Budenofalk

Budesonide, known by the trade name Budenofalk, is a corticosteroid drug that is widely used to treat a variety of inflammatory conditions, especially those affecting the respiratory tract and intestines. Budesonide helps reduce inflammation, which results in symptom relief.

Budesonide exerts an anti-inflammatory effect by inhibiting the production of inflammatory mediators in the body. This action is achieved through its ability to penetrate cells and influence various genetic pathways that control inflammatory processes.

Indications Budenofalka

Budenofalk (budesonide) is used to treat various inflammatory diseases, including ulcerative (chronic) proctitis and ulcerative (chronic) rectosigmoiditis. In this case, the use of budesonide is aimed at reducing inflammation and reducing the symptoms of these diseases, such as pain, itching, discomfort, bleeding and diarrhea.

Inflammation in the rectum (proctitis) and rectum and sigmoid colon (rectosigmoiditis) can cause significant discomfort and impair the patient's quality of life. Budenofalk, being a glucocorticosteroid drug, helps reduce inflammation and reduce the symptoms of these diseases.

Release form

1. Inhalation aerosol: This is a metered-dose spray that is inhaled through an inhaler. The inhalation aerosol allows budesonide to reach directly into the lungs where it does its work.
2. Inhalation powder: This is also a form of inhaler, but instead of a spray, it contains budesonide powder that is inhaled through an inhalation device.
3. Inhalation solution: Some manufacturers may produce budesonide as a solution that is then inhaled using a special device.

Pharmacodynamics

1. Anti-inflammatory action: Budesonide has an anti-inflammatory effect in the airways by reducing inflammation and swelling of the mucous membrane. It inhibits the production of inflammatory mediators such as prostaglandins and leukotrienes and reduces the penetration of inflammatory cells into tissues.
2. Antiallergic action: Budesonide helps reduce the sensitivity of the respiratory tract to various allergens, which reduces the risk of allergic reactions and asthma attacks.
3. Reducing mucus secretion: Budesonide reduces mucus production in the airways, which helps reduce breathing difficulties and improve lung function.
4. Local action: Budesonide acts locally in the respiratory tract, which reduces the likelihood of systemic side effects typical of systemic use of glucocorticosteroids.

Pharmacokinetics

1. Absorption: Budesonide can be administered by a variety of routes, such as inhalation, which provides direct delivery of the drug to the lungs, or by ingestion for systemic exposure. Following inhalation, it is rapidly and efficiently absorbed from the lungs into the systemic circulation.
2. Distribution: Budesonide has a high affinity for plasma proteins (approximately 85-90%), meaning that most of the drug is bound to blood proteins. It can also be distributed rapidly into body tissues, including the lungs.
3. Metabolism: Budesonide is primarily metabolized in the liver to form active metabolites, including 16α-hydroxyprednisolone. These metabolites have less biological activity than budesonide.
4. Excretion: Most of budesonide and its metabolites are excreted via the kidneys as conjugates and also via the bile.
5. Half-life: The half-life of budesonide is approximately 2-3 hours, meaning that the drug is rapidly metabolized and eliminated from the body.

Dosing and administration

For the treatment of inflammatory bowel disease:

1. Controlled release capsules for oral administration:
   • Adults (including the elderly): The initial dose is usually 9 mg once daily in the morning before breakfast. The duration of treatment may vary depending on the response to treatment and the doctor's recommendations. The maintenance dose may be reduced depending on the clinical picture.
   • Children: Budesonide capsule form is generally not recommended for use in children for the treatment of inflammatory bowel disease due to insufficient safety and efficacy data.

For the treatment of respiratory diseases:

1. Inhaled budesonide:
   • Adults and children over 12 years: The usual starting dose is 200 mcg to 400 mcg twice daily. The maximum dose may be up to 1600 mcg daily, depending on the severity of the condition.
   • Children 6 to 12 years of age: The starting dose is usually 100 mcg to 200 mcg twice daily. The maximum dose is usually not more than 400 mcg twice daily.

Specific instructions:

• The drug should be taken regularly even in the absence of symptoms, since its effect is manifested mainly in the long term.
• It is not recommended to suddenly stop taking the drug without consulting a doctor, as this may lead to an exacerbation of symptoms.
• If you are using an inhalation form, it is important to use the inhaler correctly and care for it regularly to prevent infections and ensure that you are getting the correct dosage of medication.

Use Budenofalka during pregnancy

1. FDA Risk Category:

   • Budesonide is classified as pregnancy category B, meaning animal studies have shown no risk to the fetus, but controlled studies in pregnant women have not been conducted.

2. Research data:

   • Available data from clinical trials and post-marketing surveillance indicate that systemic exposure to the fetus with inhaled budesonide is generally low. This is due to low bioavailability and extensive first-pass metabolism of the drug in the liver.

3. Use during pregnancy:

   • If it is necessary to use Budenofalk during pregnancy, it is important to minimize the dosage to the minimum effective and carefully monitor the condition of the pregnant woman and fetus. In diseases such as asthma or ulcerative colitis, maintaining control over the disease may be more important than the potential risks from using budesonide, since exacerbation of these diseases may pose a greater threat to the health of the mother and fetus.

4. Alternatives and monitoring:

   • Alternative treatments that may be safer during pregnancy should always be considered. However, if budesonide is chosen, regular medical monitoring of the mother and fetus is necessary.

Contraindications

1. Individual intolerance or allergic reaction: People with known individual intolerance to budesonide or other components of the drug should avoid using it.
2. History of nitrous oxide use: Patients who have experienced reactions to medications containing nitrous oxides should use budesonide with caution.
3. Respiratory tract infections: It is not recommended to start or continue treatment with budesonide during an exacerbation of respiratory tract infections, as this may complicate the treatment process.
4. Recent respiratory surgery: Budesonide may be contraindicated in patients with recent respiratory surgery because it may delay wound healing and increase the risk of infection.
5. Severe acute bronchial asthma: In cases of acute bronchial asthma requiring emergency medical care or hospitalization, the use of budesonide may be insufficient or even contraindicated.
6. Pregnancy and breastfeeding: The safety of using budesonide during pregnancy and breastfeeding should be assessed by a physician and a decision made taking into account the benefits to the mother and the potential risks to the fetus or child.
7. Paediatric population: Budesonide can be used in children, but the dosage should be determined by a doctor and the use should be carried out under his supervision.

Side effects Budenofalka

1. Gastrointestinal disorders:

   • Heartburn
   • Nausea
   • Vomit
   • Abdominal pain
   • Diarrhea or constipation

2. Skin disorders:

   • Rash
   • Itching
   • Redness of the skin
   • Dry skin

3. Nervous system disorders:

   • Headache
   • Dizziness
   • Nervousness
   • Insomnia

4. Musculoskeletal disorders:

   • Muscle weakness
   • Shaking

5. Other:

   • Increased appetite
   • Edema

Overdose

1. Itsenko-Cushing syndrome: Includes hypercortisolism, which manifests itself as increased appetite, weight gain, obesity, osteoporosis, as well as hypertension and hyperglycemia.
2. Decreased adrenal function: With prolonged use in high doses, adrenal insufficiency syndrome may develop, especially if treatment is suddenly discontinued.
3. Hyperglycemia: Increased gluconeogenesis and associated increase in blood glucose levels.
4. Hypertension: Increased blood pressure.
5. Osteoporosis: Decreased bone mineral density.
6. Immunosuppression: Increased risk of infections due to a decrease in the body's immune response.
7. Glucocorticosteroid insufficiency with abrupt discontinuation of treatment: Symptoms associated with adrenal insufficiency may develop, such as weakness, apathy, anorexia, nausea, vomiting, hypotension, and even shock.

Interactions with other drugs

1. Inhaled corticosteroids and other medications for asthma or COPD: Increased systemic corticosteroid effects may occur when used concomitantly with other corticosteroids, especially inhaled ones. It is important to avoid concomitant high doses of inhaled corticosteroids without consulting your doctor.
2. Antifungals: Azole antifungals such as ketoconazole, itraconazole, and others may increase blood levels of budesonide, which may lead to increased systemic corticosteroid side effects.
3. Proton pump inhibitors (PPIs): Use of PPIs such as omeprazole, esomeprazole, lansoprazole, etc. may decrease the metabolism of budesonide in the liver, leading to an increase in its concentration in the blood and possibly to increased systemic effects.
4. Anti-inflammatory medications: Do not take medications that increase the risk of ulcers or bleeding, such as NSAIDs (eg, ibuprofen, diclofenac), at the same time without consulting your doctor, as corticosteroids may increase the risk of gastrointestinal side effects.
5. Drugs that affect the effect of corticosteroids: Some drugs can increase or decrease the effects of corticosteroids. For example, antidepressants or antiepileptic drugs can decrease the effectiveness of corticosteroids.

Storage conditions

Storage conditions for Budenofalk (budesonide) may vary depending on its dosage form (e.g. inhalation suspension, tablets, capsules, etc.) and manufacturer. However, it is generally recommended to store it in a dry place at a temperature of 15°C to 30°C, protected from light and moisture.