Budesonide Inhaled

Budesonide Inhaled is a prescription medication used to treat Asthma. 

• Budesonide Inhaled is available under the following different brand names: Pulmicort Respules, Pulmicort Flexhaler.

Adult and pediatric dosage

Suspension for nebulizer

• 0.25mg/2mL
• 0.5mg/2mL
• 1mg/2mL

Powder for inhalation

• 90mcg/actuation
• 180mcg/actuation

Asthma

Adult dosage

Maintenance treatment

• Inhaled powder: 360 mcg orally every 12 hours; in some patients, may be initiated at 180 mcg every 12 hours; not to exceed 720 mcg every 12 hours

Pediatric dosage

Maintenance treatment

Nebulized suspension

• Children younger than 1 year of age: Safety and efficacy not established
• Children 1-8 years of age (prior therapy with bronchodilators alone): 0.5 mg once daily or divided every 12 hours; not to exceed 0.5 mg/day
• Children 1-8 years of age (prior therapy with inhaled corticosteroids): 0.5 mg once daily or divided every 12 hours; not to exceed 1 mg/day
• Children 1-8 years of age (prior therapy with oral corticosteroids): 1 mg once daily or divided every 12 hours; not to exceed 1 mg/day
• Symptomatic children not responding to nonsteroidal therapy: May be initiated at 0.25 mg every 12 hours

Inhaled powder

• Children younger than 6 years of age: Safety and efficacy not established
• Children 6 years of age or older: 
• 180 mcg orally every 12 hours; in some patients, may be initiated at 360 mcg every 12 hours; not to exceed 360 mcg every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Budesonide Inhaled include:

• runny or stuffy nose, 
• sneezing, 
• red, itchy, and watery eyes, 
• fever, 
• sore throat, 
• cough, 
• nausea, 
• vomiting, 
• diarrhea, 
• stomach pain, 
• loss of appetite, 
• nosebleeds, 
• headache, and
• back pain

Serious side effects of Budesonide Inhaled include:

• hives, 
• rash, 
• severe itching, 
• chest pain, 
• difficulty breathing, 
• anxiety, 
• swelling of the face, lips, tongue, or throat, 
• worsening asthma symptoms, 
• wheezing, 
• choking, 
• other breathing problems after using this medication, 
• white patches or sores inside the mouth or on the lips, 
• blurred vision, 
• tunnel vision, 
• eye pain or swelling, 
• seeing halos around lights, 
• fever, 
• chills, 
• body aches, 
• ear pain, 
• nausea, 
• vomiting, 
• worsening tiredness, 
• muscle weakness, and
• lightheadedness

Rare side effects of Budesonide Inhaled include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

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;

• Budesonide Inhaled has no noted severe interactions with other drugs.
• Budesonide Inhaled has no noted serious interactions with other drugs.
• Budesonide Inhaled has no noted moderate interactions with other drugs.
• Budesonide Inhaled has no noted minor interactions with other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug 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
• Status asthmaticus, acute bronchospasm 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Budesonide Inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Budesonide Inhaled?”

Cautions

• Respiratory tract tuberculosis, untreated fungal or bacterial infections, viral or parasitic infections, ocular herpes simplex
• Risk of more serious or fatal course of chickenpox or measles in susceptible patients (eg, unvaccinated or immunologically unexposed individuals); care must be taken to avoid exposure
• Localized infections with Candida albicans in mouth and pharynx in some patients; mouth must be rinsed after inhalation to reduce risk
• Deaths from adrenal insufficiency have occurred after abrupt withdrawal of oral steroids; taper withdrawal gradually
• Potential decrease in growth velocity in children
• Immunocompromised patients
• Hepatic impairment
• Risk of infections of nose and pharynx, including C albicans
• Decrease in bone mineral density after long-term administration of corticosteroids; monitor patients at risk
• Excessive use may suppress hypothalamic-pituitary-adrenal function; monitor closely, especially postoperatively or during periods of stress
• During periods of stress or severe status asthmaticus, supplementary systemic corticosteroids may be immediately required
• Not to be administered for rapid relief of acute bronchospasm (agent is not a bronchodilator)
• Nasal septum perforation, wheezing
• Cataracts, glaucoma, increased intraocular pressure
• Risk of systemic eosinophilic conditions, some consistent with Churg-Strauss syndrome

Pregnancy and Lactation

• There are no adequate well-controlled studies in pregnant women; however, there are published studies on use of budesonide, in pregnant women; studies of pregnant women have not shown that inhaled budesonide increases risk of abnormalities when administered during pregnancy
• There are no well-controlled human studies that have investigated effects of therapy during labor and delivery
• Lactation: There are no available data on effects of therapy on breastfed child or on milk production; budesonide, is present in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition.