Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
salbutamol sulfate
Alphapharm Pty Ltd
Registered
ASMOL UNI-DOSE _contains the active ingredient salbutamol (sulphate)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Asmol uni-dose. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you using Asmol uni-dose against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT ASMOL UNI-DOSE IS USED FOR Asmol uni-dose are plastic ampoules which contain a medicine called salbutamol, as a liquid. The liquid is changed into a fine mist of droplets by the nebuliser. Asmol uni-dose is used for the treatment of asthma, bronchitis and other breathing problems. In people who have difficulty breathing during exercise, Asmol uni-dose may also be used before exercise to keep the air passages open. Your doctor may have prescribed Asmol uni-dose for another purpose. Ask your doctor if you have any questions about why Asmol uni-dose has been prescribed for you. It belongs to a group of medicines called bronchodilators or beta-2 agonists. When your chest is tight or when you are wheezing, Asmol uni- dose is inhaled into the lungs and works rapidly to open up the air passages in your lungs to help you breathe more easily. The medicine in Asmol uni-dose gives fast relief from your chest symptoms and is often called a 'reliever' medicine. There is no evidence that Asmol uni- dose is addictive. BEFORE YOU USE ASMOL UNI-DOSE _WHEN YOU MUST NOT USE IT_ DO NOT USE ASMOL UNI-DOSE IF YOU HAVE AN ALLERGY TO ANY MEDICINE CONTAINING SALBUTAMOL. DO NOT TAKE ASMOL UNI-DOSE TO STOP A MISCARRIAGE OR PREMATURE LABOUR. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body Aqra d-dokument sħiħ
ASMOL UNI-DOSE _Salbutamol (sulfate)_ PRODUCT INFORMATION NAME OF MEDICINE The active ingredient of Asmol uni-dose is salbutamol (as sulfate). The chemical name for salbutamol sulfate is: 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(t-butylamino)ethanol sulfate. Its structural formula is: Molecular formula: Molecular Weight: CAS Registry No.: (C 13 H 21 NO 3 ) 2 H 2 SO 4 288.4 51022-70-9 DESCRIPTION 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. PHARMACOLOGY Salbutamol is a relatively selective β 2 -adrenoreceptor stimulant. It is more specific than both isoprenaline and orciprenaline for adrenergic β 2 -receptors. After oral and parenteral administration, stimulation of the β -receptors in the body, both β 1 and β 2 , occurs because: (a) β 2 selectivity is not absolute, and (b) higher concentrations of salbutamol occur in the regions of these receptors with these modes of administration. This results in the β 1 effect of cardiac stimulation, though not so much as with isoprenaline, and β 2 effects of peripheral vasodilation and hypotension, skeletal muscle tremor and uterine muscle relaxation. Metabolic effects such as hyperinsulinaemia and hyperglycaemia also may occur, although it is not known whether these effects are mediated by β 1 - or β 2 -receptors. The serum potassium levels have a tendency to fall. PHARMACOKINETICS Following inhalation, salbutamol acts topically on bronchial smooth muscle and initially the drug is undetectable in the blood. After 2 to 3 hours, low concentrations are seen, due presumably to the portion of the dose which is swallowed and absorbed in the gut. The elimination half-life of inhaled or oral salbutamol is between 2.7 and 5 hours. CHOH.CH 2 .NHC(CH 3 ) 3 HOH 2 C HO H 2 SO 4 2 ASMOL uni-dose – Product Information 2 Salbutamol is not metabolised in the lung but is converted to the 4'-o-sulphate ester in the liver. Salbutamol is excreted in the urine as free Aqra d-dokument sħiħ