Berodual Boehringer solution supports bronchiectasis (20ml)

Dosage form Bottle x 20ml
Specifications Fenoterol, ipratropium
Ingredient Boehringer

Ingredient

Composition information	Content
Fenoterol	500mcg
Ipratropium	250mcg

Uses

Indications

Berodual 20ml drugs are indicated in the following cases:

Berodual is a bronchodilator to prevent and treat symptoms in chronic respiratory obstruction with a restriction of recovery airflow such as bronchial asthma and especially chronic bronchitis with or without emphysema. Treatment should be considered in combination with anti -inflammatory drugs for patients with bronchial asthma and chronic obstructive pulmonary disease (COPD) responding to steroids.

is a 4 -level ammonium compound with anti -cholinergic effect (inhibitors). In preclinical studies, it inhibits the vagus neuropathy by antagonistic effects of acetylcholine, chemical mediators secreted from vagus nerves.

Anti -anti -cholinergic resistance prevents the increase in intracellular concentration of Ca ++ is the result of the interaction between acetylcholine and muscarinic receptors at bronchial smooth muscles. Ca ++ release through the secondary information system containing IP3 (Inositol Triphosphate) and DAG (diacylglycerol).

Bronchodilator effect after inhaling ipratropium bromide is mainly specific effect on the spot, without systemic effect.

Propertical and clinical evidence does not show the harmful effects of ipratropium bromide on mucus secretion, mucus clearance and air exchange in the respiratory tract.

fenoterol hydrobromide

is a sympathetic medication directly, stimulating selectively on the beta2 receptor, within treatment. The Beta2 receptor stimulating effect is achieved when using a higher dosage (as used in the inhibition of uterine contractions). The connection of beta2 receptors, adenyl cyclase activation via protein GS has stimulating properties.

The increase in the amppendage of protein kinase A later is the target phosphorylates protein in smooth muscle cells. This leads to a light chain myosin kinase phosphorylation, inhibiting phosphoinositide hydrolysis, and opening potassium channels activated by calcium with high conductivity.

fenoterol hydrobromide relaxes bronchodi and blood vessels and protects against bronchospasm such as histamine, methacholine, cold air, and allergens (early response). After acute treatment, the release of intermediate substances causes bronchospasm and inflammation from inhibited moisturizers. Moreover, there is an increase in the clearance of mucus after using fenoterol (0.6 mg).

High concentrations in plasma, often achieved after drinking, or more when using intravenous sugar, inhibiting uterine contractions. Also at higher doses, the effects on metabolism: decomposition of lipid and glycogen, hyperglycemia and hypokalemia - caused by an increase in the absorption of k main muscles.

The beta movement effect on the heart such as increased heart rate and heart contraction is caused by the effect on the circuit of fenoterol, stimulating the beta2 receptor on the heart and at the dose higher than the dose of treatment, stimulating the beta2 receptor. Like other beta -owners, there have been a report that extends the QTC. For fenoterol spray pump dose (MID), the above reports are individually and observed that when the dose is higher than recommended. However, the whole body concentration after use (UDVS, aerosol solution) may be higher than MDI at the recommended dose.

No clinical significance has not been established. Run is a common effect of beta -shipping owners. Unlike the bronchial muscle effect, it may appear tolerated with the systemic effects of the beta -shifting substances.

Use these two active ingredients to cause bronchodilators to act on different pharmacological positions. These two active ingredients complement each other the effect of bronchodial muscle relaxation and allow widely used treatment in bronchial diseases related to respiratory spasms. Due to this additional effect, only a very low ratio of the Beta's owner has achieved the expected effect, facilitating the appropriate dose adjustment in each patient with little adverse reactions.

In patients with asthma and COPD, it has seen a better effect than when using ipratropun or individual fenoterol. Two studies (one in asthma patients, one on COPD patient) have proved berodual for the same effect as the double dose of non -use fenoterol with ipratropium but better tolerance in studies responding to accumulated dose.

In acute bronchial spasm, 20ml Berodual has a quick effect and therefore suitable for treating acute asthma attacks.

Dynamic pharmacy

The treatment effect of combining ipratropium bromide and fenoterol hydrobromide is local effect on the respiratory tract. Therefore, the pharmacy effect of causing bronchiectasis is not related to pharmacokinetics of active ingredients in preparations.

In general, after inhalation, from 10% to 39% of the dose into the lungs, dependent on the form of preparation, inhalation techniques and equipment, while the rest of the dose is stagnant in the suck tubes, mouth and upper respiratory tract (pharyngeal). The dose is distributed into the respiratory tract after inhaling the HFA 134A or CFC dosage.

The drug in the lungs quickly in the circulation (within a few minutes). The amount of drugs in the pharyngeal is swallowed slowly and through the digestive tract. Therefore, the whole body exposure depends on the bioavailability of both oral and lungs.

After inhaling ipratropium bromide and fenoterol hydrobromide with HFA 134A or CFC pusher, the excretion through the accumulated urine 24 hours is shown to be similar to the active ingredients and the HFA 134A and CFC cell forms that can be considered as biological equivalent.

There is no evidence of the pharmacokinetic difference for the ingredients in the formula combined compared to the single substance.

fenoterol hydrobromide

The amount of pills swallowed is mainly converted into a sulphate combination. Absolute bioavailability after drinking is low (about 1.5%).

About 40% of the drug is associated with plasma proteins.

Preliminary studies on mice show that Fenoterol and its metabolites are not through the brain barrier. Fenoterol has a total clearance of 1.8L/minute and the renal clearance is 0.27L/min.

After drinking, the total amount of radioactive markers is excreted in the urine about 39% of the dose and the total amount of radioactive markers excreted through 40.2% of the dose within 48 hours.

The accumulated kidney excretion (0 - 24 hours) of ipratropium (original compound) is less than 1% of oral dose and about 3 to 13% inhaling the dose through the berodual dose. Based on this data, the whole body bioavailability of ipratropium bromide oral and inhaling is about 2% and 7 to 28% respectively. This shows that the swallow dose rate of ipratropium bromide does not contribute significantly to the whole body concentration.

The sale time of the last elimination phase is about 1.6 hours. Ipratropium has a total clearance of 2.3L/min and the renal clearance is 0.9L/min. After intravenous injection, about 60% of the dose is metabolized mainly in the liver thanks to the oxidation process. In an excreted balancing study, the excretion of the accumulated kidney (6 days) of the radioactive mark (including the original component and all metabolites) is 9.3% after taken and 3.2% after inhalation.

The total amount of radioactive markers excreted through 88.5% after taken and 69.4% after inhalation. The duration of elimination of radioactive markers (original and metabolic components) is 3.6 hours. The link of the main metabolites through the urine with the Muscarinic receptor is negligible and these metabolites are thought to be ineffective.

Before taking Berodual Boehringer solution supports bronchiectasis (20ml)

How to use

The aerosol solution is only used to inhale with the appropriate and not drinking equipment.

dilute the recommended dose with physiological saline to reach a volume of 3 - 4ml and gas until the solution is out of the solution.

Do not dilute the berodual solution of aerosol solution with distilled water. Dilute the solution before each use, and remove the unused mixed solution.

should immediately use the solution after preparing.

can control the time of aerosol time with the volume of diluted solution.

Aerosal berodual solution can be used by gas equipment available on the market. The amount of body and lung -based drug depends on the equipment used and may be higher than the HFA and CFC dosage berodual berodual depending on the efficiency of the device.

If there is an oxygen with walls, the solution is best used with gas flow 6 - 8l/min.

Patients should comply with the manufacturer's instructions on how to use, maintain and clean the equipment.

Dosage

should adjust the dose as required by each patient. Patients should be monitored medical during treatment. Unless otherwise prescribed, the recommended dose is as follows (usually should start treatment with the lowest recommended dose).

adults (including the elderly) and teenagers over 12 years old

acute asthma attack

1ml (20 drops) is enough to quickly reduce symptoms in many cases of mild to medium acute asthma attacks.

In severe cases, such as patients in the emergency room do not respond to the above dose, may need higher doses of up to 2.5ml (50 drops).

In special cases, the dose of up to 4.0ml (80 drops) can be used under medical monitoring.

In case of average bronchospasm or need ventilation, the doses should be used lower than 0.5ml (10 drops).

Children 6 - 12 years old

acute asthma attack

0.5 - 1ml (10 - 20 drops) is sufficient to quickly reduce symptoms in many cases.

In severe cases, it may take up to 2ml high doses (40 drops).

In special cases, the dose of up to 3.0ml (60 drops) may be used under medical supervision.

In case of average bronchospasm or a ventilation support, the dose should be lower than 0.5ml (10 drops).

Children under 6 years old (under 22 kg)

Due to the limited information in this age group, the dose is recommended under the medical monitoring: about 25 mcg ipratropium bromide and 50mcg fenoterol hydrobromide/kg body/dose, maximum 0.5ml (10 drops).

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Symptoms

Overdose is mainly related to fenoterol. Symptoms encountered when overdose are symptoms due to excessive Beta adrenergic stimulation, mainly tachycardia, chest drumming, tremor, hypertension, hypotension, wide pulse pressure, angina, arrhythmia and blushing. Also observed metabolic acidosis when using fenoterol at a higher dose than the recommended treatment for the specified treatment for Berodual 20ml.

Symptoms during the overdose of ipratropium bromide are usually mild (such as dry mouth, visual disorders due to regulation) due to the systemic concentration of ipratropium used in the inhaler line is very low.

Treatment

Use sedative, sleeping pills, treatment in special care units in severe cases.

The best beta2 receptor inhibitors are selected on beta, which is a specific detoxifying antidote, however, it is important to pay attention to the ability to increase bronchial obstruction and should adjust the dose carefully in patients with bronchial asthma or COPD due to the risk of heavy bronchial spasms that can cause death.

What to do when forgetting a dose?

If you forget a dose, use it as soon as possible. However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

20ml Berodual medicine is contraindicated in the following cases:

Patients who know hypersensitivity to fenoterol hydrobromide or Atropine or any excipients of the drug.

Patients with hypertrophic and tachycardia.

Be cautious when using

In cases of granting, shortness of breathing worsens quickly, you should see a doctor immediately.

Long -term treatment

In patients with bronchial asthma should only use berodual as needed. In mild COPD patients on demand (based on symptoms) may be more suitable than regular treatment.

Consider additional treatment or increase anti -inflammatory dose to control respiratory infections and to prevent evolving evil disease in bronchial and COPD patients with steroid response.

Increase the use of drugs containing Beta, such as Berodual on a regular basis to control bronchial obstruction symptoms that can reduce the effectiveness of disease control. If the bronchial obstruction progresses badly, simply increasing the dose containing the beta, berodual exceeding the recommended dose for a long time is inappropriate and may be dangerous.

In these cases, it is advisable to reconsider the patient treatment regimen, and especially treat anti -inflammatory treatment with inhaled corticosteroids suitable to prevent the possibility of bad progression threatening.

Should only use other sympathetic bronchodilators with Berodual under medical supervision.

In the following cases, berodual should only be used after evaluating the benefits/risks, especially when using higher doses recommended: diabetes have not been well controlled, recent myocardial infarction, heart disease or severe vessels, hyperthyroidism, chromumoma cell tumor.

may experience cardiovascular effects when using sympathetic neurological medications, including berodual. There are some evidence from after -sales data and literature document that records cases of rare myocardial ischemia related to the beta owner.

Patients with severe heart disease (such as ischemic heart disease, arrhythmia or severe heart failure) use berodual, so pay attention to see a doctor if there is chest pain or other symptoms showing severe heart disease. Be careful to assess symptoms such as shortness of breath and chest pain because it can originate from the heart or respiratory system.

Treatment with beta2 agonized substance is capable of reducing serious blood potassium.

Use berodual caution in patients who are likely to suffer from narrow-angle glaucoma, or have been blocked by urinary tract (such as prostate hypertrophy or bladder obstruction).

There are several individual reports on eye complications (such as pupils, increased intraocular pressure, narrow-angle glaucoma, eye pain) when using ipratropium bromide spray in substance or in combination with an eye-catching Beta drug owner.

Therefore patients should be instructed to use berodual properly. Must be cautious so that the drug does not enter the eye.

The aerosol solution is recommended to use through the mouth of the mouth. If not, you can use aerosp mask but must be suitable. Patients who are capable of being glaucine should be careful to protect the eyes.

eye pain or discomfort, blurred vision, circles or color images combined with red eye redness and corneal edema can be a sign of acute narrow-angle glaucoma. If the appearance of the above symptoms appears, it is advisable to be treated with pupils and a specialist examination immediately.

Patients with fibrosis may have stomach peristaltic disorders,

There may be instant hypersensitivity reactions after using Berodual, determined by cases of urticaria, angioed, rash, bronchospasm, pharyngeal edema and anaphylactic reaction.

Because fenoterol should use Berodual may cause positive results in testing tests for abuse of subclinical drugs, such as the case that wants to increase the achievement in sport (doping).

Berodual aerosol solution contains benzalkoniumchloride preservatives, Dinatri Edetat dihydrate stabilizer. When the aerosol of these components can cause bronchospasm in patients sensitive to the upper respiratory tract.

The ability to drive and operate machinery

has not conducted research on affecting the ability to drive and operate machinery. However, the patient should be able to have adverse effects such as dizziness, tremor, regulatory disorders, pupils and blurred vision during treatment with Berodual. Therefore, patients should be careful when driving or operating machinery. If the patient has the above side effects, it is recommended to avoid work with dangerous potential such as driving or operating machinery.

Pregnancy

Pre -clinical data combined with the existing experience shows that there is no evidence of adverse effects in fenoterol or ipratropium. However, caution should be used in pregnancy, especially in the first three months. Should pay attention to the effect of inhibiting the uterus spasm of fenoterol.

There is no clinical data available on fertility about combining ipratropium bromide and fenoterol hydrobromide. There is no adverse effect on the ability to reproduce on preclinical studies with individual components of ipratropium bromide and fenoterol hydrobromide.

Breastfeeding period

Pre -clinical studies show that Fenoterol Hydrobromide is secreted into milk. It is unknown whether ipratropium will be secreted into milk or not. But usually the amount of ipratropium to the child is negligible, especially when inhaled. Should be cautious when using Berodual for breastfeeding women.

Medicinal interaction

Beta2 -resistant beta2 agonists and Xanthine derivatives (such as theophyline) can increase bronchodilator. Simultaneously used with sympathetic beta medications, anti -cholinergic drugs and body xanthine derivatives (such as theophylline) may increase adverse reactions.

Using the same beta antacids can seriously reduce bronchodilator effects.

Hemoto hypotension caused by beta agonized drugs, which can be increased when used in combination with Xanthine, corticosteroid and diuretic derivatives. This should be most noticeable in patients with severe respiratory obstruction.

Hematopathy can lead to an increased risk of arrhythmia in patients using digoxin. Moreover, oxygen reduction can make the effects of hypotension on heart rate worse. Therefore, it is recommended to monitor blood potassium concentration in these cases.

Medicines containing beta -shunned substances, should be used carefully for patients who are taking monoamine oxidase inhibitors or three -round antidepressants, because they can increase the effect of sympathetic beta.

Halogen hydrocarbon inhaling anesthesia such as Halothane, Trichlorethylene and Enflurane may increase the effect on the heart of the beta agent.

Storage

less than 30 ° C. Store safe places outside the reach of children.

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