Budesonide / Formoterol FumaratePronunciation
Pronunciation: bue-DES-oh-nide/for-MOE-ter-ol FUE-ma-rate
Class: Respiratory inhalant combination
- Inhalation aerosol budesonide 80 mcg/formoterol 4.5 mcg per actuation
- Inhalation aerosol budesonide 160 mcg/formoterol 4.5 mcg per actuation
Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity.
Formoterol is a long-acting selective beta-2 adrenergic agonist (beta-2 agonist) with a rapid onset of action. Inhaled formoterol acts locally in the lung as a bronchodilator.
Indications and Usage
Long-term maintenance treatment of asthma; maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.
Primary treatment of status asthmaticus or other acute episodes of asthma in which intensive measures are required; hypersensitivity to any component of the product.
Dosage and AdministrationAsthma
Adults and Children 12 y of age and older
Oral Inhalation Recommended starting dose is 2 inhalations of budesonide/formoterol (80/4.5 mcg or 160/4.5 mcg) twice daily approximately 12 h apart, depending on asthma severity (max, 2 inhalations of budesonide/formoterol 160/4.5 mcg twice daily).COPD
Oral Inhalation Recommended dose is 2 inhalations of budesonide/formoterol 160/4.5 mcg twice daily. If shortness of breath occurs between doses, an inhaled short-acting beta-2 agonist should be taken for immediate relief.
- Should not be used more than twice daily or for more than 2 inhalations.
- Rinse mouth with water without swallowing after inhalation.
- Titrate to the lowest effective strength after adequate asthma stability has been achieved.
- If symptoms arise during the period between doses, an inhaled short-acting beta-2 agonist should be taken for immediate relief.
- Shake well for 5 min before using.
- Before using for the first time, prime the inhaler by releasing 2 test sprays into the air away from the face, shaking well for 5 sec before each spray. Prime the inhaler again by shaking well before each spray and releasing 2 test sprays if inhaler is not used for more than 7 days or if it is dropped.
Store at 68° to 77°F. Store with the mouthpiece down.
Drug InteractionsAdrenergic agents
Use additional adrenergic drugs with caution because the sympathomimetic effects of formoterol may be potentiated.Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin)
Pharmacologic effects of budesonide may be decreased, which could exacerbate the underlying condition. Larger doses of budesonide may be needed during coadministration of barbiturates. Monitor the clinical response and adjust the budesonide/formoterol dose accordingly.Beta-blockers (eg, propranolol)
If possible, avoid coadministration because beta-blockers may block the pulmonary effect of formoterol, in addition to producing severe bronchospasm in asthmatic patients.Contraceptive, hormonal
Budesonide exposure and risk of adverse reactions may be increased. Lower dosages of budesonide may be needed. Monitor the patient and reduce the budesonide/formoterol dose if necessary.Inhibitors of CYP3A4 (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin)
Use with caution because budesonide plasma levels may be increased.Interleukin-2
The pharmacologic effects of interleukin-2 may be decreased. Avoid concurrent use.Linezolid, MAOIs (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline)
Use with caution in patients treated with MAOIs or tricyclic antidepressants, or within 2 wk of discontinuing these agents, because the action of formoterol on the vascular system may be potentiated.Loop diuretics (eg, furosemide), thiazide diuretics (eg, hydrochlorothiazide)
ECG changes and/or hypokalemia resulting from non–potassium-sparing diuretics can be worsened by formoterol. Use with caution.Mifepristone
Coadministration is contraindicated.Quinolones (eg, levofloxacin)
The risk of quinolones-induced tendon rupture may be increased, especially in patients 60 y of age and older. Instruct patients to contact their health care provider if they develop tendon-related pain or swelling, or weakness or inability to use one of their joints. Also, instruct patients to rest and refrain from exercise if any tendon-related symptoms occur.Rifamycins (eg, rifampin)
Pharmacologic effects of budesonide may be decreased, which may exacerbate the underlying condition. Monitor the response of the patient. If an interaction is suspected, it may be necessary to increase the dose of budesonide/formoterol or stop the rifamycins. Rifamycins enzyme induction may persist for 7 days after the drug is stopped.Salicylates
Salicylate plasma concentrations may be reduced, decreasing the pharmacologic effects. Monitor salicylate concentrations and adjust the salicylate dose as needed.Warfarin
The anticoagulant effect of warfarin may be increased or decreased. Closely monitor coagulation parameters and adjust the warfarin dose as needed.
Angina pectoris, atrial and ventricular tachyarrhythmias, atrial fibrillation, extrasystoles, hypertension, hypotension, palpitations, tachycardia (postmarketing).
Headache (11%); agitation, behavior disturbances, depression, dizziness, nervousness, restlessness, sleep disturbances, tremor (postmarketing).
Nasopharyngitis (11%); pharyngolaryngeal pain (9%); nasal congestion (3%); cataract, glaucoma, increased IOP (postmarketing).
Stomach discomfort (7%); oral candidiasis (6%); vomiting (3%); nausea, oropharyngeal candidiasis (postmarketing).
Growth velocity reduction in children, hypercorticism (postmarketing).
Delayed and immediate hypersensitivity reactions, including anaphylactic reaction, angioedema, bronchospasm, dermatitis, exanthema, pruritus, and urticaria (postmarketing).
Hyperglycemia, hypokalemia (postmarketing).
Back pain (3%); muscle cramps (postmarketing).
Upper respiratory tract infection (11%); sinusitis (6%); bronchitis (5%); viral upper respiratory tract infection (4%); cough, dysphonia, throat irritation (postmarketing).
Long-acting beta-2 adrenergic agonists, such as formoterol, may increase the risk of asthma-related death. Therefore, only use for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or for patients whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a long-acting beta-2 adrenergic agonist. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use budesonide/formoterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.
Monitor for increasing use of inhaled short-acting beta-2 agonist, which may indicate deterioration of asthma.
Observe patients for evidence of systemic corticosteroid effects. Monitor the growth of children receiving budesonide/formoterol routinely (eg, via stadiometry). Closely monitor patients with a change in vision or with a history of increased IOP, glaucoma, and/or cataracts. Monitor patients with increased risk for decreased bone mineral content for changes in bone mineral density (BMD). Closely monitor use in patients with hepatic disease.
Category C .
Safety and efficacy not established in asthmatic children younger than 12 y of age. May cause reduction in growth velocity when administered to children.
Use with caution in elderly patients who have concomitant CV disease that could be adversely affected by beta-2 agonists.
Immediate hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm, may occur.
Use with caution and closely monitor patients.
Special Risk Patients
Use with caution in patients with CV disorders, especially coronary insufficiency, cardiac arrhythmias, hypertension; convulsive disorders; untreated hypokalemia; thyrotoxicosis; active or quiescent tuberculosis of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex.
Not indicated for the relief of acute bronchospasm.
Adrenal suppression, including adrenal crisis, and hypercorticism may appear in a small number of patients.
Deteriorations of disease
Do not initiate treatment in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Do not use as rescue treatment of acute episodes of bronchospasm.
In rare cases, systemic eosinophilic conditions may occur in patients receiving inhaled corticosteroids.
CV effects and fatalities have been reported with excessive use of inhaled sympathomimetic agents.
Hyperglycemia and hypokalemia
Changes in blood glucose and/or serum potassium may occur.
Patients receiving immunosuppressive agents are more susceptible to infections than healthy individuals. If patient is exposed to measles or chickenpox, appropriate prophylaxis and treatment may be warranted.
Lower respiratory tract infections, including pneumonia, have been reported following inhaled administration of corticosteroids. Localized Candida albicans infections occurred in the mouth and pharynx.
Long-term use of orally inhaled corticosteroids may affect normal bone metabolism, resulting in loss of BMD.
Glaucoma, increased IOP, and cataracts have been reported with following the long-term use of corticosteroids, including budesonide.
Life-threatening paradoxical bronchospasm may occur.
Transferring patients from systemic corticosteroid therapy to inhaled corticosteroids may unmask conditions previously suppressed by systemic corticosteroid therapy (eg, arthritis, eczema). Slowly wean patients requiring systemic corticosteroids from systemic corticosteroid use after transferring to budesonide/formoterol.
Adrenal suppression, hypercorticism.Formoterol
Angina, atrial and ventricular tachyarrhythmias, cardiac arrest, death, dizziness, headache, hyperglycemia, hypertension, hypokalemia, hypotension, metabolic acidosis, muscle cramps, nausea, nervousness, palpitation, seizures, sleep disturbances, tachycardia, tremor.
- Advise patient to read the patient Medication Guide before using product the first time and with each refill.
- Explain name, dose, action, how to use the inhaler, possible drug interactions, and potential adverse reactions of drug.
- Inform patients that formoterol increases the risk of asthma-related death and may increase the risk of asthma-related hospitalizations in children and adolescents.
- Inform patients that treatment with beta-2 agonists may lead to adverse events, which include chest pain, nervousness, palpitations, rapid heart rate, or tremor.
- Instruct patients to notify health care provider immediately if they experience decreasing effectiveness, a need for more inhalations than usual, a decrease in lung function as outlined by the health care provider, or a marked change in symptoms.
- Instruct patient to use exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider.
- Advise patients that medicine is not indicated to relieve acute asthma symptoms and not to use extra doses for that purpose.
- Advise patients not to use other long-acting beta-2 agonists when they are prescribed mometasone/formoterol.
- Advise patients that localized infections with Candida albicans may occur in the mouth and pharynx of some patients. Instruct patients to rinse the mouth after inhalation.
- Warn patient to avoid exposure to chickenpox or measles and to notify health care provider immediately if exposed.
- Advise patients that medication may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Instruct patients that deaths caused by adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Instruct patients that they will be tapered slowly from systemic corticosteroids if transferring to budesonide/formoterol.
- Advise patients that are at increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.
- Inform patients that orally inhaled corticosteroids, including budesonide, may cause a reduction in growth velocity when administered to children.
- Inform patients that long-term use of inhaled corticosteroids may increase the risk of some eye problems (eg, glaucoma, cataracts); regular eye examinations should be considered.
- Instruct patient regarding how to store, administer, and dispose of outdated medication.
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