Nazione: Indonesia
Lingua: indonesiano
Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
GUAIFENESIN; SALBUTAMOL SULFATE
GLAXO WELLCOME INDONESIA - Indonesia
GUAIFENESIN; SALBUTAMOL SULFATE
50/1 MG/5 ML
SIRUP
DUS, BOTOL @ 100 ML
GLAXO WELLCOME INDONESIA - Indonesia
2019-02-22
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 Leggi il documento completo