Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PROPYLTHIOURACIL
IMEKS PHARMA SDN. BHD.
PROPYLTHIOURACIL
500 Tablets
Sriprasit Pharma Co. Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ PROPYL TABLET 50MG Propylthiouracil (50mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What PROPYL is used for 2. How PROPYL works 3. Before you use PROPYL 4. How to use PROPYL 5. While you are using it 6. Side effects 7. Storage and Disposal of PROPYL 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT PROPYL IS USED FOR PROPYL is used to treat hyperthyroidism or overactive thyroid gland (a condition where the thyroid gland produces too much thyroid hormone). It may also be used to treat symptoms of hyperthyroidism before surgery or radioactive iodine therapy. HOW PROPYL WORKS PROPYL contains the active ingredient Propylthiouracil which belongs to a group of medicines called antithyroid drugs. It works by reducing the amount of thyroid hormones made in your thyroid gland. BEFORE YOU USE PROPYL_ _ - _When you must not use it_ Do not take PROPYL if you: • are allergic to propylthiouracil or related thioamide derivatives or any ingredients in the formulation. _If you are not sure whether you should start _ _taking this medicine, talk to your doctor. _ - _Before you start to use it _ Tell your doctor if you: • have allergies to any other medicines, food, preservatives or dyes. • are prone to getting infections. • have ever had any problems with your liver or kidneys. • have or have had asthma. • are pregnant, may become pregnant or are breastfeeding. Tell your doctor or pharmacist immediately if during treatment you suffer from: • sore throat, fever, mouth ulcers or other symptoms of infection because PROPYL may affect your body’s ability to fight an infection. • liver problems or the side effects of liver problems such as anorexia, itching or pain in the upper part of stomach on the right side. • kidney problems. Your doctor will arrange for you to have regular blood tests to make sure that the medicine is working properly. Check with your doctor if any of the following applies to you: • Some cases of severe li Perskaitykite visą dokumentą
DESCRIPTION White round biconvex tablet with a bisect and embossed with “PROPYL”, “SPS” on one side, plain on the other. Each PROPYL tablet contains 50mg Propylthiouracil USP. PHARMACODYNAMICS Within the thyroid gland, PROPYL depresses the formation of iodotyrosines by inhibiting the iodination of thyroglobulin, and reduction of the synthesis of triiodothyronine and thyroxine by inhibiting the coupling reaction between iodotyrosines. In addition, PROPYL blocks the peripheral deiodination of thyroxine (T 4 ) to the more potent triiodothyronine (T 3 ). PROPYl does not interfere with the action and release of thyroid hormones already formed. Therefore, patients may only respond to PROPYl after depletion of circulating and colloid-stored thyroid hormones. The rapid fall in serum triiodothyronine (T 3 ) concentration, before serum thyroxine (T 4 ) levels fall, parallels a clinical improvement in the thyrotoxic patient, and is generally seen after the first week. The patient may become euthyroid after 4-6 weeks. Hence, a decreased rate of conversion of circulating thyroxine (T 4 ) to triiodothyronine (T 3 ) may be clinically beneficial in patients with thyrotoxic crisis, since metabolic activity of triiodothyronine (T 3 ) is 3 to 5 times that of thyroxine (T 4 ). PHARMACOKINETICS Absorption: Propylthiouracil is rapidly absorbed from the gastrointestinal tract and has a bioavailability of 50-75%. Distribution: Propylthiouracil appears to be concentrated in the thyroid gland. It readily crosses the placenta and is distributed into breast milk. About 80% of propylthiouracil is protein bound. Metabolism: Propylthiouracil undergoes rapid first-pass metabolism in the liver where it is metabolised to its glucuronic acid conjugate. Excretion: The elimination half-life of propylthiouracil is estimated to be 1-2 hours. Propylthiouracil is mainly excreted in the urine as the glucuronic acid conjugate. Very little unchanged drug is excreted in the urine and negligible amounts are excreted in the faeces. INDICATION PROPY Perskaitykite visą dokumentą