Arrow - Salbutamol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Salbutamol 0.12%{relative} (as salbutamol sulphate)

Available from:

Actavis New Zealand Limited

INN (International Name):

Salbutamol 0.12% w/v (as salbutamol sulphate)

Dosage:

2.5 mg/2.5mL

Pharmaceutical form:

Solution for inhalation

Composition:

Active: Salbutamol 0.12%{relative} (as salbutamol sulphate) Excipient: Sodium chloride Sulfuric acid Water for injection

Units in package:

Ampoule, plastic, 2.5 mL LDPE with twist off seal, packaged in strips of 10 with Al foil overwrap, 20 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sicor (Societa Italiana Corticosteroidi) Srl

Product summary:

Package - Contents - Shelf Life: Ampoule, plastic, 2.5 mL LDPE with twist off seal, packaged in strips of 10 with Al foil overwrap - 20 dose units - 2 years unopened stored at or below 25°C protect from light 3 months opened stored at or below 25°C protect from light - Ampoule, plastic, 2.5 mL LDPE with twist off seal, packaged in strips of 10 with Al foil overwrap - 30 dose units - 2 years unopened stored at or below 25°C protect from light 3 months opened stored at or below 25°C protect from light

Authorization date:

2006-05-17

Summary of Product characteristics

ARROW – SALBUTAMOL 
DESCRIPTION 
Salbutamol (as salbutamol sulfate).  The chemical name for salbutamol sulfate 1-(4-
hydroxy-3-hydroxymethylphenyl)-2-(t-butylamino)-ethanol sulfate. Its structural 
formula is: 

2 
(C
13
H
21
NO
3
)
2
,H
2
SO
4
 Molecular weight:  576.7 

CAS No.: 51022-70-9 
Salbutamol sulfate is a white or almost white odourless powder. It is soluble in 4 
parts of water, slightly soluble in 95% alcohol, in chloroform and solvent ether. 
Approximately 1.2mg of salbutamol sulfate is equivalent to 1 mg of salbutamol. 
PRESENTATION 
The inhalation is presented in ampoules containing a sterile, clear aqueous isotonic, 
preservative-free nebuliser solution for single use.  Each ampoule of Arrow - 
Salbutamol ampoules 2.5 mg/2.5 mL contains salbutamol sulfate equivalent to 2.5 
mg of salbutamol.  Each ampoule of Arrow - Salbutamol 5 mg/2.5 mL contains 
salbutamol sulfate equivalent to 5mg of salbutamol.  Each ampoule also contains the 
inactive ingredients sodium chloride and sulfuric acid in 2.5 mL. 
CLINICAL PARTICULARS 
_ACTIONS _
Salbutamol is a short-acting, relatively selective beta
2
-adrenoceptor agonist. 
Administration by inhalation results in direct stimulation of beta
2
-adrenoceptors in 
bronchial smooth muscle and hence bronchodilation.  This is thought to be due to 
stimulation of adenyl cyclase by salbutamol, resulting in increased levels of cyclic 
AMP within cells.  These are thought to inhibit the entry of calcium ions into the cells, 
thus inhibiting smooth muscle contraction.  High levels of cyclic AMP in mast cells 
may also inhibit the release of histamine and slow reacting substance-A (SRS-A).  
After administration of salbutamol, stimulation of both beta
1
- and beta
2
-adrenoceptors 
o