Budesonide Orion
Budesonide Orion Uses, Dosage, Side Effects, Food Interaction and all others data.
Budesonide Orion is a synthetic corticosteroid having potent glucocorticoid activity and weak mineralocorticoid activity. It has approximately a 200-fold higher affinity for the glucocorticoid receptor and a 1000-fold higher topical anti-inflammatory potency than cortisol. Corticosteroids have been shown to have a wide range of inhibitory activities against multiple cell types (e.g., mast cell, eosinophil, neutrophil, macrophage, and lymphocyte) and mediators (e.g., histamine, eicosanoids, leukotriene, and cytokine) involved in allergic mediated inflammation.
Budesonide Orion is a glucocorticoid used to treat respiratory and digestive conditions by reducing inflammation. It has a wide therapeutic index, as dosing varies highly from patient to patient. Patients should be counselled regarding the risk of hypercorticism and adrenal axis suppression.
Trade Name | Budesonide Orion |
Availability | Prescription only |
Generic | Budesonide |
Budesonide Other Names | Budesónida, Budesonide |
Related Drugs | Entyvio, Humira, Stelara, Dupixent, Tysabri, Xolair, Zeposia, Colazal, ProAir Digihaler, prednisone |
Type | |
Formula | C25H34O6 |
Weight | Average: 430.5339 Monoisotopic: 430.23553882 |
Protein binding | Corticosteroids are generally bound to corticosteroid binding globulin and serum albumin in plasma. Budesonide is 85-90% protein bound in plasma. |
Groups | Approved |
Therapeutic Class | Nasal Decongestants & Other Nasal Preparations, Respiratory corticosteroids |
Manufacturer | |
Available Country | Netherlands |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Budesonide Orion is a glucocorticoid used for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Budesonide Orion Nebuliser suspension is used for the maintenance treatment and as prophylactic therapy of asthma.
Budesonide Orion Nasal Spray is used for-
- Prophylaxis and treatment of seasonal and perennial allergic rhinitis
- Prophylaxis and treatment of vasomotor rhinitis
- Symptomatic relief of nasal polyposis
- Prevention against nasal polyps after polypectomy
Budesonide Orion Inhaler is used for the maintenance treatment of asthma as prophylactic therapy in adult and paediatric patients six years of age or older. It is also used for patients requiring oral corticosteroid therapy for asthma, many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time. Budesonide Orion inhaler is not used for the relief of acute bronchospasm.
Budesonide Orion is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Allergies, Asthma, Chronic Obstructive Pulmonary Disease (COPD), Collagenous Colitis, Crohn's Disease (CD), Nasal Congestion, Oesophagitis, Eosinophilic, Polyps, Nasal, Pruritus, Rhinosinusitis, Ulcerative Colitis, Vasomotor Rhinitis, Corticosteroid-responsive dermatoses, Mild Crohn’s Disease, Moderate Crohn’s Disease
How Budesonide Orion works
The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days.
Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10.
Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.
Dosage
Budesonide Orion dosage
Children 3 months to 12 years of age: 0.5 - 1 mg twice daily.Adults and elderly: 1 - 2 mg twice daily.
Side Effects
●headache● nausea● upper abdominal pain● fatigue● acne● flatulence● joint pain● urinary tract infection● abdominal distension● constipation
Toxicity
Acute overdose of corticosteroids is rare, however prolonged high dosing of corticosteroids can lead to hypercorticism and adrenal axis suppression. In the case of overdose, reduce the dosage of corticosteroids temporarily.
A 200mg oral dose is lethal to female mice while a 400mg oral dose is lethal to male mice.
Precaution
● Since budesonide is a glucocorticoid, general warnings concerning glucocorticoids should be followed.
● Risk of impaired adrenal function when transferring from glucocorticoid treatment with higher systemiceffects to glucocorticoid treatment with lower systemic effects, such as budesonide. Taper patients slowly fromsystemic corticosteroids if transferring to budesonide.
● Potential worsening of infections (e.g., chickenpox, measles, existing tuberculosis, fungal, bacterial, viral, orparasitic infection). Use with caution in patients with these infections.
● Reduced liver function affects the elimination of glucocorticoid, and increases systemic availability of oralbudesonide.
Interaction
Avoid Cytochrome P450 3A4 inhibitors (e.g. ketoconazole, grapefruit juice). It may cause increased systemic corticosteroid effects. Budesonide Orion does not affect the plasma levels of oral contraceptives.
Food Interaction
- Take with or without food. Food delays drug absorption, but not to a clinically significant extent.
[Moderate] GENERALLY AVOID: Grapefruit juice may increase the plasma concentrations and systemic effects of orally administered budesonide.
The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruits.
According to the manufacturer, the systemic exposure of oral budesonide approximately doubles after extensive intake of grapefruit juice.
MANAGEMENT: Patients receiving budesonide should avoid the regular consumption of grapefruits and grapefruit juice to prevent undue increases in plasma budesonide levels and systemic effects.
Budesonide Orion Drug Interaction
Minor: arformoterol, arformoterol, albuterol / ipratropium, albuterol / ipratropium, albuterol, albuterolUnknown: polyethylene glycol 3350, polyethylene glycol 3350, acetaminophen, montelukast, montelukast, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, cetirizine
Budesonide Orion Disease Interaction
Moderate: hepatic impairment, hepatic impairment, hyperadrenocorticism, infections, ocular herpes simplex, ocular toxicities, osteoporosis
Volume of Distribution
The volume of distribution of budesonide is 2.2-3.9L/kg.
Elimination Route
Extended release oral capsules are 9-21% bioavailable. A 9mg dose reaches a Cmax of 1.50±0.79ng/mL with a Tmax of 2-8h and an AUC of 7.33ng*hr/mL. A high fat meal increases the Tmax by 2.3h but otherwise does not affect the pharmacokinetics of budesonide.
180-360µg metered inhaled doses of budesonide are 34% deposited in the lungs, 39% bioavailable, and reach a Cmax of 0.6-1.6nmol/L with a Tmax of 10 minutes.
A 1mg nebulized dose is 6% bioavailable, reaching a Cmax of 2.6nmol/L with a Tmax of 20 minutes.
A 9mg oral extended release tablet reaches a Cmax of 1.35±0.96ng/mL with a Tmax of 13.3±5.9h and an AUC of 16.43±10.52ng*hr/mL.
Budesonide Orion rectal foam 2mg twice daily has an AUC of 4.31ng*hr/mL.
Half Life
Budesonide Orion has a plasma elimination half life of 2-3.6h. The terminal elimination half life in asthmatic children 4-6 years old is 2.3h.
Clearance
Budesonide Orion has a plasma clearance of 0.9-1.8L/min. The 22R form has a clearance of 1.4L/min while the 22S form has a clearance of 1.0L/min. The clearance in asthmatic children 4-6 years old is 0.5L/min.
Elimination Route
Approximately 60% of a budesonide dose is recovered in the urine as the major metabolites 6beta-hydroxybudesonide, 16alpha-hydroxyprednisolone, and their conjugates. No unchanged budesonide is recovered in urine.
Pregnancy & Breastfeeding use
Pregnancy Category CThere are no adequate and well-controlled studies in pregnant women. Budesonide Orion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Nursing mothers
Budesonide Orion is secreted in human milk. So, a decision should be made whether to discontinue nursing or budesonide taking into account the clinical importance of the drug to the mother.
Use in childrenSafety and effectiveness of budesonide in pediatric patients have not been established.Use in Hepatic Impaired patientsMonitor patients for signs and/or symptoms of hypercorticism.
Contraindication
Hypersensitivity to any of the ingredients of Budesonide Orion.
Acute Overdose
If glucocorticoids are used at excessive doses for prolonged periods, systemic glucocorticoid effects such as hypercorticism and adrenal suppression may occur.
Symptoms: Decreased motor activity, piloerection, generalised oedema. Management: Immediate gastric lavage or emesis followed by supportive and symptomatic treatment.
Innovators Monograph
You find simplified version here Budesonide Orion
Budesonide Orion contains Budesonide see full prescribing information from innovator Budesonide Orion Monograph, Budesonide Orion MSDS, Budesonide Orion FDA label
FAQ
What Budesonide Orion is used for?
Budesonide Orion is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma.
What are the common side effects of Budesonide Orion?
Common side effects may include:
- headache, dizziness;
- indigestion, nausea, vomiting, stomach pain, bloating, gas, constipation;
- feeling tired;
- back pain, joint pain;
- painful urination;
- cold symptoms such as stuffy nose, sneezing, sore throat;
- pain anywhere in your body; or
- signs of too much steroid medicine in your blood.
Is it safe to use Budesonide Orion?
You should know that budesonide inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, use your fast-acting (rescue) asthma medication . Do not use budesonide inhalation again unless your doctor tells you that you should.
Is Budesonide Orion safe during pregnancy?
Budesonide Orion recommended doses are safe to use during pregnancy. Oral corticosteroids, at the doses used to treat asthma exacerbations, do not appear to pose a significant risk to the mother or child.
Is Budesonide Orion safe during breastfeeding?
Budesonide Orion recommended doses are safe to use during breastfeeding.Oral corticosteroids, at the doses used to treat asthma exacerbations, do not appear to pose a significant risk to the mother or child.
Can I drink alcohol with Budesonide Orion?
You can't drink alcohol while taking Budesonide Orion. Taking corticosteroids like Budesonide Orion can make it hard for your body to fight infections.
Can I take Budesonide Orion at night?
Budesonide Orion is usually taken once a day in the morning. Take Budesonide Orion at around the same time every day.
What does Budesonide Orion do to the body?
Budesonide Orion does control and prevent symptoms (wheezing and shortness of breath) caused by asthma.It works directly in the lungs to make breathing easier by reducing the irritation and swelling of the airways.
How many times a day can I take Budesonide Orion?
Budesonide Orion can be repeated every 12 hours for a maximum of 36 hours or until clinical improvement.
Should Budesonide Orion be taken with or without food?
You can take it with or without food. If it upsets your stomach, take it with food. Take your doses at regular intervals. Do not take your medicine more often than directed.
How long can I safely take Budesonide Orion?
Budesonide Orion should take once a day in the morning for up to 8 weeks. Your doctor may adjust your dose as needed.
Is Budesonide Orion safe for long-term use?
Budesonide Orion at a mean dose of 4.5 mg/day is an effective and safe long-term maintenance therapy in collagenous colitis, which preserves health-related quality of life.
Does Budesonide Orion raise blood sugar?
Budesonide Orion may increase blood sugar levels and so may oppose the blood sugar lowering effects of antidiabetic medicines.
Does Budesonide Orion cause bone loss?
Bone loss is reduced with Budesonide Orion, but not completely eliminated.
Can Budesonide Orion cause liver damage?
The mechanism by which Budesonide Orion might cause serum aminotransferase elevations or liver injury is not known.
What happens if I suddenly stop taking Budesonide Orion?
If you suddenly stop taking the Budesonide Orion, you may also have withdrawal symptoms such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness.
Does Budesonide Orion weaken immune system?
If you use this Budesonide Orion long-term it's can weaken your immune system.
Is Budesonide Orion a strong steroid?
Budesonide Orion is a potent steroid that undergoes extensive first-pass metabolism.