País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
bosentan monohydrate
Apotex Pty Ltd
bosentan monohydrate
Registered
BOSENTAN APOTEX _Contains the active ingredient bosentan (as monohydrate)_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about bosentan. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Bosentan APOTEX tablets. It contains the active ingredient bosentan (as monohydrate). It is used to treat high blood pressure in the blood vessels between the heart and the lungs. This condition is called pulmonary arterial hypertension. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS_ Bosentan acts to reduce abnormally high blood pressure by widening the blood vessels between the heart and lungs. It belongs to the class of medicines known as endothelin antagonists. There is no evidence that this medicine is addictive. _USE IN CHILDREN_ There is limited experience with the use of this medicine in children. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MU Leia o documento completo
Product Information – Australia APOTEX Bosentan tablets Page 1 BOSENTAN APOTEX TABLETS Bosentan may cause birth defects and is contraindicated in pregnancy (see CONTRAINDICATIONS and PRECAUTIONS). Rare cases of hepatic cirrhosis and hepatic failure have been reported in patients using bosentan (see PRECAUTIONS). NAME OF THE MEDICINE Bosentan (as monohydrate) Chemical Name: Benzenesulphonamide, 4-(1,1-dimethylethyl)-_N_-[6-(2hydroxyethoxy)-5-(2- methoxyphenoxy)[2,2’-bipyrimidin]-4-yl]-, monohydrate. Structural Formula: Molecular Formula: C 27 H 29 N 5 O 6 S•H 2 O Molecular Weight: 569.64 CAS Registry Number: 157212-55-0 DESCRIPTION Bosentan is the first of a new class of medicines, an endothelin receptor antagonist. Bosentan belongs to a class of highly substituted pyrimidine derivatives, with no chiral centres. Bosentan monohydrate, a white to off-white powder, is practically insoluble at low pH (0.1 mg/100 mL at pH 1.1 and 4.0; 0.2 mg/100 mL at pH 5.0). Solubility increases at higher pH values (43 mg/100 mL at pH 7.5). In the solid state, bosentan monohydrate is very stable, is not hygroscopic and shows no light sensitivity. Each tablet contains 62.5 mg or 125 mg bosentan (as monohydrate) as the active ingredient. In addition, each tablet contains the following inactive ingredients: methylcellulose, poloxamer, crospovidone, silicon dioxide, magnesium stearate and a coating containing hypromellose, hydroxypropylcellulose, macrogol 8000, titanium dioxide, iron oxide red and iron oxide yellow. PHARMACOLOGY PHARMACOLOGICAL ACTIONS The neurohormone endothelin-1 (ET-1) is a potent vasoconstrictor. ET-1 concentrations are elevated in plasma and lung tissue of patients with pulmonary arterial hypertension (PAH), suggesting a pathogenic role for ET-1 in this disease. Bosentan is a specific and competitive antagonist at endothelin receptor types ET A and ET B . Bosentan has a slightly higher affinity for ET A receptors than for ET B receptors. Product Information – Australia APOTEX Bosentan tablets Page 2 PHARMACO Leia o documento completo