About Budesonide (RESPI-SAPH) 250 mcg/mL 35 x 2 mL Ampoules

Budesonide (RESPI-SAPH) 250 mcg/mL 35 x 2 mL Ampoules is a nebulized corticosteroid medication formulated to provide effective, localized treatment for chronic respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). Each ampoule contains 2 mL of a suspension with 250 micrograms of budesonide per mL, designed for inhalation via a nebulizer system.

Budesonide is known for its potent anti-inflammatory properties, acting directly on the airway mucosa to reduce inflammation, swelling, and mucus production. Unlike systemic corticosteroids, nebulized budesonide delivers the active drug directly into the lungs, resulting in a rapid therapeutic effect with minimized systemic absorption and fewer side effects. Budesonide (RESPI-SAPH) 250 mcg/mL is particularly beneficial for patients requiring maintenance therapy or experiencing difficulty using handheld inhalers, such as young children or elderly individuals.

Indications of Budesonide (RESPI-SAPH) 250 mcg/mL 35 x 2 mL Ampoules

Budesonide (RESPI-SAPH) 250 mcg/mL 35 x 2 mL Ampoules is indicated for:

• Maintenance treatment of asthma in adults and children who require inhaled corticosteroid therapy.

• Management of acute exacerbations of asthma in children who are unable to use inhalers effectively.

• Adjunctive therapy in the treatment of chronic obstructive pulmonary disease (COPD), particularly in patients with a history of frequent exacerbations.

• Reducing the need for oral corticosteroids by providing localized control of airway inflammation.

Dosage of Budesonide (RESPI-SAPH) 250 mcg/mL 35 x 2 mL Ampoules

Dosage should always be individualized based on the severity of the condition and the patient’s response to treatment.

Adults and adolescents (12 years and older):

• Typical starting dose: 500–1000 mcg (2–4 mL) twice daily.

• Maintenance dose: 250–500 mcg twice daily depending on clinical response.

Children (6 months to 12 years):

• Starting dose: 250–500 mcg (1–2 mL) twice daily.

• Maintenance dose: Adjusted to the lowest effective dose to maintain asthma control.

Administration:

• The contents of the ampoule should be nebulized using a jet nebulizer connected to an air compressor.

• The suspension should be gently shaken before use and should not be mixed with other medications unless instructed.

Side Effects of Budesonide (RESPI-SAPH) 250 mcg/mL 35 x 2 mL Ampoules

Most patients tolerate Budesonide (RESPI-SAPH) 250 mcg/mL well, but side effects may occur, especially at higher doses or with prolonged use.

Common side effects:

• Hoarseness or voice changes

• Coughing or throat irritation after inhalation

• Oral thrush (fungal infection in the mouth)

• Dry mouth

Less common or serious side effects:

• Allergic reactions (rash, swelling, difficulty breathing)

• Suppression of adrenal function (with long-term use)

• Slowed growth in children (rare, with prolonged use)

• Behavioral changes such as irritability or hyperactivity in children

To reduce risk of oral thrush, patients are advised to rinse the mouth with water after each use.

Precautions for Budesonide (RESPI-SAPH) 250 mcg/mL 35 x 2 mL Ampoules

Before using Budesonide (RESPI-SAPH) 250 mcg/mL, inform your healthcare provider if you:

• Have a history of tuberculosis or untreated infections

• Are using other corticosteroid medications

• Are pregnant or breastfeeding (use only if clearly needed)

• Have liver disease, which may affect the metabolism of budesonide

• Experience frequent asthma attacks requiring rescue inhaler use

Budesonide is not a rescue medication and should not be used to relieve acute bronchospasm. A fast-acting bronchodilator should be kept on hand for sudden asthma symptoms.

Contraindications of Budesonide (RESPI-SAPH) 250 mcg/mL 35 x 2 mL Ampoules

Budesonide (RESPI-SAPH) 250 mcg/mL is contraindicated in:

• Patients with known hypersensitivity to budesonide or any of the excipients in the formulation.

• Patients with acute, severe asthma attacks requiring intensive bronchodilator therapy.

• Individuals with untreated fungal, bacterial, or viral infections, especially respiratory infections.

Storage of Budesonide (RESPI-SAPH) 250 mcg/mL 35 x 2 mL Ampoules

• Store in a cool, dry place at temperatures not exceeding 30°C.

• Keep ampoules in their original foil pouch to protect from light and moisture until ready to use.

• Once opened, use the ampoule immediately. Discard any unused portion.

• Keep out of reach of children and pets.

• Do not use after the expiration date indicated on the packaging