Pulmicort susp. 0.25mg/ml 2ml #20

Pulmicort instruction

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Composition

In the composition of drugs Pulmicort and Pulmicort Turbuhaler contains substance budesonide.
In addition, the suspension for inhalation Pulmicort also has auxiliary substances: sodium citrate, sodium chloride, polysorbate 80, sodium EDTA, purified water and anhydrous citric acid.

Form of issue

The pulmicort is available in two versions: a metered suspension for inhalation may contain 0.25 mg / ml or 0.5 mg / ml budesonide. Produced in cardboard packs, inside which contains 20 containers of 2ml.
Powder for inhalation Pulmicort Turbuhaler also has two forms of release: 200 doses of 100mkg of budesonide or 100 doses of 200mg of budesonide in a metered-dose inhaler. The inhaler itself consists of reservoirs for desiccant and storage of powder, lid and mouthpiece. The drug is packed in a cardboard box.

pharmachologic effect

The drug has a glucocorticoid, anti-inflammatory, and also anti-allergic action.

Indications for use

The drug is recommended for use in bronchial asthma, which requires therapy with glucocorticosteroids, as well as in chronic obstructive pulmonary disease.

Pharmacodynamics and pharmacokinetics

Absorption

Budesonide, which by inhalation enters the body, is rapidly absorbed. Approximately 25-30% of the dose of the drug enters the lungs. In half an hour the maximum concentration of the drug in the blood plasma is reached. Systemic bioavailability of Pulmicort is approximately 38% of the dose.

Metabolism and distribution

Binding of the drug to plasma proteins is at the level of 90%. The distribution of budesonide by volume is about 3 liters per kilogram. At the end of absorption, intensive biotransformation of budesonide takes place in the liver, as a result of which metabolites with low glucocorticosteroid activity are formed.

Excretion

The substance budesonide INN is mainly metabolized with the participation of the enzyme CYP 3A4. Then, in the conjugated form or simply in urine, unchanged metabolites are excreted from the body. Pharmacokinetics of budesonide substance in patients with impaired renal function and in children is unknown. And in patients with liver disease, the time spent in the body budesonide may increase.

Contraindications

Pulmicort and Pulmicort Turbuhaler are contraindicated for people with individual intolerance to the components of the drug. Also, with caution appoint a drug for pulmonary tuberculosis (active and inactive forms), bacterial, viral or fungal diseases of the respiratory system, as well as for cirrhosis.

Side effects

For respiratory organs: dry mouth, cough, irritation of the mucous respiratory tract, carious lesions of the oropharynx. Taking into account the possibility of carious lesion of the oropharynx, taking the drug should carefully monitor the oral hygiene.
For the endocrine system: hypofunction of the adrenal cortex, as well as symptoms of systemic actions of glucocorticosteroids.
For the central nervous system: excitability, inadequate behavior, nervousness, depression, fogging of consciousness.
Allergic reactions: contact dermatitis, rash, angioedema, hives. If a nebulizer with a mask is used, skin irritation may occur.

Instructions for use (Method and dosage)

Drugs Pulmicort and Pulmicort Turbuhaler are used as prophylactic agents in case of bronchial asthma, while using these medications for acute attacks of this disease is not advisable. Given the low probability that systemic effects will be developed, the daily dosage of these drugs can be increased to achieve an improved therapeutic effect of up to 1000 micrograms instead of combining the medication with other oral glucocorticosteroids.
To abolish the intake of oral glucocorticosteroids for switching to Pulmicort or Pulmicort Turbuhaler it is necessary for ten days, taking the previously selected doses of oral GCS, while adding a high dose of Pulmicort. After ten days, gradually reduce to the minimum effective dose intake of the oral drug (during the month, with a reduction step in terms of prednisolone of 2.5 mg). Due to this scheme, in some cases, you can even completely abandon oral GCS.
Dosage of 250 μg budesonide should be diluted slightly. How to dilute this dose: dilute the drug you need 0.9% sodium chloride solution. Before you dilute with saline, you need to take 1 ml of the drug, in order to get 2 ml.

Instructions for use Pulmicort for inhalation

The dosage of the drug should be selected by the doctor individually for each patient. If the daily dose is in the range of 1000 mkg, then you can take the entire dose of the drug at a time. If the dose is required more, it is better to take it several times.
The initial daily dose of Pulmicort to children from 6 months is 250-500 mkg. The daily dosage for adults is from 1000 to 2000 μg.
Supporting daily dosage for children from 6 months - 250-2000 mkg. Adults should take a day for 500-4000 mkg. In the case of severe obstructive conditions, the dosage may be increased upon the recommendation of the attending physician.
A mandatory condition for therapy with Pulmicort is the selection of a minimum maintenance dose individually.
Suspension of the drug Pulmicort is used for inhalations with the help of a compressor nebulizer, which is equipped with a special mask and mouthpiece. The nebulizer joins the compressor, which creates the required airflow (about 5-8 liters per minute), it must be filled in volume by 2-4 ml. Note that ultrasonic nebulizers for Pulicicort suspension are not suitable!
Before using the drug in nebulas, gently shake the container containing the inside suspension. Open the container and gently squeeze its contents into the nebulizer. In the event that only 1 ml of the suspension is needed for use, the contents of the container are squeezed out until the liquid level reaches the indicated line. Before using the remaining liquid, the liquid contained in the container must be shaken with the help of rotational movements. Given that Pulmicorte is absorbed by the nebulizer into the patient's lungs during inspiration, it is imperative that the patient be instructed so that he inhales the drug smoothly and carefully.
If inhalation does not allow children to inhale themselves with a nebulizer, then a special mask should be used, making sure that it is snug against the face.
The mouthpiece, the nebulizer chamber and the mask should be cleaned after each use, washing them with warm water using a detergent or according to the instructions of the company producing them. The nebulizer itself needs to be thoroughly rinsed, and then dried, connecting the inlet air valve or compressor with the chamber.

Overdose

In the case of acute overdose, there are no clinical manifestations. If the overdose is chronic, then the effects of hypercorticism may appear, and suppression of adrenal function may occur.
In addition, there may be clinical manifestations of hypercorticism: hypertension, muscle weakness, weight gain, amenorrhea, hyperpigmentation. Also, with a chronic overdose for the treatment of hypercorticism, the drug is gradually withdrawn, systematically reducing the dosage.

Interaction

The systemic effect of Pulmicort can be increased by estrogens and methandrostenolone, which increase the concentration of this drug in the blood plasma. The therapeutic effect of the drug is enhanced by the preliminary inhalation of beta-adrenomimetics, which expand the bronchi.

Storage conditions

Drugs Pulmicort and Pulmicort Turbuhaler should be stored in a cool dry place with an ambient temperature of not more than 30 degrees Celsius.
Containers with the suspension inside should be stored only in the original envelope, which protects the drug from light.
Shelf life - 2 years.
After opening the envelope with containers, the time of use of the drug is reduced to 3 months.
The opened container should be used within a time not exceeding 12 hours.

special instructions

In order to minimize the risk of oropharyngeal involvement, the patient should be instructed to rinse the mouth with this medicine with particular care after each inhalation.
Drugs Pulmicort and Pulmicort Turbuhaler should be avoided together with itraconazole, ketonazole, and other substances that hold CYP 3A4 in the body. If these substances were prescribed to the patient simultaneously with budesonide (the main active substance of the drug), then the time between the administration of these drugs should be maximized.
Due to the risks that the pituitary-adrenal function may be weakened, it is necessary to pay special attention to those patients who are being switched to the Pulmicort and Pulmicort-Turbuhaler receptors from oral glucocorticosteroids. In addition, special attention should be given to those patients who have received the maximum recommended doses of glucocorticosteroids for a long time. In such patients in stressful situations manifestations of symptoms and signs of adrenal insufficiency are possible. Also in cases of surgical intervention or under stress, additional therapy with systemic glucocorticosteroids is recommended.
It is necessary to pay special attention to those patients who are transferred from the system to the intake of inhaled glucocorticosteroids, and also in those cases when the hypophyseal-adrenal function is expected to be impaired. In these cases, you need to carefully lower the dose of systemic glucocorticosteroids, as well as control the adrenal hormonal function.
If a patient changes from oral glucocorticosteroids to Pulmicort or Pulmicort Turbuhaler drugs, he may experience symptoms such as joint pain or muscle pain. In this case, it may be necessary to temporarily increase the dose of oral GCS. In some cases, nausea and vomiting, headache, fatigue can also occur, indicating a systemic insufficiency of glucocorticosteroids.
If oral glucocorticosteroids were replaced with inhaled glucocorticides, then sometimes a concomitant allergy (eczema or rhinitis), which was previously stopped with systemic drugs, is manifested.
In addition, patients should be instructed that if the effectiveness of therapy with a short-acting bronchodilator is reduced, then a doctor should be consulted, as an unauthorized increase in the frequency of use of the drug may delay the appointment of an adequate dosage for treatment. If there was a sudden deterioration in the condition, then you should consider the possibility of treatment with oral GCS.

Children

A pulmicort for children and adolescents who, for a long time regardless of the mode of delivery, receive treatment with the help of GCS, can influence their growth, so the indicators of their growth should be closely monitored. In case of prescribing Pulmicort or Pulmicort Turbuhaler, one must evaluate the ratio of the benefits expected from the use of these drugs to the potential risks associated with slowing the growth of the young organism.

In pregnancy and lactation

When pregnant with budesonide, no increased risk of fetal anomalies was found. However, one should not completely exclude these risks, so when taking the drug during pregnancy, you need to use the minimum effective dosage of the drug to avoid worsening of bronchial asthma.
Animal studies have shown results of fetal anomalies with admission of GCS, but these data can not be transferred to people who receive recommended doses of glucocorticosteroids.
For nursing mothers, the following information will be helpful: there is no evidence that budesonide can enter the breast milk. But still, when prescribing this drug, it is necessary to take into account potential risks for the child, comparing them with the prospective benefit.

Reviews on Pulmicort

In the network, you can find a variety of, sometimes even opposite reviews. As a rule, among the negative, the most common are those in which allergic reactions occur after the use of the drug, the appearance of problems with the adrenal glands, as well as general body disorders associated with hormonal changes. In this case, many do not know for sure whether the drug is hormonal or not, although this is stated in the instructions.
Various forums also had reports that some complained of a sudden deterioration in well-being that occurred after the drug was discontinued. As a rule, such reviews are written by those people who abandoned the drug too sharply, rather than gradually lowering the dosage, as it should be done. Reviews on Pulmicort Turbuhaler similar.
When receiving children, the reviews are rather alarming, which is caused by concerns about the extensive list of side effects of the drug, and also because the drug is hormonal. However, categorically negative reviews of inhalations were not found in children. At the same time, many noted that with laryngitis in children, it was Pulmicort.
Among positive reviews, you can find those that mention the effectiveness of the drug already at the first reception sessions. Many people say that the drug perfectly copes with asthma attacks and it helps perfectly in the stated indications for use, as indicated by the majority of those who left the reviews.