BUDOSTER (spray)
closer to reality - my story.
I have — daaaammm — 20+ years of experience. Almost 25. At first it was a simple remedy to combat a runny nose. Then, somehow imperceptibly, it became a permanent fixture in my pocket. Over the past 10 years, it has become the most important item that is checked when leaving the house. Despite the fact that I have a supply in my car and in another, and at work... in general, everywhere. On average - one bottle of 15 ml of 0.1% solution for 1 day. That is, 30 per month, i.e. 365 per year. The average time “between” taking naphthyzine was 1.5 hours. And the worst thing is that all this after 40 years is very real and can very quickly lead to a heart attack. And I realize this, but there was no solution to the problem. Surgery is scary. I tried to endure - there was no hope - wild panic when I couldn’t breathe. The nose was “concreted” so that even naphthyzin did not immediately penetrate it. In general, one fine day my wife took me seriously and announced a treatment regimen with the drug “Budoster”. By the way, the price of the drug is about 500 rubles - it doesn’t matter to me at all. I am ready to pay 1000, 5000, and 50000 for the result.
The treatment regimen was not taken out of my head, it was prescribed to her by an otolaryngologist (my wife had pregnancy rhinitis and she also became “addicted” to vasoconstrictors - xylene), the regimen really helped her.
So it was decided to try it on me. But almost 25 years will not just heal. Mucous, mmk, dead.
And yet, they started. After the first week of using Budoster, my interval “between” increased to 3 hours. At first it seemed strange to me, somehow almost twice as strange - such a breakthrough. Or an accident? After another couple of weeks, my “between” became 5-6 hours - wow! After another week, the ""between"" became 4 hours, but I already diluted the naphthyzine half with saline solution. In a couple more weeks for the first time!!! my “between” was 12 hours. I was very impressed. At the same time, the nose breathes, you don’t have to endure much, everything is fine. So gradually came 10/18/17, when, I hope, the last time I dropped naphthyzine.
To date (11/21/17), more than a month has passed without naphthyzine.
Hard? No... not very much. Periodically, of course, it adds up, especially in the morning, but not for long, it’s tolerable. Aquamaris Strong and regular saline help. In general, progress is felt, at least some prospect is visible. These are the things... what will happen next is still unknown, we’ll wait and add details. _ Second time. After the first course of Budoster, approximately 2 months passed. The nose breathed without naphthyzine, let’s say... by 60 percent. Tolerable, after 25 years. But then I accidentally got sick, started snotting, etc. Naphthyzin was no longer dripping, only diluted xylene, the interval “between” was about 5 hours. In January I started the Budoster course again. The scheme is the same, but everything went much faster and easier. By the end of April, the nose was breathing without vasoconstrictors... by 75 percent. Sometimes it was stuffy in the morning, but it was better than after the first use. _ Third time. From the end of May to the present (June). The nose breathes 90 percent. Even in the morning I wake up breathing freely through my nose. Occasionally there is congestion, but it goes away on its own... That's it... everything is fine!
And now, actually, the treatment regimen. Before you start, be sure to read the instructions for the drug, contraindications, etc. I’m not calling for self-medication, I’m just showing what really helped me and how.
You will need 2 bottles of Budoster (Aquamaris Strong and saline solution - optional. The first dries well, the second moisturizes the mucous membrane) Be sure to select the time (morning - evening, day - night) at which you will drip Budoster. Taking into account the fact that this is a hormonal drug, it is not advisable to violate the regime (maximum, plus or minus an hour of delay). Once every 12 hours. For me it happened at 8:00 and 20:00, the alarm clock on my smartphone helped out. By this time, the nose should be breathing, i.e. Budoster is dripped into a “clean” breathing nose. Shake the bottle well before use.
So:
1. First week - 2 sprays in each nostril 2 times a day (i.e. 2 in one in the morning, 2 in the other in the morning, 2 in one in the evening and 2 in the other in the evening) 2. Second week and until the end of the first month - 1 spray in each nostril 2 times a day 3. Next, another 2 months - 1 spray in each nostril 1 time a day (morning or evening) 4. After 3 months, stop taking it.
_
I sincerely hope that this scheme will be useful to someone, that someone will breathe at least a little easier. If you have any questions, I will answer.
Do not be ill!
Budoster 100mcg/dose 10ml dosed nasal spray
pharmachologic effect
GCS.
When used inhalation, it has anti-inflammatory, anti-allergic and anti-exudative effects, which leads to a reduction in bronchial obstruction. The mechanism of action is to inhibit the release of inflammatory and allergic mediators, as well as to reduce the reactivity of the respiratory tract to their action. During the treatment, respiratory function improves, the severity and frequency of shortness of breath, attacks of suffocation, and cough are significantly reduced. The maximum clinical effect develops after 1-2 weeks of therapy. The exact mechanism of action of budesonide in the treatment of ulcerative colitis has not been fully established. Budesonide inhibits many inflammatory processes, including cytokine production, activation of inflammatory cells, and expression of adhesion molecules on endothelial and epithelial cells. At doses that are clinically equivalent to prednisolone, budesonide causes significantly less suppression of the hypothalamic-pituitary-adrenal axis and has less effect on inflammatory markers.
Data from clinical pharmacological and pharmacokinetic studies indicate that the mechanism of action of oral budesonide is based on local action in the intestine.
Composition and release form Budoster 100mcg/dose 10ml dosed nasal spray
Spray - 1 dose:
- Active substance: budesonide 100 mcg.
- Excipients: dextrose 2.38 mg, Avicel (microcrystalline cellulose and sodium carmellose in a ratio of 9:1) 0.63 mg, potassium sorbate 0.06 mg, polysorbate 80 0.01 mg, disodium edetate 0.005 mg, hydrochloric acid to pH 4.5, purified water 47.8 mg.
100 doses - dark glass bottles (1) with a dosing valve - cardboard packs.
Description of the dosage form
Nasal spray dosed in the form of a white or almost white homogeneous suspension.
Directions for use and doses
The dose is set depending on the indications, age, and dosage form.
Pharmacodynamics
GCS for intranasal use. It has a pronounced anti-inflammatory and antiallergic effect. When used in therapeutic doses, it has virtually no resorptive effect. It does not have mineralocorticoid activity and is well tolerated with long-term use. The drug has an inhibitory effect on the release of mediators of the inflammatory response, reduces the number of mast cells and eosinophilic granulocytes. Budesonide reduces the release of toxic proteins from eosinophils, free radicals from macrophages and lymphokines from lymphocytes. It also reduces the binding of adhesion molecules to endothelial cells, thereby reducing the influx of leukocytes to the site of allergic inflammation. Budesonide increases the number of β-adrenergic receptors in smooth muscle. The drug inhibits the activity of phospholipase 2A, which leads to inhibition of the synthesis of prostaglandins, leukotrienes and Freund's complete adjuvant (PAF), which induce an inflammatory response. Budesonide also inhibits histamine synthesis, which leads to a decrease in histamine levels in mast cells.
Budesonide reduces the severity of symptoms in allergic rhinitis, suppresses the late and early phases of the allergic reaction and reduces inflammation in the upper respiratory tract. The therapeutic effect develops on average after 5-7 days.
Pharmacokinetics
When administered by inhalation, 30-35% of the dose penetrates the bronchioles. Bioavailability when entering the lungs is about 73%. 25-30% enter the gastrointestinal tract. Bioavailability by oral route is 10.7%. Cmax of budesonide in plasma is achieved after 1.5-2 hours. Budesonide is quickly eliminated from the body. T1/2 for inhalation administration is 2-3 hours. Plasma clearance is 55-85 l/hour.
After oral administration in a specific dosage form, approximately 90% of budesonide is metabolized during the first pass through the liver and only about 10% is systemically available. Budesonide has a significant Vd (about 3 l/kg). Plasma protein binding averages 85-90%. Budesonide undergoes extensive biotransformation in the liver with the formation of metabolites with low glucocorticoid activity. The glucocorticoid activity of the main metabolites (6β-hydroxybudesonide and 16α-hydroxyprednisolone) does not exceed 1% of the activity of budesonide itself. The metabolism of budesonide is predominantly mediated by CYP3A isoenzymes. The rate of elimination of budesonide is limited by the degree of absorption. Budesonide is characterized by high systemic clearance (about 1.2 l/min).
Indications for use Budoster 100mcg/dose 10ml dosed nasal spray
Bronchial asthma requiring maintenance therapy with glucocorticoids.
For induction of remission in patients with mild to moderate active ulcerative colitis.
Contraindications
For inhalation use: hypersensitivity to budesonide.
For oral administration: liver cirrhosis; infectious intestinal diseases; lactation period (breastfeeding); children and adolescents up to 18 years of age; hypersensitivity to budesonide.
Application of Budoster 100 µg/dose 10 ml dosed nasal spray during pregnancy and breastfeeding
In the form of inhalations, use during pregnancy is possible when the expected benefit to the mother outweighs the potential risk to the fetus. If use is necessary during lactation, breastfeeding should be discontinued due to the lack of data on the excretion of budesonide in breast milk.
Oral administration is contraindicated during pregnancy and lactation (breastfeeding).
Use in children
The effectiveness and safety of budesonide in children under 7 years of age have not been studied.
special instructions
For inhalation use
Use with caution in patients with pulmonary tuberculosis, as well as chickenpox.
Budesonide is not intended for the relief of acute attacks of asthma in bronchial asthma. Use is not recommended for intermittent disease.
The replacement of systemic corticosteroids with inhalations is carried out gradually.
The effectiveness and safety of budesonide in children under 7 years of age have not been studied.
For oral administration
Use with caution in patients with diagnosed liver and kidney dysfunction, with diabetes mellitus, arterial hypertension, gastrointestinal diseases, osteoporosis, glaucoma or cataracts, with concomitant verified mental disorders, or in the presence of mental illness in first-degree relatives.
The use of budesonide can lead to an exacerbation of the inflammatory reaction in patients with infectious pathology and a decrease in the immune response to vaccines.
Overdose
Symptoms (in case of chronic overdose): acne, Cushing's syndrome, dysmenorrhea.
Treatment: gradual withdrawal of the drug.
Side effects Budoster 100mcg/dose 10ml dosed nasal spray
When used inhalation, irritation of the mucous membranes of the pharynx, oral cavity, nose, and candidiasis is possible; with increased sensitivity - bronchospasm.
When taken orally, side effects typical of systemic corticosteroids may occasionally occur. These side effects depend on the dose, duration of treatment, concomitant or previous treatment with other corticosteroids and individual sensitivity. Side effects of the steroid class include:
From the skin: allergic exanthema, red striae, petechiae, ecchymosis, steroid acne, delayed wound healing, contact dermatitis.
From the musculoskeletal system: aseptic necrosis of bone (femur and head of the humerus).
From the organs of vision: glaucoma, cataract.
Mental disorders: depressive syndrome, irritability, euphoria.
From the digestive system: discomfort in the stomach, duodenal ulcer, pancreatitis.
From the endocrine system: Cushing's syndrome, moon face, trunk obesity, decreased glucose tolerance, diabetes mellitus, adrenal insufficiency, growth retardation in children, impaired secretion of sex hormones (for example, amenorrhea, hirsutism, impotence).
Metabolism: sodium retention with the formation of edema, increased potassium excretion.
From the cardiovascular system: arterial hypertension, increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy).
From the immune system: impaired immune response (for example, increased risk of infections).
Drug interactions
Cimetidine and omeprazole do not have a clinically significant effect on the pharmacokinetic parameters of budesonide when taken orally. However, under the influence of cimetidine, the metabolism of budesonide in the liver may slow down.
Budesonide has lower systemic bioavailability compared to other corticosteroids, so drug interactions may be less pronounced compared to many other drugs in this class.
The risk of drug interactions may be increased in the elderly and patients with impaired renal or hepatic function.
