Entocort (Budesonide (Micronized))

Adult use

Once daily, for 4 weeks, administered rectally through the anus at bedtime. The patient should lie on the left side and administer the medication through the anus, remaining in a prone position for 5 minutes after administration. It is preferable to keep the medication in the administered area for as long as possible, ideally overnight. To prepare, add one soluble tablet to one bottle of diluent and shake vigorously for at least 10 seconds or until the tablet is completely dissolved.

This drug should not be administered to patients with systemic or localized bacterial, fungal, or viral infections, as it may worsen the infection. Additionally, patients who have previously experienced allergic reactions to this drug or its components should not use it. Patients with active tuberculosis, herpes simplex keratitis, acute psychosis, recent bowel surgery, or infections with abscesses or other pus formation should use this drug cautiously. Patients switching from systemic corticosteroid treatment to this drug must take special care until adrenal function is restored. Patients with poor liver function or hypothyroidism may experience augmented effects of this medication and should be cautious. Patients with peptic ulcers or diverticulitis may experience exacerbation of symptoms due to decreased gastric mucosa protection. Osteoporosis patients are at increased risk of weakened bones. Patients with acute glomerulonephritis, myasthenia gravis, exanthema, thrombophlebitis, mental disorders, diabetes, hypertension, hyperthyroidism, acute coronary disease, or severe ulcerative colitis should also receive cautious administration. Pregnant women or those who may become pregnant, as well as infants and children, require special attention. This drug can cause gastrointestinal discomfort, nausea, diarrhea, and skin reactions such as hives or rash, along with symptoms of insomnia, agitation, anxiety, and depression. Rarely, blurred vision may also occur. Long-term or high-dose use may lead to systemic side effects, including decreased adrenal function, weight gain, increased blood sugar, osteoporosis, reduced infection resistance, gastric ulcers, skin and muscle atrophy, hirsutism, increased blood pressure, and mental disorders. When changing treatment methods with this drug, adrenal cortex function must be carefully monitored, and any dose reduction should be done cautiously. During dose tapering, symptoms such as myalgia, arthralgia, fatigue, headache, nausea, and vomiting may occur, which might happen if the drug is insufficient, allowing temporary dosage increases when necessary. Allergic reactions may reappear during the use of this drug, so antihistamines or topical medications should be used to alleviate these symptoms. Patients with reduced liver function may experience increased drug concentration in the body and should be cautious. This drug may mask infection symptoms and pose a risk of new infections; thus, signs of infection should be closely monitored. Patients in immunosuppressed states, particularly children, are more susceptible to infections such as chickenpox or measles, so extra caution should be taken to avoid exposure to these diseases. In the event of exposure to chickenpox or measles, immediate consultation with medical professionals for preventive treatment is needed, and antiviral treatment may be necessary if an infection occurs. During the use of this drug, vaccination history and exposure to infections such as chickenpox or measles should be verified, and immediate evaluation should be sought in case of suspected infection. Caution is necessary when taking this drug along with other medications that inhibit certain enzymes in the liver and gut mucosa, as it may increase the drug concentration in the body. This drug can cause visual disturbances; if there is blurring or any abnormality in vision, an eye specialist should be consulted. During pregnancy, this drug may affect fetal growth and development, and except in special cases, it is advisable not to use it. Caution is needed during breastfeeding, as it is uncertain whether this drug is transmitted through breast milk. Due to insufficient clinical experience in children, its use should be approached cautiously. Elderly patients should use the same dosage as general adults but be closely monitored.

Serious side effects

Hives

Mild side effects

• Abdominal bloating
• nausea
• diarrhea
• rash
• itching
• insomnia
• agitation
• anxiety
• depression
• discomfort

This drug should be stored in a sealed container to prevent air and moisture from entering. It should avoid direct sunlight and be kept at a normal room temperature, meaning neither too hot nor too cold.

Appearance

Round, yellowish tablets filled with a colorless, transparent liquid, in a plastic bottle with a cap attached

Package unit

(soluble tablets + accompanying dissolving solution bottle) X 7/box