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Berodual Metered Dose Inhaler


Description
Berodual: Each metered dose (puff) contains ipratropium bromide 21 mcg, corresponding to 20 mcg anhydrous ipratropium bromide and fenoterol HBr 50 mcg.
Each mL (= 20 drops) inhalant solution contains ipratropium bromide 260 mcg, corresponding to 250 mcg anhydrous ipratropium bromide and fenoterol HBr 500 mcg.
Berodual Forte: Each unit-dose vial of solution for inhalation contains ipratropium bromide 520 mcg, corresponding to 500 mcg anhydrous ipratropium bromide and fenoterol HBr 1250 mcg.
Ipratropium bromide is (8r)-3?-hydroxy-8-isopropyl-1?H, 5?H-tropanium bromide (?)-tropate monohydrate.
Fenoterol HBr is 1-(3,5-dihydroxy-phenyl)-2-[1-(4-hydroxy-benzyl)-ethyl]- amino-ethanol hydrobromide.

Actions
Pharmacology: Berodual/Forte contains 2 active bronchodilating ingredients: Ipratropium bromide, exhibiting an anticholinergic effect, and fenoterol HBr, a ?2-adrenergic agent.
Ipratropium bromide is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. In preclinical studies, it inhibits vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve. Anticholinergics prevent the increase in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.
The bronchodilation following inhalation of ipratropium bromide is primarily a local, site-specific effect, not a systemic one.
In controlled 90-day studies in patients with bronchospasm associated with asthma, significant improvements in pulmonary function (FEV1 increases of ? (greater than or equal to) 15%) occurred in 40% of the patients.
Preclinical and clinical evidence suggest no deleterious effect of ipratropium bromide on airway mucous secretion, mucociliary clearance or gas exchange.
Fenoterol HBr is a direct-acting sympathomimetic agent, selectively stimulating ?2-receptors in the therapeutic dose range. The stimulation of ?1-receptors comes into effect at a higher dose range. Occupation of ?2-receptors activates adenyl cyclase via stimulatory Gs-protein. The increase in cyclic AMP activates protein kinase A which then phosphorylates target proteins in smooth muscle cells. This in turn leads to the phosphorylation of myosin light chain kinase, inhibition of phosphoinositide hydrolysis, and the opening of large-conductance calcium-activated potassium channels.
Fenoterol relaxes bronchial and vascular smooth muscle and protects against bronchoconstricting stimuli eg, histamine, methacholine, cold air and allergen (early response). After acute administration, the release of bronchoconstricting and pro-inflammatory mediators from mast cells is inhibited. Further, an increase in mucociliary clearance has been demonstrated after administration of higher doses of fenoterol.
Higher plasma concentrations, which are more frequently achieved with oral, or even more so, with IV administration inhibit uterine motility. Also at higher doses, metabolic effects are observed: Lipolysis, glycogenolysis, hyperglycemia and hypokalemia, the latter caused by increased K+-uptake primarily into skeletal muscle. Beta-adrenergic effects on the heart eg, increase in heart rate and contractility, are caused by the vascular effects of fenoterol, cardiac ?2-receptor stimulation, and at supratherapeutic doses by ?1-receptor stimulation. Tremor is a more frequently observed effect of ?-agonists. Unlike the effects on the bronchial smooth muscle, the systemic effects of ?-agonists are subject to the development of tolerance. In clinical studies, fenoterol was shown to be highly efficacious in manifest bronchospasm. It prevents bronchoconstriction following exposure to various stimuli eg, exercise, cold air and the early response following allergen exposure.
Concurrent use of these 2 active ingredients dilates the bronchi by affecting different pharmacological sites of action. The 2 active substances thus complement each other in their spasmolytic action on the bronchial muscles and allow a broad therapeutic use in the field of bronchopulmonary disorders associated with constriction of the respiratory tract.
The complementary action is such that only a very low proportion of the ?-adrenergic component is needed to obtain the desired effect, facilitating individual dosage suited to each patient with a minimum of adverse reactions.
In patients with asthma and with COPD, Berodual inhalation solution has been shown to be an efficacious bronchodilator not only after acute but also after chronic administration.
In patients with asthma and with chronic obstructive pulmonary disorder (COPD), Berodual has been shown to be as efficacious as double the dose of fenoterol administered without ipratropium but was better tolerated in cumulative dose-response studies. In adequately-sized studies in patients with asthma and COPD, better efficacy compared to its components ipratropium or fenoterol was demonstrated.
The effect of 4 times a day domiciliary nebulised Berodual Forte for 3 weeks was assessed in a placebo-controlled, randomised, double-blind, crossover study in 20 patients with a low bronchodilator response and steroid-resistant chronic obstructive pulmonary disease. Peak expiratory flow rate rose from 164 L/min on saline to 196 L/min on Berodual Forte. Secondary endpoint analysis revealed a fall in home inhaler usage and a rise in visual analogue scales for symptoms.
In acute bronchoconstriction, Berodual is effective shortly after administration and is therefore also suitable for treating acute attacks of asthma.
In acute asthma, the combination of fenoterol and ipratropium is effective shortly after administration and has in the majority of studies been shown to more efficacious than each of its components.

Indications
As a bronchodilator for the prevention and treatment of symptoms in chronic obstructive airway disorders with reversible bronchospasm eg, bronchial asthma and especially chronic bronchitis with or without emphysema. Concomitant anti-inflammatory therapy should be considered for patients with bronchial asthma and steroid-responsive chronic obstructive pulmonary disease (COPD).

Dosage
Dosage: Berodual: The dosage should be adapted to the individual requirements; patients should also be kept under medical observation during treatment. Unless otherwise prescribed, the following dosages are recommended.
Metered-Dose Inhaler: Adults and Children >6 years: Acute Asthma Episodes: 2 puffs are sufficient for prompt symptom relief in many cases. In more severe cases, if breathing has not noticeably improved after 5 min, 2 further puffs may be taken.
If an attack has not been relieved by 4 puffs, further puffs may be required. In these cases, patients should consult the doctor or the nearest hospital immediately.
Intermittent and Long-Term Treatment: 1-2 puffs for each administration, up to a maximum of 8 puffs/day (average 1-2 puffs 3 times daily).
Inhalation Solution: Adults (Including the Elderly) and Adolescents >12 years:
Acute Asthma Episodes: 1 mL (20 drops of Berodual, corresponding to 250 mcg of anhydrous ipratropium bromide and 500 mcg of fenoterol HBr) is sufficient for prompt symptom relief in many cases of mild to moderate exacerbations.
In particular severe cases eg, for patients in the emergency room not responding to the doses mentioned, higher doses up to 2.5 mL (50 drops) may be required.
For particular severe cases, up to 4 mL (80 drops) may be administered under medical supervision.
Intermittent and Long-Term Treatment: If repeated dosing is required, 1-2 mL (20-40 drops) for each administration, up to 4 times daily.
In cases of moderate bronchospasm or with assisted ventilation, a dose in the lower range of 0.5 mL (10 drops) is recommended.
Children 6-12 years: Acute Asthma Episodes: 0.5-1 mL (10-20 drops) are sufficient for prompt symptom relief in many cases.
In severe cases, higher doses up to 2 mL (40 drops) may be required.
For particular severe cases, up to 3 mL (60 drops) may be administered under medical supervision.
Intermittent and Long-Term Treatment: If repeated dosing is required, 0.5-1 mL (10-20 drops) for each administration, up to 4 times daily.
In cases of moderate bronchospasm or with assisted ventilation, a dose in the lower range of 0.5 mL (10 drops) is recommended.
Children <6 years (<22 kg body weight): Because there is limited information in this age group, the following dose is recommended to be given under medical supervision only:
About 25 mcg ipratropium bromide and 50 mcg fenoterol HBr per kg body weight per dose up to 0.5 mL (10 drops) up to 3 times daily.
Treatment should be usually started with the lowest recommended dose.
The recommended dose is to be diluted with physiological saline to a final volume of 3-4 mL and nebulized and inhaled until the solution is consumed.
Berodual inhalation solution may, however, not be diluted with distilled water.
The solution should be re-diluted each time before use; any residual diluted solution should be discarded.
Dosage may be dependent upon the mode of inhalation and the quality of the nebulization. The duration of inhalation can be controlled by the dilution volume.
Berodual inhalation solution can be administered using a range of commercially available nebulizing devices. Where wall oxygen is available, the solution is best administered at a flow rate of 6-8 L/min.
The dose may be repeated after intervals of at least 4 hrs, if required.
Berodual Forte: The solution is ready for use and requires no dilution. The dosage should be adapted to the individual requirements.
Adults and Children >12 years: Unless otherwise prescribed, the following dosages are recommended: Acute Asthma Episodes: 1 unit-dose vial is sufficient for prompt symptom relief in most cases, typically the hospital-based treatment of moderate to severe asthma attacks or the home- and hospital-based treatment of patients with moderate to severe COPD. If in very severe cases, 2 unit-dose vials are required for symptom relief; these should be administered under medical supervision.
Intermittent and Long-Term Treatment: 1 unit-dose vial up to 4 times daily.
Berodual Forte can be administered using a range of commercially available nebulizing devices. Where wall oxygen is available, the solution is best administered at a flow rate of 6-8 L/min.
Administration: Berodual: Instruction for Use: The correct operation of the metered-dose inhaler apparatus is essential for successful therapy.
Shake the aerosol canister and depress the valve twice before the apparatus is initially used.
Before each use, the following rules should be observed:
Remove the protective cap. Shake the metered-dose inhaler well before each use. Breathe out deeply. Hold the metered-dose inhaler and close lips over the mouthpiece. The arrow and the base of the container should be pointing upwards.
Breathe in as deeply as possible, pressing the base of the container firmly at the same time; this releases 1 metered dose. Hold the breath for a few seconds, then remove the mouthpiece from the mouth and breathe out.
The same action should be repeated for a 2nd inhalation.
Replace the protective cap after use.
The mouthpiece should always be kept clean and can be washed with warm water. If soap or detergent is used, the mouthpiece should be thoroughly rinsed in clear water.
Berodual Forte: The unit-dose vials are intended only for inhalation with suitable nebulising devices and should not be taken orally or administered parenterally.
Prepare the nebulizer for filling, according to the instructions provided by the manufacturer or doctor.
Tear 1 unit-dose vial from the strip.
Open the unit-dose vial by firmly twisting the top.
Squeeze the contents of the unit-dose vial into the nebulizer reservoir.
Assemble the nebulizer and use as directed.
After use, throw away any solution left in the reservoir and clean the nebulizer, following the manufacturer's instructions.

Overdosage
Symptoms: The effects of overdosage are expected to be primarily related to fenoterol.
The expected symptoms with overdosage are those of excessive ?-adrenergic stimulation, the most prominent being tachycardia, palpitation, tremor, hypertension, hypotension, widening of the pulse pressure, anginal pain, arrhythmias and flushing.
Expected symptoms of overdosage with ipratropium bromide (eg, dry mouth, visual accommodation disturbances) are mild and transient in nature in view of the wide therapeutic range and topical administration.
Treatment: Administration of sedatives, tranquilizers, in severe cases intensive therapy.
Beta-receptor blockers, preferably ?1-selective, are suitable as specific antidotes; however, a possible increase in bronchial obstruction must be taken into account and the dose should be adjusted carefully in patients suffering from bronchial asthma or COPD.

Contraindication
Hypertrophic obstructive cardiomyopathy and tachyarrhythmia. Hypersensitivity to fenoterol HBr or atropine-like substances, or inactive ingredients of Berodual/Forte.

Warning


Precautions
In the case of acute, rapidly worsening dyspnea (difficulty in breathing), a doctor should be consulted immediately.
Prolonged Use: In patients with bronchial asthma and mild COPD, on demand (symptom-oriented) treatment may be preferable to regular use.
The addition or the increase of anti-inflammatory therapy to control airway inflammation and to prevent deterioration of disease control should be considered for patients with bronchial asthma and with steroid-responsive COPD.
The use of increasing amounts of ?2-agonists-containing products on a regular basis to control symptoms of bronchial obstruction may suggest declining disease control. If bronchial obstruction deteriorates, it is inappropriate and possibly hazardous to simply increase the use of ?2-agonist-containing products beyond the recommended dose over extended periods of time. In this situation, the patient's therapy plan, and in particular the adequacy of anti-inflammatory therapy with inhaled corticosteroids, should be reviewed to prevent potentially life-threatening deterioration of disease control. Other sympathomimetic bronchodilators should only be used with Berodual/Forte under medical supervision.
In the following conditions, Berodual/Forte should only be used after careful risk/benefit assessment, especially when doses higher than recommended are used: Insufficiently controlled diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorders, hyperthyroidism, pheochromocytoma.
Potentially serious hypokalemia may result from ?2-agonist therapy.
Berodual/Forte should be used with caution in patients with prostatic hypertrophy or bladder-neck obstruction or predisposed to narrow-angle glaucoma.
There have been isolated reports of ocular complications (ie, mydriasis, increased intraocular pressure, narrow-angle glaucoma, eye pain) when aerosolised ipratropium bromide either alone or in combination with an adrenergic ?2-agonist was sprayed into the eyes. Thus, patients must be instructed in the correct administration of Berodual metered aerosol. Eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist's advice sought immediately.
Patients must be instructed in the correct administration of Berodual/Forte inhalation solution. Care must be taken not to allow the solution or mist to enter into the eyes. It is recommended that the nebulized solution be administered via a mouthpiece. If this is not available and a nebulizer mask is used, it must fit properly. Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes.
Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.
Use in pregnancy & lactation: Preclinical data, combined with available experience in humans have shown no evidence of ill-effects in pregnancy of fenoterol or ipratropium. Nonetheless, the usual precautions regarding the use of drugs during pregnancy, especially during the 1st trimester, should be exercised.
The inhibitory effect on uterine contraction should be taken into account.
Preclinical studies have shown that fenoterol HBr is excreted into breast milk. It is not known whether ipratropium is excreted in breast milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that ipratropium would reach the infant to an important extent, especially when taken by aerosol. However, because many drugs are excreted in breast milk, caution should be exercised when Berodual/Forte is administered to a nursing woman.
Use in children: Berodual metered-dose inhaler should only be used on medical advice and under the supervision of an adult. Because of insufficient information, the general use of Berodual Forte in children <12 years is not recommended.

Adverse Reactions
Frequent undesirable effects of Berodual/Forte are fine tremor of skeletal muscles, nervousness and dryness of the mouth; less frequent are headache, dizziness, tachycardia and palpitations, especially in susceptible patients.
Potentially serious hypokalemia may result from ?2-agonist therapy.
As with use of other inhalation therapy, cough, local irritation and less commonly, inhalation-induced bronchospasm have been reported.
As with other ?-agonist-containing products, nausea, vomiting, sweating, weakness and myalgia/muscle cramps may occur. In rare cases, decrease in diastolic blood pressure, increase in systolic blood pressure, arrhythmias, particularly after higher doses may occur.
In individual cases, psychological alterations have been reported under inhalational therapy with ?-agonist-containing products.
Ocular accommodation disturbances, gastrointestinal motility disturbances and urinary retention are rare and reversible.
Ocular side effects have been reported (see Precautions).
In rare cases, skin reactions or allergic-type reactions eg, skin rash, angioedema of the tongue, lips and face, and urticaria may occur.

Drug Interaction
Other ?-adrenergics, anticholinergics and xanthine derivatives (eg, theophylline) may enhance the bronchodilatory effect. The concurrent administration of other ?-mimetics, systemically available anticholinergics and xanthine derivatives (eg, theophylline) may increase the side effects.
A potentially serious reduction in bronchodilatation may occur during concurrent administration of ?-blockers.
Beta-agonist-induced hypokalemia may be increased by concomitant treatment with xanthine derivatives, steroids and diuretics. This should be taken into account particularly in patients with severe airway obstruction.
Hypokalemia may result in an increased susceptibility to arrhythmias in patients receiving digoxin. Additionally, hypoxia may aggravate the effects of hypokalemia on cardiac rhythm. It is recommended that serum potassium levels are monitored in such situations.
Beta-adrenergic agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of ?-adrenergic agonists may be enhanced.
Inhalation of halogenated hydrocarbon anaesthetics eg, halothane, trichloroethylene and enflurane may increase the susceptibility on the cardiovascular effects of ?-agonists.

Cautions For Usage
Berodual: The container is under pressure and should on no account be opened by force or exposed to temperatures exceeding 50?C. As the container is not transparent, it is not possible to see when the contents are used up, but shaking the container will show if there is any remaining fluid.
Berodual Forte: Since Berodual Forte contains no preservative, it is important that the contents are used soon after opening and that a fresh vial is used for each administration to avoid microbial contamination. Partly used, opened or damaged unit-dose vials should be discarded.

This website does not provide medical advice. Please always consult your physician on medical matters.

 
 


 
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