Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SALBUTAMOL SULPHATE
SM PHARMACEUTICALS SDN. BHD.
SALBUTAMOL SULPHATE
100ml mL; 60ml mL
SM PHARMACEUTICALS SDN. BHD.
PLEASE REFER TO E12 Lees het volledige document
Package Insert Page 1 of 5 SM PHARMACEUTICALS SDN. BHD. BREATHNINE (SALBUTAMOL SULPHATE) SYRUP 2 MG / 5 ML DESCRIPTION: A clear, red coloured liquid with sweet taste and raspberry flavour. COMPOSITION: Salbutamol Sulphate equivalent to 2mg / 5ml Salbutamol. ACTIONS AND MODE OR MECHANISMS OF ACTION: A direct-acting sympathomimetic amine. Acts relatively selectively on beta 2 adrenergic receptors in the lungs to relax bronchiol smooth muscle, thereby relieving bronchospasm and reducing airway resistance. Also relaxes smooth muscle of the uterus and vascular supply to the skeletal muscle. These actions are believed to result from increased production of cyclic adenosine 3'5' monophosphate (cylic 3'5' -AMP) caused by activation of the enzyme adenyl cyclase. PHARMACOLOGY (SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS): Absorption - Well absorbed from the gastrointestinal tract. Metabolism - Hepatic, primarily to salbutamol 4'-0 sulfate which has little or no beta- adrenergic blocking activity.. Half life - (plasma) 2.7 to 5 hours. Onset of action - within 30 minutes Time to peak plasma concentration - within 2 to 3 hours following a 6 mg of tritiated salbutamol sulphate. Time to peak effect – 2 to 3 hours. Duration of action – 6 hours or longer. Excretion - Renal; approximately 76% of oral dose excreted over 3 days in the urine, the majority of dose being excreted within the first 24 hours, consisting of 60% as metabolites. Faecal; About 4% of oral dose may be excreted in the faeces. INDICATIONS: a. Relief of broncial asthma b. Chronic bronchitis c. Emphysema d. Acute dyspnea CONTRAINDICATIONS: Use of this medication should be carefully considered when the following medical problems exist (reasons given where appropriate). Cardiovascular disorders, including coronary insufficiency and hypertension. Package Insert Page 2 of 5 Diabetes mellitus, Enlarged prostate, Hyperthyroidism. SIDE EFFECTS / ADVERSE REACTIONS: Fine tremor (usually hands), nervous tension, headache, peripheral vasodilation, tachycardia (seldom Lees het volledige document