Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
THYROXINE SODIUM
IDAMAN PHARMA SDN. BHD.
THYROXINE SODIUM
100Tablet Tablets; 200Tablet Tablets; 500Tablet Tablets
Sriprasit Pharma Co. Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ THYROSIT TABLET ® Thyroxine sodium (100 mcg) 1 WHAT IS IN THE LEAFLET 1. What _Thyrosit_ is used for 2. How _Thyrosit_ works 3. Before you use _ Thyrosit_ 4. How to use _Thyrosit_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _ Thyrosit_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT _THYROSIT_ IS USED FOR _Thyrosit_ is used as replacement therapy to treat thyroid hormone deficiency known as hypothyroidism. _Thyrosit_ is also used in conditions where there is a shortage of thyroid hormones supply in the body. _Thyrosit_ is also used to treat goitre or chronic lymphocytic thyroiditis, conditions in which the thyroid gland becomes enlarged causing a swelling in the front of the neck. HOW _THYROSIT_ WORKS _Thyrosit_ contains the active ingredient thyroxine sodium, which is a thyroid hormone. Thyroxine is an essential hormone produced by thyroid gland in the neck. It controls many bodily functions mainly related to growth and energy. BEFORE YOU USE _THYROSIT _ - _When you must not use it_ _ _ • Have ever had allergic reaction to thyroxine sodium, the active ingredient, or to any other ingredients in _Thyrosit_ • Have overactive thyroid gland • Subclinical hyperthyroidism (low thyroid stimulating hormone with normal thyroid levels and not being treated) • Suffer from any conditions that affect your adrenal gland and not being treated • Suffer from heart attack If you are not sure whether you should start taking this medicine, consult your doctor. - _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: • Are breast feeding or plan to breast feed • Suffer from any heart conditions such as high blood pressure, chest pain (angina), heart failure, or heart attack • Undergoing surgery • Fasting • Suffers from any conditions that affects your adrenal gland • Any abnormalities in thyroid Прочитать полный документ
4DESCRIPTION White round biconvex tablet with a bisect and embossed with “THYROSIT”, “SPS” on one side, plain on the other. Each tablet contains L-Thyroxine sodium 100mcg PHARMACODYNAMIC Thyroxine is an essential hormone that affects the rate of many physiologic processes especially the metabolic rate of body tissues and the regulation of cell growth and differentiation. Thyroxine will reverse the signs and symptoms of hypothyroidism and myxoedema by increasing renal blood flow and glomerular filtration rate, resulting in a diuresis within 24 hours following administration. In hypothyroid children, thyroxine increases epiphyseal growth and bone ossification. It is used to reduce goitre size by suppressing the secretion of thyrotropin. PHARMACOKINETICS Following oral administration, thyroxine sodium is absorbed from the GI tract. The amount absorbed increases during fasting conditions. It is distributed into most body tissues and fluids with highest concentrations in the liver and kidneys. Thyroxine does not readily cross the placenta and minimal amounts are secreted into milk. About one third of absorbed thyroxine (T4) is converted, by deiodination, to triiodothyronine (T3), an active metabolite. Thyroxine is more than 99% bound to serum proteins resulting in high serum concentration and slow metabolic clearance. The plasma half-life is 6-7 days and has the advantage that it needs only be given as a single daily dose. About 20-40% of thyroxine is eliminated unchanged in the faeces while 85% is metabolized daily through deiodination. Iodine liberated by deiodination reaction is utilised by thyroid gland for hormone synthesis or is excreted in faeces via bile or in urine. INDICATIONS _Thyrosit 100mcg is used in the: _ _- _Treatment of hypothyroidism - Replacement or substitution of diminished or absent thyroid function resulting from primary causes including functional deficiency, primary atrophy and partial or complete absence of the gland or from the effects or surgery, radiation of thyroid glands. - Repl Прочитать полный документ