Description
Trade name:
Farcolin
Compound:
Each 20 ml of solution contains:
Salbutamol sulfate 0.121 g, which is equivalent to 0.1 g pure salbutamol.
Auxiliary components:
Disodium edetate, citric acid anhydrous, sodium citrate dihydrate, benzalkonium chloride, water for injection.
Properties:
Selective β2-adrenoreceptor agonist. In therapeutic doses, it acts on β2-adrenoreceptors of bronchial smooth muscles and has a short-term (4 to 6 hours) bronchodilatory effect on β2-adrenoreceptors with a rapid onset of action (within 5 minutes) in reversible airway obstruction.
Indications:
Relief and prevention of attacks of bronchial asthma (including as part of complex therapy for asthmatic status);
As part of complex therapy for other chronic lung diseases accompanied by reversible airway obstruction, including COPD, chronic bronchitis, and pulmonary emphysema.
Method of administration and dosage:
The drug Farcolin is intended only for inhalation administration by inhalation through the mouth using a compressor nebulizer.
The duration of action of salbutamol in most patients is 4 to 6 hours.
Treatment of chronic bronchospasm resistant to traditional therapy and treatment of acute severe bronchial asthma (status asthmaticus):
Intermittent therapy:
Adults and children aged 12 years and over: the average starting dose of salbutamol administered by inhalation using a nebuliser is 2.5 mg, which is equivalent to 0.5 ml (15 drops) of Farcolin. The drug must be diluted in 2 ml of saline.
The dose can be increased to 5 mg salbumatol, which is equivalent to 1 ml (30 drops) Farcolin, which must be diluted in 1.5 ml of physiological solution. The resulting solution is immediately used for inhalation using a nebulizer. If used correctly, the procedure time will be approximately 10 minutes.
Farcolin can also be used without dilution as an emergency treatment for bronchospasm:
To do this, 2 ml (60 drops) of Farcolin (10 mg salbutamol) are placed directly into the nebulizer and inhaled until the attack is relieved. The procedure usually takes 3-5 minutes. Depending on the severity of the disease, some patients may require a larger dose.
Children over 18 months: the average initial dose of salbutamol administered by inhalation using a nebulizer is also 2.5 mg, in children over 18 months it can be increased to 5 mg. It is diluted in the same way as for adults.
Inhalations can be repeated 4 times a day.
Continuous therapy:
1-2 ml (30-60 drops) of Farcolin is diluted in 100 ml of physiological solution. The resulting solution is inhaled through a nebulizer so that the dose received is 1-2 mg of salbutamol per hour.
Contraindications:
Hypersensitivity to any component of the drug.
Children under 18 months of age (there are no data on the clinical efficacy of salbutamol in children under 18 months of age).
Non-injectable formulations of salbutamol should not be used for the management of uncomplicated preterm labour or threatened abortion.
Precautions:
Use only for inhalation through a nebulizer as prescribed by a specialist.
Should not be taken orally or used for injection.
Farcolin should be used with caution in patients with thyrotoxicosis, tachyarrhythmia, severe chronic heart failure, arterial hypertension, pheochromocytoma, during pregnancy, during breastfeeding, as well as in patients who have already taken high doses of other sympathomimetics.
Bronchodilators should not be the sole or primary component of therapy for unstable or severe asthma.
An increased need for short-acting bronchodilators, particularly β2-adrenergic receptor agonists, to relieve asthma symptoms indicates a worsening of the disease. In such cases, it is recommended to review the patient’s treatment plan.
A sudden and progressive worsening of asthma may be life-threatening, so in such situations the appropriateness of prescribing or increasing the dose of GCS should be considered. In patients at risk, daily monitoring of peak expiratory flow rate is recommended.
Beta2-adrenergic agonist therapy, especially when administered parenterally or by nebulizer, may result in hypokalemia.
Particular caution is recommended in the treatment of severe asthma attacks, since in these cases hypokalemia may be aggravated by the simultaneous use of xanthine derivatives, GCS and diuretics, as well as due to hypoxia. In such situations, it is necessary to monitor the concentration of potassium in the blood serum.
As with other inhalation therapy agents, paradoxical bronchospasm with increased wheezing may occur with salbutamol immediately after administration. This condition requires immediate treatment with an alternative formulation of salbutamol or another short-acting inhaled bronchodilator. Farcolin should be discontinued immediately, the patient’s condition assessed, and, if necessary, another fast-acting bronchodilator prescribed for continuation of treatment.
Farcolin contains benzalkonium chloride, which can also cause bronchospasm.
Like other β2-adrenoreceptor agonists, salbutamol may cause reversible metabolic changes, such as an increase in blood glucose concentration. In patients with diabetes mellitus, decompensation may develop; in some cases, ketoacidosis has been reported. Concomitant use of GCS may enhance this effect.
Very rare cases of lactic acidosis have been reported in association with the use of high doses of short-acting β2-adrenergic agonists administered intravenously or by nebulizer, mainly in patients with exacerbations of asthma. Increased lactate levels may result in dyspnoea and compensatory hyperventilation, which may be misinterpreted as signs of asthma treatment failure and lead to an unnecessary increase in the use of short-acting β2-adrenergic agonists. Therefore, it is recommended to monitor serum lactate levels and monitor for possible subsequent development of metabolic acidosis.
Side effects:
From the immune system: very rare – hypersensitivity reactions, including angioedema, urticaria, bronchospasm, arterial hypotension and collapse.
Metabolism and nutrition disorders: rare – hypokalemia. Beta2-agonist therapy may cause clinically significant hypokalemia. Very rare – lactic acidosis.
From the nervous system: often – tremor, headache; very rarely – hyperactivity.
From the cardiovascular system: often – tachycardia; uncommon – palpitations; rarely – peripheral vasodilation; very rarely – arrhythmias, including atrial fibrillation, supraventricular tachycardia and extrasystole.
From the respiratory system: very rare – paradoxical bronchospasm.
From the digestive system: uncommon – irritation of the mucous membrane of the mouth and pharynx.
From the musculoskeletal system: uncommon – muscle cramps.
Storage method:
Store at a temperature not exceeding 30 degrees in a dark place.
Shelf life after opening is 1 month.
