Seretide® 50mcg/250mcg Accuhaler® 1×60 | Generic Advair Diskus

Seretide Accuhaler 50-250

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Seretide® 50mcg/250mcg Accuhaler® is an FDA-approved brand-name inhaler. It is a combination of fluticasone (a steroid) and salmeterol (a bronchodilator) that is used to control and prevent asthma symptoms, such as shortness of breath and wheezing.

Seretide AccuhalerSeretide® 50mcg/250mcg Accuhaler® is also used to treat lung diseases such as chronic obstructive pulmonary disease (COPD), chronic bronchitis, and emphysema. It reduces irritation and swelling of the airways and opens them up for easier breathing.

Patients should note that Seretide® 50mcg/250mcg Accuhaler®  is not an emergency medicine for asthma or bronchospasm attacks, but is used as a preventive tool.

It is also important to note that Seretide® 50mcg/250mcg Accuhaler®  can be used for purposes that are not named here. You should talk to your doctor or seek advice before using this medication.

Description of the Seretide® 50mcg / 250 mcg Accuhaler®

Seretide® 50mcg / 250 mcg Accuhaler® contains Salmeterol and Fluticasone Propionate, which have different mechanisms of action.

Salmeterol

Salmeterol is a long-acting (12-hour) selective beta-2-adrenergic agonist with a long side chain associated with the outer domain of the receptor. Salmeterol provides longer bronchodilation (at least 12 hours) than the recommended doses of traditional short-acting beta-2-adrenergic agonists.

Fluticasone Propionate

Fluticasone propionate, when inhaled at the recommended doses, has a pronounced glucocorticoid anti-inflammatory effect in the lungs, which leads to a decrease in the severity of clinical symptoms and the frequency of exacerbations of asthma without the appearance of adverse reactions observed with systemic use of corticosteroids.

Inhaler

The inhaler is aluminum with a concave bottom, hermetically sealed with a dosing valve; the inner surface of the inhaler and the valve should not have visible defects.

The inhaler is a round plastic device of 2 shades of purple (dark purple and light purple) with a diameter of about 8.5 cm and a height of about 3 cm, with a dose counter showing 28 or 60 doses.The contents of the inhaler are white or almost white powder.

Dose of Seretide® 50 mcg / 250 mcg Accuhaler®

One dose of Seretide® 50 mcg / 250 mcg Accuhaler® contains:

  • salmeterol xynafoate – 36.3 mcg (in terms of salmeterol 25 mcg),
  • fluticasone propionate – 50 mcg.
  • Excipients: tetrafluoroethane.

Recommended doses

  • Adults and children 12 years and older: 2 inhalations (25 mcg of salmeterol and 50 mcg of fluticasone propionate) 2 times a day or 2 inhalations (25 mcg of salmeterol and 125 mcg of fluticasone propionate) 2 times a day, or 2 inhalations (25 mcg of salmeterol and 250 mcg of fluticasone propionate) 2 times a day.
  • Children 4 years and older: 2 inhalations (25 mcg of salmeterol and 50 mcg of fluticasone propionate) 2 times a day.
  • Currently, there is no data on the use of Seretide® 50 mcg / 250 mcg Accuhaler® in children under 4 years of age.
  • The dose of Seretide® 50 mcg / 250 mcg Accuhaler® should be reduced to the lowest dose that provides effective control of symptoms. If the symptoms are controlled by taking Seretide® 50 mcg / 250 mcg Accuhaler® 2 times a day, reducing the dose to the minimum effective may include a single dose of the drug per day.

Indications Seretide® 50 mcg / 250 mcg Accuhaler®

Regular treatment of bronchial asthma in patients who are indicated for combination therapy with long-acting beta — 2-adrenomimetic and inhaled corticosteroids:

  • patients with insufficient Disease Control against the background of constant monotherapy with inhaled corticosteroids with periodic use (if necessary) of short-acting beta-2-adrenomimetic;
  • patients with adequate Disease Control against the background of treatment with inhaled corticosteroids and long-acting beta-2-adrenomimetic.
  • Chronic obstructive pulmonary disease (COPD) maintenance therapy of COPD in patients with FEV1 <60% of the appropriate values (before bronchodilator inhalation) and repeated exacerbations in the Anamnesis, in which severe symptoms of the disease persist, despite regular therapy with bronchodilators.

Contraindications:

  • hypersensitivity to the components of the drug;
  • children under 4 years of age.

With caution: pulmonary tuberculosis, fungal, viral or bacterial respiratory infections, thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, idiopathic hypertrophic subaortic stenosis, uncontrolled hypertension, arrhythmias, prolongation of the QT interval on ECG, coronary heart disease, hypoxia of various genesis, cataract, glaucoma, hypothyroidism, osteoporosis, pregnancy, lactation.

Overdose

Symptoms: objective and subjective symptoms of salmeterol overdose include tremor, headache and tachycardia. Inhalation of doses of fluticasone propionate higher than recommended may cause temporary depression of the hypothalamic-pituitary-adrenal system. This usually does not require any emergency measures, since in most cases the normal function of the adrenal glands is restored within a few days.

With prolonged inhalation of excessively large doses of Seretide® 50 mcg / 250 mcg Accuhaler® may cause significant adrenal suppression. In the literature, there are rare reports of an acute adrenal crisis, which occurs mainly in children receiving excessively high doses for a long time (several months or years); an acute adrenal crisis is manifested by hypoglycemia, accompanied by confusion and / or convulsions. Situations that can serve as triggering factors of an acute adrenal crisis include trauma, surgery, infection, or a rapid reduction in the dose of fluticasone propionate, which is part of the drugs.

Treatment: the antidotes are cardioselective beta-blockers. In cases where it is necessary to cancel the drugs Seretide® 50 mcg / 250 mcg Accuhaler® due to an overdose of salmeterol included in its composition, the patient should be prescribed an appropriate replacement GCS.

Patients should be aware that they should not take Seretide® 50 mcg / 250 mcg Accuhaler® medications Multidisk in doses higher than recommended. It is important to regularly evaluate the effectiveness of therapy and reduce the dose to the minimum effective, i.e. to one that provides effective control of the symptoms of the disease.
.In case of chronic overdose, it is recommended to monitor the reserve function of the adrenal cortex.

Side effects of Seretide® 50 mcg / 250 mcg Accuhaler®

Seretide® 50 mcg / 250 mcg Accuhaler® contains salmeterol and fluticasone propionate, and therefore it should be expected that the drugs may cause side effects characteristic of these components. There is no evidence that the simultaneous use of salmeterol and fluticasone propionate causes additional side effects.

May cause paradoxical bronchospasm. In this case, you should immediately apply a short-acting inhalation bronchodilator, cancel the drug, and start alternative therapy, if indicated.

Salmeterol: pharmacological side effects of beta2-adrenergic receptor agonist such as tremor, palpitations and headache, hypokalemia, which are usually transient and weaken as salmeterol therapy continues, are described.
In sensitive patients, arrhythmias may occur (including atrial fibrillation, supraventricular tachycardia and extrasystole).
There are reports of arthralgia, nervousness, abdominal pain, nausea, vomiting and hypersensitivity reactions, including skin rash, peripheral edema and angioedema.

Cases of irritation of the mucous membranes of the oropharynx, changes in taste sensations (dysgeusia) are described.
There have been reports of cases of painful muscle spasms and very rare cases of hyperglycemia.

Fluticasone propionate: some patients may experience coarsening or hoarseness of the voice and candidiasis (thrush) of the oral cavity and pharynx.
Skin hypersensitivity reactions are described. Hypersensitivity reactions have also been reported, manifested in the form of angioedema (mainly swelling of the face and oropharynx), respiratory disorders (mainly dyspnea and/or bronchospasm) and anaphylactic reactions.
The severity and frequency of voice coarsening and candidiasis can be reduced by rinsing the mouth with water after inhalation. Symptomatic candidiasis can be treated with local antifungal drugs, while continuing therapy with Seretide® 50 mcg / 250 mcg Accuhaler®.

Anxiety, sleep disorders and behavioral disorders, including hyperactivity and irritability (mainly in children); hyperglycemia, have been very rarely reported.
Theoretically, it is possible to develop systemic reactions, including Cushing’s syndrome or Cushing’s symptoms, suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma.

With prolonged use of doses of a combination of salmeterol with fluticasone propionate that exceed the permitted doses, significant inhibition of the function of the adrenal cortex is possible. There are very rare reports of an acute adrenal crisis, which occurred mainly in children who received higher than the permitted doses of this combination for a long time (several months or years); symptoms of an adrenal crisis included hypoglycemia, accompanied by a decrease in consciousness and/or seizures.

Storage conditions:

in the original packaging at temperatures not exceeding 30°C. Keep out of the reach of children.