1. Name of the medicinal product
Salbutamol Sulfate 0.5mg/1ml Injection
2. Qualitative and quantitative composition
Each ampoule contains salbutamol sulfate equivalent to 0.5 mg
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
1. For the relief of bronchospasm in bronchial asthmas of all
2. Chronic bronchitis.
4.2 Posology and method of administration
Route of administration Oral.
The usual effective dose is 4mg three or four times per day. If
adequate bronchodilation is not obtained each single dose may be
gradually increased to as much as 8mg. However, it has been
established that some patients obtain adequate relief with 2mg
three or four times daily. In elderly patients or in those known to
be unusually sensitive to beta-adrenergic stimulant drugs, it is
advisable to initiate treatment with 2mg three or four times per
The following doses should be administered three or four times
2-6 years: 1-2mg
6-12 years: 2mg
Over 12 years: 2-4mg
The product is not recommended for children under 2 years of age.
The drug is well tolerated by children so that, if necessary, these
doses may be cautiously increased.
1. Salbutamol should not be used for threatened abortion during the
first or second trimester of pregnancy.
2. Salbutamol and beta-blocking drugs such as propranolol should
not usually be prescribed together.
3. Salbutamol tablets are contraindicated in patients with a
history of hypersensitivity to any of their components.
4.4 Special warnings and precautions for use
Patients with rare hereditary problems of galactose intolerance,
the lapp lactase deficiency or glucose – galactose malabsorption
should not take this medicine.
Bronchodilators should not be the only or main treatment in
patients with severe or unstable asthma.
Increasing use of bronchodilators in particular short-acting
inhaled beta2-agonists to relieve symptoms indicates deterioration
of asthma control. If patients find that short acting relief
bronchodilator treatment becomes less effective or they need more
inhalations than usual, medical attention must be sought.
Salbutamol causes peripheral vasodilation which may result in
reflex tachycardia and increased cardiac output
Salbutamol should only be administered cautiously to patients
suffering from thyrotoxicosis after careful evaluation of the
benefits and risks of treatment.
Constant monitoring of potassium levels in patients with severe
asthma is essential, potentially serious hypokalaemia may result
from beta-2 agonist therapy.
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 (see section
4.5). Diabetic patients may be unable to compensate for the
increase in blood glucose and the development of ketoacidosis has
Concurrent administration of corticosteroids can exaggerate this
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 beta agonists.
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
4.5 Interaction with other medicinal products and other forms of
The effects of salbutamol may be altered by guanethidine,
reserpine, methyldopa, tricyclic antidepressants and monoamine
There is an increased risk of hypokalaemia if high doses of
theophylline or high doses of corticosteroids are given with higher
doses of salbutamol.
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
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 (see section 4.4).
Potassium depleting agents
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, digoxin,
methyl xanthines and 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 (see section 4.4).
4.6 Pregnancy and lactation
Salbutamol should only be used during pregnancy if it is considered
essential by the physician.
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.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
The only side effect of significance is a fine tremor of skeletal
muscle, which occurs in some patients, usually the hands and the
effects are dose related. A few patients feel tense; this is also
due to the effects on skeletal muscle and not to direct CNS
stimulation. With doses of salbutamol higher than those recommended
or in patients who are unusually sensitive to beta-adrenergic
stimulants, peripheral vasodilation and a compensatory increase in
heart rate may occur.
Occasionally headaches have been reported. Lactic acidosis,
myoclonus, pulmonary oedema, hypokalaemia, cardiac arrhythmias may
also occur and very rarely hypersensitivity reactions including
angioedema, urticaria, bronchospasm, hypotension and collapse.
There have been spontaneously reports of myocardial ischemia in
post-marketing experience (frequency unknown, see section 4.4).
The preferred antidote for overdosage with salbutamol is a
cardioselective beta blocking agent, but beta blocking drugs should
be used with caution in patients with a history of bronchospasm.
Hypokalaemia may occur following overdose with salbutamol. Serum
potassium levels should be monitored.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Salbutamol is a selective Beta-2-adrenergic agonist administered
for the symptomatic relief of bronchospasm associated with chronic
or acute asthma, bronchitis or other obstructive pulmonary
diseases. Because of its relative specificity for β2receptors,
salbutamol relaxes smooth muscle of the bronchi, uterus and
vascular supply to the skeletal muscle, but generally has much less
stimulant action on the heart than does isoproterenol which has
powerful action on all beta receptors.
5.2 Pharmacokinetic properties
Salbutamol is readily absorbed from the gastrointestinal tract. Its
effects occur within 15 minutes and last for about 14 hours. The
drug is excreted in urine in about 24 hours, 50% of the drug being
excreted within 4 hours. The peak plasma concentration of
salbutamol and its metabolites is 5.1-11.7μg% at 2.5-3 hours after
an oral dose of 4mg. Salbutamol does not cross the blood brain
barrier to a significant extent, but it crosses the placental
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
The tablets also contain: maize starch, lactose monohydrate,
dispersed pink (erythrosine (E127), carmoisine (E122), titanium
dioxide (E171)), sodium starch glycollate, talc, magnesium
6.3 Shelf life
6.4 Special precautions for storage
Store below 25°C in a dry place.
6.5 Nature and contents of container
Polypropylene tubes with low density polyethylene caps. Packing
material: high density polyethylene film.
28s, 30s, 56s, 60s, 84s, 100s, 250s, 500s, 1000s
Polyethylene container with a polypropylene lid.
6.6 Special precautions for disposal and other handling