Asthalin HFA Inhaler
Qualitative and quantitative composition
Asthalin HFA Inhaler is a pressurized metered-dose inhaler delivering 100 micrograms of Salbutamol (as Salbutamol Sulfate BP) per actuation. Asthalin HFA Inhaler contains a new fuel (HFA 134a) and does not contain any chlorofluorocarbons.
What is Asthalin HFA Inhaler used for?
Asthalin HFA Inhaler is for oral inhalation use only. Asthalin HFA Inhaler may be used with a Volumatic™ spacer device by patients who find it difficult to synchronize aerosol actuation with the inspiration of breath.
Adults (including the elderly):
One inhalation (100 micrograms) may be administered as a single minimum starting dose to relieve acute asthma symptoms, including bronchospasm. This may be increased to two inhalations if necessary. Two inhalations should be taken 10-15 minutes before the challenge to prevent allergen- or exercise-induced symptoms.
For chronic therapy, two inhalations up to four times a day.
Pediatric 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 BabyhalerTM spacer device may be used to facilitate administration to children under 5 years of age.
On-demand use of Asthalin HFA Inhaler should not exceed 8 inhalations in any 24 hours. Reliance on such frequent supplementary use, or a sudden increase in dose, indicates poorly controlled or deteriorating asthma.
Special warnings and precautions for use
Patients’ inhaler technique should be checked to ensure that aerosol actuation is synchronised with the inspiration of breath for optimum drug delivery to the lungs. Patients should be warned that they may experience a different taste upon inhalation compared to their previous inhalers.
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 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 fails to give relief lasting at least three hours, the patient should be advised to seek medical advice.
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. In this situation the patient should be assessed and consideration given to the need for increased anti-inflammatory therapy (e.g. higher doses of inhaled corticosteroid or a course of oral corticosteroid).
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. Patients with underlying severe heart disease (e.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 β2-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.
Fertility, pregnancy and lactation
Pregnancy
Studies in animals have shown reproductive toxicity (see section 5.3). Safety in pregnant women has not been established. No controlled clinical trials with Salbutamol have been conducted in pregnant women. Rare reports of various congenital anomalies following intrauterine exposure to Salbutamol (including cleft palate, limb defects and cardiac disorders) have been received. Some of the mothers were taking multiple medications during their pregnancies. Asthalin HFA Inhaler should not be used during pregnancy unless clearly necessary.
Breast-feeding
As Salbutamol is probably secreted in breast milk, its use in nursing mothers requires careful consideration. It is not known whether Salbutamol has a harmful effect on the neonate, and so its use should be restricted to situations where it is felt that the expected benefit to the mother is likely to outweigh any potential risk to the neonate.
Fertility
There is no information on the effects of Salbutamol on human fertility. There were no adverse effects on fertility in animals.
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). |
| Unknown: | Myocardial ischaemia* (see section 4.4) |
| Vascular disorders | |
| Rare: | Peripheral vasodilatation. |
| Respiratory, thoracic, and mediastinal disorders | |
| Very rare: | Paradoxical bronchospasm. |
| Gastrointestinal disorders | |
| Uncommon: | 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
The most common signs and symptoms of overdose with Salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects, including hypokalaemia.
Hypokalaemia may occur following an overdose with Salbutamol. Serum potassium levels should be monitored. Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (mainly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose.
Ref. https://www.medicines.org.uk/emc/product/850/smpc
Read more about Salbutamol, also known as Albuterol.
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