Budesonide and Formoterol Fumarate Dihydrate

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE

Manufacturer: RPK Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

SYMBICORT is a combination medication used for the treatment of asthma in patients 6 years of age and older, and for the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). The medication contains budesonide, a corticosteroid, and formoterol, a long-acting beta2-adrenergic agonist (LABA). Key clinical findings indicate that SYMBICORT is effective in improving lung function and reducing symptoms in patients with asthma and COPD. Important safety information includes the risk of serious asthma-related events, cardiovascular and central nervous system effects, and the potential for immunosuppression and hypercorticism. The recommended dosage is 2 inhalations of SYMBICORT 80/4.5 or 160/4.5 twice daily for asthma, and 2 inhalations of SYMBICORT 160/4.5 twice daily for COPD. Special population considerations include the potential for growth effects in pediatric patients, and the need for careful monitoring in geriatric patients with concomitant cardiovascular disease.

Key Clinical Findings and Indications

Treatment of asthma in patients 6 years of age and older
Maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD
Improvement in lung function and reduction in symptoms

Important Safety Information

Warning

Risk of serious asthma-related events, cardiovascular and central nervous system effects, and potential for immunosuppression and hypercorticism

Contraindications

Primary treatment of status asthmaticus or other acute episodes of asthma or COPD
Hypersensitivity to any of the ingredients in SYMBICORT

Adverse Reactions

Nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis
Cardiovascular and central nervous system effects

Dosing Recommendations

General Guidance

No adjustment of dosage of SYMBICORT in geriatric patients is warranted

Asthma

Adult Dose

2 inhalations of SYMBICORT 80/4.5 or 160/4.5 twice daily

Pediatric Dose

2 inhalations of SYMBICORT 80/4.5 twice daily for patients 6 to less than 12 years of age

COPD

Adult Dose

2 inhalations of SYMBICORT 160/4.5 twice daily

Pediatric Dose

Special Population Considerations

Pregnancy

There are no adequate and well-controlled studies of SYMBICORT in pregnant women
Budesonide, a component of SYMBICORT, was teratogenic, embryocidal, and reduced fetal weights in rats and rabbits at less than the maximum recommended human daily inhalation dose

Nursing Mothers

The disposition of budesonide when delivered by inhalation from a dry powder inhaler at doses of 200 or 400 mcg twice daily for at least 3 months was studied in eight lactating women with asthma
Systemic exposure to budesonide in these women appears to be comparable to that in non-lactating women with asthma from other studies

Pediatric Use

The safety and effectiveness of SYMBICORT in asthma patients 6 to less than 12 years of age have been established in studies of up to 12-week duration
The safety profile in these patients was consistent with that observed in patients 12 years of age and older who also received SYMBICORT

Geriatric Use

Of the total number of asthma patients treated with SYMBICORT twice daily in two 12-week studies and a 26-week postmarketing study, 791 were 65 years of age or older
No overall differences in safety or effectiveness were observed between these patients and younger patients