Seretide Diskus 50/100mcg inhaler

Seretide Diskus 50/100mcg inhaler

Seretide discus
SERETIDE DISKUS

International name – fluticasone, salmeterol
Classification code – R03BX

Clinical-pharmacological group – glucocorticoid preparations for inhalation use

Composition and release form
Powder for inhalation 50 mcg+100 mcg/1 dose: inhaler Discus, 60 doses
Powder for inhalation 50 mcg+250 mcg/1 dose: inhaler Discus, 60 doses
Powder for inhalation 50 mcg+500 mcg/1 dose: inhaler diskus, 60 doses

Powder for inhalation: discus 60 doses in an inhaler
1 dose
Salmeterol (as xinafoate). . . . . . . . . . . 50 mcg
Fluticasone Propionate. . . . . . . . . . . . . . . . 100 mcg
Powder for inhalation: discus 60 doses in an inhaler
1 dose
Salmeterol (as xinafoate). . . . . . . . . . . 50 mcg
Fluticasone Propionate. . . . . . . . . . . . . . . . 250 mcg
Powder for inhalation: discus 60 doses in an inhaler
1 dose
Salmeterol (as xinafoate). . . . . . . . . . . 50 mcg
Fluticasone Propionate. . . . . . . . . . . . . . . . 500 mcg
Excipients: lactose

Clinical-pharmacological group
Combined antiasthmatic drug with anti-inflammatory and broncholytic action for inhalation use.

Pharmacological properties
The mechanism of action is determined by the characteristics of the active substances. Salmeterol – a selective agonist of β2-adrenoreceptors with long action (12 hours). The salmeterol molecule contains a long side chain that binds to the outer part of the receptor. The mentioned pharmacological feature leads to prevention of histamine-induced bronchospasm with salmeterol, prolonged (at least 12 hours) bronchodilation and reduction of bronchial hyperreactivity.
In vitro studies have shown that salmeterol effectively and long-lastingly inhibits the release of histamine, leukotrienes, and D2 prostaglandins from mast cells. Salmeterol also suppresses the early and later stages of the reaction to aeroallergens; After taking a single dose of the drug, the later stage lasts up to 30 hours.
Fluticasone propionate is a glucocorticosteroid (GC). When taken by inhalation in recommended doses, it has a pronounced anti-inflammatory effect, which leads to a decrease in the intensity of symptoms characteristic of obstructive diseases of the respiratory system and a decrease in the frequency of disease exacerbations without the side effects characteristic of systemic glucocorticosteroids. With long-term use of maximum doses of inhaled fluticasone propionate in adults and children, the daily secretion of hormones of the adrenal gland remains within the normal range. Switching patients on other inhaled GCS to inhaled fluticasone propionate has shown that daily secretion of adrenocortical hormones gradually returns to normal despite prior administration of oral GCS. During long-term administration of fluticasone propionate, the reserve function of the adrenal cortex is also maintained within the norm, which is confirmed by the results of the stimulation test. It should also be taken into account that a residual decrease in adrenal reserve function may persist after long-term therapy. Seretide Diskus provides a more convenient therapy regimen for patients.

Pharmacokinetics
Simultaneous administration of salmeterol and fluticasone propionate by inhalation does not affect the pharmacokinetic indicators of each component.
Salmeterol: Information on the pharmacokinetic parameters of salmeterol is available in a limited amount, since it is technically difficult to determine the lowest concentration of the drug in the blood plasma (200 pg/ml and less) when used by inhalation.
Fluticasone propionate: The absolute systemic bioavailability of fluticasone propionate after inhalation is 10-30%. Systemic absorption occurs predominantly in the lungs. Part of the inhaled dose may enter the stomach as a result of swallowing, but its systemic effect is minimal due to the low solubility of the drug in water and intensive metabolism in the liver. After oral administration of fluticasone propionate, the bioavailability of the drug is less than 1%. Fluticasone propionate has a high plasma clearance (1150 mL/min) and a large Vd (approximately 300 L).
Fluticasone propionate is rapidly eliminated from the circulatory system as an inactive metabolite.
Renal clearance of fluticasone propionate is negligible (less than 0.2%), less than 5% of its metabolite is excreted in urine. T1/2 is about 8 hours.

testimonials
– basic therapy accompanied by reversible obstructions of the respiratory tract of the disease (including bronchial asthma in children and adults), when it is appropriate to prescribe a combined therapy (bronchodilator and inhaled GCS group drug);
– patients on maintenance therapy of prolonged β2-adrenomimetics and inhaled glucocorticosteroids;
– patients whose symptoms of the disease persist on the background of inhaled glucocorticosteroid therapy;
– Patients on regular bronchodilator therapy who require inhaled GCS.

Administration rules and dosages
Seretide Diskus is indicated for inhalation use only. The patient should be informed that it is necessary to use Seretide disk regularly even in the absence of symptoms of the disease. During the treatment, it is also necessary to be under the supervision of the patient’s doctor in order to select the optimal dose of the drug. The starting dose of Seretide Diskus is determined based on the dose of fluticasone propionate corresponding to the severity of the disease. It is then recommended to gradually reduce the initial dose to the minimum effective dose.
Adults and adolescents aged 12 years and older are prescribed 1 inhalation (50 mcg salmeterol and 100 mcg fluticasone propionate; or 50 mcg salmeterol and 250 mcg fluticasone propionate; or 50 mcg salmeterol and 500 mcg fluticasone propionate) 2 times a day.
Children from 4 to 12 years old are prescribed 1 inhalation (50 mcg of salmeterol and 100 mcg of fluticasone propionate) 2 times a day.

Side effects
Since Seretide Diskus is a combined drug containing salmeterol and fluticasone, side effects specific to each component may occur when using the drug. Their simultaneous use does not cause additional side effects.
Salmeterol
From the side of the cardiovascular system: heart palpitations, headache (transient in nature and the intensity decreases with regular use of the drug); Rarely (in predisposed patients) – heart rhythm disturbances (including pulsatile arrhythmia, supraventricular tachycardia, extrasystoles).
Allergic reactions: rash, angioedema. Other side effects: tremor, arthralgia, throat mucosa irritation; In some cases – muscle cramps.
Fluticasone Propionate
Respiratory system: hoarseness, candidiasis of mouth and throat, paradoxical bronchospasm.
Other side effects: in rare cases – allergic skin reactions.

Contraindication
Increased sensitivity to the components of the drug.

Pregnancy and lactation
During pregnancy and lactation, the drug is prescribed only if its expected beneficial effect for the mother exceeds the potential risk for the fetus.

Special instructions
The use of Seretide Diskus is indicated for the long-term treatment of the disease. It is not recommended to use it to counter the attack. In the latter case, the use of short-acting inhaled bronchodilators (eg, salbutamol) is recommended.
An increase in the demand for bronchodilators indicates an exacerbation of the disease. A sudden and progressive exacerbation of bronchial asthma is a threat to the patient’s life, therefore, in such cases, it is necessary to review the patient’s treatment regimen and make a decision to increase the dose of GCS.
Rapid discontinuation of Seretide Diskus therapy is not recommended.
Inhaled GCS is prescribed with caution to patients with pulmonary tuberculosis (both active and inactive), as well as to patients with hyperthyroidism. To prevent the development of hoarseness and oral candidiasis, it is recommended to rinse the mouth with water after inhalation.
Inhalation drugs can cause paradoxical bronchospasm, which must be treated urgently with fast-acting bronchodilators. Elderly patients and patients with kidney failure do not require special dose selection. Use in pediatrics: data on the use of Seretide Diskus in children under 4 years of age are not available.

overdose
At present, information on Seretide Diskus overdose is not available.
Salmeterol
An overdose of salmeterol is manifested by tremors, headache and tachycardia. The best antidote in this case is cardioselective β1-adrenoblockers, although their use should be done with caution in patients with bronchospasm. If Seretide disc removal is indicated due to salmeterol overdose, the patient should be prescribed appropriate replacement steroid therapy.
Fluticasone Propionate
When using inhaled fluticasone propionate at higher than recommended doses, temporary adrenal suppression may occur. It is recommended to monitor the reserve function of the adrenal gland. In case of an overdose of fluticasone propionate, it is possible to continue treatment with the drug in doses sufficient to maintain the therapeutic effect.

Interaction with other drugs
Since very low concentrations of inhaled fluticasone propionate reach the blood plasma, adverse interactions with other medicinal products are unlikely. Seretide diskus should be prescribed with CYP3A4 enzyme inhibitors (eg, ketoconazole) with caution, since the systemic effect of fluticasone propionate can be increased.

Storage conditions and terms
The drug is stored at a temperature of no more than 30°C.
Shelf life – 2 years.

Country of manufacture
Great Britain