Pulmicort Respules 0.5 mg/2 mL (Budesonide (Unmodified))

Adult use

For the treatment of bronchial asthma, administer 1-2 milligrams (2-4 bottles) for each dose, twice a day. The maintenance dose is 0.5-1 milligrams (1-2 bottles) for each dose, twice a day.

Child use

For the treatment of bronchial asthma, administer 0.5-1 milligrams (1-2 bottles) for each dose, twice a day. The maintenance dose is 0.25-0.5 milligrams (1/2-1 bottle) for each dose, twice a day.

This medication contains the active ingredient budesonide, which is an inhaled steroid primarily used in the treatment of asthma or chronic lung diseases. This medication should not be used in patients with allergies to budesonide or any of its ingredients. Patients with pulmonary tuberculosis or viral or fungal infections should take special precautions when using this medication, as there is a risk of exacerbating the infection and should consult healthcare professionals. When patients who are dependent on oral steroids switch to this medication, it is important to gradually adjust the dosage as adrenal function may be reduced, and use it with caution. Using this medication may lead to fungal infections in the mouth or throat, so it is important to rinse the mouth well with water after inhalation. Rarely, side effects such as skin rash, urticaria, bronchospasm, and mental changes may occur, so report any unusual symptoms to healthcare professionals immediately. This medication does not provide rapid relief for acute asthma attacks, so for severe acute symptoms, a rapid-acting bronchodilator should be used, and if symptoms persist, consult a doctor. Using high doses for a long period may lead to systemic side effects such as adrenal suppression, growth delay, cataracts, and glaucoma, so regular check-ups and using the minimum necessary dose is recommended. Pregnant women should use this medication carefully when the mother’s treatment is more important than the risk to the fetus, and it can be relatively safely used during breastfeeding. When used in children, it may affect growth, so the smallest effective dose should be used while continuously monitoring growth. Care should be taken when used with other specific antifungals or medications, as drug concentrations may increase when co-administered. This medication does not affect driving or operating machinery, but if blurriness or changes in vision occur during use, immediately seek ophthalmological evaluation. Acute problems due to overdose are rare, but overuse for a long duration may lead to systemic side effects such as adrenal suppression, so caution should be exercised. If the medication does not spray properly from the nebulizer or if sediment forms, do not use it, and it is safest to use it within 3 months after opening.

Serious side effects

• Urticaria
• angioedema
• anaphylactic reaction
• bronchospasm.

Mild side effects

• Candida infection of the oropharynx
• mild throat irritation
• cough
• hoarseness
• blurred vision
• rash
• dermatitis
• skin bruising
• hyperactivity
• sleep disturbances

This medication should be stored at room temperature between 1°C and 30°C, and it is important to keep it in a tightly sealed container to protect it from air and light exposure. Store the product safely in the enclosed foil pouch to maintain light protection.

Appearance

A uniform white to off-white suspension for inhalation filled in a single-use plastic bottle.

Package unit

[(2 mL x 5)/sheet] x 6 /Box [(2 mL x 5)/sheet] x 4 /Box