Budenofalk Granules

Budesonide

9mg

DR. FALK PHARMA GMBH

Pack size	20 Sachets
Dispensing mode	POM
Source	GERMANY
Agent	PHARMALINK
Retail Price	337.50 AED

Available as:

2mg/Dose - Rectal foam 9mg - Granules

Indications

Budenofalk Granules is used for: Asthma, COPD.

Adult Dose

Inhalation Asthma Adult: As metered-dose aerosol: 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 in 2 divided doses. Max: 800 mcg bid. As nebuliser soln: Severe asthma: 1-2 mg bid. Maintenance dose: 0.5-1 mg bid.

Child Dose

Inhalation Asthma Child: 2-12 yr As metered-dose aerosol: 200-800 mcg daily in divided doses. 5-12 yr As dry powd inhaler: 200-800 mcg daily in 2 divided doses. 3 mth to 12 yr As nebuliser soln: Initially, 0.5-1 mg bid. Maintenance dose: 0.25-0.5 mg bid. Inhalation Croup Child: As nebuliser 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.

Precautions

Active or doubtfully quiescent tuberculosis, paradoxical bronchospasm; untreated fungal, bacterial, or systemic viral infections, or ocular herpes simplex infection. Lactation: Drug enters breast milk; use only if benefits greatly outweigh risks

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 : >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

Budenofalk 9mg Granules manufactured by DR. FALK PHARMA GMBH. Its generic name is Budesonide. Budenofalk is availble in United Arab Emirates. Farmaco UAE drug index information on Budenofalk Granules 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 :

Inhaler / Aerosol

Sonidar ^200mcg/Dose

Julphar (Gulf Pharmaceutical Industries)

Inhaler / Aerosol

Sonidar ^200mcg/Dose

Julphar (Gulf Pharmaceutical Industries)

Pulmicort ^100mcg/dose

ASTRAZENECA AB