Fortra Dosage/Direction for Use

Budesonide + Formoterol fumarate dihydrate (Fortra) should be administered twice daily every day by the orally inhaled route only. After inhalation, the patient should rinse the mouth with water without swallowing.
Asthma: Adult and Adolescent Patients 12 Years of Age and Older: For patients 12 years of age and older, the dosage is 2 inhalations twice daily (morning and evening, approximately 12 hours apart).
The recommended starting dosages for Budesonide + Formoterol fumarate dihydrate (Fortra) for patients 12 years of age and older are based upon patients' asthma severity. The maximum recommended dosage is Budesonide + Formoterol fumarate dihydrate (Fortra) 200mcg + 6mcg twice daily.
Improvement in asthma control following inhaled administration of Budesonide + Formoterol fumarate dihydrate (Fortra) can occur within 15 minutes of beginning treatment, although maximum benefit may not be achieved for 2 weeks or longer after beginning treatment. Individual patients will experience a variable time to onset and degree of symptom relief. If a previously effective dosage regimen of Budesonide + Formoterol fumarate dihydrate (Fortra) fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, (e.g., adding additional inhaled corticosteroid, or initiating oral corticosteroids) should be considered.
If asthma symptoms arise in the period between doses, an inhaled, short-acting β₂ agonist should be taken for immediate relief.
Chronic Obstructive Pulmonary Disease (COPD): For patients with COPD the recommended dose of Budesonide + Formoterol fumarate dihydrate (Fortra), two inhalations twice daily.
If shortness of breath occurs in the period between doses, an inhaled, short-acting β₂ agonist should be taken for immediate relief.
Special Population: Pediatric Use: There is no relevant use of Budesonide + Formoterol fumarate dihydrate (Fortra) in children 11 years of age and under or in adolescents 12 to 17 years of age in the symptomatic treatment of COPD.
Geriatric Use: As with other products containing β₂ agonists, special caution should be observed when using Budesonide + Formoterol fumarate dihydrate (Fortra) in geriatric patients who have concomitant cardiovascular disease that could be adversely affected by β₂ agonists. No adjustment of dosage of Budesonide + Formoterol fumarate dihydrate (Fortra) in geriatric patients is warranted.
Hepatic Impairment: Since both Budesonide and Formoterol are predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of Budesonide and Formoterol in plasma. The exposure of Budesonide and Formoterol may be increased in patients with liver disease. Therefore, patients with hepatic disease should be closely monitored.