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Salbutamol 2mg/5ml Oral Solution
 
 
 
 

Composition:
Each 5ml contains: Salbutamol sulfate..........................2.4mg
                             Equivalent to Salbutamol................2mg

 
  Properties
Salbutamol is a selective sympathomimetic agent of the beta-2-adrenergic receptors.
In the therapeutic doses, salbutamol has a bronchodilating action without or with a very small effect on the beta-1-adrenergic receptors of the cardiac muscles, especially in hypersensitive patients. Salbutamol acts very quick and stills the bronchospasms at doses that have no cardiac effects. Its sympathomimetic action also affects the musculature of the uterus and hence decreases the frequency and intensity of uterine contractions. Salbutamol acts by inibiting the secretion of histamin, leukotrienes and bronchocontracting prostaglandines. The bio-availability of salbutamol starts within 30 minutes after oral intake, and reaches a maximum after 2 to 3 hours. Half-life is about 5 hours. It is mostly bound to plasmaproteins (89%) and is metabolized in the liver.The main route of elimination is urinary, as much, and as a metabolite(60%), although about 4% can be traced in the faeces.

 
  Indications
Salbutamol is, due to its bronchodilating action, indicated in acute and chronic pulmonary affections.
Acute affections: symptomatic treatment of acute asthmatic crisis and bronchospasms. Prophylactic treatment to avoid asthmatic crisis after efforts or to avoid allergy upon contact with a suspected allergene.
Chronic affections: symptomatic supporting treatment of pulmonary disorders such as chronic asthma, chronic bronchitis and emphysemia in those cases where the pulmonary obstruction is reversible.

 
 

Posology and use
Salbutamol Oral Solution has to be taken three to four times a day, in the following doses:


Adults: 10ml(4mg) per intake. Maximal daily intake is 4x20ml (4x8mg).

Children older than 12 years: 5 to 10ml (2 to 4 mg) per intake. Maximal daily intake is 4x20ml (4x8mg).

Children 6-12 years: 5ml (2mg) per intake. Maximal daily intake is 60ml (24mg) divided over several doses.

Children 2-6 years: 2.5 to 5ml (1to2 mg) per intake. Maximal daily intake is 30ml (12mg) divided over several doses.

Children under 2 years: the solution is not to be administered to children younger than 2 years.

With elder patients and patients who are hypersensitive to a treatment with beta-2-agonist agents, it is recommended to use half the indicated dose for adults.
It can be necessary to increase the indicated dose, due to the personal response of the patient to the treatment, but nevertheless, it is recommended not to exceed the indicated maximal daily intakes.

The solution contains no sugar.

 
 

Contra-indications
Allergy to one of the components of the solution is a contra-indication.

 
  Adverse effects
There have been reports of patients who suffered from a fine tremor in the skeleton musculature, caused by the beta-2-agonistic property of salbutamol. An eventual tensed feeling has the same cause. At doses higher than the recommended ones (without exceeding the indicated maximal daily intakes) and in patients with a hypersensitivity to beta-2-agpmostoc agmets, a peripheric vasodilatation and a slight compensating increase of cardiac rithm have been reported.

 
  Precautions
Since, at therapeutic doses, salbutamol h as a selective effect on the beta-2-adrenergic receptors, cardiac insufficiency and hyppertension are no contra-indications, although precaution in those cases is recommended. With patients who suffer from thyreotosicosis and patients who are already taking high doses of beta-2-agonists or other bronchodilating agents (such as theophylline), care is to be taken. Administration of salbutamol can present a risk in patients who suffer from tachyarithmia, ischemic heart disease or obstructive hypertrophic cardiomyopathy. There is no need for adaption of doses in cases of renal or hepatic insufficiency.

 
  Pregnancy and the neonate
During pregnancy, salbutamol may be administered only if the advantage to be expected for the mother is more important than the eventual damage to the foetus. Salbutamol has been used for a very long time during pregnancy, even to prevent early birth, withour reports of foetal damage. Care is to be taken however during the first trimester of pregnancy, since experimental animal studies have revealed foetotoxicity, although only in very high doses. Salbutamol is reported to be excreted into breastmilk, so the use of salbutamol by breast feeding mothers is not recommended unless the advantage to be expected for the mother prevails over the eventual damage to the neonate, although the latter never has been proved.

 
  Interactions
The simultaneous use of inhalation corticosteroids is permitted to support the effect of salbutamol. They may restore a reduced response of the beta-2-adrenergic receptors to salbutamol and react on an infection of the bronchial wall. The simultaneous use of salbutamol oral solution and other oral sympatomimetic agents is contra-indicated due to the risk of cardiovascular disorders. Salbutamol may not be administered in combination with non selective beta-blocking agents such as propranolol.

 
  Overdosage
In case of overdosage, agitation, tachyarythmia, decrease of blood pressure and tremor can occur. The adverse effects will disappear when the treatment is ceased. In case of severe clinical signs of overdosage, hospitalisation must be considered for cardiovascular monitoring. A gastric lavage may be necessary, and careful treatment with cardioselective betablocking agents may be started (beware of patients with bronchospasms).

 
  Storage and stability
The solution should be kept at controlled room temperature (max. 25°C) out of reaach of children and protected from light. Close the bottle after each use. Batch-number and expiry date are indicated on the packing. The day of expiry is the first day of the indicated month.
 
     
  Sole agent: Hon Man Medicine (Wing Lee) Company  

 

 
     
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