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Ventolin Nebules

15:00
Ventolin Nebules 2.5 mg
Salbutamol

1. TRADE NAME OF THE MEDICINAL PRODUCT
Ventolin Nebules.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ventolin Nebules 2.5 mg: contain a concentration of salbutamol of 0.1% (1 mg salbutamol, as the sulphate, in 1 ml). Each Nebule contains 2.5 ml of solution equivalent to 2.5 mg salbutamol.

3. PHARMACEUTICAL FORM
Nebuliser solution.

4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Salbutamol is a selective β2 adrenoceptor agonist. At therapeutic doses it acts on the β2 adrenoceptors of bronchial muscle, with little or no action on the heart. With its fast onset of action, it is particularly suitable for the management and prevention of attack in asthma.
Bronchodilators should not be the only or the main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment as death may occur. Patients with severe asthma have constant symptoms and frequent exacerbations, with limited physical capacity, and PEF values below 60% predicted at baseline with greater than 30% variability, usually not returning entirely to normal alter a bronchodilator. These patients will require high dose inhaled (e.g. › 1 mg/day beclomethasone dipropionate) or oral corticosteroid therapy. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under urgent medical supervision.
Routine management of chronic bronchospasm - unresponsive to conventional therapy.
Treatment of acute severe asthma (status asthmaticus).

4.2 Posology and Method of Administration
Salbutamol has a duration of action of 4 to 6 hours in most patients. Ventolin Nebules are intended to be used undiluted. However, if prolonged delivery time is desirable (more than 10 minutes) dilution using normal saline for injection as a diluent may be required. Ventolin Nebules are to be used with a nebuliser, under the direction of a physician. The solution must not be injected.
Increasing use of β2 agonists may be a sign of worsening asthma. Under these conditions a reassessment of the patient's therapy plan may be required and concomitant glucocorticosteroid therapy should be considered.
Delivery of the aerosol may be by facemask, 'T' piece or via an endotracheal tube. Intermittent positive pressure ventilation 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 there may be adverse effects associated with excessive dosing, the dosage or frequency of administration should only be increased on medical advice.
As many nebulisers operate on a continuous flow basis, it is likely that nebulised drug will be released in 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.

Adults and Children:
A suitable starting dose of salbutamol by wet inhalation is
2.5 milligrams. This may be increased to 5 milligrams. Treatment may be repeated four times daily.

In adults higher dosing, up to
40 milligrams per day, can be given under strict medical supervision in hospital for the treatment of severe airways obstruction.

Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain.
As transient hypoxaemia may occur, supplemental oxygen therapy should be considered.

4.3 Contra-indications
Ventolin Nebules are contra-indicated in patients with a history of hypersensitivity to any of their components. 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 presentations should not be used for threatened abortion during the first or second trimesters of pregnancy.

4.4.b Special Warnings and Special Precautions for Use
The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests.
Increasing use of short-acting inhaled β2 agonists to control symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed. *Sudden and progressive deterioration in asthma control is potentially life threatening and consideration should be given to starting or increasing corticosteroid therapy. In patients considered at risk, daily peak flow monitoring may be instituted.
Patients receiving treatment at home with Ventolin Nebules must be warned that if either the usual relief is diminished or the usual duration of action reduced, they should not increase the dose or its frequency of administration, but should seek medical advice. Ventolin Nebules should be used with caution in patients known to have received large doses of other sympathomimetic drugs. Salbutamol should be administered cautiously to patients with thyrotoxicosis.
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.
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 concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations.
In common with other  β-adrenoceptor agonists, Ventolin can induce reversible metabolic changes, for example increased blood sugar levels.
The diabetic patient may be unable to compensate for this and the development of ketacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.

4.5 Interaction 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. Salbutamol is not contraindicated in patients under treatment with monoamine oxidase inhibitors (MAOIs).

4.6 Use During 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 foetus.
During worldwide marketing experience, rare cases of various congenital anomalies, including cleft palate and limb defects have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications during their pregnancies.
Because no consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2-3%, a relationship with salbutamol use cannot be established.
As salbutamol is probably secreted in breast milk its use in nursing mothers is not recommended unless the expected benefits outweigh any potential risk. It is not known whether salbutamol in breast milk has a harmful effect on 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 (≥l/l0,000 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 and very rare 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.

Nervous system disorders
Common: Tremor, *headache.
Very rare: Hyperactivity.

Cardiac disorders 
Common: Tachycardia.
Very rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.

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.

4.9 Overdose
The preferred antidote for overdosage with salbutamol is a cardioselective  β-blocking agent.  β-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  β2-adrenoceptor agonist. At therapeutic doses it acts on the  β2- adrenoceptors of bronchial muscle, with little or no action on the  β1 adrenoceptors of cardiac muscle.

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. The majority 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 Preclinical Safety Data
In common with other potent selective β2 receptor agonists, salbutamol has been shown to be teratogenic in mice when given subcutaneously. In a reproductive study, 9.3% of foetuses were found to have cleft palate, at 2.5mg/kg, 4 times the maximum human oral. In rats, treatment at the levels of 0.5, 2.32, 10.75 and 50mg/kg/day orally throughout pregnancy resulted in no significant foetal abnormalities. The only toxic effect was an increase in neonatal mortality at the highest dose level as the result of lack of maternal care. A reproductive study in rabbits revealed cranial malformations in 37% of foetuses at 50mg/kg/day, 78 times the maximum human oral dose.

6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Sodium chloride, Sulphuric acid, Purified water.

6.2 Incompatibilities
None reported.

6.3 Shelf Life
3 years.

6.4 Special Precautions for Storage
Ventolin Nebules should be stored at a temperature below 30°C.
Protected from light.

6.5 Nature and Contents of Container
Ventolin Nebules are plastic ampoules containing a solution of salbutamol sulphate in normal saline. Each Nebule contains 2.5ml of solution.

6.6 Instructions for Use/ Handling
Dilution:-
Ventolin Nebules may be diluted with Sodium Chloride Injection BP. Any unused solution in the chamber of the nebuliser must be discarded.

6.7 Direction for Use
ONCE A NEBULE HAS BEEN DETACHED FROM THE PLASTIC BAR. IT IS OPEN AND SHOULD BE USED IMMEDIATELY.

1.Prepare your nebuliser for filling

2.Separate one Ventolin Nebule and detach by twisting it firmly.

3.The Nebule is now open.
Take care not to spill the contents.

4.Squeeze the contents of the Nebule into the reservoir of the nebuliser. Do not dilute the contents unless instructed to do so by your doctor.
5.Assemble the nebuliser and use it as directed
6.After use, discard any remaining solution and clear your nebuliser in the usual way.

If dilution is necessary this should be carried out only as prescribed by your doctor. The usual method of dilution is to empty the Ventolin Nebule into the nebuliser reservoir, as above, and then to add the prescribed amount of sterile normal saline. The reservoir should then be gently shaken to mix the contents.

Package Quantities and Registration Number
Ventolin Nebules 5mg are each available in boxes containing 20 Nebules in pack 4 x 5.
Reg No. DKI9282000368A1

HARUS DENGAN RESEP DOKTER

Manufactured by
GlaxoSmithKline Australia Pty Ltd, Boronia, Australia

Imported by
PT. Glaxo Wellcome Indonesia, Jakarta, Indonesia
Ventolin and Nebules are trade marks of the GlaxoSmithKline group of companies
Based an GCT issue number # 13 (16 May 2003)

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