Salmeterol, Fluticasone

Airtec aerosol is intended for the treatment of asthma in patients who are shown combination therapy with long-acting ß2-adrenergic agonists and inhaled corticosteroids, namely:

• in case of insufficient control of the disease against the background of constant monotherapy with inhaled corticosteroids with the periodic use of short-acting β2-adrenomimetics;
• in the case of adequate disease control during therapy with inhaled corticosteroids and long-acting β2-adrenergic agonists.

Structure

Active ingredients: salmeterol (in the form of salmeterol xinafoate) and fluticasone propionate;

1 dose contains salmeterol xinafoate equivalent to salmeterol - 25 micrograms and fluticasone propionate - 125 micrograms.

Excipients: propellant 1,1,1,2-tetrafluoroethane (HFA 134a), polyethylene glycol 1000.

Contraindications

Hypersensitivity to the components of the drug.

Mode of application

Adults and children over 12 years of age: 2 inhalations of 25 μg of salmeterol / 50 μg of fluticasone propionate 2 times a day or 2 inhalations of 25 μg of salmeterol / 125 μg of fluticasone propionate 2 times a day, or 2 inhalations of 25 μg of salmeterol / 250 μg of fluticasone propionate 2 times per day.

Children 4-12 years: 2 inhalations of 25 μg of salmeterol and 50 μg of fluticasone propionate 2 times a day. The maximum daily dose of fluticasone propionate is 100 mcg 2 times a day.

Application features

Pregnant women

The appointment of Airtec during pregnancy is advisable only in cases where the expected benefit to the mother outweighs the possible risk to the fetus. For the treatment of pregnant women, low effective doses of fluticasone propionate are prescribed to maintain adequate control of asthma symptoms.

Children

Children and adolescents under 16 years of age who are treated with high doses of fluticasone propionate (usually ≥1000 μg / day) are at particular risk of systemic effects. Systemic effects are usually caused by treatment in high doses for a long time. Possible systemic effects include Cushings syndrome, cushingoid symptoms, inhibition of adrenal function, acute adrenal crisis, stunted growth in children and adolescents, decreased bone mineralization, cataracts and glaucoma, less commonly possible mental disorders and behavior changes, including psychomotor hyperactivity, sleep disturbances, agitation, depression or aggression.

It is recommended to regularly monitor the growth dynamics of children receiving inhaled GCS for a long time. The dose of inhaled GCS should be reduced to the minimum effective dose to control asthma symptoms.

Overdose

Signs and symptoms that can be expected with an overdose of salmeterol, typical for excessive stimulation with β2-agonists, include dizziness, tremor, headache, tachycardia, increased systolic blood pressure. If treatment with the drug must be stopped as a result of an overdose of the β2-agonist that is part of the drug, appropriate steroid replacement therapy should be prescribed. In addition, hypokalemia may occur, therefore, serum potassium levels should be monitored and the need for potassium replacement therapy taken into account.

Side effects

• nasopharyngitis;
• throat irritation;
• Hoarseness / dysphonia;
• sinusitis;
• paradoxical bronchospasm;
• muscle spasms;
• arthralgia;
• myalgia.

Interaction

Because of the danger of developing bronchospasm, the use of selective and non-selective β-blockers should be avoided, except when they are very necessary for the patient.

Co-administration with drugs containing other β-adrenergic drugs may have a potential additive effect.

Storage conditions

Store at a temperature not exceeding 30 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life is 2 years.