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VENTOLIN EVOHALER 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 Evohaler is indicated in adults, adolescents and children aged 4 to 11 years. For babies and children under 4 years of age, see sections 4.2 and 5.1. Ventolin Evohaler provides short-acting (4 to 6 hour) bronchodilation with fast onset (within 5 minutes) in reversible airways obstruction. It is particularly…
Verbatim from this product's MHRA label. Tap a section to expand.
Ventolin Evohaler is for oral inhalation use only. Ventolin Evohaler may be used with a Volumatic spacer device by patients who find it difficult to synchronise aerosol actuation with inspiration of breath.
Adults (including the elderly):
For the relief of acute asthma symptoms including bronchospasm, one inhalation (100 micrograms) may be administered as a single minimum starting dose. This may be increased to two inhalations if necessary. To prevent allergen- or exercise-induced symptoms, two inhalations should be taken 10-15 minutes before challenge.
For chronic therapy, two inhalations up to four times a day. Paediatric Population Relief of acute bronchospasm The usual dosage for children under the age of 12 years: one inhalation (100 micrograms). The dose may be increased to two inhalations if required.
Children aged 12 years and over: dose as per adult population. Prevention of allergen or exercise-induced bronchospasm The usual dosage for children under the age of 12 years: one inhalation (100 micrograms) before challenge or exertion.
The dose may be increased to two inhalations if required. Children aged 12 years and over: dose as per adult population. Chronic therapy The usual dosage for children under the age of 12 years: up to two inhalations 4 times daily. Children aged 12 years and over: dose as per adult population.
The Babyhaler spacer device may be used to facilitate administration to children under 5 years of age. On-demand use of Ventolin Evohaler should not exceed 8 inhalations in any 24 hours. 4).
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000) including isolated reports.
Very common and common events were generally determined from clinical trial data. Rare, very rare and unknown events were generally determined from spontaneous data.
Immune system disorders Very rare:
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and nutrition disorders Rare:
Hypokalaemia. Potentially serious hypokalaemia may result from beta2 agonist therapy.
Nervous system disorders Common:
Tremor, headache.
Very rare:
Hyperactivity.
Cardiac disorders Common:
Tachycardia.
Uncommon:
Palpitations.
Very rare:
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles). 4) Vascular disorders Rare: Peripheral vasodilatation.
Respiratory, thoracic and mediastinal disorders Very rare:
Paradoxical bronchospasm.
Gastrointestinal disorders Uncommon:
Patients inhaler technique should be checked to make sure that aerosol actuation is synchronised with inspiration of breath for optimum delivery of drug to the lungs. Patients should be warned that they may experience a different taste upon inhalation compared to their previous inhaler.
The inhaler contains enough salbutamol for a total of 200 actuations (puffs) only. After the 200 actuations (puffs) have been used, the inhaler can when actuated continue to release a spray of propellant which no longer contains the prescribed dose of salbutamol.
Methods such as shaking, weighing or submerging inhalers are not accurate for determining that an inhaler is empty of the prescribed dose of salbutamol. To avoid inadvertent use of an empty inhaler, maintaining a record of the number of actuations (puffs) administered to the patient should be considered.
Keeping a back-up inhaler could also be considered. 6). 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. If a previously effective dose of inhaled salbutamol no longer provides relief for a duration of three hours following administration, the patient should be advised to promptly seek medical advice.
Failing to respond to treatment with salbutamol may signal a need for urgent medical advice or treatment. , inhaled corticosteroids) should be advised to continue taking their anti-inflammatory medication even when symptoms decrease, and they do not require Ventolin Evohaler.
Increasing use of bronchodilators, in particular short-acting inhaled beta-2-agonists, to relieve symptoms, indicates deterioration of asthma control, and patients should be warned to seek medical advice as soon as possible. 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.
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.
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Mouth and throat irritation.
Musculoskeletal and connective tissue disorders Uncommon:
Muscle cramps. * reported spontaneously in post-marketing data therefore frequency regarded as unknown 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.
g. higher doses of inhaled corticosteroid or a course of oral corticosteroid). Overuse of short-acting beta-agonists may mask the progression of the underlying disease and contribute to deteriorating asthma control, leading to an increased risk of severe asthma exacerbations and mortality.
, daytime symptoms, night-time awakening, and activity limitation due to asthma) for proper treatment adjustment as these patients are at risk for overuse of salbutamol. Severe exacerbations of asthma must be treated in the normal way.
Cardiovascular effects may be seen with sympathomimetic drugs, including salbutamol. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving salbutamol should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease.
Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin. Salbutamol should be administered cautiously to patients with thyrotoxicosis. Potentially serious hypokalaemia may result from beta-2-agonist therapy, mainly from parenteral and nebulised administration.
Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations.
As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator.
Evohaler should be discontinued immediately, the patient assessed, and if necessary, a different fast-acting bronchodilator instituted for on-going use.