Pulmicort Turbuhaler powder ing.dozir. 200mkg / dose 100doz

$11.72

Pulmicort Turbuhaler powder ing.dozir. 200mkg / dose 100doz

Quantity:

SKU: 01944598102 Categories: , Tags: ,

Description

Composition
Active substance:
A single dose contains the active substance – of budesonide 100 mcg or 200 mcg.
Description:
Plastic inhaler to 100 ug / dose: rotating part inhaler light brown, on the bottom side 100 is squeezed BUDESONIDE; to 200 ug / dose: rotating part inhaler brown, on the bottom side embossed BUDESONIDE 200. The inhaler comprises a round granules from white to almost white, easily destroyed at the slightest mechanical stress. A minor part of the substance may be present in powder form.
Product form:
200 doses (for a dosage of 100 mcg / dose) at doses of 100 or 200 (for the dosage of 200 ug / dose) in the plastic inhaler, consisting of a dosing device, a reservoir for storing powder reservoir for desiccant, the mouthpiece and the screw cap. Each inhaler is placed in a cardboard box with instructions for use.
Contraindications
Hypersensitivity to budesonide.
Children up to age 6 years.
Carefully:
Caution should be exercised in the treatment of inhaled corticosteroids in patients with active or inactive forms of pulmonary tuberculosis, fungal, viral or bacterial infections of the respiratory system; cirrhosis, glaucoma, hypothyroidism.
Indications
Bronchial asthma requiring maintenance treatment with glucocorticosteroids for control of the inflammatory process. chronic obstructive pulmonary disease (COPD).
Interaction with other drugs
Budesonide was observed interaction with other drugs used in the treatment of bronchial asthma.
Ketoconazole (200 mg once daily) increases the plasma concentrations of oral budesonide (3 mg once daily) on average 6-fold at the joint reception. When receiving ketoconazole through 12 hours after receiving budesonide concentration of the latter in the blood plasma increased on average 3 times. Information about such interactions when taking inhaled budesonide is missing, but it is assumed that in this case we should expect an increase of budesonide plasma concentrations. Should not be prescribed these drugs at the same time due to lack of data. In case of concomitant administration of ketoconazole and budesonide necessary time between drug administration should be increased to the maximum possible. You should also consider reducing the dose of budesonide. Other potential CYP3A4 enzyme inhibitors (e.g., itraconazole) also cause a significant increase in plasma concentrations of budesonide.
Overdose
In overdose Pulmicort turbuhaler in doses considerably above recommended, there is no clinical manifestations. Prolonged use of the drug in doses significantly exceeding the recommended may develop systemic effect glucocorticosteroid in the form of hypercortisolism and adrenal suppression.
pharmachologic effect
Pharmacological group:
Glucocorticosteroids for local use.
Pharmacodynamics:
Budesonide is a glucocorticosteroid with a strong local anti-inflammatory action.
The exact mechanism of action of glucocorticosteroids in the treatment of asthma is not completely understood. The anti-inflammatory action such as inhibition of the release of mediators of inflammation and cytokine-mediated immune response may be the most important. Budesonide affinity to receptors of glucocorticoids is 15 times higher than that of prednisolone.
Anti-inflammatory effect of budesonide is mediated by a decrease in the degree of airway obstruction during the early and late allergic response. Budesonide reduces airway reactivity in response to inhaled histamine and methacholine.
The sooner after the diagnosis of persistent asthma treated with budesonide flow started, the greater the improvement in lung function can be expected.
Shown a dose-dependent effect on the cortisol content in plasma and urine in the patients receiving Pulmicort turbuhaler. The recommended dose medication has a much smaller effect on the adrenal function than prednisone 10 mg, as was shown in ACTH tests.
The use of budesonide in a dose of 400 mg a day for children older than 3 years does not cause systemic effects. Biochemical signs of systemic drug effects can occur when taking the drug at a dose of 400 to 800 micrograms per day. In excess doses of 800 micrograms per day systemic drug effects occur frequently.
The use of corticosteroids to treat asthma can cause growth retardation.
Marked initially small, usually transient growth delay (about 1 cm), usually within the first year of treatment. In long-term studies in clinical practice have shown that children and adolescents treated with inhaled budesonide, on average, reach the estimated growth for adults. However, in the long-term, double-blind study, mainly without budesonide dose titration to the minimum effective height of children and adolescents treated with inhaled budesonide, on reaching adulthood the average was 1.2 cm less than the placebo group (see. Recommendations for Measuring and Control growth in the sections “dosage and administration” and “special instructions”).
Therapy inhaled budesonide once or twice a day demonstrated efficacy for the prevention of asthma physical effort.
Pharmacokinetics:
Absorption
Inhaled budesonide is rapidly absorbed. After inhalation using turbuhaler about 25-35% of the measured dose to the lungs. Maximum plasma concentration is achieved after 30 minutes of inhalation. Systemic bioavailability is about 38% of the dose.
Metabolism and distribution
Binding to plasma proteins is an average of 90%. The volume of distribution of budesonide is about 3 l / kg. After absorption budesonide undergoes intensive (90%) of biotransformation in the liver with the formation of metabolites with low glucocorticosteroid activity. Glucocorticosteroid active main metabolites 6 beta gidroksibudesonida and 16 alpha-hydroxyprednisolone is less than 1% of the glucocorticosteroid budesonide activity.
breeding
Budesonide is metabolized primarily by CYP3A4 enzyme. Metabolites are unchanged in the urine or in conjugated form. A small amount of unchanged budesonide is excreted in the urine. Budesonide has a high systemic clearance (approximately 1.2 L / min). The pharmacokinetics of budesonide is proportional to the administered dose.
The pharmacokinetics of budesonide in children and patients with impaired renal function is not known. Patients with liver disease may be extended residence time in body budesonide.
Pregnancy and breast-feeding
Pregnancy
Results from animal studies have shown that glucocorticoids can cause fetal abnormalities, but these data can not be extrapolated to people receiving corticosteroids at recommended doses.
On a background of reception of budesonide in pregnant women revealed no increase risk of congenital malformations in the fetus, however, can not completely exclude the risk of their development, so during pregnancy should use the lowest effective dose of budesonide, not forgetting about the possibility of worsening of bronchial asthma.
In appointing the drug should take into account the ratio of the expected benefit to the mother and the potential risk for the baby.
Breastfeeding
Budesonide is excreted in breast milk, but when using the drug Pulmicort Turbuhaler in therapeutic doses, effects on the infant is not expected. In appointing the drug should take into account the ratio of the expected benefit to the mother and the potential risk for the baby.
Conditions of supply of pharmacies
On prescription.
side effects
Up to 10% of patients taking the drug, may have the following side effects:
Common (> 1/100)
Inhalation: Candidiasis oropharyngeal irritation of the throat, cough, hoarseness
rare (
Skin: Urticaria, rash, contact dermatitis
Respiratory tract: bronchospasm
They can also be observed neuropsychiatric symptoms such as nervousness, irritability, depression, behavioral disorders. Taking into account the risk of oropharyngeal candidiasis, the patient should be carefully rinse your mouth with water after each inhalation of the drug.
In rare cases, symptoms may arise due to systemic effects of corticosteroids, including the adrenal hypofunction.
May also experience nausea, taste alteration, hypercortisolism, gipokortitsizm, cataract, glaucoma, difficulty in swallowing, growth retardation (in children and adolescents), a decrease in bone density.
In rare cases, there was bruising on the skin.
special instructions
To minimize the risk of fungal infections of the oropharynx, the patient should be instructed on the need to thoroughly rinse your mouth with water after each inhalation of the drug.
concomitant administration of budesonide should be avoided with ketoconazole, itraconazole or other potent inhibitors of CYP3A4. In the case where budesonide and ketoconazole or itraconazole or other potential CYP3A4 inhibitors have been assigned, increase the time between drug administration to the maximum possible.
Because of the possible risk of impaired pituitary-adrenal function, special attention should be given to patients who are transferred from oral glucocorticosteroids Pulmicort an appointment. Also, special attention should be given to patients receiving high-dose corticosteroids, or receiving long-term highest possible recommended dose of inhaled glucocorticosteroids. In stressful situations, such patients may show signs and symptoms of adrenal insufficiency. Under stress or in cases surgery is recommended complementary therapy systemic corticosteroids.
Particular attention should be given to patients who are transferred from systemic to inhaled glucocorticosteroids (Pulmicort Turbuhaler), or when you can expect a breach of pituitary-adrenal function. Such patients should take special care to reduce the dose of systemic corticosteroids and hormonal control of the adrenal function. Also, patients may require administration of oral corticosteroids during stressful situations such as trauma, surgery, etc.
When switching from oral glucocorticosteroids Pulmicort Turbuhaler to patients can feel the previously observed symptoms such as muscle aches or joint pain. In such cases, you may need a temporary increase in the dose of oral corticosteroids. In rare cases, there may be symptoms such as fatigue, headache, nausea and vomiting, suggestive of systemic glucocorticosteroid insufficiency.
Substitution oral to inhaled glucocorticosteroids sometimes leads to the appearance of an existing allergy, rhinitis and eczema previously stoped systemic drugs.
In children and adolescents treated with corticosteroids (regardless of the method of delivery) over an extended period, it is recommended to regularly monitor the growth figures.
Patients should be instructed to refer to the attending physician in the event of reduced efficiency of short-acting bronchodilators therapy, as an independent increase in the frequency of the drug can lead to postponement of the destination adequate treatment. In the event of a sudden deterioration of the need to consider the possibility of treatment with oral corticosteroids.
Clinical studies and meta-analyzes have shown that the use of inhaled corticosteroids in COPD may lead to increased risk of pneumonia. However, the absolute risk in the application of budesonide small. A meta-analysis of 11 double-blind studies involving 10570 patients with COPD did not demonstrate a statistically significant increase pneumonia risk in patients treated with budesonide (including in combination with formoterol), compared with patients receiving therapy without budesonide (placebo or formoterol). The incidence of serious adverse event pneumonia was 1.9% per year during therapy comprising budesonide and 1.5% per year – with no treatment budesonide. Combined odds ratio when compared therapy comprising budesonide, with therapy without budesonide was 1.15 (95% confidence interval (CI): 0.83, 1.57). The combined risk ratio when compared to monotherapy with budesonide placebo was 1.57 (95% CI: 0.90, 2.74). Causation pneumonia using formulations containing budesonide, not installed.
Effect on the ability to drive mechanisms and
In connection with the development of neuropsychiatric symptoms should observe caution when driving vehicles and mechanisms.
Instructions for proper use turbuhaler:
The drug contained in Turbuhaler, enters the patient’s airway with the air flow when the active turbuhaler inhalation through the mouthpiece.
Note: It is important to convince the patient to carefully read the instructions for use Pulmicort turbuhaler.
To be sure that the optimal dose of the drug came to light, deep and strong inhale through a mouthpiece turbuhaler.
Do not, under any circumstances, exhale through the mouthpiece.
After inhalation of the desired dose, rinse the mouth with water to minimize the risk of fungal infections of the oropharynx.
Storage conditions
Store at a temperature below 30 ° C, the reach of children.
Dosing and Administration
The dose of Pulmicort turbuhaler selected individually.
The recommended dose in the event of inhaled glucocorticosteroid therapy in severe asthma exacerbations, as well as on the background dose reduction or withdrawal of reception of oral corticosteroids, the following:
Children older than 6 years: 100-800 mcg / day (total daily dose may be divided into 2-4 inhalation). In the event that the recommended dose of no more than 400 mcg / day, the whole dose may be taken at one time (simultaneously).
In children, the transition to a single receiving the drug should be conducted under the supervision of a pediatrician.
Adults: customary dose is 200-800 mg / day (total daily dose may be divided into 2-4 inhalation). For the treatment of severe acute asthma daily dose may be increased up to 1600 micrograms.
If the recommended dosage does not exceed 400 mg / day, the whole dose may be taken at one time (simultaneously).
When selecting a maintenance dose is necessary to seek the appointment of the minimum effective dose.
Time of onset of therapeutic effect after inhalation one dose of a few hours. The maximum therapeutic effect is achieved within 1-2 weeks after treatment. Pulmicort Turbuhaler has a prophylactic effect on bronchial asthma and does not affect the acute manifestations of the disease.
It demonstrated a better efficacy of budesonide using turbuhaler compared with the same dose of budesonide in the form of metered aerosols. In the case of patient translation being in a stable state, with Pulmicort in aerosol form for Pulmicort Turbuhaler, consider reducing the daily dose of budesonide.
To enhance the therapeutic effect can recommend an increase in the daily dose of Pulmicort turbuhaler instead of the combination of the drug with oral corticosteroids, due to lower risk of systemic effects.
Patients receiving oral glucocorticosteroids
Abolition of receiving oral glucocorticosteroids should be carried out against the background of a stable state of health of the patient. Within 10 days, it is recommended to take a high dose of Pulmicort in patients receiving oral glucocorticosteroids in the selected dose. Subsequently dose oral corticosteroids should gradually reduce (e.g., 2.5 mg of prednisolone or its equivalent) to the lowest possible level. In many cases, it manages to completely abandon the acceptance of oral glucocorticosteroids.
There are no data on the use of budesonide in patients with renal or hepatic impairment. Taking into account the elimination of budesonide at the expense of biotransformation in the liver, can be expected to increase the duration of action of the drug in patients with severe liver cirrhosis.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

ASTRAZENECA

There are no reviews yet.

Add your review