Pulmicort inhaler 200 mcg. 100 doses
Pulmicort inhaler 200 mcg. / 100 doses
Qualitative and quantitative composition
Budesonide 100 mcg / dose , 200 mcg / dose , and 400 mcg / dose.
Dry powder inhaler for multiple dosing.
Bronchial asthma requiring maintenance therapy with glucocorticosteroids for control of airway inflammation .
The dosage of Pulmicort Turbohaler is individual . The recommended starting dose and the highest recommended dose of Pulmicort Turbohaler based on prior treatment of asthma are shown in the table below .
Treated with non-steroidal preparations 400 to 800 mcg daily 1,600 mcg daily
Inhaled glucocorticoids 400 mcg to 800 mcg per day daily 1600
Oral glucocorticoids 800 to 800 mcg daily 1600 mcg daily
Children 6 years and up
Treated with non-steroidal preparations 400 to 800 mcg daily 800 mcg daily
Inhaled glucocorticosteroids 400 mcg daily 800 mcg daily
Oral glucocorticoids 400 to 800 mcg daily 800 mcg daily
The improvement in the asthmatic patients after inhalation of Pulmicort Turbohaler can be observed 24 h after inhalation , but the maximum effect can not be reached before the end of 1-2 weeks or more after onset of treatment . Taken twice a day ( morning and evening) is usually sufficient . One intake per day may be administered to adult patients who need 200-400 mcg budesonide daily. Then, the dosage can be taken in the morning or evening . If the deteriorated state of the asthma should increase the dose.
Note: In all patients it is desirable to apply the lowest effective dose that controls asthma.
Of drug Pulmicort Turbohaler is fed into the lungs by inhalation and it is important that the patient be instructed to breathe in forcefully and deeply through the mouthpiece .
To reduce the development of candida infection in the oral cavity and pharynx , the patient should be instructed to awake rinse your mouth with water after each dose.
Patients not taking glucocorticoids
Patients who require maintenance therapy of their astamata may respond better than Pulmicort Turbohaler at recommended doses in the table above . For patients who do not respond well to the nasal dose can achieve better response at higher doses.
Patients maintained with inhaled glucocorticosteroids
Clinical studies in humans have shown a good efficacy of the same amount of budesonide adopted in Turbohaler, instead of a pressurized aerosol (pMDI). When patients treated with Pulmicort pMDI switched Turbohaler asthma and responds well , it may be possible to reduce the dose of the even half of that in pMDI. Also in patients undergoing other inhaled glucocorticosteroids for Pulmicort Turbohaler may attempt to reduce the dose after initially starting with the same dose as in the previous preparation.
Patients maintained on oral glucocorticosteroids
Pulmicort Turbohaler may permit the replacement or significant reduction in the dose of oral glucocorticoids , providing the same or better control of asthma. Originally Pulmicort Turbohaler should be used together with the usual maintenance dose for the patient oral glucocorticosteroids. After approximately one week oral dose is gradually reduced to the lowest possible level. It is recommended to slowly reduce the dose. In many cases, a complete replacement of oral glucocorticoids with Pulmicort Turbohaler. During dose reduction some patients experience symptoms of withdrawal of steroid treatment , such as pain in joints and muscles , fatigue and depression, regardless of maintenance or improvement of the condition of the lungs. Such patients should be encouraged to continue to Pulmicort Turbohaler, but should be monitored for objective signs of adrenal insufficiency . If you find evidence of adrenal insufficiency , systemic corticosteroids should be increased temporarily and then the reduction should be even slower. During periods of stress or severe attacks such patients may require additional treatment with systemic corticosteroids.
The safety and effectiveness of Pulmicort Turbohaler., When taken in doses exceeding those recommended has not been investigated .
Svrahchuvstvitelnist known to budesonide .
Special warnings and precautions for use
Pulmicort Turbohaler. It is intended for fast relief of acute asthma attacks requiring inhaled short-acting bronchodilators . If patients do not respond efficiently than short acting bronchodilator , or they need more inhalations than usual , you should seek medical attention . In this situation, you should consider the need for increased anti-inflammatory therapy , eg . higher doses of inhaled budesonide or rate oral corticosteroid.
Particular care is required in patients who are transferred from systemic corticosteroids to inhaled . During this period of suppression of the HPA , patients may exhibit signs or symptoms of adrenal insufficiency , when subjected to trauma , surgery or infection ( particularly in gastroenteritis ) or other conditions causing acute loss of electrolytes. Although Pulmicort Turbohaler can control astamatichnite symptoms in these cases at the recommended doses, it provides less than normal physiological levels of systemic glucocorticoids and lacks ?????????????????????????? activity which is necessary to control these conditions izvanredini .
Some patients feel unwell in a special way during the suspension of glucocorticosteroids , eg . aching joints and muscles. Effect of glucocorticosteroids total failure may be suspected when it occurs, in rare cases , symptoms such as fatigue , headache, nausea and vomiting. In such cases it may sometimes be necessary to increase temporarily the dose oral glucocorticoids .
Replacement of systemic steroids to inhalation therapy sometimes reveals allergies , e.g. rhinitis or eczema , which were formerly controlled by systemic treatment . These allergies should be treated symptomatically with antihistamines or topical preparations .
Reduced liver function may affect the elimination of corticosteroids. The intravenous pharmacokinetics of budesonide, however, was similar in patients with cirrhosis and healthy subjects. Pharmacokinetics after oral administration of budesonide is affected by impaired hepatic function as evidenced by increased systemic availability . This is of little importance in Pulmicort Turbohaler, as after inhalation , the contribution of orally administered dose to the systemic availability is very low.
Special care is needed in patients with pulmonary tuberculosis.
Interactions with other medicaments and other forms of interaction
Budesonide showed no vzaomodeystvie with other drugs used to treat asthma . Ketokakanozol , a potent inhibitor of cytochrome P450 3A , the major metabolic enzyme of corticosteroids , increased plasma levels of budesonide orally . At recommended doses, cimetidine has a slight , but clinically insignificant effect and omeprazole - no effect on the pharmacokinetics of oral budesonide .
Pregnancy and lactation
In pregnant animals the application of budesonide and other corticosteroids is associated with abnormalities in the developing fetus . Relevance of these findings to humans is unknown. Like other drugs , the adoption of budesonide during pregnancy requires carefully assess the benefits and risks for the mother to the fetus. Inhaled glucocorticoids have to be taken into account because of their low systemic effect in comparison with the same doses of active anti-asthma drugs other .
No evidence of the passage of budesonide in breast milk.
Effects on ability to drive and use machines
Pulmicort Turbohaler not affect the ability to drive and use machines .
Clinical trials have shown no commonly occurring adverse reactions. Literature and post-marketing experience has shown that you have the following side effects:
Slightly draznenene throat , cough , lethargy
Infection of the oropharynx with Candida
Immediate or delayed hypersensitivity reactions including rash, contact deramatit , urticaria, bronchospasm and angiootok
Psychiatric symptoms such as nervousness , anxiety and depression , and abnormal behavior
There have been rare reports of skin injuries after inhalation of glucocorticoids .
In rare cases, unknown mechanism medication for inhalation can cause bronchospasm .
In rare cases can occur and symptoms of systemic glucocorticosteroid effects , including decreased function of the adrenal gland, probably depending on the dose inhaled glucocorticoids , treatment time , simultaneous, pre- treatment with steroids and individula sensitivity.
Not expected acute overdose even in excessive doses Pulmicort Turbohaler cause clinical problems . When used continuously in excessive doses can generate systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression .
Budesonide is a glucocorticosteroid with high topical anti-inflammatory aktivnoost .
The exact mechanism is not an action of glucocorticoids in the treatment of asthma is not fully understood. Perhaps of interest are the anti-inflammatory action by inhibiting the release of inflammatory mediator and suppression of immune responses tsitokinmediiranite . The intrinsic activity of budesonide , as measured by its affinity for the glucocorticosteroid receptor is approximately 15 times higher than that of prednisolone .
Clinical studies astamtitsi comparing inhaled and oral budesonide demonstrate statistically significant efficacy of inhalatsionnniya but not of oral budesonide versus placebo . Thus , the therapeutic effect of conventional doses of budesonide inhalation may largely explain the direct effects on the airways.
Budesonide has antianaphylactic and anti-inflammatory action in challenge studies in animals and humans , resulting in reduced bronchoconstriction in early and late allergic reactions. It was also shown that budesonide reduced the reactivity of the airways of the direct and indirect irritation hyperreactive patients. Treatment with budesonide is effective in the prevention of asthma , exercise induced .
At recommended doses Pulmicort Turbohaler causes significantly less effect on adrenal function of prednisolone 10 mg, as demonstrated by ASNT tests . No clinically significant changes in plasma cortisol levels in response to stimulation of ACTH acceptance of budesonide 1600 mcg daily for 3 months in adults and 800 msg daily in children. Term follow-up up to 52 weeks confirmed the lack of suppression of the HPA axis . Studies with Pulmicort Turbohaler healthy volunteers show dozavisim effect on cortisol in plasma and urine.
In children treated for 2-6 years with budesonide in Turbohaler with daily doses up to 400 mcg has not demonstrated an effect on growth compared with children of non-steroidal therapy.
After inhalation through Turbohaler, approximately 25-30 % of the metered dose is deposited in the lungs, which is approximately two times more than that in uoptreba of a pressurized aerosol .
The maximum plasma concentration after oral inhalation of a single dose of 800 mcg of budesonide is about 4 nmol / l and was observed after 30 min systemic availability of budesonide in Turbohaler is estimated to be 38 % of the metered dose , which samo1 / 6 due to the assumed drug . The kinetics of budesonide is proportional to the dose at the correct dosage .
The volume of distribution of budesonide is approximately 3 l / kg. Plasma protein binding averages 85-90 %.
Budesonide undergoes considerable / about 90% / biotransformations in its first passage through the liver to metabolites with less glucocorticoid activity. GCS activity of the main metabolites , 6 b- hydroxybudesonide and 16 a- hydroxyprednisolone is less than 1% of that of budesonide .
Metabolites of budesonide were removed , as such or in the form of conjugates in the kidney. In urine, no unchanged budesonide . Budesonide has a high systemic clearance (approximately 1.2 L / min ) and the plasma half-life after intravenous administration is on average 2-3 hours.
Preclinical safety data
The results of the acute , subacute and chronic toxicity studies have shown that the systemic effects of budesonide , eg . decrease of body weight and atrophy of the lymphoid tissues and adrenal cortex is weaker or similar to those of other glucocorticosteroids.
Budesonide, evaluated in six different test systems showed no mutagenic and clastogenic action.
Increased number of brain gliomas in mazhli rats in a carcinogenicity study was not confirmed by repeated studies in which cases of glioma not differ between groups with active treatment ( budesonide , prednisolone , triamcinolone acetonide ) and control groups .
Changes in the liver (primary hepatotseluralni neoplastic growths ) found in the original carcinogenicity study in rats were seen on repeated measurements with budesonide, as well as the comparator glucocorticosteroids. These effects appear to be due to a receptor effect and as such form a group effect .
The available clinical data showing correlation that budesonide or other glucocorticosteroids do not cause brain gliomas or primary hepatocellular neoplastic growths in man.
List of excipients
Other Ingredients : None.
Instructions for use
How to use Turbohaler?
Turbohaler is an inhaler for dispensing powder from which the inhalable medicament pure without additives . As you breathe in dust Turbohaler enters airways. It is important to breathe deeply and strongly through the mouthpiece of the device. Turbohaler is easy to use . Just follow the instructions below:
1. Unscrew and remove the cover.
2 . Hold the inhaler upright with the colored rotating part down. Load the inhaler by rotating the handle end and then back to the starting position ( second rotation does not increase the load the dose).
3 . Exhale completely by holding the device away .
4 . Carefully place the mouthpiece between your teeth , close your lips and inhale forcefully and deeply through the mouth.
5 . Before you exhale remove the nozzle from your mouth and hold as you assumed air .. If you are prescribed more than one dose , repeat steps 2-5 .
6 . Replace the battery cover .
7 . Rinse mouth with water after you breathed your prescribed dose.
Note: Never exhale through the mouthpiece .
Always put the cap well after use.
Since the dosage amount is very small , you may not feel the taste after inhalation. However, you can be sure that the dose is administered , if you follow the instructions.
Clean the outside of the nozzle regularly (weekly ) with a dry cloth. Do not use water to clean the nozzle .
How do I know that the inhaler is empty?
When you first see the red line in the display window , there are about 20 doses . When the red line reaches the bottom of the window , the inhaler is empty. The sound you hear when shaking it is not medicine .