Budecort Respules 1mg2ml Respirator Suspension

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Budesonide BP

Available from:

CIPLA MALAYSIA SDN BHD

INN (International Name):

Budesonide BP

Units in package:

4 x 5s Units; 6 x 5x Units

Manufactured by:

CIPLA LTD

Summary of Product characteristics

_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only _
BUDECORT RESPULES 1MG/2ML RESPIRATOR SUSPENSION
COMPOSITION
Each 2 ml respule contains
Budesonide USP ………1 mg
DOSAGE FORM
Solution for inhalation via a nebulizer.
PRODUCT DESCRIPTION
A white to off white homogenous redispersible suspension filled in 2
ml FFS respules. On
visual examination, there is no sign of leakage or physical damage.
PHARMACOLOGY
_PHARMACODYNAMICS _
Budesonide is a glucocorticosteroid which possesses a high local
anti-inflammatory
action, with a lower incidence and severity of adverse effects than
those seen with oral
corticosteroids.
Topical anti-inflammatory effect
The exact mechanism of action of glucocorticosteroids in the treatment
of asthma is not
fully understood. Anti-inflammatory actions, such as inhibition of
inflammatory mediator
release and inhibition of cytokine-mediated immune response are
probably important.
A clinical study in asthmatics comparing inhaled and oral budesonide
at doses calculated
to achieve similar systemic bioavailability demonstrated statistically
significant evidence
of efficacy with inhaled but not oral budesonide compared with
placebo. Thus, the
therapeutic effect of conventional doses of inhaled budesonide may be
largely explained
by its direct action on the respiratory tract.
In a provocation study pre-treatment with budesonide for four weeks
has shown
decreased bronchial constriction in immediate as well as late
asthmatic reactions.
Onset of effect
After a single dose of orally inhaled budesonide, delivered via dry
powder inhaler,
improvement of the lung function is achieved within a few hours. After
therapeutic use of
orally inhaled budesonide delivered via dry powder inhaler,
improvement in lung function
has been shown to occur within 2 days of initiation of treatment
although maximum benefit
may not be achieved for up to 4 weeks.
Airway reactivity
Budesonide has also been shown to decrease airway reactivity to
histamine and
methacholine in hyperreactive patien