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budesonide inhaled (Rx)Brand and Other Names:Pulmicort Respules, Pulmicort Flexhaler

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

suspension for nebulizer

  • 0.25mg/2mL
  • 0.5mg/2mL
  • 1mg/2mL

powder for inhalation

  • 90mcg/actuation
  • 180mcg/actuation
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Asthma

Maintenance treatment

Inhaled powder: 360 mcg PO q12hr; in some patients, may be initiated at 180 mcg q12hr; not to exceed 720 mcg q12hr

Administration

Suspension should be administered via jet nebulizer connected to air compressor with adequate air flow and equipped with mouthpiece or suitable face mask; ultrasonic nebulizer should not be used

Dosage Forms & Strengths

suspension for nebulizer

  • 0.25mg/2mL
  • 0.5mg/2mL
  • 1mg/2mL

powder for inhalation

  • 90mcg/actuation
  • 180mcg/actuation
more...

Asthma

Maintenance treatment

Nebulized suspension

  • <1 years: Safety and efficacy not established
  • 1-8 years (prior therapy with bronchodilators alone): 0.5 mg once daily or divided q12hr; not to exceed 0.5 mg/day
  • 1-8 years (prior therapy with inhaled corticosteroids): 0.5 mg once daily or divided q12hr; not to exceed 1 mg/day
  • 1-8 years (prior therapy with PO corticosteroids): 1 mg once daily or divided q12hr; not to exceed 1 mg/day
  • Symptomatic children not responding to nonsteroidal therapy: May be initiated at 0.25 mg q12hr

Inhaled powder

  • <6 years: Safety and efficacy not established
  • >6 years: 180 mcg PO q12hr; in some patients, may be initiated at 360 mcg q12hr; not to exceed 360 mcg q12hr
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Adverse Effects

>10%

Respiratory infection (34-38%)

Rhinitis (7-12%)

Otitis media (1-12%)

1-10%

Nasopharyngitis (10%)

Nasal congestion (3%)

Pharyngitis (3%)

Allergic rhinitis (2%)

Viral gastroenteritis (2%)

Viral upper respiratory tract infection (2%)

Oral candidiasis (1%)

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Warnings

Contraindications

Hypersensitivity

Status asthmaticus, acute bronchospasm

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

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Pregnancy & Lactation

Pregnancy category: B

Lactation: Drug enters breast milk; use only if benefits greatly outweigh risks

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Anti-inflammatory corticosteroid; has potent glucocorticoid activity and weak mineralocorticoid activity

Absorption

Bioavailability: 6-13%

Onset: 24 hr to 2 wk

Peak plasma time: 1-2 hr

Distribution

Protein bound: 85-90%

Vd: 3 L/kg

Metabolism

Metabolized in liver by CYP3A4

Metabolites: 16-Alpha hydroxyprednisolone, 6-beta hydroxybudesonide

Elimination

Half-life: 2-3 hr

Excretion: Urine (60%), feces (40%)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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