|Indication & Dosage
Asthma, ChronicÂ obstructive pulmonary disease
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.Â
Child:Â â‰¥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
||May be taken with or without food.
||Primary treatment of status asthmaticus or other acute episodes of asthma.
||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
||Headache, nasopharyngitis, upper respiratory tract infections,
stomach discomfort, vomiting, oral candidiasis, back pain, nasal congestion, sinusitis.
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.Â 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.
||Inhalation:Â Store at
||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 Î²2-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:Â Budesonide: Orally inhaled budesonide is rapidly absorbed in the lungs. Formoterol: Rapidly
absorbed after inhalation.
Distribution:Â Budesonide: 85-90% bound to plasma proteins.
Primary metabolism pathway is via direct glucuronidation and O-demethylation followed by conjugation to inactive metabolites.
Excretion:Â Budesonide: Excreted in urine and faeces as metabolites. Formoterol: Excreted mainly in urine and some in
||R03AC13 - formoterol ; Belongs to the class of adrenergic
inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.Â
R03BA02 - budesonide ; Belongs to the class
of other inhalants used in the treatment of obstructive airway diseases, glucocorticooids.Â
D07AC09 - budesonide ; Belongs to the class of potent
(group III) corticosteroids. Used in the treatment of dermatological diseases.Â
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting
locally. Used in the treatment of intestinal inflammation.Â
R01AD05 - budesonide ; Belongs to the class of topical corticosteroids used as nasal