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VENTOLIN RESPIRATOR SOLUTION

Active substance(s): SALBUTAMOL SULPHATE / SALBUTAMOL SULPHATE / SALBUTAMOL SULPHATE

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1.

NAME OF THE MEDICINAL PRODUCT

Ventolin Respirator Solution 5 mg/ml.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Aqueous, colourless to light yellow solution, pH 3.5, providing 5 mg/ml of salbutamol (as
Salbutamol Sulfate BP).
Excipients with known effect: Benzalkonium chloride (see section 4.4).
For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Solution for nebulisation.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Ventolin Respirator Solution is indicated in adults, adolescents and children aged
4 to 11 years. For babies and children under 4 years of age, see Section 4.2.
Ventolin Respirator Solution is indicated for use in the routine management of
chronic bronchospasm unresponsive to conventional therapy, and in the treatment
of acute severe asthma.

4.2

Posology and method of administration

Ventolin Respirator Solution is for inhalation use only, to be breathed in through the mouth, under
the direction of a physician, using a suitable nebuliser. The solution should not be injected or
swallowed. Ventolin Respirator Solution may be administered intermittently or continuously.
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Intermittent administration
Adults: Ventolin Respirator solution 0.5 ml (2.5 mg of salbutamol) should be diluted to a final
volume of 2 ml with sterile normal saline. This may be increased to 1 ml (5 mg of salbutamol)
diluted to a final volume of 2.5 ml. The resulting solution is inhaled from a suitably driven
nebuliser until aerosol generation ceases. Using a correctly matched nebuliser and driving source
this should take about ten minutes.
Ventolin Respirator Solution may be used undiluted for intermittent administration. For this, 2 ml
of Ventolin Respirator Solution (10 mg of salbutamol) is placed in the nebuliser and the patient
allowed to inhale the nebulised solution until bronchodilation is achieved. This usually takes 3 - 5

minutes. Some adult patients may require higher doses of salbutamol up to 10 mg, in which case
nebulisation of the undiluted solution may continue until aerosol generation ceases.
Paediatric Population
The same mode of administration for intermittent administration is also applicable to children.
The minimum starting dosage for children under the age of 12 years is 0.5 ml (2.5 mg of
salbutamol) diluted to 2 to 2.5 ml with sterile normal saline. Some children (over the age of 18
months) may, however, require higher doses of salbutamol up to 5 mg. Intermittent treatment may
be repeated up to four times daily.
Children aged 12 years and over: Dose as per adult population.
In infants under 18 months the clinical efficacy of nebulised salbutamol is uncertain. As transient
hypoxaemia may occur supplemental oxygen therapy should be considered.
Other pharmaceutical forms may be more appropriate for administration in children under 4 years
old.
Continuous administration
Ventolin Respirator Solution is diluted with sterile normal saline to contain 50-100 micrograms of
salbutamol per ml, (1-2 ml solution made up to 100 ml with diluent). The diluted solution is
administered as an aerosol by a suitably driven nebuliser. The usual rate of administration is 12 mg per hour.
4.3

Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.
Non-IV formulations of salbutamol must not be used to arrest uncomplicated premature labour or
threatened abortion.

4.4

Special warnings and precautions for use
Ventolin Respirator Solution must only be used by inhalation, to be breathed in
through the mouth, and must not be injected or swallowed.
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.

Patients receiving treatment at home should be warned to seek medical advice if
treatment with Ventolin Respirator Solution becomes less effective. As there may be
adverse effects associated with excessive dosing the dosage or frequency of
administration should only be increased on medical advice.
Patients being treated with Ventolin Respirator Solution may also be receiving
other dosage forms of 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. 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.
Ventolin Respirator Solution should be used with care in patients known to have
received large doses of other sympathomimetic drugs.
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.
In common with other β-adrenoceptor agonists, salbutamol can induce reversible
metabolic changes such as 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.
Lactic acidosis has been reported in association with high therapeutic doses of
intravenous and nebulised short-acting beta-agonist therapy, mainly in patients
being treated for an acute asthma exacerbation (see Section 4.8). Increase in
lactate levels may lead to dyspnoea and compensatory hyperventilation, which
could be misinterpreted as a sign of asthma treatment failure and lead to
inappropriate intensification of short-acting beta-agonist treatment. It is therefore
recommended that patients are monitored for the development of elevated serum
lactate and consequent metabolic acidosis in this setting.
A small number of cases of acute angle-closure glaucoma have been reported in
patients treated with a combination of nebulised salbutamol and ipratropium
bromide. A combination of nebulised salbutamol with nebulised anticholinergics
should therefore be used cautiously. Patients should receive adequate instruction

in correct administration and be warned not to let the solution or mist enter the
eye.
Salbutamol should be administered cautiously to patients suffering from
thyrotoxicosis.
Ventolin Respirator Solution contains Benzalkonium chloride which may cause
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.
Ventolin Respirator Solution should be discontinued immediately, the patient
assessed, and if necessary a different fast-acting bronchodilator instituted for ongoing use.
4.5.

Interactions with other medicinal products and other forms of interaction
Should not normally be prescribed with non-selective β-blocking drugs such as
propranolol.

4.6

Fertility, pregnancy and lactation
Pregnancy
Administration of drugs during pregnancy should only be considered if the
expected benefit to the mother is greater than any possible risk to the foetus. As
with the majority of drugs, 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 foetus at very high dose levels.
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 (see section 5.3).

4.7.

Effects on ability to drive and use machines

None reported.

4.8

Undesirable effects

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). 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.
Unknown:
Lactic acidosis (see section 4.4)
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.

4.9

Overdose
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 and lactic acidosis
(see sections 4.4 and 4.8).
Hypokalaemia may occur following 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
(particularly 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.
5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group:
andrenoreceptor agonists
ATC code: R03AC02

Andrenergics,

inhalants.

Selective

beta-2-

Salbutamol is a selective β2-agonist providing short-acting (4-6 hour)
bronchodilation with a fast onset (within 5 minutes) in reversible airways
obstruction. At therapeutic doses it acts on the β2-adrenoceptors of bronchial
muscle. With its fast onset of action, it is particularly suitable for the management
and prevention of attack in asthma.

5.2

Pharmacokinetic properties

Salbutamol administered intravenously has a half-life of 4 to 6 hours and is cleared
partly renally and partly by metabolism to the inactive 4'-0-sulfate (phenolic sulfate)
which is also excreted primarily in the urine. The faeces are a minor route of
excretion. Most of a dose of salbutamol given intravenously, orally or by inhalation is
excreted within 72 hours. Salbutamol is bound to plasma proteins to the extent of
10%.
After administration by the inhaled route between 10 and 20% of the dose reaches
the lower airways. The remainder is retained in the delivery system or is
deposited in the oropharynx from where it is swallowed. The fraction deposited in
the airways is absorbed into the pulmonary tissues and circulation, but is not
metabolised by the lung. On reaching the systemic circulation it becomes
accessible to hepatic metabolism and is excreted, primarily in the urine, as
unchanged drug and as the phenolic sulfate.
The swallowed portion of an inhaled dose is absorbed from the gastrointestinal
tract and undergoes considerable first-pass metabolism to the phenolic sulfate.
Both unchanged drug and conjugate are excreted primarily in the urine.

5.3

Preclinical safety data
In an oral fertility and general reproductive performance study in rats at doses of 2
and 50 mg/kg/day, with the exception of a reduction in number of weanlings
surviving to day 21 post partum at 50 mg/kg/day, there were no adverse effects on
fertility, embryofetal development, litter size, birth weight or growth rate.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients
Preservative: Benzalkonium chloride
Sulphuric acid if required to adjust to pH 3.5.
Purified water

6.2.

Incompatibilities
None known.

6.3.

Shelf life
Unopened: 3 years. Following opening for the first time: 28 days.

6.4.

Special precautions for storage

Store below 25°C. Protect from light. Discard any contents remaining one month after
opening the bottle.

6.5

Nature and contents of container

Screw-capped 10 ml amber glass bottle.
Screw-capped 20 ml amber glass bottle.

6.6

Special precautions for disposal
Inhalation use only, using a suitable nebuliser.
The nebulised solution may be inhaled through a face mask, “T” piece or via an
endotracheal tube. Intermittent positive pressure ventilation (IPPV) may be used,

but is rarely necessary. When there is a risk of anoxia through hypoventilation,
oxygen should be added to the inspired air.
As many nebulisers operate on a continuous flow basis, it is likely that nebulised
drug will be released into the local environment. Ventolin Respirator Solution
should therefore be administered in a well ventilated room, particularly in
hospitals when several patients may be using nebulisers at the same time.
Ventolin Respirator Solution may be diluted with sterile normal saline (see section
4.2).
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.
7

MARKETING AUTHORISATION HOLDER
Glaxo Wellcome UK Ltd
trading as GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex UB11 1BT.

8.

MARKETING AUTHORISATION NUMBER

PL 10949/0244

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

Date of first authorisation: 15 May 1987
Date of latest renewal: 12 October 2010

10

DATE OF REVISION OF THE TEXT
09/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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