AIRYCORT

Budesonide is a glucocorticoid that is a mix of the 22R and 22S epimer used to treat inflammatory conditions of the lungs and intestines such as asthma, COPD, Crohn's disease, and ulcerative colitis. 5, 6 Budesonide was granted FDA approval on 14 February 1994.

It is also available in a with formoterol.

Budesonide extended-release capsules are indicated for the treatment and maintenance of mild to moderate Crohn's disease. 9, 10 Various inhaled budesonide products are indicated for prophylactic therapy in asthma 11, 12, 14 and to reduce exacerbations of COPD.

A budesonide nasal spray is available over the counter for symptoms of hay fever and upper respiratory allergies.

Extended-release capsules are indicated to induce remission of mild to moderate ulcerative colitis and a rectal foam is used for mild to moderate distal ulcerative colitis.

In addition, a delayed-release capsule formulation of budesonide is indicated to reduce proteinuria in adults with IgA nephropathy at risk of rapid disease progression. 18, 21 Budesonide is indicated to treat eosinophilic esophagitis (EoE): For this indication, it is only approved for use in adults in Europe 19 while it is approved for short-term use (12 weeks) in patients 11 years of age and older in the US.

Budesonide is a glucocorticoid used to treat respiratory and digestive conditions by reducing inflammation. 9, 10, 11, 12, 14, 15, 16 It has a wide therapeutic index, as dosing varies highly from patient to patient. 9, 10, 11, 12, 14, 15, 16 Patients should be counselled regarding the risk of hypercorticism and adrenal axis suppression. 9, 10, 11, 12, 14, 15, 16.

Extended release oral capsules are 9-21% bioavailable. 9, 10 A 9 mg dose reaches a C max of 1.50±0.79ng/mL with a T max of 2-8h and an AUC of 7.33ng*hr/mL. 9, 10 A high fat meal increases the T max by 2.3h but otherwise does not affect the pharmacokinetics of budesonide. 9, 10 180-360 µg metered inhaled doses of budesonide are 34% deposited in the lungs, 39% bioavailable, and reach a C max of 0.6-1.6nmol/L with a T max of 10 minutes.

A 1 mg nebulized dose is 6% bioavailable, reaching a C max of 2.6nmol/L with a T max of 20 minutes.

A 9 mg oral extended release tablet reaches a C max of 1.35±0.96ng/mL with a T max of 13.3±5.9h and an AUC of 16.43±10.52ng*hr/mL.

Budesonide rectal foam 2 mg twice daily has an AUC of 4.31ng*hr/mL.

The volume of distribution of budesonide is 2.2-3.9 L/kg. 9, 10, 11, 12, 15, 16.

Budesonide is 80-90% metabolized at first pass.

Budesonide is metabolized by

CYP3A to its 2 major metabolites, 6beta-hydroxybudesonide and 16alpha-hydroxyprednisolone. 4, 7 The glucocorticoid activity of these metabolites is negligible (<1/100) in relation to that of the parent compound.

CYP3A4 is the strongest metabolizer of budesonide, followed by CYP3A5, and CYP3A7.

Hover over products below to view reaction partners Budesonide 6-beta-hydroxybudesonide 22-hydroxy Intermediate Metabolite of Budesonide 16alpha-butyrloxyprednisolone 16-alpha-hydroxyprednisolone delta6-budesonide 23-hydroxybudesonide.

Approximately 60% of a budesonide dose is recovered in the urine as the major metabolites 6beta-hydroxybudesonide, 16alpha-hydroxyprednisolone, and their conjugates. 9, 10, 11, 12, 14, 15, 16 No unchanged budesonide is recovered in urine. 9, 10, 11, 12, 14, 15, 16.

Budesonide has a plasma elimination half life of 2-3.6h. 9, 10, 11, 15 The terminal elimination half life in asthmatic children 4-6 years old is 2.3h.

Budesonide has a plasma clearance of 0.9-1.8 L/min. 9, 10, 15, 16 The 22R form has a clearance of 1.4 L/min while the 22S form has a clearance of 1.0 L/min.

The clearance in asthmatic children 4-6 years old is 0.5 L/min. 12, 14.

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Acute overdose of corticosteroids is rare, however prolonged high dosing of corticosteroids can lead to hypercorticism and adrenal axis suppression. 9, 10, 11, 12, 14, 15, 16 In the case of overdose, reduce the dosage of corticosteroids temporarily. 9, 10, 11, 12, 14, 15, 16 A 200 mg oral dose is lethal to female mice while a 400 mg oral dose is lethal to male mice. 9, 10, 15.

Do not use in children under 6 years of age if you have ever had an allergic reaction to any of the ingredients Ask a doctor before use if you have had recent nose ulcers or nose surgery have had a nose injury that has not healed are using a steroid medicine for asthma, allergies or skin rash have an eye infection have or had glaucoma or cataracts When using this product the growth rate of some children may be slower some symptoms may get better on the first day of treatment.

It may take up to two weeks of daily use to feel the most symptom relief. do not share this bottle with anyone else as this may spread germs remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if you have, or come into contact with someone who has, chickenpox, measles or tuberculosis you have or develop symptoms of an infection such as persistent fever you have any change in vision you have severe or frequent nosebleeds If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Read insert (inside package) on how to: get a new bottle ready (primed) before first use prime bottle again if not used for two days use the spray clean the spray nozzle ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER adults and children 12 years of age and older once daily, spray 2 times into each nostril while sniffing gently once your allergy symptoms improve, reduce to 1 spray in each nostril per day CHILDREN TO UNDER 12 YEARS OF AGE the growth rate of some children may be slower while using this product.

Talk to your child’s doctor if your child needs to use the spray for longer than two months a year children to under 12 years of age an adult should supervise use once daily, spray 1 time into each nostril while sniffing gently if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day children under 6 years of age do not use do not use more than directed if you forget a dose, do not double the next dose do not spray into eyes or mouth if allergy symptoms do not improve after two weeks, stop using and talk to a doctor do not use for the common cold shake well before each use.