VENTOLIN NEBULES 2.5MG

Active substance: SALBUTAMOL SULPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ventolin Nebules 2.5mg.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Plastic ampoule containing 2.5ml of a sterile 0.1% w/v solution of salbutamol
(as Salbutamol Sulphate BP) in normal saline.

3.

PHARMACEUTICAL FORM
Solution for inhalation via a nebuliser.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Ventolin Nebules are indicated in adults, adolescents and children, see Section
4.2.
Salbutamol is a selective β2-agonist providing short-acting (4-6 hour)
bronchodilation with a fast onset (within 5 minutes) in reversible airways
obstruction.
Ventolin Nebules are 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 Nebules are 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.

Adults (including the elderly): 2.5mg to 5mg salbutamol up to four times a
day. Up to 40mg per day can be given under strict medical supervision in
hospital.
Paediatric Population
Children aged 12 years and over: Dose as per adult population.
Children aged 4-11 years: 2.5mg to 5mg up to four times a day.
Other pharmaceutical forms may be more appropriate for administration in
children under 4 years old.
Infants under 18 months old: Clinical efficacy of nebulised salbutamol in
infants under 18 months is uncertain. . As transient hypoxia may occur
supplemental oxygen therapy should be considered.
Ventolin Nebules are intended to be used undiluted. However, if prolonged
delivery time (more than 10 minutes) is required, the solution may be diluted
with sterile normal saline.

4.3.

Contra-Indications
Although intravenous salbutamol, and occasionally salbutamol tablets, are
used in the management of premature labour uncomplicated by conditions
such as placenta praevia, ante-partum haemorrhage or toxaemia of pregnancy,
inhaled salbutamol preparations are not appropriate for managing premature
labour. Salbutamol preparations should not be used for threatened abortion.
Ventolin Nebules are contra-indicated in patients with a history of
hypersensitivity to any of the components.

4.4

Special warnings and precautions for use
Ventolin Nebules 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 seek medical advice if treatment
with Ventolin Nebules becomes less effective. The dosage or frequency of
administration should only be increased on medical advice.

Patients being treated with Ventolin Nebules may also be receiving other
dosage forms of short-acting inhaled bronchodilators to relieve symptoms.
Increasing use of bronchodilators, in particular short-acting inhaled β2agonists 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 patients 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 suffering from
thyrotoxicosis.
Ventolin Nebules 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.

4.5. Interactions with other Medicinal Products and other Forms of
Interaction
Salbutamol and non-selective β-blocking drugs such as propranolol, should
not usually be prescribed together.

4.6.

Pregnancy and Lactation
Administration of drugs 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 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 fetus at very high dose levels.
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
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 and
<1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <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.
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.

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 Nebules should be discontinued immediately, the
patient assessed, and, if necessary, alternative therapy instituted.
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

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.

Consideration should be given to discontinuation of treatment and appropriate
symptomatic therapy such as cardioselective beta-blocking agents in patients
presenting with cardiac symptoms (e.g. tachycardia, palpitations). Betablocking drugs should be used with caution in patients with a history of
bronchospasm.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Salbutamol is a selective β2-agonist providing short-acting (4-6 hour)
bronchodilatation 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’-O-sulphate
(phenolic sulphate) 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 sulphate.
The swallowed portion of an inhaled dose is absorbed from the gastrointestinal
tract and undergoes considerable first-pass metabolism to the phenolic
sulphate. Both unchanged drug and conjugate are excreted primarily in the
urine.

5.3.

Pre-clinical Safety Data
No additional preclinical safety data are included here.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Sodium chloride
Sulphuric acid if required to adjust pH
Purified water

6.2.

Incompatibilities
None known.

6.3.

Shelf-Life
3 years if unopened.
3 months after removal from the foil overwrap, (see below).

6.4.

Special Precautions for Storage
Ventolin Nebules should be stored below 30°C. The Nebules should be
protected from light after removal from the foil tray.

6.5.

Nature and Contents of Container

Low density polyethylene ampoules available in boxes of 20 or 40 in strips of
5 or 10. Sample pack of 5.

6.6.

Instructions for use/handling
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 some
nebulised drug will be released into the local environment. Ventolin Nebules
should therefore be administered in a well-ventilated room, particularly in
hospitals when several patients may be using nebulisers at the same time.
Dilution: Ventolin Nebules may be diluted with, sterile normal saline.
Solutions in nebulisers should be replaced daily.

7

MARKETING AUTHORISATION HOLDER
Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT

8.

MARKETING AUTHORISATION NUMBER(S)
PL 10949/0085

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
MAA:
Renewed:

10

1 March 1994
11 July 1997

DATE OF REVISION OF THE TEXT

07/02/2012

Expand view ⇕

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.

Hide
(web2)