Betoptic C - instructions for use, dose, side effects, contraindications

Excipients: benzalkonium chloride, a solution equivalent to benzalkonium chloride 0.1 mg; polystyrene sulfonic acid 2.5 mg; Carbomer 974P 4.5 mg; boric acid 4.0 mg; mannitol 45.0 mg; disodium edetate 0.1 mg; Nlauryl sarcosine 0.3 mg; sodium hydroxide and / or hydrochloric acid concentrated to pH adjustment; water purified to 1.0 ml.

Description:

The suspension is white or almost white.

Pharmacotherapeutic group:Anti-glaucoma - beta-blocker

ATX: & nbsp

S.01.E.D.02 Betaxolol

Pharmacodynamics:

Betaxolol - selective beta₁-adrenoceptor without internal sympathomimetic activity. Does not have a membrane-stabilizing (local anesthetic) action.

With topical application betaxolol reduces both increased and normal intraocular pressure, due to decreased production of intraocular fluid. The onset of the hypotensive effect is usually observed 30 minutes after instillation, and the maximum decrease in the ophthalmotonus occurs approximately in 2 hours. After a single instillation, the effect on the ophthalmotonus persists for 12 hours. Betaxolol, in comparison with other beta-adrenoblockers, does not cause a reduction in blood flow in the optic nerve.

Betaxolol does not cause miosis, spasm of accommodation, hemeralopia, "swaddling" effect before the eyes (unlike myotics).

Pharmacokinetics:Betaxolol is highly lipophilic, as a result of which it penetrates well through the cornea into the anterior chamber, C_mOh in the anterior chamber is determined 20 minutes after instillation. With topical application, systemic absorption is low, the concentration in the plasma is below the threshold (2 ng / ml) of detection. Excretion mainly through the kidneys.

Indications:

Decrease in intraocular pressure as a monotherapy or in combination with other drugs:

- with increased intraocular pressure;

- with open-angle glaucoma.

Contraindications:

Individual hypersensitivity to the components of the drug.

Sinus bradycardia, atrioventricular block II-III degree, cardiogenic shock, heart failure, heart failure in history, syndrome of weakness of the sinus node in patients with an artificial pacemaker, children under 18 years of age.

Carefully:

Thyrotoxicosis, myasthenia gravis, diabetes mellitus, Reynaud's syndrome, pheochromocytoma, simultaneous administration of oral beta-blockers.

Pregnancy and lactation:

Fertility

Data on the effect of Betoptik® C on human fertility are not available.

Pregnancy

Do not use during pregnancy, except when it is really necessary.

Sufficient experience in the use of the drug during pregnancy is not present.

According to the results of epidemiological studies, no malformative effects were detected, but with oral administration of β-adrenoblockers, there is a risk of intrauterine growth retardation. In addition, signs and symptoms of β-blockade (such as bradycardia, hypotension, respiratory distress syndrome, and hypoglycemia) were detected during the newborn period when β-adrenoblockers were taken by the mother before the birth.

It is necessary to carry out careful monitoring of newborns during the first days of life if the drug Betoptik® C was used by the mother during pregnancy.

Information on reducing systemic absorption can be found in the section "Method of administration and dose".

Lactation

β-adrenoblockers are excreted in breast milk and can cause serious adverse reactions in children breastfed. However, it is unlikely that a sufficient amount of the drug will be present in breast milk if therapeutic doses of Betoptic® C are used to induce the development of clinical symptoms of β-blockade in newborns.

Possible application for the treatment of nursing mothers as prescribed by the attending physician, if the expected curative effect exceeds the risk of development of possible side effects.

Information on reducing systemic absorption can be found in the section "Method of administration and dose".

Dosing and Administration:

Locally. Shake the bottle before use!

1-2 drops in the conjunctival sac of the eye 2 times a day.

To reduce the risk of developing systemic side effects, it is recommended after the instillation of the drug to squeeze the tear ducts at the inner corner of the eye (for 1-2 minutes).

In some patients, intraocular pressure stabilization occurs within a few weeks, therefore it is recommended to monitor intraocular pressure during the first month of treatment.

If the required level of intraocular pressure is not achieved with monotherapy, combination therapy should be prescribed.

Side effects:

Disturbances on the part of the organ of sight

Very often, in 10% of cases, there is discomfort in the eyes.

Often, in 1-10% of cases, blurred vision, increased tearing.

Infrequently, in 0.1-1% of cases: spot keratitis, keratitis, conjunctivitis, blepharitis,blurred vision, photophobia, eye pain, dry eye, asthenopia, blepharospasm, itching of the eye, eye discharge, crusting on the edges of the eyelids, inflammation, eye irritation, a violation of the conjunctiva, conjunctival edema, eye redness.

Rarely, in 0.01-0.1% of cases, cataracts were observed.

Frequency unknown: redness of eyelids.

Disturbances from the nervous system

Often: headache.

Rarely: faint.

Frequency unknown: dizziness.

Heart Disease

Uncommon: bradycardia, tachycardia.

The frequency is unknown: arrhythmia.

Vascular disorders

Rarely: hypotension.

Disturbances from the respiratory system, chest and mediastinal organs

Infrequent: asthma, dyspnea, rhinitis.

Rarely: cough, rhinorrhea.

Disorders from the gastrointestinal tract

Infrequently: nausea.

Rarely: dysgeusia.

Disturbances from the skin and subcutaneous tissues

Rarely: dermatitis, rash.

Frequency unknown: alopecia

Violations of the genitals and mammary gland

Rarely: decreased libido.

Disorders of the psyche

Rarely: anxiety.

Frequency not known: insomnia, depression.

Immune system disorders

Frequency unknown: hypersensitivity

General disorders and reactions at the site of administration

Frequency unknown: asthenia.

With the use of β-blockers (in the form of eye drops), there were other undesirable reactions that can develop with the use of the preparation Betoptic® C:

Immune system disorders: systemic allergic reactions, including Quincke edema, urticaria, local and generalized rash, itching, anaphylactic reactions.

Disorders from the metabolism and nutrition: ghypoglycemia

Disorders of the psyche: Mr.nightmares, memory loss.

Impaired nervous system: cerebrovascular disorders, cerebral ischemia, aggravation of signs and symptoms of myasthenia gravis gravis, paresthesia.

Disorders from the side of the organ of vision: detachment of the choroid of the eye after filtration operations, decreased corneal sensitivity, corneal erosion, ptosis, diplopia.

Heart Disease: chest pain, palpitations, swelling, chronic heart failure, AV block, cardiac arrest, heart failure.

Vascular disorders: the phenomenon of Raynaud, cold hands and feet.

Disturbances from the respiratory system, chest and mediastinal organs: bronchospasm (predominantly in patients with bronchospasm in the anamnesis).

Disturbances from the gastrointestinal tract: dyspepsia, diarrhea, dry mouth, abdominal pain, vomiting.

Disturbances from the skin and subcutaneous tissues: psoriasis rash or exacerbation of psoriasis.

Violations of the genitals and breast: sexual dysfunction.

Common disorders and reactions at the site of administration: fatigue.

Overdose:

If eye contact is excessive, it is recommended to wash eyes with warm water.

If the drug is taken orally by the symptoms of an overdose of β₁-adrenoblockers can be: bradycardia, hypotension, acute heart failure and bronchospasm.

Treatment symptomatic and supportive.

Interaction:

In patients receiving the drug Betoptik® C and simultaneously taking other beta-blockers orally, the risk of developing adverse reactions (both systemic and local) may be higher due to a possible additive effect.Such patients should be under careful medical supervision.

With the simultaneous administration of β-blockers for topical ophthalmic use with oral forms of calcium channel blockers, P-blockers, antiarrhythmic drugs (including amiodarone), digitalis glycosides, parasympathomimetics, guanethidine and drugs depleting catecholamine stocks, such as reserpine, there may be an increase in such effects as lowering blood pressure and bradycardia.

In some cases, as a result of the simultaneous use of β-adrenoblockers and adrenaline (epinephrine), mydriasis may develop.

With the simultaneous appointment of muscle relaxants and hypoglycemic agents, there may be an increase in their effect.

β-adrenoblockers can worsen the effect of epinephrine used in anaphylactic reactions. It should be used with extreme caution in patients with atopy or anaphylaxis in anamnesis.

When combined with sympathomimetics, they intensify their vasoconstrictive effect.

Care should be taken when combining betaxolol and adrenergic psychotropic drugs, as a result of the possible increase in their effect.If necessary, it can be used in combination with other local ophthalmic preparations. In this case, the interval between their use should be at least 10 minutes.

Special instructions:

Diabetes: β-blockers should be used with caution in patients with a tendency to spontaneous hypoglycemia and patients with mild diabetes mellitus, since these drugs can mask the signs and symptoms of acute hypoglycemia.

Thyrotoxicosis: β-adrenoblockers can mask certain symptoms of hyperthyroidism (eg, tachycardia). In patients with suspected thyrotoxicosis, β-blockers should not be abruptly abolished, as this may cause an increase in symptoms.

Myasthenia gravis: β-adrenoconvertors can cause symptoms and signs similar to those in myasthenia gravis (for example: diplopia, ptosis, general weakness).

Surgery: An anesthesiologist should be advised that the patient is taking betaxolol. Before the planned operation, β-adrenoblockers should be gradually (not immediately!) Canceled 48 hours before the general anesthesia, tk. during general anesthesia, they can reduce the sensitivity of the myocardium to sympatheticstimulation necessary for the work of the heart (for example, they can block the action of the systemic β adrenaline agonist).

Pulmonology: caution should be exercised in prescribing β-blockers to patients with a greatly reduced function of the respiratory system. Despite the fact that clinical studies have shown no effect of betaxolol on the function of external respiration, one should not exclude the possibility of hypersensitivity to the drug.

Risk of anaphylactic reaction: patients taking β- adrenoblockers, may have a history of atopy or anaphylactic reactions. In the case of repeated reactions, such patients may not be sensitive to the usual doses of epinephrine necessary for arresting anaphylaxis.

Betaxolol should be used with caution in patients with severe peripheral circulation disorders (ie with Reynaud's syndrome and pheochromocytoma).

At local appointment β-adrenoblockers can get in a system blood flow. Thus, β-adrenoblockers can cause cardiovascular, pulmonary and other adverse reactions, as with intravenous and parenteral administration.

Cases of severe respiratory and cardiovascular disorders, including death from bronchospasm in patients with bronchial asthma and death from heart failure are described.

Infringements from cepgt; in patients with cardiovascular diseases (eg, coronary heart disease, Prinzmetal angina, heart failure) and hypotension, therapy with β-blockers should be critically evaluated and the possibility of treatment with other active substances should be considered. It should be closely monitored for signs of exacerbation of the disease and adverse reactions in patients suffering from cardiovascular diseases.

Diseases of the cornea: β-adrenoblockers can cause dry eyes. Use the drug with caution in patients with corneal disease.

Vascular wall detachment: cases of detachment of the choroid of the eye are described with the use of drugs that prevent the formation of intraocular fluid (eg, timolol, acetazolamide) after filtering operations. The preparation Betoptik® C contains a preservative benzalkonium chloride, which can cause eye irritation and discoloration of soft contact lenses.Avoid direct contact with soft contact lenses. For patients using contact lenses, before using the drug, the lenses should be removed and placed back no earlier than 15 minutes after instillation of the drug.

Do not touch the tip of the dropper bottle to any surface to avoid contamination of the vial and its contents. The bottle must be closed after each use.

Effect on the ability to drive transp. cf. and fur:

Patients who, after instillation of the drug, temporarily have reduced vision or other visual impairments, it is not recommended to engage in activities requiring increased attention and response before recovery.

Form release / dosage:

Eye drops, 0,25%.

Packaging:

To 5 ml in a plastic bottle-dropper "Droptainer™".

1 bottle is placed together with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature of 8 to 30 ° C, in a place protected from light.

Keep out of the reach of children.

Shelf life:

2 years.

Use within 4 weeks after opening the vial.

Do not use after the expiry date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015599 / 01

Date of registration:25.03.2009 / 25.03.2013

Expiration Date:Unlimited

The owner of the registration certificate:ALKON PHARMACEUTICS, LLC ALKON PHARMACEUTICS, LLC Russia

Manufacturer: & nbsp

ALCON-COUVREUR, n.v. s.a. Belgium

Representation: & nbspALKON PHARMACEUTICS LLCALKON PHARMACEUTICS LLCRussia

Information update date: & nbsp25.01.2017

Illustrated instructions

Instructions

Betoptik® С (Betoptic® S)