Berodual Boehringer solution supports bronchiectasis (10ml)
Dosage form Bottle
Specifications Fenoterol, ipratropium
Ingredient Chronic respiratory obstruction
Ingredient
| Composition information | Content |
| Fenoterol | 0.05mg |
| Ipratropium | 0.02mg |
Uses
Indications
10 ml Berodual medicine is indicated in the following cases:
Berodual contains two active active active ingredients: ipratropium bromide anti -anti -cholinergic and fenoterol hydrobromide beta. This level 4 ammonium compound with anti -cholinergic effects (inhibitors). In preclinical studies, it inhibits the vagus neuropathy by antagonistic effects of acetylcholine, the chemical mediator secreted from the vagus nerve. The anti -cholinergic resistance prevents the increase in intracellular concentration of Ca ++ is the result of the interaction between acetylcholine and the muscarinic receptors at the bronchial smooth muscle. Ca ++ liberation through 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 This is a sympathetic medication directly, stimulating the selection of curls on the beta receptor; During treatment. Beta receptor stimulating effects, achieved when using higher doses (as used in uterine contractions). The bonding of beta 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, inhibiting phosphoinositide hydrolysis, and opening a potassium channel 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 (dose of 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 effect on metabolism: decomposition of lipid and glycogen, hyperglycemia and hypokalemia - caused by an increase in the absorption of K+. Beta -controlled effects on the heart such as increased heart rate and heart contraction are caused by the effect on the circuit of fenoterol, stimulating beta receptors; On the heart, and at a higher dose than the treatment dose, stimulating the beta receptor, as well as other beta -owners, there has been a report that extends the QTC, with untreated clinical significance. 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 agonist. 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 Beta's owner has achieved the expected effect, facilitating the appropriate dose of each patient with little adverse reactions. In patients with asthma and COPD, it has found better than when using ipratropium or fenoterol separately. 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 tolerated in studies responding to accumulated dose. In acute bronchospasm, Berodual has a quick effect and therefore suitable for treating acute asthma attacks. The treatment effect of combining ipratropium bromide and fenoterol hydrobromide is local effect on the respiratory tract. Therefore, the pharmacuric effect of causing bronchiectasis is not related to the dynamics of the active ingredients in the preparation. generally after inhalation gas, from 10% to 39% of the dose into the lungs, depends on the form of dosage, inhalation techniques and equipment, while the rest of the dose is stagnant in the suck tube, mouth and upper respiratory tract (pharyngeal). The dose is distributed into the airways after inhaling the dosage containing HFA 134A or the CFC pusher is the same. The drug in the lungs quickly entered 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 low (about 1.5%). After inhaling the berodual spray bottle, about 1% of the inhaled dose is eliminated as free fenoterol in urine 24 hours. Based on this data, the total bioavailability of Fenoterol Hydrobromide inhaled is about 7%. 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 1.8 l/min and cleared through the kidney of 0.27 l/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 in feces is 40.2% of the dose within 48 hours. The accumulated kidney excretion (0 - 24 hours) of ipratropium (original compound) is 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 2.3 l/min and the renal clearance is 0.9 l/min. After intravenous injection, about 60% of the dose is metabolized mainly in the liver thanks to oxidation. In an excreted balancing study, the excretion of the accumulated kidney (6 days) of the radioactive mark (including the original ingredient and all metabolites) is 9.3% after taken and 3.2% after inhalation. The total amount of radioactive markers excreted in stool is 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. Dynamic pharmacy
Before taking Berodual Boehringer solution supports bronchiectasis (10ml)
How to use
Before using the dosage spray for the first time, adhere to the following rules:
Remove the protective lid and press the spray valve twice.
Before using the dose sprayer should adhere to the following principles
1. Remove the protective lid (if you do not use the sprayer for more than 3 days, you need to start the valve once).
2. Exhale your best.
3. Hold the spray as shown in Figure 1, suck around the lip around the tube. The arrow and the bottom of the spray bottle are facing up.
4. Inhale maximum, and press strongly at the bottom of the spray bottle to release a standard dose. Hold your breath for a few seconds, then pull out the tube out of your mouth and exhale. Do the same with the second spray.
5. Close the protective lid after each use.
No transparent spray so it is impossible to know when the drug is over. The spray provides 200 doses. When using up the spray bottle can still contain a small amount of fluid. However, it is advisable to replace the new spray because the patient may not receive the right dose of treatment.
It is possible to estimate the remaining drug in the vase by checking as follows:
Alternatively, remove the spray bottle from a plastic suck tube and drop into the basin of water, the remaining drug in the bottle can be estimated by observing the position of the spray bottle in the water.
The important thing is to keep the pipe clean to ensure that the drug is not left and preventing the spray.
To clean, first remove the protective lid and remove the bottle from the suck tube. Wash the tube under warm water until there is no more stagnant and/or dust.
Plastic suck tubes are specially designed to use for Berodual, ensuring patients always receive the right amount of treatment. Do not use the suck tube with any other dose sprayer nor use Berodual with any suck tube except for the sucking tube provided with the drug.
The dose spray has a pressure, so in any case is not tried to open the spray or let the spray be contacted with temperatures above 50 ° C.
Dosage
should adjust the dose as required by each patient. Except for other prescriptions, the following doses are recommended for adults and children over 6 years old:
acute asthma attack
2 sprays are suitable to quickly reduce symptoms in many cases. In more severe cases, if shortness of breath does not improve after 5 minutes, you can use 2 more sprays.
If asthma attacks do not get better after 4 sprays, you can spray more. In this case, patients should see a doctor or go to the nearest hospital immediately.
interrupted and prolonged treatment
For asthma, berodual spray bottle should be used only based on demand).
1 - 2 sprays for each use, up to 8 sprays a day (average 1-2 sprays 3 times daily).
Should only use Berodual sprayer to dose for children as directed by the doctor and under the supervision of adults.
Should guide patients to use the right dose spray bottle to ensure effective treatment.
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 caused by excessive Beta adrenergic stimulation, mainly fast heartbeat, chest drum, tremor, hypertension, hypotension, wide pulse pressure, angina, arrhythmia and flushing face. Also observed metabolic acidosis when using fenoterol at a higher dose than the recommended dose for treatment for Berodual.
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.
Beta receptor inhibitors, preferably selected on beta, are appropriate detoxifying antidles; However, the possibility of increasing bronchial obstruction and should be carefully adjusted in patients with bronchial asthma or COPD due to the risk of severe bronchospasm of bad progress that can cause death.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not use double the prescribed dose.
Side Effects
When using 10 ml Berodual medicine, you may experience unwanted effects (ADR).
The following adverse effects may be due to the anti -cholinergic effect and Beta's beta owner. Treatment of inhaled berodual may show local stimulating symptoms. The adverse reactions to the drug are determined from the data obtained in clinical trials and vigilance during the use of the drug.
The most common side effects in clinical trials are coughing, dry mouth, headache, tremor, sore throat, nausea, dizziness, shortness of breath, fast heartbeat, hitting chest drum, vomiting, hypertension of systolic and restlessness.
Instructions on how to handle ADR
When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Berodual 10 ml drug contraindicated in the following cases:
Caution when using
for the first time using Berodual Berodual spray bottle containing HFA, some patients may see a slightly different taste than the type of CEC -containing spray bottle. It is advisable to notify the patient to know when switching from one form to another. The patient should be given two types of formulas that can be swapped for all purposes and the difference in taste does not affect safety or effectiveness.
In cases where the granting, shortness of breathing badly quickly, you should see a doctor immediately.
Long -term treatment
In patients with bronchial asthma should only use Berodual, when necessary. 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 agonized substances; As Berodual on a regular basis to control bronchial obstruction symptoms can reduce the effectiveness of disease control. If the bronchial obstruction worsens, simply increases the dose of the drug containing beta; Berodual overdose recommended for a long time is inappropriate and may be dangerous. In these cases, it is recommended to review the patient treatment regimen, and especially the level of anti -inflammatory treatment with inhaled corticosteroids 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 benefits/risks, especially when using higher doses recommended
Diabetes have not been well controlled, recently myocardial infarction, severe cardiovascular disease, hyperthyroidism, chrome cell tumor.
may experience cardiovascular effects when using sympathetic neurological medications, including berodual. There are some evidence from after -sales and literature data posted recorded cases of rare myocardial ischemia related to the beta agonist. Patients with severe heart disease (such as ischemic heart disease, arrhythmia or severe heart failure) use berodual, should pay attention to see a doctor if chest pain or other symptoms for 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 beta -shunned substance; Able to reduce serious blood potassium.
Should use berodual caution in patients who are likely to have narrow angle glaucoma, or have been blocked with 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 ipratropium bromide is a single spray or combined with a beta -owners; eye contact.
Therefore patients should be instructed to use berodual properly. Must be cautious so that the drug does not enter the eye.
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 treat with pupils and go to a specialist immediately.
Patients with fibrosis may have gastric - intestinal peristaltic disorders.
There may be instant hypersensitivity reactions after using Berodual, described by rare 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).
The ability to drive and operate machinery
There has been no research on the ability to drive and operate machinery.
However, patients 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 Ipratropium bromide and fenoterol hydrobromide. Pre -clinical studies on individual fertilizers ipratropium bromide and fenoterol hydrobromide do not see adverse effects on fertility.
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
Beta, cholinergic -resistant and Xanthine derivatives (such as theophylline) can increase bronchodilator. Simultaneously used with sympathetic beta medications, anti -cholinergic drugs and body xanthine derivatives (such as theophylline) may increase adverse reactions.
Using with beta antacids can seriously reduce bronchodilator effects.
Hematopoly is reduced by Beta, which can increase when used in combination with Xanthine, corticosteroid, and diuretic. 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 agonized substances; Caution should be used 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 in a safe place, in the reach of children.
Expiry date: 24 months from the date of production.
Do not use overdue drugs indicated on the packaging.
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