PULMICORT RESPULES

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

BUDESONIDE

Tersedia dari:

ASTRAZENECA INDONESIA - Indonesia

INN (Nama Internasional):

BUDESONIDE

Dosis:

0,25 MG/ML

Bentuk farmasi:

CAIRAN INHALER

Unit dalam paket:

BOX, 4 PAK @ 5 RESPULES @ 2 ML

Diproduksi oleh:

ASTRAZENECA Pharmaceuticals - Sweden

Tanggal Otorisasi:

2016-04-28

Karakteristik produk

Pulmicort
 Product Information (budesonide for inhalation), sterile
1 (12)
PULMICORT

(budesonide for oral inhalation)
Sterile
PRODUCT INFORMATION
QUALITATIVE & QUANTITATIVE COMPOSITION
One single dose unit contains 0.5 mg or 1.0 mg budesonide per 2 mL.
For excipients, see section LIST OF EXCIPIENTS.
PHARMACEUTICAL FORM
Sterile nebuliser suspension. White to off-white suspension in plastic
single dose units.
NAME OF THE DRUG
The active ingredient, budesonide, is a non-halogenated glucocorticoid
structurally related to
16
α
hydroxyprednisolone. The chemical name is 16
α
, 17
α
- 22R,
S-propylmethylenedioxy-pregna-1, 4-diene-11
β
, 21-diol-3, 20-dione; MW 430.5.
O
H
3
C
HO
H
3
C
C
CH
2
OH
O
O
C
O
H
CH
2
CH
2
CH
3
CAS Number: 51333-22-3
DESCRIPTION
Budesonide is a white to off-white powder, freely soluble in
chloroform, sparingly soluble in
ethanol and practically insoluble in water and heptane. Budesonide
melts with
decomposition between 224
°
C and 231.5
°
C.
PULMICORT RESPULES nebulising suspension for inhalation is a white to
off-white
suspension in plastic single dose units. PULMICORT RESPULES contain
budesonide 0.5
mg/2 mL or 1.0 mg/2 mL as the active ingredient plus, disodium
edetate, sodium chloride,
polysorbate 80 (E433) citric acid
–
anhydrous (E330), sodium citrate (E331) and water for
injections.
PHARMACOLOGY
Pharmacotherapeutic group: Inhalation drugs for obstructive airway
diseases.
ATC-code R03B A02
PULMICORT is a corticosteroid for inhalation use in the treatment and
prophylaxis of
asthma.
Studies in animals and humans have shown an advantageous ratio between
topical
anti-inflammatory activity and systemic glucocorticoid effect over a
wide dose range. This is
explained by the extensive first pass hepatic degradation of
budesonide after systemic
Pulmicort
 Product Information (budesonide for inhalation), sterile
2 (12)
absorption, approximately 85
–
90%, in combination with the low potency of formed
metabolites.
Budesonide is approximately twice as potent as beclomethasone
dipropion