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P  - Caution when used during pregnancy

L  - Caution when used during lactation

Molecule Info

 
Indication & Dosage Inhalation
Asthma, Chronic obstructive pulmonary disease
Adult: As combination preparations in 2 strengths: Per inhalation containing (budesonide(mcg)/formoterol fumarate(mcg)): 80/4.5 or 160/4.5: 2 inhalations bid. Patients who are receiving low-medium dose inhaled corticosteroid may be started on lower strength combination while those receiving medium-high dose inhaled corticosteroid may be started on higher strength combination. Patients who are not adequately controlled on the lower strength combination may convert to the higher strength combination after 1-2 wk of treatment. Not to use more than 4 inhalations/day of either strength. 
Child: ≥12 yr: As combination preparations in 2 strengths: Per inhalation containing (budesonide(mcg)/formoterol fumarate(mcg)): 80/4.5 or 160/4.5: 2 inhalations bid via the orally inhaled route only. Max daily dose: 640 mcg budesonide/18 mcg formoterol fumarate.
Administration May be taken with or without food.
Contraindications Primary treatment of status asthmaticus or other acute episodes of asthma.
Special Precautions May increase the risk of death in patients. Not to be used for transferring patients from systemic corticosteroid treatment. May produce paradoxical bronchospasm which is life-threatening. Caution when used in patients with CV diseases, especially coronary insufficiency, cardiac arrhythmias and hypertension. Chronic use may further decrease bone mineral content when used in patients with advanced age, osteoporosis, poor nutrition, sedentary lifestyle or tobacco use. May reduce growth velocity when used in paediatric patients. Caution when used in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral or parasitic infections, or ocular herpes simplex. Pregnancy and lactation.
Adverse Drug Reactions Headache, nasopharyngitis, upper respiratory tract infections, stomach discomfort, vomiting, oral candidiasis, back pain, nasal congestion, sinusitis.
Drug Interactions Concomitant admin with CYP3A4 inhibitor e.g. itraconazole, clarithromycin, erythromycin may inhibit the metabolism of budesonide. Concurrent use with nonpotassium-sparing diuretics may lead to ECG changes and/or hypokalaemia. Please consult detailed drug interactions before prescribing.

Pregnancy Category (US FDA) 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.
Storage Inhalation: Store at 20-25°C.
Pharmacology Budesonide is a corticosteroid that has mainly glucocorticoid activity. It prevents and controls inflammation by controlling the rate of protein syntheis, decreasing the migration of polymorphonuclear leucocytes/fibroblasts and reversing capillary permeability. Formoterol fumarate is a selective β2-adrenergic agonist. It causes bronchodilation by catalysing the conversion of adenosine triphosphate to cyclic-3', 5'-adenosine monophosphate (cyclic AMP) resulting in bronchial smooth muscle relaxation.
Absorption: Budesonide: Orally inhaled budesonide is rapidly absorbed in the lungs. Formoterol: Rapidly absorbed after inhalation.
Distribution: Budesonide: 85-90% bound to plasma proteins.
Metabolism: Formoterol: Primary metabolism pathway is via direct glucuronidation and O-demethylation followed by conjugation to inactive metabolites.
Excretion: Budesonide: Excreted in urine and faeces as metabolites. Formoterol: Excreted mainly in urine and some in faces.
ATC Classification R03AC13 - formoterol ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases. 
R03BA02 - budesonide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticooids. 
D07AC09 - budesonide ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases. 
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation. 
R01AD05 - budesonide ; Belongs to the class of topical corticosteroids used as nasal decongestants.
 

Brand/Product Info


Total Products : 7       
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
BUFOCORT 100 Square Pharmaceuticals Ltd. Budesonide 100 mcg + Formoterol 6 mcg Cozycap 5x6's: 210.60 MRP
BUFOCORT 200 Square Pharmaceuticals Ltd. Budesonide 200 mcg + Formoterol 6 mcg Cozycap 5x6's: 270.90 MRP
BUFOCORT 400 Square Pharmaceuticals Ltd. Budesonide 400 mcg + Formoterol 12 mcg Cozycap 5x6's: 421.50 MRP
SYMBION 4.5/160 Beximco Pharmaceuticals Ltd Formoterol fumarate dihydrate 4.5 HFA Inhaler 1's: 980.00 MRP
SYMBION 4.5/80 Beximco Pharmaceuticals Ltd Formoterol fumarate dihydrate 4.5 HFA Inhaler 1's: 625.00 MRP
SYMBION 6/100 Beximco Pharmaceuticals Ltd Formoterol Bexicap 30's: 210.00 MRP
SYMBION 6/200 Beximco Pharmaceuticals Ltd Formoterol Bexicap 30's: 270.00 MRP
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