Budesonide information from DrugsUpdate
P - Cautioned while taken during pregnancy
L - Cautioned while taken during lactation
Budesonide is a glucocorticoid steroid for the treatment of asthma, non-infectious rhinitis (including hay fever and other allergies), and for treatment and prevention of nasal polyposis. Additionally, it is used for Crohn's disease (inflammatory bowel disease).
It is marketed by AstraZeneca as a nasal inhalant under the brand name Rhinocort (in Denmark, as Rhinosol), as an oral inhalant under the brand name Pulmicort, and as either an enema or a modified release oral capsule under the brand name Entocort. It is also sold in combination with formoterol (Oxis) in a single inhaler, under the brand name Symbicort. In Brazil it's marketed by Eurofarma under the brand name Noex.
Pharmacodynamics
Pharmacokinetics
Budesonide controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes, fibroblasts, reverses capillary permeability and lysosomal stabilisation at the cellular level to prevent or control inflammation.
Absorption: Rapid and almost complete after oral admin but has poor systemic availability.
Metabolism: Undergoes first-pass metabolism.
Budesonide Indications / Budesonide Uses
Information Not Available
Budesonide Adverse Reactions / Budesonide Side Effects
Loss of skin collagen and SC atrophy; local hypopigmentation of deeply pigmented skin; dryness, irritation, epistaxis, rarely ulceration or perforation of the nasal septum; smell and taste disturbances; hoarseness and candidiasis of the mouth or throat.
Precautions
Information Not Available
Special Precautions
Active or doubtfully quiescent tuberculosis, paradoxical bronchospasm; children, elderly; pregnancy, lactation.
Other Drug Interactions
Information Not Available
Other Interactions
Information Not Available
Dosage
Oral
Inflammatory bowel disease
Adult: Active disease: 9 mg daily; up to 8 wk, reduce dose before stopping therapy. Recurring episodes of active disease: May repeat an 8-wk course. Maintenance of remission: 6 mg once daily, for up to 3 mth; thereafter, gradually reduce dose before stopping treatment.
Hepatic impairment: Dose reduction may be needed.
Nasal
Treatment and prevention of rhinitis
Adult: Initially, 200 mcg into each nostril daily, reduced to 100 mcg into each nostril daily until symptoms are controlled. Or initially, 100 mcg into each nostril bid.
Nasal
Nasal polyps
Adult: 100 mcg bid into each nostril up to 3 mth.
Inhalation
Asthma
Adult: MDI: 400 mcg daily in 2 divided doses, increased up to 1.6 mg daily in severe cases. Maintenance: 200-400 mcg daily. As dry powd inhaler: 200-800 mcg daily in single dose or 2 divided doses. As nebulised solution: Usual dose: 1-2 mg inhaled bid. Maintenance dose: 0.5-1 mg bid.
Child: MDI: 50-400 mcg bid. Nebulised solution: 3 mth-12 yr: Initially, 0.5-1 mg bid. Maintenance dose: 0.25-0.5 mg bid.
Max Dosage: Adult: Dry powd inhaler: 800 mcg bid.
Food(before/after)
Should be taken with food. (Swallow whole, do not chew/crush. Avoid grapefruit juice.)
List of Contraindications
Budesonide and Pregnancy
Caution when used during pregnancy
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Budesonide and Lactation
Caution when used during lactation
Budesonide and Children
Not recommended for children younger than 6 yr of age (intranasal, oral inhaler) or younger than 12 mo of age (respules); safety and efficacy not established in children for Entocort EC . Corticosteroids may suppress growth in children and adolescents, particularly with higher doses over extended periods. Plot growth in children on prolonged therapy. Inform health care provider if abnormalities noted.
Budesonide and Geriatic
Select dose with caution, reflecting greater frequency of decreased hepatic, renal, or cardiac function and comorbidity.
Budesonide and Other Contraindications
Hypersensitivity. Acute infections uncontrolled by antimicrobial chemotherapy.
Storage
Inhalation: Store at 20-25°C.
Nasal: Store at 20-25°C.
Oral: Store at 20-25°C.
Lab interference
Inhalation: Store at 20-25°C.
Nasal: Store at 20-25°C.
Oral: Store at 20-25°C.
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