Berodual N aerosol 50 + 20mkg, 10ml (200 doses)

Prevention and symptomatic treatment of chronic obstructive airway diseases with reversible bronchospasm: bronchial asthma, chronic obstructive bronchitis, complicated or uncomplicated by emphysema.

Inhalation

Solution for inhalation. Adults and children over 12 years of age for relief of seizures - 20Ц80 drops (1Ц4 ml). With long-term therapy - 1-2 ml (20-40 drops) up to 4 times a day. In cases of moderately pronounced bronchospasm or the need for assisted ventilation of the lungs - 0.5 ml (10 drops). Children 6-12 years old for relief of seizures - 0.5-1 ml (10-20 drops) once, for severe attacks - 2-3 ml (40-60 drops), with prolonged therapy - 0.5-1 ml ( 10-20 drops) 4 times a day, with moderate bronchospasm - 0.5 ml (10 drops). Children under 6 years of age (body weight less than 22 kg) (only under medical supervision) at the rate of 25 ?g of ipratropium bromide and 50 ?g of fenoterol hydrobromide per 1 kg of body weight, up to 0.5 ml (10 drops) up to 3 times a day.

The recommended dose immediately before use is diluted with physiological solution to a volume of 3-4 ml and inhaled through a nebulizer for 6-7 minutes until the solution is completely consumed. Berodual solution for inhalation should not be diluted with distilled water. The solution should be diluted immediately before use, the diluted solution remaining after inhalation should be destroyed.

The dose depends on the mode of inhalation and the technical characteristics of the nebulizer. The duration of inhalation can be controlled through the volume of the diluted solution.

Berodual inhalation solution can be applied using various commercially available inhalation devices. In the presence of a centralized stationary oxygen supply, the solution is best administered at a rate of 6Ц8 l / min. If necessary, repeated inhalations are carried out at intervals of at least 4 hours.

Spray can. Adults and children over 6 years old are prescribed 2 inhalation doses. If relief of breathing does not occur within 5 minutes, 2 more inhalation doses can be prescribed. If 4 inhalations are ineffective, you should immediately seek medical help.

With long-term and intermittent therapy - 1-2 doses 3 times a day (up to 8 inhalations a day).

To obtain the maximum effect, it is necessary to use the metered aerosol correctly.

Before using the metered aerosol for the first time, shake the can and press the bottom of the can twice.

Each time you use a metered aerosol, the following rules must be observed:

1. Remove the protective cap.

2. Take a slow, deep breath.

3. While holding the balloon, clasp the tip with your lips. The cylinder must be upside down.

4. Making the deepest possible inhalation, simultaneously quickly press the bottom of the balloon until one inhalation dose is released. Hold your breath for a few seconds, then remove the tip from your mouth and exhale slowly. Repeat steps to obtain the second inhalation dose.

5. Put on the protective cap.

6. If the aerosol can has not been used for more than 3 days, before use, press the bottom of the can once until a cloud of aerosol appears.

The balloon is designed for 200 inhalations. After that, the cylinder should be replaced. Although some content may remain in the balloon, the amount of drug released by inhalation may be reduced.

The balloon is opaque, so the amount of the drug in the balloon can be determined only in the following way: after removing the protective cap, the balloon is immersed in a container filled with water. The amount of the drug is determined depending on the position of the balloon in the water.

The handpiece should be kept clean and, if necessary, can be rinsed in warm water. After using soap or detergent, rinse the handpiece thoroughly with clean water.

Warning: the plastic adapter for the mouth is specially designed for the metered aerosol Berodual N and serves for accurate dosing of the drug. The adapter must not be used with other metered aerosols. Do not use metered-dose tetrafluoroethane-containing aerosol Berodual N with any other adapters, except for the adapter supplied with the cylinder.

The contents of the cylinder are under pressure. The cylinder must not be opened and heated above 50 ? C.

Active substance:

ipratropium bromide

fenoterol hydrobromide

Hypersensitivity, hypertrophic obstructive cardiomyopathy, tachyarrhythmia, pregnancy (I trimester).

pharmachologic effect

Combined bronchodilator drug. Contains two components with bronchodilator activity: ipratropium bromide - an m-anticholinergic antagonist, and fenoterol hydrobromide - a beta2-adrenergic agonist.

Bronchodilation with inhalation of ipratropium bromide is mainly due to local rather than systemic anticholinergic action.

Ipratropium bromide is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. Ipratropium bromide inhibits reflexes mediated by the vagus nerve. Anticholinergics prevent an increase in intracellular calcium concentration, which occurs due to the interaction of acetylcholine with the muscarinic receptor located on the smooth muscles of the bronchi. The release of calcium is mediated by a system of secondary mediators, which include ITP (inositol triphosphate) and DAG (diacylglycerol).

In patients with bronchospasm associated with COPD (chronic bronchitis and pulmonary emphysema), a significant improvement in lung function (an increase in FEV1 and peak expiratory flow rate by 15% or more) was noted within 15 minutes, the maximum effect was achieved after 1-2 hours and continued in most patients up to 6 hours after administration.

Ipratropium bromide does not adversely affect mucus secretion in the respiratory tract, mucociliary clearance and gas exchange.

Fenoterol hydrobromide selectively stimulates ?2-adrenergic receptors at a therapeutic dose. Stimulation of? 1-adrenergic receptors occurs when used in high doses.

Fenoterol relaxes the smooth muscles of the bronchi and blood vessels and counteracts the development of bronchospastic reactions caused by the influence of histamine, methacholine, cold air and allergens (immediate hypersensitivity reactions). Immediately after administration, fenoterol blocks the release of inflammatory mediators and bronchial obstruction from mast cells. In addition, with the use of fenoterol at a dose of 600 ?g, an increase in mucociliary clearance was noted.

The beta-adrenergic effect of the drug on cardiac activity, such as an increase in the frequency and strength of heart contractions, is due to the vascular action of fenoterol, stimulation of the ?2-adrenergic receptors of the heart, and when used in doses exceeding therapeutic ones, stimulation of the ?1-adrenergic receptors.

As with the use of other beta-adrenergic drugs, an increase in the QTc interval was observed when used in high doses. When fenoterol was used with metered-dose aerosol inhalers (MDIs), this effect was inconsistent and was noted when doses exceeded the recommended ones. However, after using fenoterol with nebulizers (solution for inhalation in vials with a standard dose), the systemic exposure may be higher than when using the drug with the help of MDI in recommended doses. The clinical significance of these observations has not been established.

The most commonly observed effect of ?-adrenergic receptor agonists is tremor. In contrast to the effects on the smooth muscles of the bronchi, tolerance can develop to the systemic effects of ?-adrenergic receptor agonists. The clinical significance of this manifestation has not been clarified.

With the combined use of ipratropium bromide and fenoterol, the bronchodilatory effect is achieved by acting on various pharmacological targets. These substances complement each other, as a result, the antispasmodic effect on the muscles of the bronchi is enhanced and a wide range of therapeutic action is provided for bronchopulmonary diseases, accompanied by constriction of the airways. The complementary action is such that to achieve the desired effect, a lower dose of the beta-adrenergic component is required, which allows you to individually select an effective dose with virtually no side effects.

In case of acute bronchoconstriction, the effect of the drug BerodualЃ N develops quickly, which makes it possible to use it in acute attacks of bronchospasm.

Indications of the drug BerodualЃ N

Prevention and symptomatic treatment of obstructive airway diseases with reversible bronchospasm:

• bronchial asthma;

• COPD;

• chronic bronchitis, complicated or not complicated by emphysema.

Dosage regimen

The dose is set individually.

For relief of seizures, adults and children over 6 years of age are prescribed 2 inhalation doses. If relief of breathing does not occur within 5 minutes, 2 more inhalation doses can be prescribed.

The patient should be informed about immediate medical attention if there is no effect after 4 inhalation doses and the need for additional inhalations.

For long-term and intermittent therapy, 1-2 inhalations are prescribed for 1 reception, up to 8 inhalations / day (on average, 1-2 inhalations 3 times / day).

In bronchial asthma, the drug should be used only as needed.

BerodualЃ N in children should be used only as directed by a doctor and under the supervision of adults.

Terms of use of the drug

The patient should be instructed on the correct use of the metered aerosol.

Before using a new inhaler for the first time, take the inhaler upside down, remove the protective cap and make 2 injections into the air by pressing the bottom of the can 2 times.

Each time you use a metered aerosol, the following rules must be observed:

1. Remove the protective cap.

2. Exhale slowly, fully.

3. While holding the inhaler, tightly clasp the mouthpiece with your lips. The arrow and the bottom of the cylinder must point up.

4. Start inhaling and simultaneously press firmly on the bottom of the balloon until one inhalation dose is released. Continue to inhale slowly to the maximum and hold your breath for a few seconds. Then remove the mouthpiece from your mouth and exhale slowly.

To obtain the second inhalation dose, repeat the steps from step 2.

5. Put on the protective cap.

6. If the aerosol can has not been used for more than 3 days, then before use, press the bottom of the can once until a cloud of aerosol appears.

Because the balloon is not transparent, it is impossible to determine visually whether it is empty. The balloon is designed for 200 inhalations. After using this number of doses, a small amount of solution may remain in it. However, the inhaler should be replaced as otherwise, you may not receive the required treatment dose.

The amount of drug remaining in the bottle can be checked as follows:

shake the container, this will show if there is any liquid left in it; another way is to remove the plastic mouthpiece from the bottle and place the bottle in a container of water. The content of the cylinder can be estimated depending on its position in the water.

The inhaler should be cleaned at least once a week. It is important to keep the mouthpiece of the inhaler clean to prevent any drug from entering it, which could block the release of the aerosol.

During cleaning, first remove the protective cap and remove the balloon from the inhaler. Pass a stream of warm water through the inhaler, make sure to remove the drug and / or visible dirt.

After cleaning, shake the inhaler and let it air dry without using heating devices. Once the mouthpiece is dry, insert the can into the inhaler and put on the protective cap.

The plastic mouthpiece is designed specifically for the use of the metered aerosol BerodualЃ N and serves for accurate dosing of the drug. This mouthpiece should not be used with other metered-dose aerosols. You also cannot use BerodualЃ N aerosol with other adapters, except for the mouthpiece supplied with the bottle.

The contents of the cylinder are under pressure.

The cylinder must not be opened or heated to more than 50 ? C.

Side effect

Many of the listed undesirable effects can be a consequence of the anticholinergic and beta-adrenergic properties of the drug BerodualЃ N. BerodualЃ N, like any inhalation therapy, can cause local irritation. Adverse drug reactions were determined on the basis of data obtained in clinical trials and in the course of pharmacological surveillance of the drug after its registration.

The most common side effects reported in clinical trials were cough, dry mouth, headache, tremors, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, increased systolic blood pressure, and nervousness.

Determination of the categories of the frequency of adverse reactions that may occur during treatment: very often (? 1/10), often (from? 1/100 to <1/10), infrequently (from? 1/1000 to <1/100), rarely (from? 1/10 000 to <1/1000), very rarely (<1/10 000); the frequency is unknown (the frequency cannot be estimated from the available data).

From the immune system: rarely * - anaphylactic reaction, hypersensitivity, angioedema; rarely - urticaria.

From the side of metabolism: rarely * - hypokalemia.

From the nervous system and psyche: infrequently - nervousness, headache, tremors, dizziness; rarely - excitement, mental disturbances.

From the side of the organ of vision: rarely * - glaucoma, increased intraocular pressure, accommodation disturbances, mydriasis, blurred vision, eye pain, corneal edema, conjunctival hyperemia, the appearance of a halo around objects.

From the side of the cardiovascular system: infrequently - tachycardia, palpitations, increased systolic blood pressure; rarely - arrhythmia, atrial fibrillation, supraventricular tachycardia , myocardial ischemia , increased diastolic blood pressure.

From the respiratory system: often - cough; infrequently - pharyngitis, dysphonia; rarely - bronchospasm, pharyngeal irritation, pharyngeal edema, laryngospasm , paradoxical bronchospasm , dryness of the pharynx *.

From the digestive system: infrequently - vomiting, nausea, dry mouth; rarely - stomatitis, glossitis, gastrointestinal motility disorders, diarrhea, constipation , oral edema .

Skin and subcutaneous tissue disorders: itching, hyperhidrosis *.

From the musculoskeletal system: rarely - muscle weakness, muscle spasm, myalgia.

From the urinary system: rarely - urinary retention.

Contraindications for use

• hypertrophic obstructive cardiomyopathy;

• tachyarrhythmia;

• I trimester of pregnancy;

• children under 6 years of age;

• hypersensitivity to drug components;

• hypersensitivity to atropine-like substances.

With caution, the drug should be prescribed for angle-closure glaucoma, coronary insufficiency, arterial hypertension, insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic diseases of the cardiovascular system, hyperthyroidism, pheochromocytoma, prostatic hypertrophy, obstruction of the bladder neck, with cystic fibrosis, in children over 6 years old.

Application during pregnancy and lactation

The drug is contraindicated for use in the first trimester of pregnancy.

Existing clinical experience has shown that fenoterol and ipratropium do not adversely affect pregnancy. However, when using these drugs in the II and III trimesters of pregnancy, the usual precautions should be followed.

The inhibitory effect of fenoterol on uterine contractility should be taken into account.

Preclinical studies have shown that fenoterol hydrobromide can pass into breast milk. For ipratropium, no such data have been obtained. A significant effect of ipratropium on an infant, especially in the case of an aerosolized drug, is unlikely. Nevertheless, given the ability of many drugs to be excreted in breast milk, caution should be exercised when prescribing BerodualЃ N to women who are breastfeeding.

There are no clinical data on the effect of fenoterol hydrobromide, ipratropium bromide, or their combination on fertility. Preclinical studies have not shown the effect of ipratropium bromide and fenoterol hydrobromide on fertility.

Application for impaired renal function

The drug is used with caution in obstruction of the bladder neck.

Application in children

Contraindicated in children under 6 years of age.

The drug is used with caution in children over 6 years of age.

special instructions

Dyspnea

If shortness of breath (shortness of breath) suddenly worsens, see a doctor immediately.

Hypersensitivity

After using the drug BerodualЃ N, reactions of immediate hypersensitivity may occur, signs of which in rare cases may be urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, anaphylactic shock.

Paradoxical bronchospasm

BerodualЃ N, like other inhaled drugs, can cause paradoxical bronchospasm, which can be life-threatening. In case of development of paradoxical bronchospasm, the use of the drug BerodualЃ N should be stopped immediately and switched to alternative therapy.

Long-term use

” пациентов с бронхиальной астмой ЅеродуалЃ Ќ следует примен¤ть только по мере необходимости. ” пациентов с легкой формой ’ќЅЋ симптоматическое лечение может оказатьс¤ предпочтительнее регул¤рного применени¤. ” пациентов с бронхиальной астмой следует помнить о необходимости проведени¤ или усилени¤ противовоспалительной терапии дл¤ контрол¤ воспалительного процесса дыхательных путей и течени¤ заболевани¤.

–егул¤рное применение возрастающих доз препаратов, содержащих бета2-адреномиметики, таких как ЅеродуалЃ Ќ, дл¤ купировани¤ бронхиальной обструкции может вызвать неконтролируемое ухудшение течени¤ заболевани¤. ¬ случае усилени¤ бронхиальной обструкции увеличение дозы бета2-агонистов, в т.ч. препарата ЅеродуалЃ Ќ, больше рекомендуемой в течение длительного времени не только не оправдано, но и опасно. ?л¤ предотвращени¤ угрожающего жизни ухудшени¤ течени¤ заболевани¤ следует рассмотреть вопрос о пересмотре плана лечени¤ пациента и адекватной противовоспалительной терапии ингал¤ционными кортикостероидами.

?ругие симпатомиметические бронходилататоры следует назначать одновременно с препаратом ЅеродуалЃ Ќ только под медицинским наблюдением.

Ќарушени¤ со стороны ? “

” пациентов, имеющих в анамнезе муковисцидоз, возможны нарушени¤ моторики ? “.

Ќарушени¤ со стороны органа зрени¤

—ледует избегать попадани¤ препарата в глаза.

ЅеродуалЃ Ќ следует назначать с осторожностью пациентам, предрасположенным к развитию закрытоугольной глаукомы. »звестны отдельные сообщени¤ об осложнени¤х со стороны органа зрени¤ (например, повышение внутриглазного давлени¤, мидриаз, закрытоугольна¤ глаукома, боль в глазах), развившихс¤ при попадании ингал¤ционного ипратропи¤ бромида (или ипратропи¤ бромида в сочетании с агонистами ?2-адренорецепторов) в глаза. —имптомами острой закрытоугольной глаукомы могут быть боль или дискомфорт в глазах, затуманивание зрени¤, по¤вление ореола у предметов и цветных п¤тен перед глазами в сочетании с отеком роговицы и покраснением глаз, вследствие конъюнктивальной инъекции сосудов. ?сли развиваетс¤ люба¤ композици¤ этих симптомов, показано применение глазных капель, снижающих внутриглазное давление, и немедленна¤ консультаци¤ специалиста.

—истемные эффекты

ѕри следующих заболевани¤х: недавно перенесенном инфаркте миокарда, сахарном диабете с неадекватным гликемическим контролем, т¤жело протекающих органических заболевани¤х сердца и сосудов, гипертиреозе, феохромоцитоме или обструкции мочеиспускательных путей (например, при гиперплазии предстательной железы или обструкции шейки мочевого пузыр¤) ЅеродуалЃ Ќ следует назначать только после тщательной оценки соотношени¤ риск/польза, особенно в дозах, превышающих рекомендуемые.

¬ли¤ние на сердечно-сосудистую систему

¬ постмаркетинговых исследовани¤х отмечались редкие случаи возникновени¤ ишемии миокарда при приеме агонистов ?-адренорецепторов. ѕациентов с сопутствующими серьезными заболевани¤ми сердца (например, »Ѕ—, аритми¤ми или выраженной сердечной недостаточностью), получающих ЅеродуалЃ Ќ, следует предупреждать о необходимости обращени¤ к врачу в случае по¤влени¤ болей в сердце или других симптомов, указывающих на ухудшение заболевани¤ сердца. Ќеобходимо обращать внимание на такие симптомы, как одышка и боль в груди, т.к. они могут быть как сердечной, так и легочной этиологии.

vипокалиеми¤

ѕри применении агонистов ?2-адренорецепторов может возникать гипокалиеми¤.

” спортсменов применение препарата ЅеродуалЃ Ќ, в св¤зи с наличием в его составе фенотерола, может приводить к положительным результатам тестов на допинг.

—ледует учитывать, что препарат содержит небольшое количество этанола (13.313 мг в одной дозе).

¬ли¤ние на способность к управлению транспортными средствами и механизмами

»сследовани¤ по изучению вли¤ни¤ препарата на способность управл¤ть транспортными средствами и механизмами не проводились.

—ледует соблюдать осторожность при выполнении данных видов де¤тельности, т.к. возможно развитие головокружени¤, тремора, нарушени¤ аккомодации глаз, мидриаза и нечеткого зрени¤. ѕри возникновении указанных выше нежелательных ощущений пациент должен воздержатьс¤ от таких потенциально опасных действий, как управление транспортными средствами и механизмами.

ѕередозировка

—имптомы: симптомы передозировки обычно св¤заны преимущественно с действием фенотерола. ¬озможно по¤вление симптомов, св¤занных с избыточной стимул¤цией ?-адренорецепторов. Ќаиболее веро¤тно по¤вление тахикардии, оощущени¤ сердцебиени¤, тремора, артериальной гипо- или гипертензии, увеличени¤ пульсового давлени¤, стенокардических болей, аритмии, приливов, метаболического ацидоза, гипокалиемии.

—имптомы передозировки ипратропи¤ бромида, такие как сухость во рту, нарушение аккомодации глаз, учитыва¤ большую широту терапевтического действи¤ и ингал¤ционное применение, как правило, мало выражены и имеют преход¤щий характер.

Ћечение: необходимо прекратить прием препарата. —ледует учитывать данные мониторировани¤ кислотно-щелочного баланса крови. ѕоказаны седативные препараты, транквилизаторы, в т¤желых случа¤х - интенсивна¤ терапи¤.

¬ качестве специфического антидота возможно применение бета-адреноблокаторов, предпочтительно селективных бета1-адреноблокаторов. ќднако следует помнить о возможном усилении бронхиальной обструкции под вли¤нием бета-адреноблокаторов и тщательно подбирать дозу дл¤ пациентов, страдающих бронхиальной астмой или ’ќЅЋ, в св¤зи с опасностью т¤желого бронхоспазма, который может привести к смертельному исходу.

Ћекарственное взаимодействие

?лительное одновременное применение препарата ЅеродуалЃ Ќ с другими антихолинергическими препаратами не рекомендуетс¤ в виду отсутстви¤ данных.

Ѕета-адреномиметики и антихолинергические средства, ксантиновые производные (в т.ч. теофиллин) могут усиливать бронхолитическое действие препарата ЅеродуалЃ Ќ.

ѕри одновременном применении других бета-адреномиметиков, поступающих в системный кровоток антихолинергических средств или ксантиновых производных (в т.ч. теофиллина) возможно усиление побочных эффектов.

¬озможно значительное ослабление бронхолитического действи¤ препарата ЅеродуалЃ Ќ при одновременном назначении бета-адреноблокаторов.

vипокалиеми¤, св¤занна¤ с применением бета-адреномиметиков, может быть усилена одновременным назначением ксантиновых производных, v — и диуретиков. Ётому следует удел¤ть особое внимание при лечении пациентов с т¤желыми формами обструктивных заболеваний дыхательных путей.

Hypokalemia may increase the risk of arrhythmias in patients receiving digoxin. In addition, hypoxia can exacerbate the negative effects of hypokalemia on heart rate. In such cases, it is recommended to monitor the concentration of potassium in the blood serum.

Beta2-adrenomimetics should be used with caution in patients receiving MAO inhibitors and tricyclic antidepressants, because these drugs are able to enhance the action of beta-adrenergic drugs.

Means for inhalation anesthesia containing halogenated hydrocarbons (including halothane, trichlorethylene, enflurane) can increase the adverse effect of beta2-adrenergic drugs on the cardiovascular system.