Formoterol/Budesnide Inhaled

Formoterol/Budesnide Inhaled is a prescription medication used to treat Asthma and Chronic Obstructive Pulmonary Disease (COPD).

• Formoterol/Budesnide Inhaled is available under the following different brand names: Symbicort

Adult and pediatric dosage

Aerosol

• (80mcg/4.5mcg)/actuation
• (160mcg/4.5mcg)/actuation

Asthma

Adult dosage

• 160mcg/9mcg (2 actuations of 80 mcg/4.5 mcg) every 12 hours; for more severe asthma, 320 mcg/9mcg (2 actuations of 160 mcg/4.5 mcg) every 12 hours; not to exceed 320 mcg/9 mcg every 12 hours

Pediatric dosage

• Children younger than 6 years of age: Safety and efficacy not established 
• Children 6-12 years of age: 160 mcg/9 mcg (2 actuations of 80 mcg/4.5 mcg) every 12 hours
• Children 12 years and older: 
  • 160 mcg/9 mcg (2 actuations of 80 mcg/4.5 mcg) every 12 hours; for more severe asthma, 320 mcg/9 mcg (2 actuations of 160 mcg/4.5) every 12 hours; not to exceed 320 mcg/9 mcg every 12 hours
  • If the response is inadequate after 1-2 weeks of therapy with 80 mcg/4.5 mcg, switching to 160 mcg/4.5 mcg may provide additional control

Chronic Obstructive Pulmonary Disease

Adult dosage

• 160 mcg/9 mcg (2 actuations of 80 mcg/4.5 mcg) every 12 hours; not to exceed 320 mcg/9 mcg every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Formoterol/Budesnide Inhaled include:

• throat pain or irritation, 
• white patches in the mouth or throat, 
• stomach discomfort, 
• vomiting, 
• back pain, 
• headache, 
• flu symptoms, 
• stuffy or runny nose, 
• sneezing, 
• sinus pain, and 
• sore throat  

Serious side effects of Formoterol/Budesnide Inhaled include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• worsening breathing problems, 
• sores or white patches in the mouth and throat, 
• pain when swallowing, 
• tremors, 
• nervousness, 
• chest pain, 
• fast or pounding heartbeats, 
• cough with mucus, 
• shortness of breath, 
• wheezing, 
• choking, 
• other breathing problems after using this medication, 
• blurred vision, 
• tunnel vision, 
• eye pain or redness, 
• seeing halos around lights, 
• fever, 
• chills, 
• body aches, 
• unusual tiredness, 
• increased thirst, 
• increased urination, 
• dry mouth, 
• fruity breath odor, 
• leg cramps, 
• constipation, 
• irregular heartbeats, 
• fluttering in the chest, 
• numbness or tingling, 
• muscle weakness, 
• limp feeling,
• tiredness, 
• weakness,
• lightheadedness, 
• nausea, and 
• vomiting

Rare side effects of Formoterol/Budesnide Inhaled include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Formoterol/Budesnide Inhaled has severe interactions with no other drugs. 
• Formoterol/Budesnide Inhaled has serious interactions with at least 68 other drugs.
• Formoterol/Budesnide Inhaled has moderate interactions with at least 247 other drugs.
• Formoterol/Budesnide Inhaled has minor interactions with at least 17 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Formoterol/Budesnide Inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Formoterol/Budesnide Inhaled?”

Cautions

• Risk of LABAs used as monotherapy
  • Use of LABAs as monotherapy (without inhaled corticosteroids) for asthma is associated with an increased risk of asthma-related death
  • Data from controlled clinical trials also suggest that the use of LABA as monotherapy increases the risk of asthma-related hospitalization in a pediatric and adolescent patient
  • These findings are considered a class effect of LABA monotherapy
  • When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone
• Do not initiate in patients experiencing rapidly deteriorating or potentially life-threatening asthma or COPD episodes; additionally, increased inhaled SABA use is a marker of deteriorating asthma
• Do not use for relief of acute symptoms (rescue therapy)
• Maximum dosage must not be exceeded, because of the increased risk of serious cardiovascular effects
• Localized infections with Candida albicans in the mouth and pharynx occur in some patients; to reduce risk, the mouth must be rinsed after inhalation
• Monitor COPD patients for signs and symptoms of pneumonia and lung infections
• The risk of more serious or fatal course of chickenpox or measles exists in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure
• Excessive use may suppress hypothalamic-pituitary-adrenal function; monitor closely, especially postoperatively or during periods of stress
• During periods of stress, a severe asthma attack, or a severe COPD exacerbation, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction
• Risk of paradoxical bronchospasm, which may be life-threatening; discontinue and treat immediately with inhaled SABA
• Risk of immediate hypersensitivity reactions (eg, urticaria, angioedema, rash, bronchospasm)
• Cardiovascular and central nervous system (CNS) effects due to excess beta-adrenergic stimulation; may result in asthma-related death; use with caution in patients with cardiovascular or convulsive disorders or thyrotoxicosis
• Particular care is needed to transfer patients from systemic to inhaled corticosteroids; potentially fatal adrenal insufficiency may occur before or afterward; taper withdrawal gradually
• Decrease in bone mineral density after long-term administration of corticosteroids; monitor patients at risk; assess bone mineral density initially and periodically thereafter
• May decrease growth velocity in children; monitor
• Risk of cataracts, glaucoma, and increased IOP; monitor
• Risk of systemic eosinophilic conditions, some consistent with Churg-Strauss syndrome
• The risk of transient hypokalemia; may not warrant supplementation
• Risk of overdose if used with additional long-acting beta2-agonist in other combination products
• Hypercorticism and adrenal suppression; may occur with very high dosages or at the regular dosage in susceptible individuals; discontinue therapy if such changes occur

Pregnancy and Lactation

• In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control
• There are no well-controlled human studies that have investigated the effects of therapy during labor and delivery; because of the potential for beta-agonist interference with uterine contractility, use of therapy during labor should be restricted to those patients in whom the benefits outweigh the risk
• There are no available data on the breastfed child or milk production; budesonide, like other inhaled corticosteroids, is present in human milk; there is no available data on the presence of formoterol fumarate in human milk; formoterol fumarate is present in rat milk; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or underlying maternal condition.