Fortra Special Precautions

Asthma-Related Death: Long-acting β₂ adrenergic agonists (LABA), such as Formoterol, increase the risk of asthma-related death. When treating patients with asthma, Budesonide + Formoterol should only be used for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Budesonide + Formoterol inhaler) 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 inhaler for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
Deterioration of Disease and Acute Episodes: Budesonide + Formoterol inhaler should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. It should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. When beginning treatment with Budesonide + Formoterol inhaler, patients who have been taking oral or inhaled, short-acting β₂ agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.
Excessive Use of Budesonide + Formoterol inhaler and Use with Other Long-Acting β₂ Agonists: Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using Budesonide + Formoterol inhaler should not use additional LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate) for any reason, including prevention of exercise-induced bronchospasm (EIB) or the treatment of asthma or COPD.
Local Effects: Candida albicans infection of the mouth and pharynx may occur in subjects treated with Budesonide + Formoterol inhaler. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise the patient to rinse the mouth following inhalation.
Pneumonia or other Respiratory Tract Infections: Lower respiratory tract infections, including pneumonia, have been reported in patients with chronic obstructive pulmonary disease (COPD) following the inhaled administration of corticosteroids. Monitor patients for signs and symptoms of pneumonia and other potential lungs infections.
Immunosuppression: Persons who are on drugs that suppress the immune system are more susceptible to infections than healthy individuals. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Budesonide + Formoterol inhaler.
Hypercorticism and Adrenal Suppression: It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Budesonide + Formoterol inhaler slowly.
Paradoxical Bronchospasm and Upper Airway Symptoms: As with other inhaled medicines, Budesonide + Formoterol inhaler can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs discontinue Budesonide + Formoterol inhaler and institute alternative therapy.
Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm), may occur after administration of Budesonide + Formoterol inhaler.
Cardiovascular and Central Nervous System Effects: Budesonide + Formoterol inhaler should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension because of β adrenergic stimulation.
Reduction in Bone Mineral Density: Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. Patients should be assessed for bone mineral density initially and periodically thereafter.
Effect on Growth: Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving Budesonide + Formoterol inhaler routinely.
Glaucoma and Cataracts: Glaucoma and cataracts have been reported in patients with asthma and COPD following the long-term administration of inhaled corticosteroids, including Budesonide. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Eosinophilic Conditions and Churg-Strauss Syndrome: In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients.
Coexisting Conditions: Budesonide + Formoterol inhaler should be used with caution in patients with convulsive disorders or thyrotoxicosis, diabetes mellitus and ketoacidosis.
Hypokalemia: β adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.
Hyperglycemia: As for all β₂ adrenoceptor agonists, additional blood glucose controls should be considered in diabetic patients.