Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
amiodarone hydrochloride, Quantity: 200 mg
Alphapharm Pty Ltd
Tablet, uncoated
Excipient Ingredients: povidone; lactose monohydrate; purified talc; microcrystalline cellulose; crospovidone; magnesium stearate; colloidal anhydrous silica
Oral
30 tablets
(S4) Prescription Only Medicine
Severe cases of tachyarrhythmias (e.g. Wolff-Parkinson-White syndrome; supraventricular, nodal and ventricular tachycardias; atrial flutter and fibrillation; ventricular fibrillation) not responding to other therapy. Treatment should be initiated in hospital. It is recommended that the patient should be regularly monitored for possible toxicity (e.g. thyroid function, chest X-ray, ophthalmological examination, liver function etc.) during the entire course of therapy and for several months after discontinuation.
Visual Identification: Normal convex white uncoated tablets marked "AM" breakline "200" on one side and "G" on the reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1991-10-30
ARATAC _amiodarone hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Aratac. 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 Aratac against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT ARATAC IS USED FOR Aratac is used to control a fast or irregular heart beat. Aratac belongs to a group of medicines called antiarrhythmics. It works by lengthening the gap between one heartbeat and the next, helping to bring the heart rate to a slower and more regular pace. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY ARATAC HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Aratac for another reason. Aratac is not recommended for use in children, as its safety and effectiveness in children has not been established. Aratac is available only with a doctor's prescription. There is no evidence that Aratac is addictive. BEFORE YOU TAKE ARATAC _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ARATAC IF YOU ARE ALLERGIC TO: • AMIODARONE HYDROCHLORIDE (EG. CORDARONE X) • IODINE • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, coughing, an asthma attack or hayfever. DO NOT TAKE ARATAC IF YOU HAVE OR HAVE HAD ANY THYROID PROBLEMS. DO NOT TAKE ARATAC IF YOU HAVE HEART PROBLEMS THAT MAY CAUSE YOU TO FAINT. If you have a pacemaker, your doctor may allow the use of it. DO NOT TAKE ARATAC IF YOU HAVE ANY IF THE FOLLOWING: • low blood pressure • heart disease or failure. • severe problems in breathing respiratory failure • shock DO NOT TAKE ARATAC IF YOU ARE P Pročitajte cijeli dokument
AUSTRALIAN PRODUCT INFORMATION ARATAC _Amiodarone hydrochloride _ 1 NAME OF THE MEDICINE Amiodarone hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amiodarone hydrochloride is a Class III antiarrhythmic agent. Aratac 100 and Aratac 200 tablets contain 100 mg and 200 mg amiodarone hydrochloride, as the active ingredient, respectively. List of excipients with known effect: Aratac also contains sulfites and sugars as lactose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Aratac 100: White, marked "AM" breakline "100" on one side and "G" on other. Aratac 200: White, marked "AM" breakline "200" on one side and "G" on other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe cases of tachyarrhythmias (e.g. Wolff-Parkinson-White syndrome; supraventricular, nodal and ventricular tachycardias; atrial flutter and fibrillation; ventricular fibrillation) not responding to other therapy. Treatment should be initiated in hospital. It is recommended that the patient should be regularly monitored for possible toxicity (e.g. thyroid function, chest X-ray, ophthalmological examination, liver function etc.) during the entire course of therapy and for several months after discontinuation. 4.2 DOSE AND METHOD OF ADMINISTRATION Due to poor absorption and wide inter-patient variability of absorption, the initial loading and subsequent maintenance dosage schedules of the drug in clinical use has to be individually titrated. It is particularly important that the minimum effective dose be used. In all cases the patient's management must be judged on the individual response and well being. The following dosage regimen is usually effective. ADULTS Initial Stabilisation. Treatment should be started with 200 mg three times daily and may be continued for 1 week. The dosage should then be reduced to 200 mg twice daily for a further week. Maintenance. After the initial period the dosage should be reduced to 200 mg daily, or less if appropriate. Rarely, the patient may require a higher Pročitajte cijeli dokument