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VENTOLIN is a brand name for Albuterol (also known as Salbutamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ventolin Solution for Intravenous Infusion is indicated in adults and adolescents. Ventolin Solution for Intravenous Infusion should be administered under the direction of a physician. It is indicated for two distinct clinical situations: a) For the relief of severe bronchospasm. b) For the short term management of…
Verbatim from this product's MHRA label. Tap a section to expand.
Ventolin Solution for Intravenous Infusion is used to prepare an infusion solution. It should not be injected undiluted. Ventolin Solution for Intravenous Infusion should not be administered in the same syringe or infusion as any other medication.
1. In severe bronchospasm.
Adults:
A suitable solution for infusion providing 10 micrograms salbutamol/ml is prepared by diluting 5ml Ventolin Solution for Intravenous Infusion to 500ml with an infusion solution such as Sodium Chloride and Dextrose Injection BP. Other suitable diluents are Water for Injections BP, Sodium Chloride Injection BP or Dextrose Injection BP.
3 to 2ml/minute of the above infusion solution) are usually adequate. Higher doses have been used with success in patients with respiratory failure. Paediatric Population The safety and efficacy of Ventolin Solution for Intravenous in children under the age of 12 has not been established.
From the available data no recommendation on posology can be made.
Children aged 12 years and over:
Dose as per adult population 2. In the short term management of uncomplicated premature labour. Treatment with Ventolin Solution for Intravenous Infusion should only be initiated by obstetricians/physicians experienced in the use of tocolytic agents.
It should be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetus health status. Duration of treatment should not exceed 48 hours as data show that the main effect of tocolytic therapy is a delay in delivery of up to 48 hours; no statistically significant effect on perinatal mortality or morbidity has been observed in randomised, controlled trials.
This short term delay may be used to implement other measures known to improve perinatal health. 3). 4).
Special cautions for infusion:
The dose must be individually titrated with reference to suppression of contractions, increase in pulse rate and changes in blood pressure, which are limiting factors. These parameters should be carefully monitored during treatment.
A maximum maternal heart rate of 120 beats per min should not be exceeded. 4). The volume of fluid in which the drug is administered should thus be kept to a minimum. A controlled infusion device should be used, preferably a syringe pump.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000). Very common and common events were generally determined from clinical trial data.
Rare, very rare and unknown events were generally determined from spontaneous data. The most common undesirable effects of Ventolin Solution for Intravenous Infusion are correlated with the betamimetic pharmacological activity and may be limited or avoided by a close monitoring of hemodynamic parameters, such as blood pressure and heart rate, and an appropriate adjustment of the dose.
They normally recede upon therapy discontinuation.
Immune system disorders Very rare:
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse. Metabolism and nutrition disorders Common: *Hypokalaemia. 4) Nervous system disorders Very common: Tremor.
Common:
Headache.
Very rare:
Hyperactivity. Cardiac disorders Very common: ¹Tachycardia. Very common: *Tachycardia. g. atrial fibrillation, supraventricular tachycardia and extrasystoles. g. 4) Rare: ¹Peripheral vasodilatation. Rare: *Peripheral vasodilatation. Respiratory, thoracic and mediastinal disorders Uncommon: ¹Pulmonary oedema.
Uncommon: *Pulmonary oedema.
Gastrointestinal disorders Unknown:
Nausea, vomiting. In the management of premature labour, intravenous infusion of Ventolin has very rarely been associated with nausea and vomiting.
Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment, including lung-function testing, as patients are at risk of severe attacks and even death.
Physicians should consider using the maximum recommended dose of inhaled corticosteroid and/or oral corticosteroid therapy in these patients. The dosage or frequency of administration should only be increased on medical advice. Patients being treated with Ventolin Solution for Intravenous Infusion may also be receiving short-acting inhaled bronchodilators to relieve symptoms.
Increasing use of bronchodilators, in particular short-acting inhaled β2- agonists to relieve symptoms, indicates deterioration of asthma control. The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective, or more inhalations than usual are required.
g. higher doses of inhaled corticosteroid or a course of oral corticosteroid). Severe exacerbations of asthma must be treated in the normal way. The use of Ventolin Solution for Intravenous Infusion in the treatment of severe bronchospasm does not obviate the requirement for corticosteroid therapy as appropriate.
When practicable, administration of oxygen concurrently with parenteral Ventolin is recommended, particularly when it is given by intravenous infusion to hypoxic patients. In common with other β- adrenoceptor agonists, salbutamol can induce reversible metabolic changes such as hypokalaemia and increased blood glucose levels.
Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect. g. an increase in insulin dosage) can be taken to counter any metabolic change occurring.
Ventolin Solution for Intravenous Infusion is contra-indicated in the following conditions: - Any condition at a gestational age < 22 weeks - as a tocolytic agent in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease.
g. severe toxaemia, intrauterine infection, vaginal bleeding resulting from placenta praevia, eclampsia or severe preeclampsia, placental abruption, or cord compression. - intrauterine foetal death, known lethal congenital or lethal chromosomal malformation.
g. aortic stenosis. 1. v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Albuterol in United Kingdom.
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Infusion rates providing 10 to 45 micrograms salbutamol/minute are generally adequate to control uterine contractions. A starting rate of 10 micrograms/minute is recommended, increasing the rate at 10-minute intervals until there is evidence of patient response shown by diminution in strength, frequency or duration of contractions.
Thereafter, the infusion rate may be increased slowly until contractions cease. Careful attention should be given to cardio-respiratory function and fluid balance monitored. Once uterine contractions have ceased the infusion rate should be maintained at the same level for one hour and then reduced by 50% decrements at six hourly intervals.
If labour progresses despite treatment the infusion should be stopped. 3 for precautions with diabetic patients).
For use in a syringe pump:
Prepare a solution providing 200 micrograms salbutamol/ml by diluting 10ml Ventolin Solution for Intravenous Infusion with 40ml diluent. 225ml/minute of this solution.
Other infusion methods:
Prepare a solution providing 20 micrograms salbutamol/ml by diluting 10ml Ventolin Solution for Intravenous Infusion with 490ml diluent. 25ml/minute of this solution. Instructions to open the ampoule Ampoules are equipped with the OPC (One Point Cut) opening system and must be opened using the following instructions: • hold with one hand the bottom part of the ampoule as indicated in Picture 1 • put the other hand on the top of the ampoule positioning the thumb above the coloured point and press as indicated in Picture 2 Picture 1 Picture 2
Musculoskeletal and connective tissue disorders Common:
Muscle cramps. 4). ¹ Frequency associated with bronchospasm indication, where the reaction has also been seen in the obstetric indication. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
For these patients it may be preferable to dilute Ventolin Solution for Intravenous Infusion in Sodium Chloride Injection BP rather than in diluents containing dextrose. Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol.
There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with salbutamol. Tocolysis Any decision to initiate therapy with Ventolin Solution for Intravenous Infusion should be undertaken after careful consideration of the risks and benefits of treatment.
Treatment should only be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetal health status. Tocolysis with beta-agonists is not recommended when membranes have ruptured or the cervix dilation is beyond 4cm.
Ventolin Solution for Intravenous Infusion should be used with caution in tocolysis and supervision of cardiorespiratory function and ECG monitoring, should be performed throughout treatment. 5) Treatment should be discontinued if signs of myocardial ischaemia (such as chest pain or ECG changes) develop.
g. 3). In premature labour in a patient with known or suspected cardiac disease, a physician experienced in cardiology should assess the suitability of treatment before intravenous infusion with Ventolin Solution for Intravenous Infusion.
Pulmonary oedema As maternal pulmonary oedema and myocardial ischaemia have been reported during or following treatment of premature labour with beta-agonists, careful attention should be given to fluid balance and cardio-respiratory function.
Patients with predisposing factors including multiple pregnancies, fluid overload, maternal infection and pre-eclampsia may have an increased risk of developing pulmonary oedema. v. infusion will limit risk of fluid overload. 8). Blood pressure and heart rate Increases in maternal heart rate of the order of 20 to 50 beats per minute usually accompany infusion of beta-agonists.
The maternal pulse rate should be monitored and the need to control such increases by dose reduction or drug withdrawal should be evaluated on a case by case basis. Generally maternal pulse rate should not be allowed to exceed a steady rate of 120 beats per minute.
Maternal blood pressure may fall slightly during the infusion; the effect being greater on diastolic than on systolic pressure. Falls in diastolic pressure are usually within the range of 10 to 20mmHg. The effect of infusion on foetal heart rate is less marked, but increases of up to 20 beats per minute may occur.
In order to minimise the risk of hypotension associated with tocolytic therapy, special care should be taken to avoid caval compression by keeping the patient in the left or right lateral positions throughout the infusion. Diabetes Administration of beta agonists is associated with a rise of blood glucose.
Therefore blood glucose and lactate levels […]