מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
atenolol, Quantity: 5 mg/mL
AFT Pharmaceuticals Pty Ltd
Atenolol
Oral Liquid, solution
Excipient Ingredients: propylene glycol; propyl hydroxybenzoate; saccharin sodium; purified water; citric acid monohydrate; sorbitol solution (70 per cent) (non-crystallising); sodium citrate dihydrate; methyl hydroxybenzoate; Flavour
Oral
300 mL
Medicine Registered
(S4) Prescription Only Medicine
All grades of hypertension including hypertension of renal origin.,Frequent disabling angina without evidence of cardiac failure,Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including those with acute myocardial infarction),Myocardial infarction - late intervention (beta-blocker class effect greater than 12 hours after onset of chest pain)
Visual Identification: Clear colourless slightly viscous liquid with lemon-lime flavour; Container Type: Bottle; Container Material: Plastic; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2012-08-03
Atenolol-AFT Atenolol 50 mg/10 mL, Oral solution What is in this leaflet This leaflet answers some common questions about Atenolol-AFT. It does not contain all 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 taking Atenolol-AFT against the benefits they expect it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. What Atenolol-AFT is used for Atenolol belongs to a group of medicines called beta-blockers. It makes the heart beat slower and less forcefully reducing the amount of oxygen required by the heart and the volume of blood it has to pump. This results in lower blood pressure. It widens the blood vessels in the body, causing blood pressure to fall. It helps the heart to beat more regularly. Atenolol-AFT is used to: • lower high blood pressure (hypertension) • prevent angina • treat irregular heart rhythm or beat (arrhythmias) • treat heart attacks, or reduce the risk of heart complications following a heart attack Atenolol-AFT may be used alone or in combination with other medicines to treat your condition. Atenolol-AFT may also be used in emergency situations or during surgery to treat a fast heart beat before, during or after surgery. Hypertension: Everybody has blood pressure. Blood pressure helps to move the blood around your body. Your blood pressure will change during the day, depending on how busy you are or how you are feeling. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed. Regular blood pressure checks are the only way to know if you have hypertension. There are usually no symptoms with hypertension and you may feel fine. If hypertension is not treated, serious health problems e.g. stroke, heart disease and kidney failure may occur. Atenolol-AFT helps to lower you קרא את המסמך השלם
Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION ATENOLOL-AFT (ATENOLOL) ORAL SOLUTION 1. NAME OF THE MEDICINE Atenolol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Atenolol-AFT, oral solution, contains 50 mg atenolol per 10 mL of the solution. Atenolol is a white or to almost white crystalline powder which is sparingly soluble in water, soluble in ethanol and slightly soluble in methylene chloride. The pKa for atenolol is 9.6. Atenolol-AFT, oral solution also contains sorbitol solution (70 per cent) (non-crystallising), methyl hydroxybenzoate, propyl hydroxybenzoate, sodium saccharin, citric acid monohydrate, sodium citrate, propylene glycol and lemon lime flavour PHL0132956 (Proprietary Ingredient 11570). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Atenolol-AFT, oral solution is a clear, colourless, slightly viscous liquid with a lemon-lime odour and flavour which contains 50 mg Atenolol per 10 mL of solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • All grades of hypertension, including hypertension of renal origin. • Frequent disabling angina without evidence of cardiac failure. • Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including those associated with acute myocardial infarction). • Myocardial infarction - Late intervention (β-blocker class effect greater than 12 hours after onset of chest pain) 4.2 DOSE AND METHOD OF ADMINISTRATION Dose While literature suggests that atenolol as an oral liquid behaves in the same way as atenolol tablets, no data directly comparing the bioavailability of Atenolol-AFT with atenolol tablets is available. Dose titration should be undertaken in a controlled manner and patients changing from the tablets to the oral liquid (or vice versa) should be monitored with the dosage being adjusted as appropriate. Page 2 of 14 Given the possibility of more calibrated dose titration with an oral solution, it may be appropriate to initiate doses at less than 50 mg. However, this would require an individua קרא את המסמך השלם