Seretide - Instructions For Use, Indications, Doses

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Seretide - Instructions For Use, Indications, Doses
Seretide - Instructions For Use, Indications, Doses

Video: Seretide - Instructions For Use, Indications, Doses

Video: Seretide - Instructions For Use, Indications, Doses
Video: How to Use a Metered Dose Inhaler 2024, November
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Seretid

Instructions for use:

  1. 1. Release form and composition
  2. 2. Indications for use
  3. 3. Contraindications
  4. 4. Method of application and dosage
  5. 5. Side effects
  6. 6. Special instructions
  7. 7. Drug interactions
  8. 8. Terms and conditions of storage

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from 648 rub.

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Aerosol for inhalation metered dose Seretide
Aerosol for inhalation metered dose Seretide

Seretide is a combined drug with bronchodilator, anti-inflammatory, anti-asthmatic, glucocorticoid, beta-adrenomimetic action.

Release form and composition

Dosage form - metered dose inhalation aerosol: suspension of white or almost white color (120 doses in an aluminum inhaler with a concave bottom, hermetically sealed dosing valve, in a cardboard box 1 inhaler without visible surface defects and a valve complete with a plastic spray).

Content of active ingredients in 1 dose of Seretide:

  • salmeterol xinafoate: 0.0363 mg, equivalent to 0.025 mg of salmeterol;
  • fluticasone propionate: 0.05 mg, 0.125 mg, or 0.25 mg.

Auxiliary components: 1,1,1,2-tetrafluoroethane.

Indications for use

Regular use of Seretide is indicated for patients with bronchial asthma, the treatment of which involves the simultaneous use of long-acting beta 2 -adrenomimetics and inhaled glucocorticosteroids (GCS):

  • patients in whom continuous monotherapy with inhaled corticosteroids and periodic use of short-acting beta 2 -adrenomimetics does not allow achieving complete control of the disease;
  • patients with complete control of bronchial asthma during treatment with a long-acting beta 2 -adrenomimetic and inhaled GCS;
  • patients with persistent bronchial asthma, who are prescribed GCS (in the form of initial maintenance therapy) to achieve control over the disease.

In addition, the drug is used in the form of maintenance therapy for chronic obstructive pulmonary disease (COPD) with an FEV1 value (forced expiratory volume in the first second of the forced expiratory maneuver) less than 60% of the prescribed values (before inhalation of the bronchodilator) and recurrent exacerbations in history in patients with persisting severe symptoms of the disease against the background of regular therapy with bronchodilators.

Contraindications

  • age up to 4 years;
  • individual intolerance to the components of the drug.

Seretide should be used with caution in acute or latent pulmonary tuberculosis, cataracts, glaucoma, thyrotoxicosis, osteoporosis, bacterial, fungal or viral respiratory infections, in the treatment of any drugs of the sympathomimetic group (risk of increased systolic blood pressure (BP) and heart rate (Heart rate), especially in patients exceeding therapeutic doses), with cardiovascular diseases, including arrhythmias (supraventricular tachycardia, extrasystole, atrial fibrillation, ventricular premature beats), with hypokalemia, since increased doses of sympathomimetics can cause a transient decrease in serum potassium concentration; in patients with diabetes mellitus.

During pregnancy and breastfeeding, the drug is prescribed only after assessing the balance of benefits and risks of therapy, if the expected effect for the mother is much higher than the possible risk for the fetus and child.

Method of administration and dosage

Aerosol is used only by inhalation.

The optimal effect is achieved with regular use of the drug, even in the absence of clinical symptoms of the disease.

Before the first use, it is necessary to check the quality of the inhaler. After removing the cap from the mouthpiece, take the inhaler in your hand, putting your thumb on the base under the mouthpiece and holding with the rest of your fingers, shake the inhaler vigorously, releasing a couple of jets into the air. After making sure that the inhaler is in good working order and has no visible damage, you can start using it.

It is recommended to shake the contents of the can before each spraying so that the preparation is evenly mixed. Then the inhaler in an upright position with the bottom up is clamped with the fingers of one hand, so that the thumb is on the base under the mouthpiece, brought to the mouth. The procedure should be performed calmly, without rushing. Exhaling deeply (as far as possible), place the mouthpiece in the mouth between the teeth and close the lips tightly around it (without biting the mouthpiece). While inhaling through the mouth, pressing on the bottom of the inhaler, spray the drug, continuing to inhale slowly, deeply. After spraying, the inhaler is removed from the mouth while holding the breath. The breath should be held as long as possible, then, after about 0.5 minutes, a second spray should be applied. After the procedure, rinse your mouth well with water and spit it out. The inhaler should be closed immediately by pressing and snapping the cap onto the mouthpiece in the desired position without force.

The first few procedures can be performed in front of a mirror. Particular attention should be paid to inhalation, it should be very slow and start before directly pressing the valve.

If a misty cloud appears from the corners of the mouth or the top of the inhaler, the procedure should be repeated.

Young children should be assisted by an adult when using the inhaler. Patients who find it difficult to perform the correct breathing maneuver (including young children) can use Seretide through a spacer.

The appointment of the dosage regimen, course duration or dose change should be made by the doctor, regularly assessing the effectiveness of therapy.

For the treatment of bronchial asthma, the lowest dose that provides effective control of symptoms should be used. It is recommended to prescribe the form of the drug in which the dose of fluticasone propionate corresponds to the severity of the disease.

Patients in whom taking Seretide 2 times a day provides complete control over symptoms can be prescribed the minimum effective dose with a frequency of taking 1 time per day.

The use of the drug can improve the control of symptoms of bronchial asthma in patients who do not achieve a sufficient therapeutic effect from taking inhaled GCS. When replacing with Seretide, an equivalent dose of previously administered GCS should be used.

For patients in whom the course of bronchial asthma can be controlled only with inhaled GCS, the transition to treatment with a combined aerosol can reduce the dose of GCS necessary to control the course of asthma.

Recommended dosage regimen:

  • bronchial asthma: patients over 12 years of age (at a dose of 0.025 mg of salmeterol and 0.05 mg or 0.125 mg, or 0.25 mg of fluticasone propionate) - 2 sprays 2 times a day; children 4 years and older (at a dose of 0.025 mg salmeterol and 0.05 mg fluticasone propionate) - 2 sprays 2 times a day;
  • COPD: adults (at a dose of 0.025 mg salmeterol and 0.25 mg fluticasone propionate) - no more than two inhalations 2 times a day.

In case of impaired renal and / or liver function, dose reduction is not required in elderly patients.

The inhaler requires careful maintenance, it must be cleaned at least once a week. Without removing the metal can from the casing, remove the protective cap from the mouthpiece and wipe it inside and out with a cotton swab, and the plastic casing only on top. Then close the mouthpiece with a protective cap.

Side effects

Adverse events identified in clinical trials:

  • from the respiratory system, chest and mediastinal organs: often - hoarseness and / or dysphonia; infrequently - throat irritation;
  • parasitic and infectious pathologies: often - candidiasis of the mouth and pharynx, in patients with COPD - pneumonia;
  • from the nervous system: very often - headache; infrequently - tremor;
  • from the heart: infrequently - tachycardia, heart palpitations, atrial fibrillation; rarely - arrhythmia, including supraventricular tachycardia, extrasystole and ventricular extrasystole;
  • from the immune system: infrequently - hypersensitivity skin reactions, shortness of breath; rarely - anaphylactic reactions;
  • on the part of nutrition and metabolism: infrequently - hyperglycemia; very rarely - hypokalemia;
  • from the endocrine system: infrequently - cataract; rarely - glaucoma;
  • mental disorders: infrequently - sleep disturbances, anxiety; rarely - changes in behavior, including irritability, hyperactivity (more often in children);
  • from the musculoskeletal system and connective tissue: often - arthralgia, muscle spasms;
  • dermatological reactions: infrequently - bruising.

Side effects of post-registration observations:

  • from the respiratory system, chest and mediastinal organs: rarely - paradoxical bronchospasm;
  • from the immune system: rarely (hypersensitivity reactions) - bronchospasm, angioedema (more often swelling of the face, mouth and pharynx);
  • from the endocrine system: rarely (systemic effects) - cushingoid symptoms, Cushing's syndrome, a decrease in bone mineral density, suppression of adrenal function, growth retardation in children and adolescents.

special instructions

Seretide is not intended for the relief of acute attacks of bronchial asthma. For this purpose, the patient should always carry a fast-acting, short-acting inhaled bronchodilator (including salbutamol).

An increase in shortness of breath after direct application of an aerosol indicates the development of paradoxical bronchospasm. The patient must immediately apply a short-acting inhaled bronchodilator, discontinue the drug and consult a doctor.

The drug can be used for initial maintenance therapy of persistent bronchial asthma only in patients with indications for the use of GCS and after determining their approximate dose.

An increase in the frequency of use of short-acting bronchodilators indicates a deterioration in disease control, in which case you should consult a doctor.

An immediate appeal of the patient to a doctor is required in case of a sudden and increasing deterioration in the control of bronchospastic syndrome, in the absence of adequate control of the disease from the dose used.

Abrupt withdrawal of the drug can cause an exacerbation of the condition in patients with asthma, and in COPD - cause symptoms of decompensation, therefore, the termination of treatment should be carried out under the supervision of a physician, gradually reducing the dose.

The possibility of developing pneumonia against the background of the use of Seretide should be taken into account by the doctor when treating COPD. It is necessary to carefully monitor the patient's condition due to the similarity of the symptoms of the two pathologies.

Due to the risk of developing undesirable systemic effects for the treatment of bronchial asthma, the lowest effective dose should be used to ensure control of symptoms.

The patient should be aware of the need to use GCS in emergency stressful situations, accompanied by adrenal suppression.

During surgical operations and resuscitation measures, the degree of adrenal insufficiency should be determined.

With long-term treatment of children with inhaled GCS, it is recommended to regularly measure their growth.

Particular care and regular monitoring of the function of the adrenal cortex is required in the treatment of patients transferred to inhalation therapy of fluticasone propionate with oral corticosteroids. In this case, systemic GCS should be canceled gradually.

In patients with hypoxia and exacerbation of bronchial asthma, it is necessary to control the content of potassium ions in plasma.

The metal spray should not be immersed in water.

Care should be taken when driving vehicles and mechanisms, since the action of the drug can cause the development of side effects that affect the speed of psychomotor reactions.

Drug interactions

The use of non-selective and selective beta-blockers is indicated only in case of urgent need, because of the risk of bronchospasm, such combinations are recommended to be avoided when treating patients with Seretid.

With the simultaneous use of Seretide:

  • monoamine oxidase inhibitors, tricyclic antidepressants - increase the risk of developing undesirable effects from the cardiovascular system;
  • xanthine derivatives, diuretics and GCS - contribute to the development of hypokalemia, especially in patients with hypoxia, exacerbation of bronchial asthma.

Since inhalation of fluticasone propionate does not cause an increase in its plasma concentration due to high systemic clearance in the intestine and liver under the influence of the CYP3A4 isoenzyme of the cytochrome P 450 system and intensive metabolism, the risk of developing clinically significant interactions with other drugs is insignificant.

Ritonavir (a highly active inhibitor of the isoenzyme CYP3A4) can cause a sharp increase in the concentration of fluticasone propionate in plasma, and as a result - a significant decrease in serum cortisol. Intranasal or inhalation use of fluticasone propionate in combination with ritonavir can cause adrenal suppression and Cushing's syndrome. Therefore, concomitant administration of these drugs should be avoided, unless the risk of systemic side effects of GCS is inferior to the potential benefit of therapy for the patient.

Other inhibitors of the isoenzyme CYP3A4 do not significantly increase the plasma concentration of fluticasone propionate and their intake has practically no effect on serum cortisol levels. However, strong CYP3A4 inhibitors, such as ketoconazole, are recommended to be used with caution, as their use increases the risk of increased systemic effects of the drug.

The drug is compatible with cromoglycic acid.

Terms and conditions of storage

Keep out of the reach of children.

Store in a place protected from direct sunlight at temperatures up to 30 ° C, do not freeze.

Shelf life is 2 years.

Seretide: prices in online pharmacies

Drug name

Price

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Seretide 25 mcg + 50 mcg / dose 120 doses inhalation aerosol 1 pc.

648 r

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Seretide 25 mcg + 125 mcg / dose 120 doses aerosol for inhalation metered 1 pc.

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Seretide Multidisk 50 mcg + 100 mcg / dose 60 doses powder for inhalation metered 1 pc.

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Seretide aerosol for in. dosage. 25mcg + 50mcg / dose 120 doses

999 RUB

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Seretide Multidisk 50 mcg + 250 mcg / dose 60 doses powder for inhalation dosed 1 pc.

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Seretide Multidisk powder for in. dosage. 50 mcg + 100 mcg / dose 60 doses

1150 RUB

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Seretide aerosol for in. dosage. 25mcg + 125mcg / dose 120 doses

1325 RUB

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Seretide Multidisk powder for in. dosage. 50 mcg + 250 mcg / dose 60 doses

1400 RUB

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Seretide 25 mcg + 250 mcg / dose 120 doses aerosol for inhalation metered 1 pc.

1457 RUB

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Seretide Multidisk 50 mcg + 500 mcg / dose 60 doses powder for inhalation dosed 1 pc.

1742 RUB

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Seretide Multidisk powder for in. dosage. 50 mcg + 500 mcg / dose 60 doses

1794 RUB

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Seretide aerosol for in. dosage. 25mkg + 250mkg / dose 120 doses

1867 RUB

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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!

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