Budesonide Easyhaler, 1 piece, 2.5 g, 200 mcg/dose, dosed powder for inhalation
To minimize the risk of fungal infection of the oropharynx, the patient should be instructed to thoroughly rinse the mouth with water after each inhalation of the drug.
Co-administration of budesonide with ketoconazole, itraconazole or other potential CYP3A4 inhibitors should be avoided. If budesonide and ketoconazole or itraconazole or other potential CYP3A4 inhibitors have been prescribed, the time between doses should be increased to the maximum possible.
Due to the possible risk of weakening pituitary-adrenal function, special attention should be paid to patients who are transferred from oral corticosteroids to taking Pulmicort®. Also, special attention should be paid to patients who have taken high doses of GCS, or who have been receiving the highest recommended doses of inhaled GCS for a long time. In stressful situations, these patients may exhibit signs and symptoms of adrenal insufficiency. In case of stress or in cases of surgical intervention, it is recommended to carry out additional therapy with systemic corticosteroids.
Particular attention should be paid to patients who are transferred from systemic to inhaled GCS (Pulmicort® Turbuhaler®), or in cases where a violation of the pituitary-adrenal function can be expected. In such patients, the dose of systemic corticosteroids should be reduced with extreme caution and the hormonal function of the adrenal glands should be monitored. Patients may also need to be prescribed oral corticosteroids during stressful situations, such as trauma, surgery, etc.
When switching from oral corticosteroids to Pulmicort® Turbuhaler®, patients may experience previously observed symptoms such as muscle pain or joint pain. In such cases, a temporary increase in the dose of oral corticosteroids may be necessary. In rare cases, symptoms such as fatigue, headache, nausea and vomiting may occur, indicating systemic insufficiency of GCS.
Replacing oral corticosteroids with inhaled ones sometimes leads to the manifestation of existing allergies (for example, rhinitis and eczema), which were previously treated with systemic drugs.
In children and adolescents receiving treatment with corticosteroids (regardless of the method of delivery) for an extended period, it is recommended to regularly monitor growth parameters.
Patients should be instructed to contact their physician if the effectiveness of therapy with short-acting bronchodilators decreases, because An independent increase in the frequency of use of the drug may lead to a delay in the prescription of adequate treatment. In case of sudden deterioration of the condition, it is necessary to consider the possibility of a course of treatment with oral corticosteroids.
Impact on the ability to drive a car or use other machinery.
Pulmicort® Turbuhaler® does not affect the ability to drive a car or use other machinery.
Instructions for the correct use of Turbuhaler®
The drug contained in Turbuhaler® enters the patient's respiratory tract along with air flows when active inhalation is performed through the Turbuhaler® mouthpiece.
Attention:
it is important to convince the patient to carefully read the instructions for using Pulmicort® Turbuhaler®.
To be sure that the optimal dose of the drug has reached the lungs, you need to inhale deeply and forcefully through the Turbuhaler® mouthpiece.
Under no circumstances should you exhale through the mouthpiece.
After inhaling the required dose of the drug, rinse your mouth with water in order to minimize the risk of fungal infection of the oropharynx.
How to use Pulmicort® Turbuhaler®
Turbuhaler® is a multi-dose inhaler that allows you to dose and inhale the drug in very small doses. When the patient inhales, Turbuhaler® powder is delivered to the lungs. Therefore, it is important that the patient inhales forcefully and deeply through the mouthpiece.
Turbuhaler® is very easy to use. You just need to follow the instructions given below:
1. Unscrew and remove the cap.
2. Keep the inhaler upright
, dispenser down. Load the dose into the inhaler by turning the dispenser counterclockwise until it stops, and then turn the dispenser to its original position until it clicks.
3. Exhale
.
Do not exhale through
the mouthpiece.
Before exhaling, remove the inhaler from your mouth.
4. Gently squeeze the mouthpiece between your teeth, purse your lips and inhale deeply and forcefully
through the mouth. The mouthpiece should not be chewed or squeezed tightly with your teeth.
If inhalation of more than one dose is required, repeat steps 2–5.
5. Close the inhaler with the cap.
6. Rinse your mouth with water.
IMPORTANT!
Never exhale through the mouthpiece. Always cap the inhaler tightly after use.
Since the amount of powder inhaled is very small, the patient may not be able to taste the powder after inhalation. However, if he followed the instructions, he can be sure that he inhaled the required dose of the drug.
Cleaning
Clean the outside of the mouthpiece regularly (once a week) with a dry cloth.
Do not use water or other liquids to clean the mouthpiece.
How do you know if your inhaler is empty?
When a red indicator appears in the dose window, it means there are approximately 20 doses left in the inhaler. The inhaler is empty when the red mark reaches the bottom edge of the dose indicator window.
The sound heard when the inhaler is shaken is produced by the drying agent, not the medication.
Budesonide (Budesonidum)
For inhalation use: dry or irritated mouth, dry or irritated throat, flu-like symptoms, pharyngitis, laryngitis, dysphonia (dose-dependent effect), cough, headache. Oropharyngeal candidiasis, bruising (high doses), fatigue, weakness, malaise, insomnia, dizziness, weight gain, abdominal pain, nausea or vomiting, constipation or diarrhea, chest pain, palpitations, tachycardia, arrhythmias, cystitis, allergic reactions, swelling of the face, fingers, ankles, feet, lower extremities, unpleasant taste. Esophageal candidiasis, gastroenteritis, slow growth in children, osteoporosis (more than 1500 mcg per day - a significant decrease in bone mineral density), cataracts (increased risk of developing posterior subcapsular cataracts with long-term treatment with high doses), hypertension, hypercortisolism, hyperglycemia, menstrual irregularities , fever, mental disorders (anxiety, aggressive reactions, depression, psychosis), bleeding from the rectum, nosebleeds, hemorrhagic rash and thinning of the skin (400-2000 mcg per day), fainting, adrenal insufficiency (suppression of adrenal function during therapy at a dose more than 1500 mcg per day, but sensitivity varies significantly among patients), pneumonia, bronchospasm, allergic reactions, decreased sense of smell and taste, increased risk of developing glaucoma or increased intraocular pressure with long-term treatment with high doses, suppression of the hypothalamic-pituitary-adrenal axis (minimal at a dose of more than 1500 mcg per day (400 mcg per day in children)).
For intranasal use: mild and transient burning sensation, dryness or other irritation in the nasal cavity and pharynx, sneezing attacks, headache.
Formation of scabs in the nasal cavity, nosebleeds, persistent rhinorrhea and nasal congestion, watery eyes, sore throat, hoarseness, cough, lethargy, dizziness, nausea or vomiting, stomach pain, loss of sense of taste or smell. Candidiasis of the nasal cavity and pharynx, atrophic rhinitis, ulceration of the nasal mucosa, perforation of the nasal septum, conjunctivitis, increased intraocular pressure, glaucoma, cataracts, muscle pain, shortness of breath, allergic reactions, tinnitus.
When used orally: the incidence and severity of side effects depend on the duration of use, the size of the dose used and the ability to comply with the circadian rhythm of the prescription.
From the endocrine system: decreased glucose tolerance, “steroid” diabetes mellitus or manifestation of latent diabetes mellitus, suppression of adrenal function, Itsenko-Cushing syndrome (moon face, pituitary type obesity, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia, stretch marks ), delayed sexual development in children.
From the digestive system: nausea, vomiting, pancreatitis, “steroid” ulcer of the stomach and duodenum, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups. In rare cases, increased activity of liver transaminases and alkaline phosphatase.
From the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest); development (in predisposed individuals) or increased severity of chronic heart failure, changes in the electrocardiogram characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of necrosis, slowing down the formation of scar tissue, which can lead to rupture of the heart muscle.
From the nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, pseudotumor of the cerebellum, headache, convulsions.
From the senses: posterior subcapsular cataract, increased intraocular pressure with possible damage to the optic nerve, a tendency to develop secondary bacterial, fungal or viral eye infections, trophic changes in the cornea, exophthalmos.
From the metabolic side: increased excretion of Ca2+, hypocalcemia, increased body weight, negative nitrogen balance (increased protein breakdown), increased sweating.
Caused by mineralocorticoid activity: fluid and Na+ retention (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).
From the musculoskeletal system: slowing of growth and ossification processes in children (premature closure of the epiphyseal growth plates), osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the head of the humerus and femur), rupture of muscle tendons, steroid myopathy, decreased muscle mass (atrophy).
From the skin and mucous membranes: delayed wound healing, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, steroid acne, stretch marks, tendency to develop pyoderma and candidiasis.
Allergic reactions: generalized (skin rash, itching, anaphylactic shock), local allergic reactions.
Other: development or exacerbation of infections (the appearance of this side effect is facilitated by jointly used immunosuppressants and vaccination), leukocyturia, withdrawal syndrome.
With intravenous administration: arrhythmias, hot flashes, convulsions. Locally - burning, numbness, pain, paresthesia at the injection site, infection at the injection site, rarely - necrosis of surrounding tissues, scar formation at the injection site; atrophy of the skin and subcutaneous tissue when administered intramuscularly (injection into the deltoid muscle is especially dangerous).
When administered parenterally, crystals of the drug may be deposited in the head, neck, nasal turbinates, and scalp, and sudden loss of vision may occur in the vessels of the eye.
With intracranial administration - nosebleeds (during neurosurgical operations).
For external use: steroid acne, purpura, telangiectasia, burning and itching of the skin, irritation and dry skin. With long-term use and/or when applied to large surfaces, systemic side effects are possible.
