Budicort ER ER Tablet
Budesonide Oral
9mg
Incepta Pharmaceuticals Ltd.
| Pack size | 30's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 30.00 AED |
Indications
Budicort ER ER Tablet is used for:
Ulcerative Colitis
Adult Dose
Oral
ER Tablet
Ulcerative Colitis
Indicated for induction of remission of active, mild-to-moderate ulcerative colitis
Adult: 9 mg ER tablet to be taken once daily in the morning for up to 8 weeks.
Child Dose
Oral
Eosinophilic Esophagitis
Indicated for eosinophilic esophagitis (EoE) in patients aged >11 years
Suspension: 2 mg (10 mL) PO BID x 12 weeks
Renal Dose
Renal impairment
Not studied; intact budesonide is not renally excreted, but metabolites are renally excreted to a large extent; metabolites have negligible corticosteroid activity compared with budesonide
Administration
May be taken with or without food
Contra Indications
Known hypersensitivity to budesonide or any of the ingredients in tablets
Precautions
Hypercorticism and adrenal suppression: Since Budesonide is a glucocorticosteroid, follow general warnings concerning glucocorticoids.
Transferring patients from systemic glucocorticoids:
Risk of impaired adrenal function when transferring from glucocorticoid treatment with higher systemic effects to glucocorticoid treatment with lower systemic effects, such as Budesonide. Taper patients slowly from systemic corticosteroids if transferring to Budesonide.
Immunosuppression: Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
MONITORING PARAMETERS
When used in autoimmune hepatitis, liver function tests should be monitored every 2 weeks for 1 month, then at least every 3 months.
Pregnancy-Lactation
Pregnancy
Available data from published case series, epidemiological studies and reviews with oral budesonide use in pregnant females have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes
Animal data
SC administration during organogenesis at doses ~0.5 times or ~0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities; maternal toxicity was observed in both rats and rabbits at these dose levels; based on animal data, advise pregnant females of potential risk to a fetus
Clinical considerations
Studies showed an association of adverse pregnancy outcomes in women with Crohn disease, including preterm birth and low birth weight infants, during periods of increased disease activity (including increased stool frequency and abdominal pain)
IgA nephropathy in pregnancy is associated with adverse maternal outcomes, including increased rates of cesarean section, pregnancy-induced hypertension, pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including stillbirth and low birth weight
Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy; carefully observe infants for signs of hypoadrenalism (eg, poor feeding, irritability, weakness, vomiting), and managed accordingly
Lactation
Breastfeeding is not expected to result in significant exposure of the infant
No lactation studies have been conducted; no information is available on effects on infants or effects on milk production
One published study reports that budesonide is present in human milk following maternal inhalation of budesonide
Routine monitoring of linear growth in infants is recommended with chronic use of budesonide in nursing mother
Interactions
Avoid Cytochrome P450 3A4 inhibitors (e.g. ketoconazole, grapefruit juice). May cause increased systemic corticosteroid effects.
Contraindicated (3)
lopinavir
mifepristone
ribociclib
Adverse Effects
Side effects of Budesonide Oral :
>10%
Headache (21%)
Acne (<5-15%)
Nausea (11%)
Respiratory infection (11%)
IgAN
Hypertension (16%)
Peripheral edema (14%)
Muscle spasms (13%)
Acne (11%)
1-10%
Back pain (7%)
Dizziness (7%)
Abdominal pain (6%)
Dyspepsia (6%)
Vomiting (6%)
Fatigue (5%)
IgAN
Dermatitis (7%)
Weight increased (7%)
Dyspnea (6%)
Face edema (6%)
Dyspepsia (5%)
Fatigue (5%)
Hirsutism (5%)
Frequency Not Defined
Adrenal suppression
Amnesia
Anaphylactic reactions
Benign intracranial hypertension
Diarrhea
Facial edema
Fever
Flu syndrome
GI irritation
Hypokalemia
Increased appetite
Insomnia
Migraine
Nervousness
Pharyngitis
Rash
Xerostomia
Weight gain
Mechanism of Action
Budesonide has a high topical glucocorticosteroid (GCS) activity and substantial first-pass elimination. The formulation contains budesonide in an extended-release tablet core. The tablet core is enteric coated to protect dissolution in gastric juice which delays budesonide release until exposure to a pH ≥ 7 in the small intestine. Upon disintegration of the coating, the core matrix provides extended release of budesonide in a time-dependent manner.
Note
Budicort ER 9mg ER Tablet manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Budesonide Oral. Budicort ER is availble in Bangladesh.
Farmaco BD drug index information on Budicort ER ER Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.