Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
levothyroxine sodium, Quantity: 0.2 mg
Aspen Pharma Pty Ltd
levothyroxine sodium
Tablet, uncoated
Excipient Ingredients: magnesium stearate; dextrin; lactose monohydrate; maize starch
Oral
150 tablets, 200
(S4) Prescription Only Medicine
OROXINE is indicated for the management of demonstrated thyroid hormone deficiency.,OROXINE is also used to suppress thyrotropin (TSH) for the management of TSH-responsive tumours of the thyroid.
Visual Identification: White, biconvex, round tablet, scored and marked "200" on one side , plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2006-05-17
EUTROXSIG - Consumer Medicine Information Page 1 of 4 EUTROXSIG ® _levothyroxine sodium tablets _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about EUTROXSIG tablets. It does not contain all the available information about the medicine. 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 EUTROXSIG against the benefits they expect it will have. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS EUTROXSIG USED FOR _ _ EUTROXSIG is available in tablets of four different strengths: 50 micrograms, 75 micrograms, 100 micrograms and 200 micrograms. The active ingredient in EUTROXSIG is levothyroxine sodium, which is a thyroid hormone. It is used as replacement therapy in the treatment of thyroid hormone deficiency. EUTROXSIG is used to treat: 1. Thyroid hormone deficiency also known as hypothyroidism. Hypothyroidism is a disease in which the thyroid gland is underactive and does not produce enough thyroxine, a hormone, which is important for controlling your metabolism. Symptoms of hypothyroidism include tiredness, muscle weakness and cramps; feeling the cold; a slow heart rate; dry and flaky skin; hair loss; a deep husky voice and weight gain. 2. TSH-responsive tumours (certain tumours of the thyroid gland) of the thyroid. For these conditions to be treated, patients need a supply of thyroid hormones in their body. EUTROXSIG replaces the shortage of thyroid hormones. USE EUTROXSIG ONLY AS DIRECTED. Your doctor may have prescribed the medicine for another condition. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor’s prescription. BEFORE YOU TAKE IT _ _ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE EUTROXSIG IF YOU ARE ALLERGIC TO: • levothyroxine sodium or any other thyroid h Prečítajte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION – EUTROXSIG (LEVOTHYROXINE SODIUM) TABLETS 1 NAME OF THE MEDICINE Levothyroxine sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EUTROXSIG tablets are available in four strengths and contain levothyroxine sodium 50, 75, 100 or 200 micrograms as the active ingredient. They also contain the following excipients: maize starch, lactose monohydrate, dextrin and magnesium stearate. 3 PHARMACEUTICAL FORM White, biconvex, round tablets. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS EUTROXSIG is indicated for the management of demonstrated thyroid hormone deficiency. EUTROXSIG is also used to suppress thyrotropin (TSH) for the management of TSH- responsive tumours of the thyroid. 4.2 D OSE AND METHOD OF ADMINISTRATION Thyroxine is best taken as a single daily dose first thing in the morning. It should be taken with water and on an empty stomach, and at least 30 minutes and preferably 60 minutes before the intake of any food or other medications. Thyroxine is best ingested in the fasting state, as food will impair absorption. The dose should be individualised on the basis of clinical response and biochemical tests. Regular monitoring of TSH and thyroxine is recommended when starting therapy or changing the dose. ADULTS INITIAL DOSE Commence with thyroxine 50 to 100 micrograms daily. Increase the daily dose by 25 to 50 micrograms according to response at not less than 4-weekly intervals, up to 100 to 200 micrograms daily. In patients aged 60 years and over and in those with ischaemic heart disease, thyroxine therapy should normally be initiated with low doses (25 or 50 μg/day). Wherever possible, whole tablets should be taken (e.g. if the dose required is 150 µ g then 1 x 100 µ g tablet and 1 x 50 µ g tablet should be taken, rather than 1½ x 100 µ g tablets). 2 When there is no contraindication to full thyroxine replacement, a TSH level of about 1 mU/L with a serum thyroxine level in the high-normal range, usually indicates optimal therapy. MAINTENANCE DOSES ADULTS: 100 to 200 Prečítajte si celý dokument