Combimist L Inhaler – Combined Bronchodilator for Asthma Treatment
Combimist L Inhaler is a combined bronchodilator, containing separately Ipratropium (20 mcg) + Levosalbutamol (50 mcg). Ipratropium (20 mcg) is an inhaled glucocorticosteroid, it has an anti-inflammatory effect in the recommended doses (has a lower frequency of side effects than systemic glucocorticosteroids). Levosalbutamol (50 mg) is a selective beta2-adrenergic receptor agonist that relaxes bronchial smooth muscles in patients with reversible airway obstruction.
How fast does the effect appear?
Bronchodilator effect occurs quickly, within 1-3 minutes after inhalation. It persists for 12 hours after a single dose inhalation. The concentration of this substance in the lungs after inhalation is 32-44% of the delivered dose. Systemic bioavailability is 49% of the delivered dose. Inhaled formoterol is rapidly absorbed, the concentration of formoterol in the lungs after inhalation is 28-49% of the delivered dose. Systemic bioavailability – 61% of the delivered dose.
When is this medicine used?
Combimist L Inhaler is used in:
- bronchial asthma (poorly controlled by the intake of inhaled glucocorticosteroids and short-acting beta2-adrenostimulants or adequately controlled by inhaled glucocorticosteroids and long-acting beta2-adrenostimulants).
- chronic obstructive pulmonary disease (symptomatic therapy in patients with severe chronic obstructive pulmonary disease and with a history of recurrent exacerbations, in the presence of severe symptoms of the disease on the backgroud of therapy with long-acting bronchodilators).
Dosage and mode of application
Inhalation. The inhaler is applied only with the help of a special device – an aerolize. The selection of the dose is made individually and depends on the disease severity.
Dosage for kids
Children over 6 years old
Due to the lack of clinical experience in children under 6 years of age, one of the Combimist L Inhaler components should not be used in this age group.
Treatment of children with mild bronchial asthma can begin with a dose of 200 mcg per day.
What are an absolute contraindication of this inhaler?
- Hypersensitivity to drug components or lactose.
- Children’s age (up to 6 years old).
When to take this medicine with caution?
Combimist L Inhaler should be taken with caution in the following cases:
- pulmonary tuberculosis;
- fungal, viral or bacterial respiratory infections;
- diabetis mellitus;
- uncontrolled hypokalemia;
- hypertrophic cardiomyopathy;
- severe arterial hypertension;
- cardiac aneurysm;
- ischemic heart disease;
- cardiac aneurysm.
Is it possible to take this inhaler during pregnancy?
It is not defined the Food and Drug Administration recommendation category. Adequate and well-controlled human studies have not been conducted.
Ipratropium: Food and Drug Administration Category C. In studies in rabbits, formoterol taken orally at doses 7,000-11,000 times the recommended human dose has been associated with an increase in cysts liver in the fetus. In studies on rats, inhalation of formoterol at a dose of 0.004-1.2 mg / kg did not have an undesirable effect on the fetus, but was accompanied by an increase in the likelihood of tachycardia in the mother. With systemic use, beta2-adrenergic agonists reduce the contractile activity of the uterus and can cause delay in labor, with inhalation use this effect is unlikely to be met.
Levosalbutamol: Food and Drug Administration Category C recommendation. The drug of choice during pregnancy in the United States due to its extensive clinical experience. Standard doses of inhaled glucocorticosteroids usually do not cause fetal abnormalities.
Adequate and well-controlled human studies have not been conducted. In pharmacological doses, they can cause placental insufficiency, fetal weight deficiency, stillbirth. The teratogenic effect has not been confirmed. Animal studies have shown an increase in the incidence of cleft palate, placental insufficiency, spontaneous abortion, and intrauterine growth retardation. In newborns whose mothers received inhaled glucocorticosteroids during pregnancy, adrenal insufficiency should be excluded.
There is no evidence of penetration into breast milk. However, analogs of these funds penetrate into breast milk.
Are side effects dangerous?
The severity of side effects is determined individually. The most common side effects are: headache, tachycardia, tremors, candidiasis and irritation of the mucous membrane of the oropharynx, cough, hoarseness, muscle cramps, agitation, anxiety, nausea, dizziness, sleep disturbances, exanthema, urticaria, pruritus, bronchospasm.
Levosalbutamol – depression, behavioral disturbances (mainly in children), systemic side effects of glucocorticosteroids (suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density, cataracts and increased intraocular pressure), hypersensitivity reactions of immediate or delayed types (dermatitis, angioedema and bronchospasm), the appearance of bruising.
Ipratropium – angina pectoris, hyperglycemia, change in taste, lability of blood pressure, paradoxical bronchospasm, arrhythmia, atrial fibrillation, supraventricular tachycardia and extrasystole.
Is overdose possible?
The overdose is possible. The symptoms are tremors, headache, palpitations and tachycardia, decreased blood pressure, metabolic acidosis, hypokalemia, and hyperglycemia. With prolonged use of excessive doses – the systemic effect of glucocorticosteroids (hypercortisolism and suppression of adrenal function). Treatment: symptomatic.
What are possible and banned interactions?
- Ketoconazole: significant increase in plasma concentration of the main component.
- Beta-adrenergic receptor blockers (including in the form of eye drops): weakening the formoterol effect.
- Quinidine: increased risk of QT prolongation and ventricular arrhythmias.
- Disopyramide: increased risk of QT prolongation and ventricular arrhythmias.
- Procainamide: increased risk of QT prolongation and ventricular arrhythmias.
- Phenothiazines: increased risk of QT prolongation and ventricular arrhythmias.
- Antihistamines (terfenadine): an increased risk of QT prolongation and ventricular arrhythmias.
- Monoamine oxidase inhibitors and tricyclic antidepressants: increased risk of QT prolongation and ventricular arrhythmias.
- Dopamine: decreased myocardial tolerance of beta2-adrenostimulants.
- Levothyroxine sodium: decreased myocardial tolerance of beta2-adrenostimulants.
- Oxytocin: decreased myocardial tolerance of beta2-adrenostimulants.
- Ethanol: decreased myocardial tolerance of beta2-adrenostimulants.
- Monoamine oxidase inhibitors: increased risk of high blood pressure.
- Furazolidone: increased risk of high blood pressure.
- Procarbazine: increased risk of high blood pressure.
- Halogenated hydrocarbon drugs for general anesthesia: increased risk of arrhythmias.
- Other beta-adrenostimulants increase the severity of the side effects of formoterol.
- Xanthine derivatives: increased risk of hypokalemia.
- CCM: increased risk of hypokalemia.
- Diuretics: increased risk of hypokalemia.
- Cardiac glycosides: increased risk of hypokalemia.