Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
digoxin, Quantity: 250 microgram
Aspen Pharma Pty Ltd
Tablet, uncoated
Excipient Ingredients: magnesium stearate; rice starch; lactose monohydrate; oxidised maize starch; hydrolysed maize starch
Oral
100 tablets
(S4) Prescription Only Medicine
Congestive heart failure - Sigmaxin is useful regardless of whether the failure is predominantly of the left or right ventricle, or involves both sides of the heart. It is particularly useful in heart failure resulting from chronic overload (hypertension, valvular lesions, atherosclerotic heart disease) in which the supply of energy is not impaired. Sigmaxin does not cause major benefit in situations in which the metabolic energy supply is compromised as in thyrotoxicosis, hypoxia, and severe thiamine deficiency. Atrial fibrillation - Because Sigmaxin depresses conduction in the atrioventricular bundle, producing a slower ventricular beat, it is valuable in atrial fibrillation. It will frequently convert atrial flutter into fibrillation and, upon withdrawal of the drug, normal sinus rhythm may be restored. Paroxysmal atrial tachycardia - Sigmaxin may relieve or prevent an attack, but its use in paroxysmal ventricular tachycardia is dangerous.
Visual Identification: White, biconvex, round tablet scored and coded "X3A" on the upper face. Bottom face plain.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2002-07-29
SIGMAXIN- Consumer Medicine Information Page 1 of 4 SIGMAXIN digoxin CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SIGMAXIN . 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 SIGMAXIN 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 SIGMAXIN IS USED FOR SIGMAXIN belongs to a group of medicines known as cardiac glycosides. They work by slowing down the rate while increasing the force of your heart when it beats. It is used to treat certain heart problems, such as: CHRONIC HEART FAILURE Heart failure is when your heart can’t pump strongly enough to supply blood needed through out the whole body. It is not the same as a heart attack and does not mean that your heart stops. CERTAIN TYPE OF IRREGULAR HEART BEATS Irregular heart rhythms caused by an electrical problem in the upper chamber of your heart. They cause your heart to beat too fast or in an uneven way. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SIGMAXIN HAS BEEN PRESCRIBED FOR YOU. There is no evidence that SIGMAXIN is addictive. BEFORE YOU TAKE IT WHEN YOU MUST NOT TAKE IT DO NOT TAKE SIGMAXIN IF YOU HAVE AN ALLERGY TO: digoxin or other cardiac glycosides any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction to SIGMAXIN may include: shortness of breath, wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body skin rash, itching or hives DO NOT TAKE SIGMAXIN IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: intermittent or complete heart block or second degree atrioventricular block, (conditions Read the complete document
SIGMAXIN- Product Information Page 1 of 19 AUSTRALIAN PRODUCT INFORMATION SIGMAXIN (DIGOXIN) 1. NAME OF THE MEDICINE Digoxin 2. QUALITATIVE AND QUANTITAIVE COMPOSITION SIGMAXIN TABLETS contain DIGOXIN 0.250 MG, Lactose, maize starch, hydrolyzed maize starch, rice starch, magnesium stearate. SIGMAXIN PG TABLETS contain DIGOXIN 0.0625 MG, Lactose, maize starch, hydrolyzed maize starch, rice starch, magnesium stearate, povidone, colouring (indigo carmine - CI73015). Excipients with known effect: Sigmaxin and Sigmaxin PG contain sugars (as lactose) 3. PHARMACEUTICAL FORM TABLETS, 250 microgram (white, biconvex, round tablet, scored and coded “X3A” on upper face, bottom face plain): 100s. PG (PAEDIATRIC/GERIATRIC) TABLETS, 62.5 microgram (blue, biconvex, round tablet, coded ”U3A” on upper face, bottom face plain): 200s. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CONGESTIVE HEART FAILURE - Digoxin is useful regardless of whether the failure is predominantly of the left or right ventricle, or involves both sides of the heart. It is particularly useful in heart failure resulting from chronic overload (hypertension, valvular lesions, atherosclerotic heart disease) in which the supply of energy is not impaired. Digoxin does not cause major benefit in situations in which the metabolic energy supply is compromised as in thyrotoxicosis, hypoxia, and severe thiamine deficiency. ATRIAL FIBRILLATION - Because Digoxin depresses conduction in the atrioventricular bundle, producing a slower ventricular beat, it is valuable in atrial fibrillation. It will frequently convert atrial flutter into fibrillation and, upon withdrawal of the drug, normal sinus rhythm may be restored. PAROXYSMAL ATRIAL TACHYCARDIA - Digoxin may relieve or prevent an attack, but its use in paroxysmal ventricular tachycardia is dangerous. 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage of Digoxin must be adjusted individually for each patient and the suggested doses are intended only as a guide. Use of the drug in heart failure should be based on Read the complete document