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4.9 Overdose
The preferred antidote for overdosage with salbutamol is a cardioselective â-blocking agent. However,
Symptoms and Signs
The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events (see Special Warnings and Precautions for Use and Undesirable Effects).
Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when salbutamol overdose has been taken via the oral route.
Treatment
Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such as cardio-selective beta-blocking agents in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations).
Beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
6.6 Instructions for Use and Handling
No special requirements.
Salbutamol syrup may be diluted with Purified Water BP (50% v/v). The resulting mixture should be protected from light and used within 28 days.
A 50% v/v dilution of salbutamol syrup has been shown to be adequately preserved against microbial contamination.
Admixture of salbutamol syrup with other liquid preparation is not recommended.
4.3 Contraindications
Salbutamol should not be used as a tocolytic agent in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease.
4.4 Special Warnings and Precautions for Use
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 salbutamol.
Tocolysis
Salbutamol should be used with caution in tocolysis and supervision of cardiorespiratory function, including ECG monitoring, should be considered. Treatment should be discontinued if signs of myocardial ischaemia (such as chest pain or ECG changes) develop. Salbutamol should not be used as a tocolytic agent in patients with significant risk factors for or pre-existing heart disease (see section 4.3).
Respiratory indications
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.
4.8 Undesirable Effects
Unknown: Myocardial ischaemia* (see section 4.4)
* reported spontaneously in post-marketing data therefore frequency regarded as unknown
Obstetric indications
Uncommon: Myocardial ischaemia*.
*In the management of pre-term labour with salbutamol injection/solution for infusion.
4.2 Posology and Method of Administration
etc……
For premature labour (or to control contractions or counteract overdosage of oxytocics):
Intravenous Infusion:-
Infusion rates of 10 – 45 micrograms per minute are generally adequate. A starting rate of 10 micrograms per minute is recommended, increasing the rate until there is evidence of patient response.
Careful attention should be given to cardio-respiratory function and fluid balance monitoring. The maternal pulse rate should be monitored regularly and should not be allowed exceed 140 bpm. Treatment discontinuation should be considered should signs of pulmonary oedema or myocardial ischaemia develop. (see section 4.4 ‘Special Warnings and Precautions for Use’ and section 4.8 ‘Undesirable Effects’)
Once uterine contractions have ceased the infusion rate should be maintained at the same level for one hour and then reduced by 50% decrements at 6 hourly intervals. Treatment may be continued orally.
Children:-
At present there is insufficient evidence to recommend a dosage regimen for routine use in children.
.....etc
etc........
Diabetic patients and those concurrently receiving corticosteroids should be monitored frequently during intravenous infusion of Ventolin so that remedial steps (e.g. an increase in insulin dosage) can be taken to counter any metabolic change occurring. For these patients Ventolin Concentrate Solution for Intravenous Infusion should be diluted with Sodium Chloride Injection BP, rather than Sodium Chloride and Dextrose Injection BP.
Lactic acidosis has been reported very rarely 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 Adverse Reaction section). 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.
Salbutamol causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output. Caution should be used in patients with angina, severe tachycardia or thyrotoxicosis.
As maternal pulmonary oedema
…..etc
etc.....
Metabolism and nutrition disorders
Rare: Hypokalaemia
Potentially serious hypokalaemia may result from beta-2-agonist therapy.
Very rare: Lactic acidosis
Lactic acidosis has been reported very rarely in patients receiving intravenous and nebulised salbutamol therapy for the treatment of acute exacerbation.
Nervous system disorders
Cardiac disorders
Very common: Tachycardia, palpitations
Uncommon:
* In the management of pre-term labour with salbutamol injection/solution for infusion
Rare: Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.
…..etc.
ETC……………….
Infusion rates of 10-45 micrograms per minute are generally adequate. A starting rate of 10 micrograms per minute is recommended, increasing the rate until there is evidence of patient response.
Careful attention should be given to cardio-respiratory function and fluid balance monitoring.
The
Once uterine contractions have ceased the infusion rate should be maintained at the same level for one hour and then reduced by 50% decrements at 6-hourly intervals. Treatment may be continued orally.
4.4 Special warnings and precautions for use
ETC……………..
As maternal pulmonary oedema has been reported during or following treatment of premature labour with
In the treatment of premature labour by intravenous infusion of salbutamol increases in maternal heart rate of the order 20 to 50 beats per minute usually accompany the infusion. The maternal pulse rate should be monitored and not normally allowed to exceed a steady rate of 140 beats per minute.
………………ETC
Enhancement of physiological tremor may occur with Ventolin. This effect is caused by a direct action on skeletal muscle and is common to all
Occasionally headaches have been reported.
Ventolin parenteral preparations may dilate some peripheral arterioles leading to a small reduction in arterial pressure and a compensatory increase in cardiac rate. Increases in heart rate are more likely to occur in patients with normal heart rates and these increases are dose-dependent. In patients with pre-existing sinus tachycardia, especially those in status asthmaticus, the heart rate tends to fall as the condition of the patient improves.
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely.
There have been very rare reports of muscle cramps.
Potentially serious hypokalaemia may result from
As with other
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) may occur, usually in susceptible patients.
Tachycardia may occur in some patients.
In the management of premature labour, intravenous infusion of Ventolin has occasionally been associated with nausea and vomiting.
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 and very rare events were generally determined from spontaneous data.
Immune system disorders
Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Rare: Hypokalaemia.
Potentially serious hypokalaemia may result from beta-2 agonist therapy.
Very common: Tremor.
Common: Headache.
Very rare: Hyperactivity.
Very common: Tachycardia, palpitations.
Vascular disorders:
Rare: Peripheral vasodilatation.
Respiratory, thoracic and mediastinal disorders:
Uncommon: Pulmonary oedema.
In the management of pre-term labour, salbutamol injection/solution for infusion have 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
Very rare: Nausea, vomiting.
In the management of premature labour, intravenous infusion of salbutamol has very rarely been associated with nausea and vomiting.
Musculoskeletal and connective tissue disorders
Common: Muscle cramps.
Injury, poisoning and procedural complications
Very rare: Slight pain or stinging on i.m. use of undiluted injection.