Description
Release form
Eye drops in the form of a clear, colorless or light yellow liquid.
Pharmacological action of
Anti-glaucoma – beta-blocker
Indications
Reducing increased intraocular pressure in patients with ophthalmic hypertension and primary open-angle glaucoma as monotherapy or in combination with other drugs.
Use during pregnancy and lactation
Pregnancy
There is no sufficient experience with the use of the drug during pregnancy. The use of betaxolol during pregnancy is possible only if the expected benefit to the mother outweighs the possible risk to the fetus.
According to the results of epidemiological studies, malformative effects were not detected. It is known that when taking beta-blockers orally, there is a risk of intrauterine growth retardation. In addition, signs and symptoms of beta-blockade (such as bradycardia, hypotension, respiratory distress syndrome, and hypoglycemia) may occur in newborns when beta-blockers were taken by the mother before delivery. When using the drug during pregnancy, it is necessary to monitor the condition of newborns during the canine days of life.
Breastfeeding
Beta blockers are excreted in breast milk and can cause serious adverse reactions in breastfed babies. It is unlikely that with topical application of therapeutic doses of betaxolol in breast milk, a sufficient amount of the drug will be present to cause the development of clinical symptoms of beta-adrenoblockade in newborns. Due to the fact that the risk of developing systemic effects cannot be excluded, a decision must be made to stop breastfeeding or to cancel betaxolol therapy, taking into account the need to continue breastfeeding for the baby and the benefit of therapy for the mother.
Fertility
No data on the effect of betaxolol on fertility.
Special instructions
Diabetes mellitus
Beta-blockers should be used with caution in patients with a tendency to spontaneous hypoglycemia and labile diabetes, as these drugs may mask the signs and symptoms of acute hypoglycemia.
Thyrotoxicosis
Beta-blockers may mask some symptoms of hyperthyroidism (such as tachycardia). In patients with suspected thyrotoxicosis, beta-adrenoblockers should not be abruptly abolished, as this can cause an increase in symptoms.
Myasthenia gravis
Beta-blockers can cause symptoms and signs similar to those of myasthenia gravis (eg, diplopia, ptosis, general weakness).
Surgery
An anesthetist should be made aware of what the patient is taking. Before the planned operation, beta-blockers should be gradually (not simultaneously) withdrawn 48 hours before general anesthesia, as during general anesthesia, they can reduce the sensitivity of the myocardium to the sympathetic stimulation necessary for heart function (for example, they can block the action of adrenaline).
Pulmonology
There are reports of respiratory reactions, including death, due to bronchospasm in patients with bronchial asthma with the use of some beta-blockers in ophthalmology.
Caution should be given to patients with moderate to moderate severity of asthma (including a medical history), and to patients with mild to moderate chronic obstructive pulmonary disease.
Anaphylactic reactions
When betaxolol is used by patients with atopy or severe anaphylactic reactions to various allergens, a more pronounced reaction to repeated administration of these allergens and immunity to standard doses of epinephrine when stopping anaphylactic reactions can be observed.
Betaxolol should be used with caution in patients with severe peripheral circulation disorders (i.e., in patients with severe Raynaud’s disease or Raynaud’s syndrome, as well as pheochromocytoma).
When used locally, beta-blockers can enter the systemic circulation and cause unwanted reactions from the cardiovascular, pulmonary and other systems.
Describes cases of severe respiratory and cardiovascular disorders, including death from bronchospasm in patients with bronchial asthma and death from heart failure with betaxolol.
Heart abnormalities
In patients with cardiovascular disease (e.g., coronary heart disease, Prinzmetal angina, heart failure) and arterial hypotension, beta-blocker therapy should be critically evaluated with consideration of the possibility of treatment with drugs of other groups. Careful monitoring of the development of signs of exacerbation of the disease and adverse reactions in patients suffering from cardiovascular diseases is necessary.
Corneal diseases
Beta-blockers can cause dry eyes. In patients with corneal diseases, the drug should be used with caution.
The main pathogenetic aspect of the treatment of angle-closure glaucoma is the need to open the anterior chamber angle, which is achieved by narrowing the pupil with the help of myotics. does not affect the diameter of the pupil, therefore, with open-angle glaucoma, the drug should be used only in combination with mystics.
Choroidal detachment
Cases of choroidal detachment with medications that reduce the production of intraocular fluid (eg, timolol, acetazolamide) after fistulizing antiglaucomatous operations are described.
The drug contains a preservative that can cause eye irritation and discoloration of soft contact lenses. Direct contact of the drug with soft contact lenses should be avoided. Patients using contact lenses before using the drug, you should remove the lenses and install them back no earlier than 15 minutes after installation.
Impact on the ability to drive transp. Wed and fur .:
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.
Composition
1 ml betaxolol hydrochloride 5.6 mg, which corresponds to the content of betaxolol 5 mg
Excipients:3.165 mg,
water d / i – up to 1 ml.
Dosage and Administration
Topically. 1-2 drops in the conjunctival sac 2 times a day.
In some patients, stabilization of intraocular pressure occurs within a few weeks, therefore it is recommended to control intraocular pressure during the first month of treatment.
The duration of the drug is determined by the attending physician depending on the effectiveness of the therapy.
With insufficient clinical efficacy of monotherapy, additional therapy is prescribed.
The use of two beta-blockers for topical use is not recommended.
To reduce the systemic absorption of the drug, nasolacrimal occlusion is recommended – pressing the inner edges of the eyelids for 2-3 minutes after instillation of the drug.
Switching from another antihypertensive therapy
When switching from therapy with one beta-blocker to therapy with another drug from the beta-blocker group, it is recommended to complete the full day of therapy with the previously used antihypertensive agent, and the next day to begin the instillation of 0.25% betaxolol in each affected eye by 1 drop 2 times a day.
In the absence of an adequate response to therapy, the dose may be increased to 1-2 drops of a 0.5% betaxolol solution in each affected eye twice a day.
When
Switching from another antihypertensive therapy
When switching from therapy with one beta-blocker to therapy with another drug from the beta-blocker group, it is recommended to complete the full day of therapy with the previously used antihypertensive agent, and the next day to begin the instillation of 0.25% betaxolol in each affected eye by 1 drop 2 times a day.
In the absence of an adequate response to therapy, the dose may be increased to 1-2 drops of a 0.5% betaxolol solution in each affected eye twice a day.
When
Switching from another antihypertensive therapy
When switching from therapy with one beta-blocker to therapy with another drug from the beta-blocker group, it is recommended to complete the full day of therapy with the previously used antihypertensive agent, and the next day to begin the instillation of 0.25% betaxolol in each affected eye by 1 drop 2 times a day.
In the absence of an adequate response to therapy, the dose may be increased to 1-2 drops of a 0.5% betaxolol solution in each affected eye twice a day.
When
In the absence of an adequate response to therapy, the dose may be increased to 1-2 drops of a 0.5% betaxolol solution in each affected eye twice a day.
When
In the absence of an adequate response to therapy, the dose may be increased to 1-2 drops of a 0.5% betaxolol solution in each affected eye twice a day.
Whenduring the transition from therapy with a hypotensive drug of another group, except for beta-blockers, instillations of the previously prescribed drug are continued with the addition of instillations of one drop of a 0.25% solution of betaxolol to each affected eye twice a day. The next day, the previously applied treatment is canceled and betaxolol therapy continues.
Use in the pediatric population
According to limited data, it can be recommended for reducing intraocular pressure in case of true congenital glaucoma, infantile and juvenile congenital glaucoma in the preoperative period or in case of ineffective surgical treatment. Before using the drug, it is necessary to carefully assess the risks and benefits of using betaxolol in the pediatric population by carefully collecting an anamnesis for systemic disorders.
In case the benefit exceeds the risk, it is recommended to use 1 drop once a day in the minimum available concentration. If the hypotensive effect is insufficient, it is necessary to switch to the use 2 times a day with an interval between instillations of 12 hours. It is necessary to control ocular and systemic side effects within 1-2 hours after the first instillation.
Side effects
Like other medicines in the form of eye drops, it can enter the systemic circulation, which leads to the development of systemic side effects.
Adverse reactions are presented in accordance with the following gradation of the frequency of their development: very often (? 10%) often (? 1, <10%) infrequently (? 0.1, <1%) rarely (? 0.01, <0, 1%) very rarely ( Visual disturbances Very often: eye discomfort. Often: blurred vision, increased lacrimation. Infrequently: spot keratitis, keratitis, conjunctivitis, blepharitis, visual impairment, photophobia, pain dry eye syndrome, asthenopia, blepharospasm, itching in the eye, discharge from the eyes, formation of crusts on the edges of the eyelids, eye irritation, conjunctival disturbances, conjunctival edema, hyperemia Rarely: cataracts, decreased corneal sensitivity, redness of the eyelids Violations with side of the nervous system Often: headache Rarely: fainting Frequency unknown: dizziness Heart disorders Infrequently: bradycardia, tachycardia Frequency unknown: arrhythmia Disorders of the blood vessels hypotension. Disorders of the respiratory system, organs of the chest and mediastinum Infrequently: bronchospasm, shortness of breath, rhinitis. Rarely: cough, rhinorrhea. Disorders of the gastrointestinal tract Uncommon: nausea. Rarely: dysgeusia. Disorders of the skin and subcutaneous tissue Rarely: dermatitis, rash, alopecia. Reproductive system and breast disorders Rarely: decreased libido. Mental disorders Rarely: anxiety, insomnia, depression. General disorders and reactions at the injection site Frequency unknown: asthenia. Immune system disorders Unknown frequency: hypersensitivity. Other adverse reactions have been observed,system: allergic systemic reactions, including angioedema, urticaria, local and generalized rash, pruritus, anaphylactic reactions. Metabolism and nutritional disorders: hypoglycemia. Mental disorders: nightmares, memory loss, hallucinations, psychoses, confusion. Disorders of the nervous system: cerebrovascular disorders, cerebral ischemia, aggravation of signs and symptoms of myasthenia gravis, paresthesia. Disorders of the organ of vision: detachment of the choroid after fistulizing antiglaucoma operations, corneal erosion, ptosis, diplopia. Heart disorders: chest pain, palpitations, swelling, chronic heart failure, atrioventricular block, heart failure, heart failure, slowing of atrioventricular conduction or worsening of the degree of blockade. Vascular disorders: Raynaud’s phenomenon, cooling and cyanosis of the hands and feet, aggravation of the existing intermittent claudication. Disorders of the respiratory system, chest and mediastinal organs: bronchospasm (mainly in patients with a history of bronchospastic diseases). Disorders of the gastrointestinal tract: dyspepsia, diarrhea, dry mouth, abdominal pain, vomiting. Disorders of the skin and subcutaneous tissue: psoriasis rash or exacerbation of psoriasis. Disorders of the musculoskeletal system: myalgia. Disorders of the genitals and mammary gland: sexual dysfunction, impotence. General disorders and reactions at the injection site: fatigue. Drug Interactions No specific studies of the interaction of betaxolol with other drugs have been conducted. In patients receiving and at the same time taking other beta-blockers orally, the risk of developing adverse reactions (as systemic, local) may be higher due to a possible additive effect. Such patients should be under close medical supervision. With the simultaneous administration of beta-blockers for topical ophthalmic use with oral forms of slow calcium channel blockers, beta-blockers, antiarrhythmic drugs (including), cardiac glycosides, parasympathomimetics, guanethidine, and drugs that deplete such catecholines, effects like lowering blood pressure and severe bradycardia. There have been cases of mydriasis with the simultaneous use of beta-blockers and epinephrine. With the simultaneous administration of betaxolol with muscle relaxants and hypoglycemic agents, an increase in the effect of the latter can be observed. Beta-blockers can reduce the effect of adrenaline used to stop anaphylactic reactions. It should be used with extreme caution in patients with a history of atopy or anaphylaxis. When used together with sympathomimetics, an increase in their vasoconstrictive affect. Caution should be exercised in the combined use of betaxolol and adrenergic psychotropic drugs due to the possible increase in their effect. If necessary, can be used in combination with other local ophthalmic preparations, in which case the interval between their use should be at least 10 minutes. Overdose of If the contents of the vial are accidentally swallowed, beta-blockade symptoms may develop, including bradycardia, hypotension, acute heart failure, and bronchospasm. Treatment of overdose symptoms should be symptomatic and supportive. If topical is used, rinse eyes with warm water. The active substance Betaxolol Terms and conditions prescription Formulation eye drops Assignment Dlya vzrosl h in naznacheniyu Vracha Indications Hypertension,frewaf Indications Glaucoma Grotex Ltd. LLC, Russia
