Budeson Dry powder inhalation capsule

Budesonide inhaled

200mcg

Acme Laboratories Ltd.

Pack size	30 doses unit
Dispensing mode
Source
Agent
Retail Price	90 AED

Indications

Budeson Dry powder inhalation capsule is used for: Asthma

Adult Dose

Adult: Inhalation Asthma Maintenance treatment of asthma as prophylactic therapy Previous Therapy: Bronchodilators alone Recommended starting dose: 200 to 400 mcg twice daily Highest recommended dose: 400 mcg twice daily Previous Therapy: Inhaled corticosteroids Recommended starting dose: 200 to 400 mcg twice daily Highest recommended dose: 800 mcg twice daily In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids, dosing with Budesonide inhaler 200 mg or 400 mg once daily may be considered. Budesonide inhaler can be administered once daily either in the morning or in the evening. If the once-daily treatment with Budesonide inhaler does not provide adequate control of asthma symptoms, the total daily dose should be increased and/or administered in divided doses. Previous Therapy: Oral corticosteroids Recommended starting dose: 400 to 800 mcg twice daily Highest recommended dose: 800 mcg twice daily As nebulizer soln: Severe asthma: 1-2 mg bid. Maintenance dose: 0.5-1 mg bid.

Child Dose

Children Inhalation Asthma <6 years: Safety and efficacy not established Child> 6 years Previous Therapy: Bronchodilators alone Recommended starting dose: 200 mcg twice daily Highest recommended dose: 400 mcg twice daily Previous Therapy: Inhaled corticosteroids Recommended starting dose: 200 to 400 mcg twice daily Highest recommended dose: 400 mcg twice daily In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids, dosing with Budesonide inhaler 200 mg or 400 mg once daily may be considered. Budesonide inhaler can be administered once daily either in the morning or in the evening. If the once-daily treatment with Budesonide inhaler does not provide adequate control of asthma symptoms, the total daily dose should be increased and/or administered in divided doses. Previous Therapy: Oral corticosteroids Recommended dose: The highest recommended dose in children is 400 mg twice daily As nebulizer soln: 3 mth to 12 yr Initially, 0.5-1 mg bid. Maintenance dose: 0.25-0.5 mg bid. Inhalation Croup Child: As nebulizer soln: 2 mg as a single dose or as 2 doses of 1 mg w/ 30 min interval, may be repeated 12 hrly for a max of 36 hr or until clinical improvement is observed.

Renal Dose

Administration

Contra Indications

Hypersensitivity to any of the ingredients of this preparation. Status asthmaticus, acute bronchospasm.

Precautions

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

Pregnancy-Lactation

Pregnancy There are no adequate well-controlled studies in pregnant women; however, there are published studies on use of budesonide, in pregnant women; studies of pregnant women have not shown that inhaled budesonide increases risk of abnormalities when administered during pregnancy There are no well-controlled human studies that have investigated effects of therapy during labor and delivery Animal data In animal reproduction studies, therapy, administered by subcutaneous route, caused structural abnormalities, was embryocidal, and reduced fetal weights in rats and rabbits at less than maximum recommended human daily inhalation dose (MRHDID), but these effects were not seen in rats that received inhaled doses approximately 2 times the MRHDID; experience with oral corticosteroids suggests that rodents are more prone to structural abnormalities from corticosteroid exposure than humans In women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control Lactation There are no available data on effects of therapy on breastfed child or on milk production; budesonide, is present in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Interactions

Increased systemic exposure w/ potent CYP3A4 inhibitors (e.g. ketoconazole). Decreased systemic exposure w/ CYP3A4 inducers (e.g. carbamazepine).

Adverse Effects

Side effects of Budesonide inhaled : >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%)

Mechanism of Action

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.

Note

Budeson 200mcg Dry powder inhalation capsule manufactured by Acme Laboratories Ltd.. Its generic name is Budesonide inhaled. Budeson is availble in Bangladesh. Farmaco BD drug index information on Budeson Dry powder inhalation capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Budesonide inhaled :

Inhaler

Aeronid 100 ^100mcg

Beximco Pharmaceuticals Ltd.

Inhaler

Aeronid 200 HFA ^200mcg

Beximco Pharmaceuticals Ltd.

Aerosol Inhalation

Aeronid 200 ^{200 mcg}

Beximco Pharmaceuticals Ltd.

Nebuliser Suspension

Budicort 0.5 ^0.5mg

Incepta Pharmaceuticals Ltd.

Nebuliser Suspension

Budicort 1 ^1mg

Incepta Pharmaceuticals Ltd.