Budenofalk

Budesonide, known by the trade name Budenofalk, is a corticosteroid drug that is widely used to treat various inflammatory diseases, especially diseases of the respiratory tract and intestines. Budesonide helps reduce inflammation, which leads to symptom relief.

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

Indications Budenofalk

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 along with the sigmoid colon (rectosigmoiditis) can cause significant discomfort and reduce 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 spray that is inhaled through an inhaler. An inhalation aerosol allows budesonide to reach directly into the lungs, where it exerts its effect.
2. Inhalation powder: This is also a form of inhaler, but instead of a spray it contains budesonide powder, which is inhaled through an inhalation device.
3. Inhalation solution: Some manufacturers may produce budesonide as a solution, which is then inhaled using a special device.

Pharmacodynamics

1. Anti-inflammatory effect: Budesonide has an anti-inflammatory effect in the respiratory tract by reducing inflammation and swelling of the mucous membrane. It suppresses the production of inflammatory mediators such as prostaglandins and leukotrienes, and also reduces the penetration of inflammatory cells into tissues.
2. Antiallergic effect: Budesonide helps reduce the sensitivity of the respiratory tract to various allergens, which reduces the risk of allergic reactions and asthmatic attacks.
3. Reducing mucus secretion: Budesonide reduces mucus production in the respiratory tract, 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 characteristic of systemic use of glucocorticosteroids.

Pharmacokinetics

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

Dosing and administration

For the treatment of inflammatory bowel diseases:

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

For the treatment of respiratory tract diseases:

1. Inhaled budesonide:
   • Adults and children over 12 years of age: The usual starting dose is 200 mcg to 400 mcg twice daily. The maximum dose can reach 1600 mcg per day, depending on the severity of the condition.
   • Children 6 to 12 years: The starting dose is usually 100 mcg to 200 mcg twice daily. The maximum dose usually does not exceed 400 mcg twice a day.

Specific instructions:

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

Use Budenofalk during pregnancy

1. FDA Risk Category:

   • Budesonide is classified as a category B drug for use during pregnancy. This means that animal studies have shown no risk to the fetus, but no controlled studies have been conducted in pregnant women.

2. Research data:

   • Available data from clinical studies and post-marketing surveillance indicate that systemic fetal exposure with inhaled budesonide is generally low. This is due to low bioavailability and intensive metabolism of the drug during the first passage through 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 the fetus. For diseases such as asthma or ulcerous colitis, maintaining disease control may be more important than the potential risks of using budesonide, since exacerbation of these diseases can pose a greater threat to the health of the mother and fetus.

4. Alternatives and monitoring:

   • It is always worth considering alternative treatments that may be safer during pregnancy. However, if the choice falls on budesonide, regular medical monitoring of the condition of the pregnant woman and the fetus is necessary.

Contraindications

1. Individual intolerance or allergic reaction: People with a known individual intolerance to budesonide or other components of the drug should avoid its use.
2. After a history of nitrous oxide use: Patients who have experienced a reaction 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 as it may delay wound healing and increase the risk of infection.
5. Severe form of acute bronchial asthma: In case of acute bronchial asthma requiring emergency medical care or hospitalization, the use of budesonide may be insufficient or even contraindicated.
6. Pregnancy and breast-feeding: The safety of budesonide during pregnancy and breast-feeding should be assessed by a physician, and the decision to use it should be made taking into account the benefits to the mother and the potential risks to the fetus or child.
7. Children: Budesonide can be used in children, but the dosage must be determined by a doctor, and use must be carried out under his supervision.

Side effects Budenofalk

1. Gastrointestinal tract disorders:

   • Heartburn
   • Nausea
   • Vomiting
   • Stomach 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. Others:

   • Increased appetite
   • Swelling

Overdose

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

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 corticosteroids. It is important to avoid concomitantly prescribing high doses of inhaled corticosteroids without consulting your doctor.
2. Antifungals: Azole antifungals such as ketoconazole, itraconazole and others may increase budesonide blood concentrations, which may result in increased systemic corticosteroid side effects.
3. Proton pump inhibitors (PPIs): Use of PPIs such as omeprazole, esomeprazole, lansoprazole, etc. May reduce 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 drugs: Do not take drugs that increase the risk of ulcers or bleeding, such as NSAIDs (eg, ibuprofen, diclofenac), without consulting a doctor, as corticosteroids may increase the risk of side effects on the gastrointestinal tract.
5. Drugs that affect the effect of corticosteroids: Some drugs can increase or decrease the effects of corticosteroids. For example, antidepressants or antiepileptic drugs may reduce 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.