discontinuation of treatment.

Side effects Bimatoprost Eg

In clinical studies, more than 1, 800 patients were treated with bimatoprost 0.3 mg / ml, eye drops in solution. By pooling data from phase III clinical studies of bimatoprost 0.3 mg / ml, eye drops in solution as monotherapy or combination therapy, the most common treatment-related adverse events were:

· Eyelash growth up to 45% in the first year with an incidence of new cases reduced to 7% at 2 years and 2% at 3 years;

· Conjunctival hyperemia (mostly minimal to mild and considered non-inflammatory) up to 44% of patients in the first year with an incidence of new cases reduced to 13% at 2 years and 12% at 3 years;

· Eye pruritus up to 14% of patients in the first year with an incidence of new cases reduced to 3% at 2 years and 0% at 3 years. Less than 9% of patients had to stop treatment due to an adverse event in the first year, with an additional 3% stop incidence in the second and third year.

The undesirable effects described below have been reported during clinical trials with bimatoprost 0.3 mg / ml eye drops in solution or after marketing. Most were ocular, mild, and none were serious.

Very common side effects (≥ 1/10) frequent (≥ 1/100 to <1/10); infrequent (≥ 1/1000 to <1/100); rare (≥ 1/10 000 to <1/1000); very rare (<1 / 10, 000); indeterminate frequency (can not be estimated based on available data) are listed in the table below according to organ system classes. Within each frequency group, adverse effects are presented in order of decreasing severity.

Class of organ systems

Frequency

Undesirable effect

Immune system disorders

Not known frequency

Hypersensitivity reaction including signs and symptoms of ocular allergy and allergic dermatitis

Nervous system disorders

Frequent

headaches

Rare

Feelings of vertigo

Eye disorders

Very common

Conjunctival hyperemia, eye pruritus, eyelash growth

Frequent

Superficial punctate keratitis, corneal erosion, ocular burn, allergic conjunctivitis, blepharitis, decreased visual acuity, asthenopia, conjunctival edema, foreign body sensation, dry eye, eye pain, photophobia, watery eyes, eye discharge, visual disturbance / blurred vision, increased iris pigmentation, darkening of eyelashes, eyelid erythema, eyelid pruritus

Rare

Retinal hemorrhage, uveitis, cystoid macular edema, iritis, blepharospasm, eyelid retraction, periorbital erythema, eyelid edema

Not known frequency

enophthalmos

Vascular disorders

Frequent

Hypertension

Respiratory, thoracic and mediastinal disorders

Not known frequency

Asthma, exacerbation of asthma, exacerbation of COPD and dyspnea

Gastrointestinal disorders

Rare

nausea

Skin and subcutaneous tissue disorders

Frequent

Pigmentation of the periocular skin

Rare

Hirsutism

General disorders and administration site conditions

Rare

Asthenia

investigations

Frequent

Abnormal liver function tests

Adverse reactions reported with phosphate eye drops:

Cases of corneal calcification have been very rarely reported with the use of phosphate-containing eye drops in some patients with significant changes in the cornea.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

Popular Posts

Category Medicinal Products, Next Article