budesonide inhalation

BUDESONIDE INHALATION

Manufacturer: Lupin Pharmaceuticals, Inc.

Score: 148.0

Quick Summary

Budesonide inhalation suspension is an inhaled corticosteroid used for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. It is not indicated for the relief of acute bronchospasm. The recommended starting dose is 0.5 mg total daily dose, and the highest recommended dose is 1 mg total daily dose. Budesonide inhalation suspension should be administered via a jet nebulizer connected to an air compressor. The most common adverse reactions include respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, and rash.

Key Clinical Findings and Indications

Maintenance treatment of asthma
Prophylactic therapy in children 12 months to 8 years of age
Not indicated for the relief of acute bronchospasm

Important Safety Information

Warning

For inhalation only. Do not swallow. Only use budesonide inhalation suspension with a jet nebulizer machine that is connected to an air compressor.

Contraindications

Primary treatment of status asthmaticus or other acute episodes of asthma
Hypersensitivity to budesonide or any of the ingredients

Adverse Reactions

Respiratory infection
Rhinitis
Coughing
Otitis media
Viral infection
Moniliasis
Gastroenteritis
Vomiting
Diarrhea
Abdominal pain
Ear infection
Epistaxis
Conjunctivitis
Rash

Dosing Recommendations

General Guidance

Titrate to the lowest effective dose

Bronchodilators alone

Adult Dose

0.5 mg once daily or 0.25 mg twice daily

Pediatric Dose

0.25 mg once daily

Inhaled corticosteroids

Adult Dose

0.5 mg once daily or 0.25 mg twice daily

Pediatric Dose

0.25 mg once daily

Oral corticosteroids

Adult Dose

0.5 mg twice daily

Pediatric Dose

Not recommended

Special Population Considerations

Pregnancy

There are no adequate well-controlled studies of budesonide inhalation suspension in pregnant women
Use with caution

Nursing Mothers

Budesonide is present in human milk
Use with caution

Pediatric Use

Safety and effectiveness in children 12 months to 8 years of age have been established
Not recommended for children under 12 months

Geriatric Use

No overall differences in safety were observed between geriatric patients and younger patients
Use with caution