Index of drugs

Reduction of intraocular pressure in adult patients with open-angle glaucoma or intraocular hypertension who have not responded adequately to topically applied β-blockers or prostaglandin analogs.

1 ml of solution contains 0.3 mg of bimatoprost and 5 mg of Timolol (in the form of timolol maleate). The preparation contains benzalkonium chloride.

The product contains two active substances that reduce intraocular pressure through complementary mechanisms of action. The combined effect of both components results in an additional reduction in intraocular pressure compared to the use of each separately. Bimatoprost, a synthetic prostamide, similar in structure to prostaglandin F_2α, reduces intraocular pressure by increasing the outflow of aqueous humor through the mesh of collagen fibers at the angle of perception of the eye and the severity of the outflow by the choroidal scleral route. Timolol is a non-selective blocker of β-adrenergic receptors, lacking significant intrinsic sympathomimetic activity, direct cardiac arrest and stabilizing cellular membranes. Timolol reduces intraocular pressure by reducing the production of aqueous humor. Systemic absorption of individual components of the drug is very small and does not change as a result of co-administration in the form of a single preparation, nor was the accumulation of any of the components.

Hypersensitivity to the active substances or to any of the excipients. Respiratory hypersensitivity, including bronchial asthma or bronchial asthma, a severe form of chronic obstructive pulmonary disease. Sinus bradycardia, sick sinus syndrome, sinus-atrioventricular block, atrio-ventricular block IIst. or IIIst. uncontrolled with a pacemaker. Symptomatic heart failure, cardiogenic shock.

The active ingredients in the preparation can be absorbed systemically. Due to the content of timolol (a β-blocker), the same types of cardiovascular and respiratory adverse events may occur, as well as other, as in the case of beta-blockers administered systemically (incidence less than for systemic administration). Patients with cardiovascular disease (eg coronary heart disease, Prinzmetal angina or heart failure) and hypertension treated with β-blockers should be critically assessed and treatment with other active substances considered. Patients with cardiovascular disease should be monitored for symptoms of the severity of these diseases and side effects. Due to dromotropic action of β-blockers, caution should be exercised when treating patients with atrioventricular block Ist. Caution should be exercised in patients with severe peripheral circulatory disturbances / diseases (ie severe forms of Raynaud's disease or Raynaud's syndrome). Respiratory reactions have been reported, including deaths due to bronchial spasm, in patients with asthma, following the administration of some ophthalmic β-blockers. In patients with mild / moderate chronic obstructive pulmonary disease (COPD), the product should be used with caution and only if the expected benefit outweighs the potential risk. Β-blockers should be administered with caution to patients prone to spontaneous hypoglycaemia or to unstable diabetes, since beta-blockers may mask the signs and symptoms of acute hypoglycaemia. β-blockers may also mask the symptoms of hyperthyroidism. β-blockers of ophthalmologies may cause dry eyes - care should be taken in patients with corneal diseases. When timolol is administered to patients already taking a systemic beta-blocker, the effects on intraocular pressure or known symptoms of systemic beta blockade may be exacerbated. The response should be carefully monitored in these patients. The use of two local β-adrenergic blockers is not recommended.When beta-blockers are used in patients with a history of atopy or a severe anaphylactic reaction to various allergens, a more intense reaction to repeated exposure to such allergens and lack of clinical response to the usual dose of adrenaline used to treat anaphylactic reactions may occur. Cases of choroidal dissection have been observed in connection with the administration of solutions of aqueous suppressants (eg timolol or acetazolamide) after filtration. Ophthalmic beta blocking drugs can suppress the action of β-agonists, e.g. adrenaline. If you are taking Timolol, tell your anesthetist. In patients with impaired hepatic or renal function, the drug should be used with caution. The preparation should be used with caution in patients with aphasia, patients with pseudophakia and tearing of the posterior capsule, and in patients with known risk factors for macular edema (eg intraocular surgery, retinal vein occlusion, inflammatory eye disease or diabetic retinopathy). The drug should be used with caution in patients with active intraocular inflammation (eg with uveitis) due to the risk of exacerbation of inflammation. There is a risk of hair growth in places where the solution comes into contact with the skin frequently - it is important to prevent eye leakage to the cheek or other area of ​​the skin. The benzalkonium chloride contained in the preparation may cause eye irritation. Before taking the product, remove contact lenses and re-insert them after at least 15 minutes. Benzalkonium chloride tinted with soft contact lenses. Avoid contact of the preparation with soft contact lenses. Benzalkonium chloride causes punctate keratopathy and / or toxic ulcerative corneal defects - with frequent or long-term use of the preparation, supervision of patients with dry eye syndrome or damaged cornea is required. The preparation has not been studied in patients with inflammatory ocular conditions, with neovascular glaucoma, closed-angle glaucoma, congenital glaucoma or narrow-angle glaucoma. More frequent eye exposure to more than 1 dose of bimatoprost per day may reduce the effect of reducing intraocular pressure. Patients using the product together with other prostaglandin analogs should be monitored to detect changes in intraocular pressure. The safety and efficacy of the preparation in children from 0 to 18 years have not yet been established.

There are no adequate data on the use of bimatoprost and timolol during pregnancy. It should not be used during pregnancy unless clearly necessary. If the preparation was used before delivery, the newborn should be closely monitored during the first days of life (risk of blockade of β-adrenergic receptors, eg bradycardia, hypotension, respiratory disorders, hypoglycaemia). Do not use during breast-feeding.

Very common: conjunctival hyperemia. Common: pain and dizziness, superficial punctate keratitis, corneal erosion, burning sensation in the eye, pruritus of the eye, stabbing pain in the eye, feeling of a foreign body, dry eye, eyelid edema, eye pain, photophobia, discharge from the eye, disorder vision, eyelid pruritus, worsening of visual acuity, eyelid inflammation, eyelid edema, eye irritation, pathological tearing, excessive eyelash growth, rhinitis, eyelid skin pigmentation, excessive hair growth, hyperpigmentation of the skin around the eyes. Uncommon: inflammation of the iris, conjunctival edema, eyelid pain, poor vision, folded eyelashes, hyperpigmentation of the iris, deepening the eyelid, eyelid retraction, shortness of breath. Not known: cystic macular edema, bronchospasm (mainly in patients with pre-existing bronchospastic disease). Additional side effects observed for one of the active substances that may also be present during the use of the preparation.bimatoprost: allergic conjunctivitis, eyelash darkening, blepharospasm, retinal hemorrhage, uveitis, periorbital erythema, blurred vision, hypertension, asthenia, nausea, abnormal liver function tests.timolol: systemic allergic reactions (including angioedema, urticaria, local and general rash, pruritus, anaphylaxis), hypoglycaemia, insomnia, depression, nightmares, memory loss, syncope, cerebrovascular accident, worsening of signs and symptoms of myasthenia gravis, paraesthesia, ischemia brain, reduced corneal sensitivity, double vision, ptosis, choroidal dissection after surgical filtration, keratitis, blurred vision, atrioventricular block, cardiac arrest, arrhythmia, bradycardia, heart failure, congestive heart failure, chest pain , palpitations, edema, hypotension, Raynaud's symptoms, cold feet and hands, cough, taste disorders, nausea, diarrhea, indigestion, dry mouth, abdominal pain, vomiting, alopecia, psoriasis-like rash or exacerbation of psoriasis, skin rash, muscle pain, sexual dysfunction, depressed libido, os Weakening / fatigue. In some patients with significant corneal damage, very rare cases of corneal calcification associated with the use of eye drops with phosphate content have been reported.

Adults, including the elderly: the recommended dose is 1 drop for the affected eye (s), instilled once a day in the morning or evening. It should be administered every day at the same time of the day. Available literature data indicate that evening administration may be more effective at reducing intraocular pressure than administration in the morning. However, when considering taking the medication in the morning or evening, the patient's probability of compliance with the prescribed schedule of use should be taken into account. If a dose is missed, treatment should be continued with the Next dose as per the treatment plan. The dose should not exceed 1 drop per day to the affected eye (eyes). If more than one ophthalmic topical treatment is necessary, each should be given at least 5 minutes apart. The use of nasolabial tract occlusion or closure of the eyelids for 2 minutes reduces the systemic absorption of the drug. This can lead to a reduction in the incidence of systemic side effects and increased local efficacy.