Salbutamol Other names: Albuterol Salbutamol

Chemical formula: C₁₃H₂₁NO₃  Molecular mass: 239.311 g/mol  PubChem compound: 2083

Interactions

Salbutamol interacts in the following cases:

Monoamine oxidase inhibitors

The effects of salbutamol may be altered by monoamine oxidase inhibitors.

Sympathomimetics

Salbutamol nebuliser solutions should be used with care in patients known to have received large doses of other sympathomimetic medicinal products.

Corticosteroids

Owing to the hypokalaemic effect of beta-agonists, concurrent administration of serum potassium depleting agents known to exacerbate the risk of hypokalaemia, such as corticosteroids, should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia.

Tricyclic antidepressants

The effects of salbutamol may be altered by tricyclic antidepressants.

Severe heart failure

Patients with underlying severe heart disease (e.g. 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.

Anti-diabetics

The administration of beta-agonists is associated with a rise of blood glucose, which can be interpreted as an attenuation of anti-diabetic therapy; therefore individual anti-diabetic therapy may need to be adjusted.

Diuretics

Owing to the hypokalaemic effect of beta-agonists, concurrent administration of serum potassium depleting agents known to exacerbate the risk of hypokalaemia, such as diuretics, should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia.

Halogenated anaesthetics

Owing to the additional antihypertensive effect, there is increased uterine inertia with risk of haemorrhage; in addition, serious ventricular rhythm disorders due to increased cardiac reactivity, have been reported on interaction with halogenated anaesthetics. Treatment should be discontinued, whenever possible, at least 6 hours before any scheduled anaesthesia with halogenated anaesthetics.

Xanthines

Owing to the hypokalaemic effect of beta-agonists, concurrent administration of serum potassium depleting agents known to exacerbate the risk of hypokalaemia, such as xanthines, should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia.

Digoxin

Owing to the hypokalaemic effect of beta-agonists, concurrent administration of serum potassium depleting agents known to exacerbate the risk of hypokalaemia, such as digoxin, should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia.

Guanethidine

The effects of salbutamol may be altered by guanethidine.

Isocarboxazid

Co-administration of salbutamol with isocarboxazid causes an increase in blood pressure.

Methyldopa

The effects of salbutamol may be altered by methyldopa.

Midodrine

Co-administration of salbutamol with midodrine causes an increase in blood pressure.

Phenelzine

Co-administration of salbutamol with phenelzine results in an increase in blood pressure.

Rasagiline

Co-administration of salbutamol with rasagiline results in an increase in blood pressure.

Reserpine

The effects of salbutamol may be altered by reserpine.

Theophylline

There is an increased risk of hypokalaemia if high doses of theophylline are given with higher doses of salbutamol.

Paradoxical bronchospasm

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. Salbutamol nebuliser solutions should be discontinued, and if necessary a different fast-acting bronchodilator instituted for on-going use.

Ischaemic heart disease

Patients with underlying severe heart disease (e.g. ischaemic heart disease) 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.

Cardiac arrhythmia

Patients with underlying severe heart disease (e.g. arrhythmia) 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.

Diabetes mellitus

Administration of beta agonists is associated with a rise of blood glucose. Therefore blood glucose and lactate levels should be monitored in diabetics and diabetic treatment adjusted accordingly to meet the needs of the diabetic during tocolysis. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported.

Thyrotoxicosis

Salbutamol should only be administered cautiously to patients suffering from thyrotoxicosis after careful evaluation of the benefits and risks of treatment.

Pregnancy

Administration of medicinal products during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.

As with the majority of medicinal products, there is little published evidence of the safety of salbutamol in the early stages of human pregnancy, but in animal studies there was evidence of some harmful effects on the fetus at very high dose levels.

Salbutamol should only be used during pregnancy if it is considered essential by the physician.

Nursing mothers

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.

Carcinogenesis, mutagenesis and fertility

Fertility

There is no information on the effects of salbutamol on human fertility. There were no adverse effects on fertility in animals.

Effects on ability to drive and use machines

None known.

Adverse reactions


Oral administration

The frequencies of adverse reactions are ranked according to the following MedDRA convention: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

Immune system disorders

Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse

Metabolism and nutrition disorders

Not known: Lactic acidosis, Hypokalaemia

Nervous system disorders

Not known: Headaches, Myoclonus

Cardiac disorders

Not known: Peripheral vasodilation and compensatory increase in heart rate*, Cardiac arrhythmias, Myocardial ischemia**

Respiratory, thoracic and mediastinal disorders

Not known: Pulmonary oedema

Musculoskeletal and connective tissue disorders

Not known: Skeletal muscle tremor***, Tense feeling****

* With doses of salbutamol higher than those recommended or in patients who are unusually sensitive to beta-adrenergic stimulants.
** There have been spontaneously reports of myocardial ischemia in post-marketing experience (frequency unknown).
*** A fine tremor, which occurs in some patients, usually the hands and the effects are dose related.
**** Due to the effects on skeletal muscle and not to direct CNS stimulation.

Respiratory administration

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 (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 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

Not known: Lactic acidosis.

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.

Not known: Myocardial ischaemia*.

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

IV / IM / SC administration

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.

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 beta-agonist therapy.

Unknown: Lactic acidosis

Nervous system disorders

Very common: Tremor.

Common: Headache.

Very rare: Hyperactivity.

Cardiac disorders

Very common: Tachycardia.

Common: Palpitations.

Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.

Unknown: Myocardial ischaemia*

Vascular disorders

Rare: Peripheral vasodilatation.

Respiratory, thoracic and mediastinal disorders

Uncommon: Pulmonary oedema.

In the management of pre-term labour, Ventolin Injection has uncommonly been associated with pulmonary oedema. Patients with predisposing factors including multiple pregnancies, fluid overload, maternal infection and pre-eclampsia may have an increased risk of developing pulmonary oedema.

Gastrointestinal disorders

Unknown: Nausea, vomiting*.

Musculoskeletal and connective tissue disorders

Common: Muscle cramps.

Injury, poisoning and procedural complications

Unknown: Slight pain or stinging on intramuscular use of undiluted injection*.

* reported spontaneously in post-marketing data therefore frequency regarded as unknown.

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