BERODUAL F UDV Fenoterol Hydrobromide / Ipratropium Bromide 1.25mg / 500mcg per 4mL Solution for Inhalation 4mL 1's
Indications/Uses
Dosage/Direction for Use
Berodual MDI: Adults and Children >6 years: Acute Asthma Episodes: 2 actuations are sufficient for prompt symptom relief in many cases. In more severe cases, if breathing has not noticeably improved after 5 min, two further actuations may be taken.
If an attack has not been relieved by 4 actuations, further actuations may be required. In these cases, patients should consult the doctor or the nearest hospital immediately.
Intermittent and Long-Term Treatment (in asthma fenoterol hydrobromide/ipratropium bromide (Berodual) pressurised inhalation, solution should be used only on an as needed basis).
1-2 actuations for each administration, up to a maximum of 8 actuations per day (average 1-2 actuations 3 times daily).
In children fenoterol hydrobromide/ipratropium bromide (Berodual) pressurised inhalation should only be used on medical advice and under the supervision of an adult.
Berodual F UDV: Treatment should be initiated and administered under medical supervision, e.g. in the hospital setting. Home based treatment can be recommended in exceptional cases (severe symptoms or experienced patients requiring higher doses) when a low dose rapid acting beta-agonist bronchodilator such as fenoterol hydrobromide + ipratropium bromide (Berodual) pressurised inhalation solution has been insufficient in providing relief after consultation with an experienced physician.
The treatment with the nebuliser solution in UDVs should always be started with the lowest recommended dose (1 UDV). In very severe cases two unit dose vials may be required for symptom relief. Administration should be stopped when sufficient symptom relief is achieved.
Adults (including the elderly) and adolescents >12 years: Acute episodes of bronchospasm: 1 unit-dose vial is sufficient for prompt symptom relief in most cases. In very severe cases two unit dose vials may be required for symptom relief.
Children ≤ 12 years: Because of insufficient information the general use in children ≤ 12 years of age is not recommended.
Administration: Berodual MDI: Before first time use of the pressurised inhalation, solution the following rules should be observed: Remove protective cap and depress the valve twice.
Before each use, the following rules should be observed: 1. Remove protective cap. (If the inhaler has not been used for more than three days the valve has to be actuated once).
2. Breathe out deeply.
3. Hold the inhaler, and close lips around the mouthpiece. The arrow and the base of the container should be pointing upwards.
4. Breathe in as deeply as possible, pressing the base of the canister firmly at the same time, this releases one pressurised inhalation. 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 second inhalation.
5. Replace the protective cap after use.
Berodual F UDV: This solution is ready for use and requires no dilution.
The unit dose vials are intended only for inhalation with suitable nebulising devices and must not be taken orally or administered parenterally.
Fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) solution for inhalation can be administered using a range of commercially available nebulising devices. The lung and systemic drug exposure is dependent on the nebuliser used and may be higher than with Fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) pressurised inhalation solution depending on the efficiency of the device.
Where wall oxygen is available the solution is best administered at a flow rate of 6 - 8 litres per minute.
The instructions provided by the manufacturer of the nebulising device for proper care, maintenance and cleaning of the equipment should be followed.
1. Prepare the nebuliser for filling, according to the instructions provided by the manufacturer or physician.
2. Tear one unit dose vial from the strip.
3. Open the unit dose vial by firmly twisting the top.
4. Squeeze the content of the unit dose vial into the nebuliser reservoir.
5. Assemble the nebuliser and use as directed.
6. After use throw away any solution left in the reservoir and clean the nebuliser, following the manufacturer's instructions.
Overdosage
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation, the most prominent being tachycardia, palpitation, tremor, hypertension, hypotension, widening of the pulse pressure, anginal pain, arrhythmias and flushing.
Metabolic acidosis and hypokalaemia have also been observed with fenoterol when applied in doses higher than recommended for the approved indications of fenoterol hydrobromide/ipratropium bromide (Berodual/Berodual F UDV).
Expected symptoms of overdosage with ipratropium bromide (such as dry mouth, visual accommodation disturbances) are mild and transient in nature, in view of the wide therapeutic range and topical administration.
Therapy: Treatment with fenoterol hydrobromide/ipratropium bromide (Berodual) should be discontinued. Acid base and electrolyte monitoring should be considered. Administration of sedatives, and in severe cases intensive care treatment may be needed.
Beta-receptor blockers, preferably beta1-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 because of the risk of precipitating severe bronchospasm, which may be fatal.
Contraindications
Warnings
The mouthpiece must never be used with any other pressurised inhalation, solution nor must the fenoterol hydrobromide/ipratropium bromide (Berodual) pressurised inhalation, solution be used with any mouthpiece other than the one supplied with the product.
The container is under pressure and should by no account be opened by force or exposed to temperatures above 50°C.
Special Precautions
The inhibitory effect of fenoterol on uterine contraction should be taken into account.
Lactation: Non-clinical studies have shown that fenoterol hydrobromide is excreted into breast milk. It is unknown whether ipratropium is excreted into breast milk. But it is unlikely that ipratropium would reach the infant to an important extent, especially when taken by aerosol. However, caution should be exercised when fenoterol hydrobromide/ipratropium bromide (Berodual F UDV) is administered to a nursing woman.
Adverse Reactions
The most frequent side effects reported in clinical trials were cough, dry mouth, headache, tremor, pharyngitis, nausea, dizziness, dysphonia, tachycardia, palpitations, vomiting, blood pressure systolic increased and nervousness.
Drug Interactions
Other beta-adrenergics and anticholinergics and xanthine derivatives (such as theophylline) may enhance the bronchodilatory effect. The concurrent administration of other beta-mimetics, systemically available anticholinergics and xanthine derivatives (eg, theophylline) may increase the adverse reactions.
A potentially serious reduction in bronchodilation may occur during concurrent administration of beta-blockers.
Hypokalaemia induced by beta2-agonists may be increased by concomitant treatment with xanthine derivatives, corticosteroids, 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.
Beta2-agonist containing medicinal products should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta-adrenergic agonists may be enhanced.
Inhalation of halogenated hydrocarbon anesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility on the cardiovascular effects of beta-agonists.
Caution For Usage
Clean your mouthpiece at least once a week.
It is important to keep the mouthpiece of your inhaler clean to ensure that medicine does not build up and block the spray.
For cleaning, first take off the dust cap and remove the canister from the mouthpiece. Rinse warm water through the mouthpiece until no medication build-up and/or dirt is visible.
After cleaning shake out the mouthpiece and let it air-dry without using any heating system. Once the mouthpiece is dry, replace the canister and the dust cap.
Berodual F UDV: Since the unit dose vials contain 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.
Unused vials should be discarded three months after opening of the pouch.
Storage
Action
Pharmacology: Mode of Action: Fenoterol hydrobromide/ipratropium bromide (Berodual F UDV/Berodual MDI) contains two active bronchodilating ingredients: Ipratropium bromide, exhibiting an anticholinergic effect and fenoterol hydrobromide, a beta-adrenergic agent.
Ipratropium bromide is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. In non-clinical 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 Ca++ which caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. Ca++ release is mediated by the second messenger system consisting of IP3 (inositol triphosphate) and DAG (diacylglycerol).
The bronchodilation following inhalation of ipratropium bromide is primarily a local, site-specific effect, not a systemic one.
Non-clinical and clinical evidence suggest no deleterious effect of ipratropium bromide on airway mucous secretion, mucociliary clearance or gas exchange.
Fenoterol hydrobromide is a direct-acting sympathomimetic agent, selectively stimulating beta2-receptors in the therapeutic dose range. The stimulation of beta1-receptors comes into effect at a higher dose range. Occupation of beta2-receptors activates adenyl cyclase via a 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 hydrobromide relaxes bronchial and vascular smooth muscles and protects against bronchoconstricting stimuli such as 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 (0.6 mg).
Higher plasma concentrations, which are more frequently achieved with oral or even more so with intravenous 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 such as increase in heart rate and contractility, are caused by the vascular effects of fenoterol, cardiac beta2-receptor stimulation and, at supratherapeutic doses, by beta1-receptor stimulation. As with other beta-adrenergic agents, QTc prolongations have been reported. For fenoterol pressurised inhalation, solutions these were discrete and observed at doses higher than recommended. However, systemic exposure after administration with nebulisers (nebuliser solution, nebuliser solution in unit dose vials) might be higher than with recommended pressurised inhalation, solution doses. The clinical significance has not been established. Tremor is a more frequently observed effect of beta-agonists. Unlike the effects on the bronchial smooth muscle, the systemic effects of β-agonists are subject to the development of tolerance.
Concurrent use of these two active ingredients dilates the bronchi by affecting different pharmacological sites of action. The two 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 β-adrenergic component is needed to obtain the desired effect, facilitating individual dosage suited to each patient with a minimum of adverse reactions.
MedsGo Class
Features
- Fenoterol
- Ipratropium