SYMBICORT TURBUHALER POWDER FOR INHALATION 80MKG/4.5MKGDOZ

Dosage and administration

Symbicort® Turbuhaler® It is not intended for the initial treatment of intermittent and mild persistent bronchial asthma.

Selection of the dose of drugs that are part of Symbicort Turbuhaler, is carried out individually and depending on the severity of the disease. This should be taken into account not only at the start of treatment with combined drugs, but also when changing the dose of the drug.

In the event that individual patients require a different combination of doses of active substances than in Symbicort.® Turbuhaler®, should be assigned a separate beta2-adrenomimetics and / or corticosteroids in separate inhalers.

Bronchial asthma

Symbicort® Turbuhaler® 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose

Patients should be under constant medical supervision for adequate selection of the dose of Symbicort Turbuhaler.The dose should be reduced to the lowest, against which the optimal control of the symptoms of bronchial asthma is maintained. While achieving complete control over the symptoms of bronchial asthma against the background of the minimum recommended dose drug, in the next step, you can try the appointment of monotherapy with inhaled GCS.

There are two approaches to prescribing therapy with Symbicort Turbuhaler:

- as maintenance therapy Symbicort® Turbuhaler® assignedfor ongoing maintenance therapy in combination with with a separate beta2short-acting adrenostimulator for relief of seizures;

- as maintenance therapy and for relief of attacks Symbicort® Turbuhaler® appointed for continuous maintenance therapy, and on request when symptoms appear.

As maintenance therapy

The patient must always carry with him a separate inhaler with beta2short-acting adrenostimulator for relief of seizures.

appoint symbicort® Turbuhaler® 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose 1-2 inhalations 2 times / day. If necessary, you can increase the dose to 4 inhalations 2 times / day.

appoint symbicort® Turbuhaler® 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose 1-2 inhalations 2 times / day.

appoint symbicort® Turbuhaler® 80 / 4.5 mg / dose 1-2 inhalations 2 times / day.

After achieving optimal control of the symptoms of bronchial asthma while taking the drug 2 times / day, it is recommended to titrate the dose to the lowest effective, up to receiving 1 time / day, in cases where, according to the doctor, the patient requires maintenance therapy in combination with long-acting bronchodilators.

Increase beta frequency2short-acting adrenostimulants are indicative of a deterioration in overall disease control and require revision of anti-asthma therapy.

As maintenance therapy and for relief of seizures.

Patient must always carry Symbicort® Turbuhaler® for relief of seizures.

In this case, the drug is especially indicated for patients with insufficient control over bronchial asthma and the need for frequent use of drugs for the relief of seizures; with instructions in the history of exacerbations of asthma requiring medical intervention.

The need to carefully control the emergence of dose-dependent side effects in patients using a large number of inhalations for relief of seizures.

appoint symbicort® Turbuhaler® 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose; The recommended dose is 2 inhalations per day: 1 inhalation in the morning and evening, or 2 inhalations 1 time per day only in the morning or only in the evening. Some patients may be given a maintenance dose of Symbicort.® Turbuhaler® 160 / 4.5 mcg / dose 2 inhalation 2 times / day. If symptoms occur, 1 additional inhalation is necessary. With further increase in symptoms within a few minutes, another 1 additional inhalation is prescribed, but not more than 6 inhalations for stopping 1 attack.

Usually, no more than 8 inhalations per day are required, but you can increase the number of inhalations to 12 per day for a short time. In patients who use more than 8 inhalations per day, a review of therapy is recommended.

Symbicort® Turbuhaler® 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose as maintenance therapy and for relief of seizures Not recommended children and adolescents under the age of 18.

Symbicort® Turbuhaler® 320/9 mcg / dose

the drug is prescribed in 1 inhalation 2 times / day. If necessary, you can increase the dose to 2 inhalations 2 times / day. After achieving optimal control of the symptoms of bronchial asthma while taking the drug 2 times / day, it is recommended to titrate the dose to the lowest effective level, up to and including 1 time / day.

appoint 1 inhalation 2 times / day.

Symbicort® Turbuhaler® 320/9 mcg / dose not recommended children under 12 years old due to the lack of clinical data.

Patients should regularly visit the doctor to control the optimal dose of the drug. The dose should be reduced to the lowest, against which the optimal control of the symptoms of bronchial asthma is maintained. After achieving optimal control of the symptoms of bronchial asthma while taking the drug 2 times / day, it is recommended to titrate the dose to the lowest effective, up to receiving 1 time / day, in cases where, according to the doctor, the patient requires maintenance therapy in combination with long-acting bronchodilators.

COPD

appoint symbicort® Turbuhaler® 160 / 4.5 mcg / dose, 2 inhalations, 2 times / day or Symbicort® Turbuhaler® 320/9 mcg / dose 1 inhalation 2 times / day.

There is no need for a special selection of the drug dose for elderly patients.

No data on the use of Symbicort Turbuhaler patients with renal or hepatic insufficiency. Since budesonide and formoterol are excreted mainly with the participation of hepatic metabolism, in patients with severe cirrhosis of the liver we can expect a slower rate of excretion of the drug.

The mechanism of action of the turbuhaler is such that when the patient inhales through the mouthpiece, the air flows carry the medicinal substance into the respiratory tract.

It is necessary to instruct the patient:

- carefully study the "Instructions for use" turbuhaler;

- breathe heavily and deeply through the mouthpiece to ensure that the optimal dose of the drug is released into the lungs;

- never exhale through the mouthpiece;

- in order to minimize the possibility of developing a fungal infection of the oropharynx, rinse your mouth with water after each inhalation. It is also necessary to rinse your mouth with water after inhalation to relieve symptoms and the case of candidiasis of the mucous membrane of the mouth and throat.

The patient may not feel the taste or feel the drug after using the turbuhaler, due to the small amount of the substance delivered.

Turbuhaler- multi-dose inhaler, which allows to dose and inhale the drug in very small doses. When you inhale the powder from the turbuhaler is delivered to the lungs. therefore, it is important that the patient take a deep and deep breath through the mouthpiece.

Before first use turbuhaler must be prepared for work:

1. Unscrew and remove the cap.

2. Hold the inhaler vertically red with the dispenser down. Do not hold the inhaler by the mouthpiece while turning the dispenser. Turn the dispenser until it stops in one direction, and then also all the way - in the opposite direction. Perform the above procedure twice.

Now the inhaler is ready for use, it is not necessary to repeat this procedure of preparing a turbuhaler for operation before each use.

For a single dose the patient must perform the following procedure:

1. Unscrew and remove the cap.

2. Hold the inhaler vertically red with the dispenser down.Do not hold the inhaler by the mouthpiece while turning the dispenser. In order to measure the dose, turn the dispenser until it stops in one direction, and then also all the way - in the opposite direction.

3. Exhale. Do not exhale through the mouthpiece.

4. Carefully place the mouthpiece between the teeth, squeeze the lips and inhale strongly and deeply through the mouth. The mouthpiece does not chew or squeeze your teeth.

5. Before exhaling, remove the inhaler from the mouth.

6. If inhalation of more than one dose is required, repeat paragraphs. 2-5.

7. Close the inhaler with a cap, check that the cap of the inhaler is carefully screwed on.

8. Rinse your mouth with water without swallowing.

You can not remove the mouthpiece, because It is attached to an inhaler and cannot be removed. The mouthpiece of the turbuhaler rotates, but do not rotate it unnecessarily.

Since the amount of inhaled powder is very small, you can not feel the taste of the powder after inhalation.

However, absolutely accurate compliance with the instructions provides inhalation (inhalation) of the required dose of the drug.

If, before taking the drug, the procedure for loading the inhaler more than once was mistakenly repeated, then during inhalation the patients will still receive one dose of the drug. In this case, the dose indicator will show the total number of metered doses.

The sound that is heard when the inhaler is shaken is produced by a drying agent, not a drug substance.

The need to replace the inhaler

The dose indicator shows the approximate number of doses remaining in the inhaler, the dose count for filling a turbuhaler starts from the 60th or 120th dose (depending on the total number of doses acquired by the turbuhaler). The indicator shows an interval of 10 doses, so it does not show every metered (loaded) dose.

The turbuhaler delivers the required dose of the drug, even if changes in the dose indicator window are not noticeable.

The appearance of a red background in the dose indicator window means that 10 doses of the drug remain in the turbuhaler. When the number 0 appears on a red background in the middle of the dose window, the inhaler should be discarded.

You should pay attention to the fact that even when the indicator window shows the number 0, the dispenser continues to rotate. However, the dose indicator stops recording the number of doses (stops moving) and the figure 0 remains in the dose window of the inhaler.

Cleaning

Regularly (once a week), the mouthpiece should be cleaned outside with a dry cloth. Do not use water or other liquid to clean the mouthpiece.

Recycling

Care should be taken when handling the used inhaler and remember that a certain amount of the drug may remain inside the inhaler.

Side effect

Against the background of co-administration of two drugs, there was no increase in the incidence of adverse reactions.

The most frequent adverse reactions associated with taking the drug are those pharmacologically expected for beta.2-adrenomimetikov undesirable side effects, like tremor and tachycardia, which usually have a moderate degree of severity and disappear in a few days after the start of treatment.

During the use of budesonide in COPD, bruising and pneumonia occurred at 10% and 6%, respectively, compared with 4% and 3% in the placebo group (p> 0.001 and p> 0.01, respectively).

From the side of the central nervous system: often (> 1/100, <1/10) - headache; less often (> 1/1000, <1/100) - psychomotor agitation, anxiety, nausea, dizziness, sleep disorders; very rarely (<1/10 000) - depression, behavioral disorders (mainly in children), taste disorders.

Since the cardiovascular system: often (> 1/100, <1/10) - tachycardia; less often (> 1/1000, <1/100) - tachycardia; rarely (> 1/10 000, <1/1000) - atrial fibrillation, supraventricular tachycardia, extrasystole; very rarely (<1/10 000) - angina, fluctuations in blood pressure.

From the musculoskeletal system: often (> 1/100, <1/10) - tremor; less often (> 1/1000, <1/100) - muscle cramps.

On the part of the respiratory system: often (> 1/100, <1/10) - candidiasis of the mucous membrane of the oral cavity and pharynx, mild irritation in the throat, cough, hoarseness; rarely (> 1/10 000, <1/1000) - bronchospasm.

Dermatological reactions: less often (> 1/1000, <1/100) - bruising; rarely (> 1/10 000, <1/1000) - exanthema, urticaria, pruritus, dermatitis, angioedema.

Metabolic disorders: rarely (> 1/10 000, <1/1000) - hypokalemia; very rarely (<1/10 000) - hyperglycemia, symptoms of systemic action of corticosteroids (including adrenal hypofunction).

Systemic effects of inhaled corticosteroids can be observed when taking the drug in high doses for a long time.

Application beta2β-adrenomimetics can lead to an increase in blood levels of insulin, free fatty acids, glycerol, ketone derivatives.

Use of the drug during pregnancy and lactation

There are no clinical data on the use of Symbicort Turbuhaler or the combined use of budesonide and formoterol in pregnancy.

When pregnancy Symbicort® Turbuhaler® should be prescribed only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus. Budesonide should be used in the smallest effective dose necessary to maintain adequate control of the symptoms of bronchial asthma.

It is not known whether budesonide and formoterol are excreted in human breast milk. Symbicort® Turbuhaler® may be prescribed to nursing women if the expected benefit to the mother is greater than the potential risk to the baby.

Application for violations of kidney function

No data on the use of Symbicort Turbuhaler patients with renal failure.

special instructions

It is recommended to gradually reduce the dose of the drug before discontinuing treatment and it is not recommended to abruptly discontinue therapy.

Symbicort® Turbuhaler® 80 / 4.5 mcg / dose and 320/9 mcg / dose is not intended to treat patients with severe bronchial asthma.

Symbicort® Turbuhaler® not intended for the initial selection of therapy in the early stages of the treatment of bronchial asthma.

The increase in the frequency of taking bronchodilators as emergency drugs indicates a deterioration in the course of the underlying disease and is the basis for revising the tactics of treating bronchial asthma. An unexpected and progressive deterioration in the control of symptoms of bronchial asthma or COPD is a potentially life-threatening condition and requires urgent medical intervention. In this situation, you should consider the possibility of increasing the dose of GCS, ie the appointment of a course of oral corticosteroids or treatment with antibiotics in the event of infection.

Patients are advised to constantly carry emergency medications, or Symbicort.® Turbuhaler® (for patients with bronchial asthma using Symbicort® Turbuhaler® for maintenance therapy and for relief of seizures), beta2short-acting adrenomimetics (for all patients using Symbicort® Turbuhaler® only for maintenance therapy).

The patient’s attention should be paid to the necessity of regularly receiving a maintenance dose of Symbicort Turbuhaler in accordance with the selected therapy, even in cases of no symptoms of the disease. Inhalation of Symbicort Turbuhaler for relief of seizures should be carried out only when symptoms occur, but the use of the drug is not indicated for regular prophylactic use, i.e. before exercise. In such cases, the use of a separate short-acting bronchodilator is indicated.

Treatment Symbicort turbuhaler should not begin in the period of exacerbation of bronchial asthma.

As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of the drug. In this connection, it is necessary to discontinue therapy with Symbicort Turbuhaler, review the tactics of treatment and, if necessary, prescribe alternative therapy.

Systemic effects can occur when taking any inhaled GCS, especially when taking high doses of drugs over a long period of time. The manifestation of systemic action is less likely with inhalation therapy than with the use of oral GCS. Possible systemic effects include suppression of adrenal function, growth retardation in children and adolescents, a decrease in bone mineral density, cataracts and glaucoma.

It is recommended to regularly monitor the growth of children who receive long-term inhaled GCS. In the case of established growth retardation, therapy should be reviewed to reduce the dose of inhaled GCS. It is necessary to carefully evaluate the ratio of the benefits of GCS therapy to the possible risk of growth retardation. At the choice of therapy consultation of the children's pulmonologist is recommended.

Based on limited research data on long-term administration of GCS, it can be assumed that most children and adolescents receiving therapy with inhaled budesonide will eventually achieve normal growth rates for adults. At the same time, a slight (about 1 cm) short growth retardation was reported, mainly in the first year of treatment.

Due to the potential effect of inhaled GCS on bone mineral density, special attention should be paid to patients taking the drug in high doses for a long time with the presence of risk factors for osteoporosis. Studies of long-term use of inhaled budesonide in children at an average daily dose of 400 mcg or in adults at an average daily dose of 800 mcg did not show a noticeable effect on bone mineral density. There are no data on the effect of high doses of the drug on bone mineral density.

If there is reason to believe that, against the background of previous systemic treatment of GCS, the adrenal function was impaired, precautions should be taken when transferring patients to Symbicort Turbuhaler.

The advantages of inhaled budesonide therapy, as a rule, minimize the need to take oral GCS, but in patients who discontinue therapy with oral GCS, adrenal insufficiency may persist for a long time. Patients who in the past needed emergency high-dose GCS, received long-term treatment with high-dose inhaled GCS, may also be in this risk group. It is necessary to provide for the additional appointment of GCS in the period of stress or surgery.It is recommended to instruct the patient about the need to rinse your mouth with water after inhalation in order to prevent the development of oral mucosa candidiasis.

Formoterol may cause prolongation of the QT interval, so the drug should be used with caution in patients with an extended QT interval.

The need for the use and dose of inhaled GCS in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial respiratory infections should be reconsidered.

Special precautions should be observed in patients with unstable bronchial asthma, using short-acting bronchodilators, to relieve seizures during exacerbation of severe bronchial asthma, since the risk of hypokalemia increases with hypoxia and in other conditions when the likelihood of the development of symptoms of hypokalemic action increases. In such cases, it is recommended to control the content of potassium in serum.

During the treatment period, blood glucose concentration should be monitored in patients with diabetes mellitus.

Symbicort® Turbuhaler® contains lactose (less than 1 mg / dose). Usually this amount does not cause adverse reactions in patients with lactose intolerance .

Use in pediatrics

Symbicort® Turbuhaler® 80 / 4.5 mcg / dose and 160 / 4.5 mcg / dose contraindicated children under 6 years old.

Influence on ability to drive motor transport and control mechanisms

Symbicort® Turbuhaler® does not affect the ability to drive vehicles and management mechanisms. May affect the ability to drive vehicles and control mechanisms in the development of side effects.

Overdose

Symptoms: in acute overdose of budesonide, even in large doses, clinically significant symptoms are not expected. With chronic intake of budesonide in excessive doses, a systemic effect of corticosteroids, such as hypercorticism and suppression of adrenal function, may manifest.

In case of overdose of formoterol - tremor, headache, heart palpitations; in some cases, it was reported about the development of tachycardia, hyperglycemia, hypokalemia, prolongation of the QT intervalc, arrhythmias, nausea, vomiting.

For acute bronchial obstruction, formoterol administration at a dose of 90 mcg for 3 hours was safe.

Treatment: shown supportive and symptomatic treatment.

If it is necessary to cancel Symbicort Turbuhaler due to an overdose of formoterol, which is included and the composition of the combined preparation, consideration should be given to the appointment of an appropriate SCS.

Drug interaction

With simultaneous ingestion of Ketoconazole at a dose of 200 mg 1 time / day and budesonide at a dose of 3 mg, the concentration of budesonide in plasma increases on average 6 times. When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in plasma increases by an average of 3 times. There is no information about such interaction with budesonide during inhalation, but a noticeable increase in the plasma concentration of the drug should be expected. Since no data are currently available for advice on dose selection, this combination of drugs should be avoided. If this is not possible, the intervals between taking ketoconazole and budesonide should be maximized. The possibility of reducing the dose of budesonide should also be considered. Other potent inhibitors of CYP3A4 may also significantly increase the content of budesonide in plasma. The appointment of Symbicort Turbuchaler is not recommended as a maintenance therapy and for the relief of seizures in patients receiving potent CYP3A4 inhibitors.

Β-adrenoreceptor blockers can weaken or inhibit the action of formoterol. Symbicort® Turbuhaler® should not be administered simultaneously with beta-blockers (including eye drops), unless absolutely necessary.

With the simultaneous use of Symbicort Turbuhaler and quinidine, disopyramide, procainamide, phenothiazino