国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMIODARONE HYDROCHLORIDE
IMEKS PHARMA SDN. BHD.
AMIODARONE HYDROCHLORIDE
50 Tablets; 20 Tablets; 100 Tablets
Salutas pharma GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ AMIOHEXAL 200 Amiodarone hydrochloride (200mg) WHAT IS IN THIS LEAFLET 1. What Amiohexal is used for 2. How Amiohexal works 3. Before you use Amiohexal 4. How to use Amiohexal 5. While you are using it 6. Side effects 7. Storage and Disposal of Amiohexal 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT AMIOHEXAL IS USED FOR Amiohexal contains the active ingredient Amiodarone hydrochloride. Amiohexal is used to control fast or irregular heartbeat. HOW AMIOHEXAL WORKS Amiohexal belongs to the group of medicines called antiarrhythmics. It works by lengthening the gap between one heart beat and the next, thus helping to bring the heart rate to a slower and more regular pace. BEFORE YOU USE AMIOHEXAL_ _ _- When you must not use it _ Do not take Amiohexal if you: • Have ever had allergic reaction to Amiodarone hydrochloride, the active ingredient or to any other ingredients in Amiohexal. • Have ever had allergic reaction to iodine • Disease of thyroid gland • Hypokalemia (low level of potassium salt in blood) • Sinus bradycardia (very slow heart beat) • Have any other heart problems particularly involving regulation of heart beat. If you are using pacemaker, your doctor may allow the use of it • Are pregnant, think you are pregnant or planning to become pregnant or are breastfeeding _ _ _- Before you start to use it _ Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you: • Have a history of swelling of the face, lips, tongue, throat, hands or feet • Have any breathing problems or asthma • Suffer from any liver problems • Suffer from any thyroid problems • Have any eyes problems • Have low blood pressure • Other heart conditions • Are about to have an operation • Planning to become pregnant or are pregnant or are breastfeeding • An elderly patient If you are not sure whether you should start taking this medicine, consult your d 阅读完整的文件
DIRECTION FOR USE PLEASE READ CAREFULLY! Each AMIOHEXAL 200 TABLET contains Amiodarone HCl 200 mg. DESCRIPTION White, round tablets, biconvex with one-sided score notch. INDICATIONS - Symptomatic and tachycardiac supraventricular disturbances of heart rhythm such as AV-junctional tachycardias, supraventricular tachycardias associated with Wolff-Parkinson-White syndrome or paroxysmal atrial fibrillation when other drugs cannot be used. - Severe symptomatic ventricular tachycardiac ventricular disturbances of heart rhythm. RECOMMENDED DOSAGE AMIOHEXAL 200 is a highly toxic drug; therefore the lowest effective dosage should be used so as to minimise the risk and occurrence of adverse effects. Dosage of amiodarone hydrochloride must be carefully adjusted according to individual requirements and response, patient tolerance, and the general condition and cardiovascular status of the patient. Clinical and ECG monitoring of cardiac function, is recommended during therapy with the drug. When dosage adjustment is necessary, the patient should be monitored closely for an extended period of time because of the long and variable elimination half-life of amiodarone and the difficulty in predicting the length of time required to attain a new steady-state plasma concentration of the drug. LOADING DOSE: 600 mg amiodarone (corresponding to 3 tablets of AMIOHEXAL 200) per day for 8-10 days; in some cases, dosages of up to 1200 mg amiodarone (corresponding to 6 tablets of AMIOHEXAL 200) may be required per day. The dosage is then reduced gradually to maintenance dose. It is recommended to perform loading-dose phase of therapy in a hospital setting. MAINTENANCE DOSE: Usually 200 mg amiodarone (corresponding to 1 tablet of AMIOHEXAL 200) per day for 5 days per week, with a pause of 2 days, and this is possible due to prolonged half-life of amiodarone. AMIOHEXAL 200 may also be given on every second day (1 tablet of AMIOHEXAL 200 may be given on every second day when a dose of 100 mg daily is recommended). In some cases, higher dosages 阅读完整的文件