VENTOLIN EXPECTORANT

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Unit dalam paket:

DUS, 1 BOTOL PLASTIK @ 100 ML

Tanggal Otorisasi:

2022-07-24

Karakteristik produk

Page 1 of 5
VENTOLIN™ EXPECTORANT
SALBUTAMOL
GUAIPHENESIN
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
2 mg salbutamol, as sulphate, and 100 mg guaiphenesin in each 10 mL of
syrup.
2. PHARMACEUTICAL FORM
Syrup (sugar free).
3. CLINICAL PARTICULARS
3.1 INDICATIONS
Salbutamol
is
a
selective
beta-
2
adrenoceptor
agonist.
At
therapeutic
doses
it
acts
on
the
beta-
2
adrenoceptors of bronchial muscle, with little or no action on the
beta-
1
adrenoceptors of the heart. The
combination of salbutamol with guaiphenesin is designed to relieve
respiratory obstruction and improve
pulmonary ventilation.
Bronchodilators should not be the only or main treatment in patients
with severe or unstable asthma. Severe
asthma requires regular medical assessment as death may occur.
Patients with severe asthma have
constant symptoms and frequent exacerbations, with limited physical
capacity, and PEF values below 60%
predicted at baseline with greater than 30% variability, usually not
returning entirely to normal after a
bronchodilator. These patients will require high dose inhaled (e.g
greater than 1 mg/day beclometasone
dipropionate)
or
oral
corticosteroid
therapy.
Sudden
worsening
of
symptoms
may
require
increased
corticosteroid dosage which should be administered under urgent
medical supervision.
Respiratory disorders where bronchospasm and excessive secretion of
tenacious mucus are complicating
factors, e.g. bronchial asthma, chronic bronchitis and emphysema.
3.2 DOSAGE AND ADMINISTRATION
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Increasing use of beta-
2
agonist may be a sign of worsening asthma. Under these conditions a
reassessment
of the patient’s therapy plan may be required and concomitant
glucocorticosteroid therapy should be
considered.
As
there
may
be
adverse
effects
associated
with
excessive
dosing,
the
dosage
or
frequency
of
administration should only be increased on medical advice.
POPULATIONS
The volumes of syrup quoted are based on a formulation strength of 2
mg salbutamol per 10 mL of syru