البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
eplerenone, Quantity: 50 mg
Viatris Pty Ltd
Eplerenone
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; hypromellose; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400
Oral
10, 30, 50, 60
(S4) Prescription Only Medicine
INSPRA is indicated: To reduce the risk of cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3-14 days of an acute myocardial infarction (see CLINICAL TRIALS and DOSAGE AND ADMINISTRATION). To reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF less than or equal to 30% or LVEF less than or equal to 35% in addition to QRS duration of greater than 130 msec), in addition to standard optimal therapy (see CLINICAL TRIALS).
Visual Identification: Arc-diamond shape, yellow, film-coated tablet with the following debossing: 'Pfizer' on one side of the tablet, 'NSR' over '50' on the other; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-06-22
INSPRA ® (IN-SPRA) _Eplerenone_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Inspra. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Inspra against the benefits it is expected to 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 INSPRA IS USED FOR _WHAT INSPRA DOES_ • THIS MEDICINE IS USED TO TREAT HEART FAILURE IN PATIENTS WHO HAVE EXPERIENCED A HEART ATTACK. A heart attack occurs when one of the major blood vessels supplying blood to your heart becomes blocked. This means that your heart cannot receive the oxygen it needs and becomes damaged. This may lead to further problems, such as heart failure, irregular heart rhythms and blood clots. Heart failure means that the heart muscle is weak and cannot pump blood strongly enough to supply all the blood needed throughout the body. Heart failure is not the same as heart attack, and may start off with mild or no symptoms, but as the condition progresses, patients may feel short of breath or may get tired easily after light physical activity such as walking. Some patients may wake up short of breath at night, or have to prop their heads up during sleep to avoid this problem. Fluid may collect in different parts of the body, often first noticed as swollen ankles and feet. • THIS MEDICINE IS ALSO USED TO REDUCE THE RISK OF DEATH OR NEED FOR HOSPITALISATIONS DUE TO HEART FAILURE IN PATIENTS WITH CHRONIC HEART FAILURE. _HOW INSPRA WORKS_ Your body makes a substance called aldosterone. It is important for regulating blood pressure and is one of the factors involved in heart function. Sometimes aldosterone can cause changes in our body that lead to heart failure. Inspra works by blocking the action of aldosterone, and slowing the progress اقرأ الوثيقة كاملة
Version: ujpinspt10821 Supersedes: pfpinspt11219 Page 1 of 26 AUSTRALIAN PRODUCT INFORMATION – INSPRA ® (EPLERENONE) 1. NAME OF THE MEDICINE Eplerenone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each INSPRA tablet contains 25 or 50 mg eplerenone. EXCIPIENT(S) WITH KNOWN EFFECT lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tablet, film coated INSPRA is supplied as yellow, arc diamond, film-coated tablets containing 25 or 50 mg eplerenone. 25 MG TABLET: stylised with ‘NSR’ over ‘25’ on one side and ‘Pfizer’ on the other. 50 MG TABLET: stylised with ‘NSR’ over ‘50’ on one side and ‘Pfizer’ on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INSPRA is indicated: • to reduce the risk of cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3-14 days of an acute myocardial infarction (see Section 4.2 Dose and method of administration and Section 5.1 Pharmacodynamic properties - Clinical trials). • to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA Class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30% or LVEF ≤35% in addition to QRS duration of > 130 msec), in addition to standard optimal therapy (see Section 5.1 Pharmacodynamic properties - Clinical trials). Version: ujpinspt10821 Supersedes: pfpinspt11219 Page 2 of 26 4.2 DOSE AND METHOD OF ADMINISTRATION FOR POST-MYOCARDIAL INFARCTION HEART FAILURE PATIENTS INSPRA is usually administered in combination with standard therapies. The recommended dose of INSPRA is 50 mg once daily. Treatment should be initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks as tolerated by the patient. In the pivotal clinical study EPHESUS, eplerenone was added to standard medical therapy within 3-14 days after an acute qualifying myocardial infarction. There is evidence that t اقرأ الوثيقة كاملة