Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
digoxin, Quantity: 0.0625 mg
Aspen Pharma Pty Ltd
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate; povidone; indigo carmine; oxidised maize starch; rice starch
Oral
60 tablets, 200 tablets, 500 tablets (E), 100 tablets (E)
Medicine Registered
(S4) Prescription Only Medicine, Not scheduled. Not considered by committee
INDICATIONS AS AT 26 JULY 2000 : Congestive heart failure - Lanoxin 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. Lanoxin 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 Lanoxin 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 - Lanoxin may relieve or prevent an attack, but its use in paroxysmal ventricular tachycardia is dangerous.
Visual Identification: Blue, biconvex, round tablet, coded "U3A" on the upper face. Bottom face plain.; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
1991-08-02
LANOXIN ® Tablets and Liquid – Consumer Medicine Information Page 1 of 5 LANOXIN ® Tablets & Liquid digoxin CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LANOXIN. 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 LANOXIN 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 IS LANOXIN LANOXIN 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY LANOXIN HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed LANOXIN for another reason. There is no evidence that LANOXIN is addictive. BEFORE YOU TAKE IT When you must not take it DO NOT TAKE LANOXIN 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 LANOXIN 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 LANOXIN IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • intermittent or complete heart block or second degree atrioventricular b Baca dokumen lengkap
LANOXIN – Product Information Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION LANOXIN (DIGOXIN) 1. NAME OF THE MEDICINE Digoxin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION LANOXIN TABLETS contain DIGOXIN 0.250 MG. Excipients with known effect: Sugars (as lactose monohydrate) LANOXIN PG TABLETS contain DIGOXIN 0.0625 MG. Excipients with known effect: Sugars (as lactose monohydrate) LANOXIN PAEDIATRIC ELIXIR: Each mL contains DIGOXIN 0.05 MG. Excipients with known effect: Sugars (as sucrose), alcohol (as ethanol 10.6% v/v) LANOXIN ADULT INJECTION: Each 2 mL contains DIGOXIN 0.50 MG. Excipients with known effect: alcohol (as ethanol 10.6% v/v). LANOXIN INFANTS INJECTION: Each 2 mL contains DIGOXIN 0.05 MG. Excipients with known effect: alcohol (as ethanol 10.6% v/v). For the full list of excipients, see section 6.1 List of excipients 3. PHARMACEUTICAL FORM LANOXIN TABLETS - White, biconvex, round tablet scored and coded "X3A" on the upper face. Bottom face plain. LANOXIN PG TABLETS - Blue, biconvex, round tablet, coded "U3A" on the upper face. Bottom face plain. LANOXIN ELIXIR - Clear, bright yellow liquid with a characteristic odour. Free of obvious visible contamination. LANOXIN ADULT INJECTION - Clear colourless liquid, free of obvious visible contamination. LANOXIN INFANT INJECTION - Clear colourless liquid, free of obvious visible contamination. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CONGESTIVE HEART FAILURE - Lanoxin 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. Lanoxin 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 Lanoxin depresses conduction in the atrioventricular bundle, producing a slower v Baca dokumen lengkap