COMPOSITION
Bufocort®100 Cozycap : Each capsule contains Budesonide BP 100 mcg and
Formoterol Fumarate Dihydrate BP 6 mcg. Bufocort®200 Cozycap : Each
capsule contains Budesonide BP 200 mcg and Formoterol Fumarate Dihydrate
BP 6 mcg. Bufocort®400 Cozycap : Each capsule contains Budesonide BP 400
mcg and Formoterol Fumarate Dihydrate BP 12 mcg.
DESCRIPTION
Bufocort® Cozycaps are a combination of Budesonide BP and Formoterol
Fumarate Dihydrate BP. Budesonide BP is a potent glucocorticoid that binds
with high affinity to the glucocorticoid receptor. Formoterol Fumarate
Dihydrate BP is a very potent, long-acting β2 – adrenoceptor agonist with a
high intrinsic activity and a rapid onset of action.
PHARMACOLOGY
Pharmacodynamics : Bufocort® Cozycap contain both Budesonide BP and
Formoterol Fumarate Dihydrate BP ; therefore, the mechanism of action
described below for the individual components apply to Bufocort® Cozycap.
Budesonide BP : It is an anti-inflammatory corticosteroid that exhibits potent
glucocorticoid activity and weak mineralocorticoid activity. Inflammation is an
important component in the pathogenesis of asthma. Corticosteroids have a
wide range of inhibitory activities against multiple cell types (e.g., mast cells,
eosinophils, neutrophils, macrophages and lymphocytes) and mediators (e.g.,
histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic and
non-allergic-mediated inflammation. These anti-inflammatory actions of
corticosteroids may contribute to their efficacy in asthma.
Formoterol Fumarate Dihydrate BP : It is a long-acting, selective β2 –
adrenergic agonist with a rapid onset of action. Inhaled Formoterol Fumarate
Dihydrate BP acts locally in the lungs as a bronchodilator.The pharmacological
effects of β2 -adrenoceptor agonist drugs are attributable to the stimulation of
intracellular adenyl cyclase, the enzyme that catalyses the conversion of
adenosine triphosphate (ATP) to cyclic AMP. Increased cyclic AMP levels cause
relaxation of bronchial smooth muscle and inhibit the release of mediators of
immediate hypersensitivity from the cells, especially from mast cells.
INDICATIONS
Bufocort® Cozycaps are indicated in the regular treatment of asthma. They
are also indicated in the symptomatic treatment of severe chronic obstructive
pulmonary disease (COPD), with a history of repeated exacerbations despite
regular therapy with long-acting bronchodilators.
DOSAGE AND ADMINISTRATION
Asthma
Dosage is individual and should be adjusted according to disease severity.
When control has been achieved, the dose should be titrated to the lowest
effective dose.
For Bufocort® there are two treatment approaches:
(A) Maintenance Therapy: Patients should be advised to have their separate
rapid acting bronchodilator available for rescue use at all times.
Adults (18 Years and Older)
Bufocort® 100 / 200 Cozycap: 1-2 Cozycaps, twice daily, maximum dose is 4
Cozycaps,twice daily.
Bufocort® 400 Cozycap: 1 Cozycaps,twice daily, maximum dose is 2 Cozycaps,
twice daily.

Bufocort® as needed in response to symptoms. Patients should be advised to
always have Bufocort® available for use.
Adults (18 years and older): The recommended maintenance dosage is 2
inhalations per day as maintenance therapy (either one Cozycap twice daily, or
two Cozycaps in either the morning or the evening), although some patients
may require two Cozycaps twice daily.
Patients should take 1 additional Cozycap as needed in response to symptoms.
If symptoms persist after a few minutes, an additional Cozycap should be
taken.Not more than 6 Cozycaps should be taken on any single occasion.
A total daily dose of more than 8 Cozycaps is not normally needed; however, a
total daily dose of up to 12 Cozycaps could be used for a limited period.
Patients using more than 8 Cozycaps daily should be strongly recommended
to seek medical advice.
COPD (Chronic Obstructive Pulmonary Disease)
Bufocort® 200 Cozycap : 2 Cozycaps ,twice daily.
CONTRAINDICATION
Bufocort® Cozycaps are contraindicated in patients with a history of
hypersensitivity to any of the components of the drug product.
PRECAUTION
Budesonide BP and Formoterol Fumarate Dihydrate BP Cozycap should be
administered with caution in patients with severe cardiovascular disorders,
including heart rhythm abnormalities, diabetes mellitus, untreated
hypokalaemia, or thyrotoxicosis. Paradoxical bronchospasm may occur. In such
cases, Budesonide BP and Formoterol Fumarate Dihydrate BP Cozycap should
be discontinued immediately.
PREGNANCY AND LACTATION
Administration of Bufocort® Cozycaps in pregnant women and lactating
mother should only be considered if the expected benefit to the mother is
greater than any possible risk to the foetus.
SIDE EFFECT
Budesonide BP: Hoarseness, and candidiasis (thrush) of the mouth and throat
can occur in some patients. Cutaneous hypersensitivity reactions have been
reported.
Formoterol Fumarate Dihydrate BP: Tremor, palpitations, and headache have
been reported. Cardiac arrhythmias, muscle cramps, and hypersensitivity
reactions, including rash, oedema, and angio-oedema, may occur in some
patients.